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115th Congress     }                                    {   Rept. 115-748
                         HOUSE OF REPRESENTATIVES
 2d Session        }                                    {      Part 1

======================================================================



 
                EVERY PRESCRIPTION CONVEYED SECURELY ACT

                                _______
                                

 June 12, 2018.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

 Mr. Walden, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                        [To accompany H.R. 3528]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 3528) to amend title XVIII of the Social 
Security Act to require e-prescribing for coverage under part D 
of the Medicare program of prescription drugs that are 
controlled substances, having considered the same, report 
favorably thereon with an amendment and recommend that the bill 
as amended do pass.

                                CONTENTS

                                                                   Page

Purpose and Summary..............................................     3
Background and Need for Legislation..............................     3
Committee Action.................................................     3
Committee Votes..................................................     4
Oversight Findings and Recommendations...........................     4
New Budget Authority, Entitlement Authority, and Tax Expenditures     4
Congressional Budget Office Estimate.............................     4
Federal Mandates Statement.......................................    26
Statement of General Performance Goals and Objectives............    26
Duplication of Federal Programs..................................    26
Committee Cost Estimate..........................................    26
Earmark, Limited Tax Benefits, and Limited Tariff Benefits.......    27
Disclosure of Directed Rule Makings..............................    27
Advisory Committee Statement.....................................    27
Applicability to Legislative Branch..............................    27
Section-by-Section Analysis of the Legislation...................    27
Changes in Existing Law Made by the Bill, as Reported............    27
Exchange of Letters with Additional Committees of Referral.......    51

    The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``Every Prescription Conveyed Securely 
Act''.

SEC. 2. REQUIRING E-PRESCRIBING FOR COVERAGE OF COVERED PART D 
                    CONTROLLED SUBSTANCES.

  (a) In General.--Section 1860D-4(e) of the Social Security Act (42 
U.S.C. 1395w-104(e)) is amended by adding at the end the following:
          ``(7) Requirement of e-prescribing for controlled 
        substances.--
                  ``(A) In general.--Subject to subparagraph (B), a 
                prescription for a covered part D drug under a 
                prescription drug plan (or under an MA-PD plan) for a 
                schedule II, III, IV, or V controlled substance shall 
                be transmitted by a health care practitioner 
                electronically in accordance with an electronic 
                prescription drug program that meets the requirements 
                of paragraph (2).
                  ``(B) Exception for certain circumstances.--The 
                Secretary shall, pursuant to rulemaking, specify 
                circumstances with respect to which the Secretary may 
                waive the requirement under subparagraph (A), with 
                respect to a covered part D drug, including in the case 
                of--
                          ``(i) a prescription issued when the 
                        practitioner and dispenser are the same entity;
                          ``(ii) a prescription issued that cannot be 
                        transmitted electronically under the most 
                        recently implemented version of the National 
                        Council for Prescription Drug Programs SCRIPT 
                        Standard;
                          ``(iii) a prescription issued by a 
                        practitioner who has received a waiver or a 
                        renewal thereof for a specified period 
                        determined by the Secretary, not to exceed one 
                        year, from the requirement to use electronic 
                        prescribing, pursuant to a process established 
                        by regulation by the Secretary, due to 
                        demonstrated economic hardship, technological 
                        limitations that are not reasonably within the 
                        control of the practitioner, or other 
                        exceptional circumstance demonstrated by the 
                        practitioner;
                          ``(iv) a prescription issued by a 
                        practitioner under circumstances in which, 
                        notwithstanding the practitioner's ability to 
                        submit a prescription electronically as 
                        required by this subsection, such practitioner 
                        reasonably determines that it would be 
                        impractical for the individual involved to 
                        obtain substances prescribed by electronic 
                        prescription in a timely manner, and such delay 
                        would adversely impact the individual's medical 
                        condition involved;
                          ``(v) a prescription issued by a practitioner 
                        allowing for the dispensing of a non-patient 
                        specific prescription pursuant to a standing 
                        order, approved protocol for drug therapy, 
                        collaborative drug management, or comprehensive 
                        medication management, in response to a public 
                        health emergency, or other circumstances where 
                        the practitioner may issue a non-patient 
                        specific prescription;
                          ``(vi) a prescription issued by a 
                        practitioner prescribing a drug under a 
                        research protocol;
                          ``(vii) a prescription issued by a 
                        practitioner for a drug for which the Food and 
                        Drug Administration requires a prescription to 
                        contain elements that are not able to be 
                        included in electronic prescribing, such as a 
                        drug with risk evaluation and mitigation 
                        strategies that include elements to assure safe 
                        use; and
                          ``(viii) a prescription issued by a 
                        practitioner for an individual who--
                                  ``(I) receives hospice care under 
                                this title; or
                                  ``(II) is a resident of a skilled 
                                nursing facility (as defined in section 
                                1819(a)), or a medical institution or 
                                nursing facility for which payment is 
                                made for an institutionalized 
                                individual under section 1902(q)(1)(B), 
                                for which frequently abused drugs are 
                                dispensed for residents through a 
                                contract with a single pharmacy, as 
                                determined by the Secretary in 
                                accordance with this paragraph.
                  ``(C) Dispensing.--Nothing in this paragraph shall be 
                construed as requiring a sponsor of a prescription drug 
                plan under this part, MA organization offering an MA-PD 
                plan under part C, or a pharmacist to verify that a 
                practitioner, with respect to a prescription for a 
                covered part D drug, has a waiver (or is otherwise 
                exempt) under subparagraph (B) from the requirement 
                under subparagraph (A). Nothing in this paragraph shall 
                be construed as affecting the ability of the plan to 
                cover or the pharmacists' ability to continue to 
                dispense covered part D drugs from otherwise valid 
                written, oral or fax prescriptions that are consistent 
                with laws and regulations. Nothing in this paragraph 
                shall be construed as affecting the ability of the 
                beneficiary involved to designate a particular pharmacy 
                to dispense a prescribed drug to the extent consistent 
                with the requirements under subsection (b)(1) and under 
                this paragraph.
                  ``(D) Enforcement.--The Secretary shall, pursuant to 
                rulemaking, have authority to enforce and specify 
                appropriate penalties for non-compliance with the 
                requirement under subparagraph (A).''.
  (b) Effective Date.--The amendment made by subsection (a) shall apply 
to coverage of drugs prescribed on or after January 1, 2021.

                          Purpose and Summary

    H.R. 3528, Every Prescription Conveyed Securely Act, was 
introduced on July 28, 2017, by Rep. Katherine Clark (D-MA) and 
Rep. Markwayne Mullin (R-OK) to require e-prescribing for 
coverage of prescribed controlled substances under the Medicare 
Part D program.

                  Background and Need for Legislation

    The Medicare program serves as the healthcare coverage 
provider to over 58 million beneficiaries. This number is 
projected to rise to over 80 million by 2030. In serving the 
over age 65 population, Medicare accounts for a large share of 
total opioid prescriptions. In 2016, one out of every three 
beneficiaries was prescribed an opioid through Medicare Part D. 
In total, this equates to almost 80 million prescriptions and 
$4 billion in Medicare Part D spending. While many Medicare 
beneficiaries with serious pain-related conditions are being 
properly prescribed opioids, there is mounting evidence of 
opioid misuse in the Medicare system. As more seniors and 
individuals with disabilities come into the program, the 
challenges of fraud, misuse, and abuse will only increase.
    This bill seeks to deter prescription fraud and the 
diversion of opioids by better securing the prescriptions of 
controlled substances covered under Medicare Part D by 
requiring the use of electronic prescribing for such drugs. 
This bill ensures that prescriptions for controlled substances 
covered under Medicare Part D are transmitted securely from the 
prescriber to the dispensing pharmacy and reduces the potential 
for fraudulent prescriptions.

                            Committee Action

    On April 11 and 12, 2018, the Subcommittee on Health held a 
hearing entitled ``Combating the Opioid Crisis: Improving the 
Ability of Medicare and Medicaid to Provide Care for Patients'' 
to review legislation related to the opioid epidemic. The 
Subcommittee received testimony from:
           Kimberly Brandt, Principal Deputy 
        Administrator for Operations, Centers for Medicare and 
        Medicaid Services, U.S. Department of Health and Human 
        Services;
           Michael Botticelli, Executive Director, 
        Grayken Center for Addiction, Boston Medical Center;
           Toby Douglas, Senior Vice President, 
        Medicaid Solutions, Centene Corporation;
           David Guth, CEO, Centerstone;
           John Kravitz, CIO, Geisinger Health System; 
        and,
           Sam Srivastava, CEO, Magellan Health.
    On April 25, 2018, the Subcommittee on Health met in open 
markup session and forwarded H.R. 3528, as amended, to the full 
Committee by a voice vote. On May 9, 2018, the full Committee 
on Energy and Commerce met in open markup session and ordered 
H.R. 3528, as amended, favorable reported to the House by a 
voice vote.

                            Committee Votes

    Clause 3(b) of rule XIII requires the Committee to list the 
record votes on the motion to report legislation and amendments 
thereto. There were no record votes taken in connection with 
ordering H.R. 3528 reported.

                 Oversight Findings and Recommendations

    Pursuant to clause 2(b)(1) of rule X and clause 3(c)(1) of 
rule XIII, the Committee held a hearing and made findings that 
are reflected in this report.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    Pursuant to clause 3(c)(2) of rule XIII, the Committee 
finds that H.R. 3528 would result in no new or increased budget 
authority, entitlement authority, or tax expenditures or 
revenues.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII, the following is 
the cost estimate provided by the Congressional Budget Office 
pursuant to section 402 of the Congressional Budget Act of 
1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                      Washington, DC, June 6, 2018.
Hon. Greg Walden,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed document with cost estimates for the 
opioid-related legislation ordered to be reported on May 9 and 
May 17, 2018.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contacts are Tom Bradley 
and Chad Chirico.
            Sincerely,
                                             Mark P. Hadley
                                        (For Keith Hall, Director).
    Enclosure.

Opioid Legislation

    Summary: On May 9 and May 17, 2018, the House Committee on 
Energy and Commerce ordered 59 bills to be reported related to 
the nation's response to the opioid epidemic. Generally, the 
bills would:
           Provide grants to facilities and providers 
        that treat people with substance use disorders,
           Direct various agencies within the 
        Department of Health and Human Services (HHS) to 
        explore nonopioid approaches to treating pain and to 
        educate providers about those alternatives,
           Modify requirements under Medicaid and 
        Medicare for prescribing controlled substances,
           Expand Medicaid coverage for substance abuse 
        treatment, and
           Direct the Food and Drug Administration 
        (FDA) to modify its oversight of opioid drugs and other 
        medications that are used to manage pain.
    Because of the large number of related bills ordered 
reported by the Committee, CBO is publishing a single 
comprehensive document that includes estimates for each piece 
of legislation.
    CBO estimates that enacting 20 of the bills would affect 
direct spending, and 2 of the bills would affect revenues; 
therefore, pay-as-you-go procedures apply for those bills.
    CBO estimates that enacting H.R. 4998, the Health Insurance 
for Former Foster Youth Act, would increase net direct spending 
by more than $2.5 billion and on-budget deficits by more than 
$5 billion in at least one of the four consecutive 10-year 
periods beginning in 2029. None of the remaining 58 bills 
included in this estimate would increase net direct spending by 
more than $2.5 billion or on-budget deficits by more than $5 
billion in any of the four consecutive 10-year periods 
beginning in 2029.
    One of the bills reviewed for this document, H.R. 5795, 
would impose both intergovernmental and private-sector mandates 
as defined in the Unfunded Mandates Reform Act (UMRA). CBO 
estimates that the costs of those mandates on public and 
private entities would fall below the thresholds in UMRA ($80 
million and $160 million, respectively, in 2018, adjusted 
annually for inflation). Five bills, H.R. 5228, H.R. 5333, H.R. 
5554, H.R. 5687, and H.R. 5811, would impose private-sector 
mandates as defined in UMRA. CBO estimates that the costs of 
the mandates in three of the bills (H.R. 5333, H.R. 5554, and 
H.R. 5811) would not exceed the UMRA threshold for private 
entities. Because CBO is uncertain how federal agencies would 
implement new authority granted in the other two bills, H.R. 
5228 and H.R. 5687, CBO cannot determine whether the costs of 
those mandates would exceed the UMRA threshold.
    Estimated cost to the Federal Government: The estimates in 
this document do not include the effects of interactions among 
the bills. If all 59 bills were combined and enacted as one 
piece of legislation, the budgetary effects would be different 
from the sum of the estimates in this document, although CBO 
expects that any such differences would be small. The costs of 
this legislation fall within budget functions 550 (health), 570 
(Medicare), 750 (administration of justice), and 800 (general 
government).
    Basis of estimate: For this estimate, CBO assumes that all 
of the legislation will be enacted late in 2018 and that 
authorized and estimated amounts will be appropriated each 
year. Outlays for discretionary programs are estimated based on 
historical spending patterns for similar programs.

Uncertainty

    CBO aims to produce estimates that generally reflect the 
middle of a range of the most likely budgetary outcomes that 
would result if the legislation was enacted. Because data on 
the utilization of mental health and substance abuse treatment 
under Medicaid and Medicare is scarce, CBO cannot precisely 
predict how patients or providers would respond to some policy 
changes or what budgetary effects would result. In addition, 
several of the bills would give the Department of Health and 
Human Services (HHS) considerable latitude in designing and 
implementing policies. Budgetary effects could differ from 
those provided in CBO's analyses depending on those decisions.

Direct spending and revenues

    Table 1 lists the 22 bills of the 59 ordered to be reported 
that would affect direct spending or revenues.

                                             TABLE 1.--ESTIMATED CHANGES IN MANDATORY SPENDING AND REVENUES
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                         By fiscal year, in millions of dollars--
                                ------------------------------------------------------------------------------------------------------------------------
                                   2018     2019     2020     2021     2022     2023     2024     2025     2026     2027     2028   2019-2023  2019-2028
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      INCREASES OR DECREASES (-) IN DIRECT SPENDING
 
Legislation Primarily Affecting
 Medicaid:
    H.R. 1925, At-Risk Youth           0        *        5        5        5       10       10       10       10       10       10        25          75
     Medicaid Protection Act of
     2017......................
    H.R. 4998, Health Insurance        0        0        0        0        0        *       10       21       33       46       61         *         171
     for Former Foster Youth
     Act.......................
    H.R. 5477, Rural                   0       13       35       58       68       83       27        9        3        3        3       256         301
     Development of Opioid
     Capacity Services Act.....
    H.R. 5583, a bill to amend         0        *        *        *        *        *        *        *        *        *        *         *           *
     title XI of the Social
     Security Act to require
     States to annually report
     on certain adult health
     quality measures, and for
     other purposes............
    H.R. 5797, IMD CARE Act....        0       38      158      251      265      279        0        0        0        0        0       991         991
    H.R. 5799, Medicaid DRUG           0        *        *        1        1        1        1        1        1        1        1         2           5
     Improvement Acta..........
    H.R. 5801 Medicaid                 0        *        *        *        *        *        *        *        *        *        *         *           *
     Providers Are Required To
     Note Experiences in Record
     Systems to Help In-Need
     Patients (PARTNERSHIP)
     Acta......................
    H.R. 5808, Medicaid                0        *       -1       -1       -1       -1       -2       -2       -2       -2       -2        -4         -13
     Pharmaceutical Home Act of
     2018a.....................
    H.R. 5810, Medicaid Health         0       94       58       62       56       52       48       43       38       32       25       323         509
     HOME Act..................
Legislation Primarily Affecting
 Medicare:
    H.R. 3528, Every                   0        0        0      -24      -35      -33      -30      -33      -32      -31      -32       -92        -250
     Prescription Conveyed
     Securely Act..............
    H.R. 4841, Standardizing           0        0        0        *        *        *        *        *        *        *        *         *           *
     Electronic Prior
     Authorization for Safe
     Prescribing Act of 2018...
    H.R. 5603, Access to               0        2        *        *        *        1        1        1        2        2        2         3          11
     Telehealth Services for
     Opioid Use Disorders Act..
    H.R. 5605, Advancing High          0        0        0       15       26       24       23       23       10        1        *        65         122
     Quality Treatment for
     Opioid Use Disorders in
     Medicare Act..............
    H.R. 5675, a bill to amend         0        0        0       -6       -7       -7       -7       -8       -9       -9      -11       -20         -64
     title XVIII of the Social
     Security Act to require
     prescription drug plan
     sponsors under the
     Medicare program to
     establish drug management
     programs for at-risk
     beneficiaries.............
    H.R. 5684, Protecting              0        0        0        *        *        *        *        *        *        *        *         *           *
     Seniors From Opioid Abuse
     Act.......................
    H.R. 5796, Responsible             0       10       25       50       10        5        0        0        0        0        0       100         100
     Education Achieves Care
     and Healthy Outcomes for
     Users' Treatment Act of
     2018......................
    H.R. 5798, Opioid Screening        0        0        *        1        1        1        1        1        1        1        1         2           5
     and Chronic Pain
     Management Alternatives
     for Seniors Act...........
    H.R. 5804, Post-Surgical           0        0       25       30       25       20       10        5        0        0        0       100         115
     Injections as an Opioid
     Alternative Acta..........
    H.R. 5809, Postoperative           0        0        0        0       10       15       20       25       30       35       45        25         180
     Opioid Prevention Act of
     2018......................
Legislation Primarily Affecting
 the Food and Drug
 Administration:
    H.R. 5333, Over-the-Counter        0        0        *        *        *        *        *        *        *        *        *         *           *
     Monograph Safety,
     Innovation, and Reform Act
     of 2018a..................
 
                                                         INCREASES OR DECREASES (-) IN REVENUESb
 
    H.R. 5752, Stop Illicit            0        *        *        *        *        *        *        *        *        *        *         *          *
     Drug Importation Act of
     2018......................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual amounts may not sum to totals because of rounding. * = between -$500,000 and $500,000. Budget authority is equivalent to outlays.
aThis bill also would affect spending subject to appropriation.
bOne additional bill, H.R. 5228, the Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act, would have a negligible effect on revenues.

    Legislation Primarily Affecting Medicaid. The following 
nine bills would affect direct spending for the Medicaid 
program.
    H.R. 1925, the At-Risk Youth Medicaid Protection Act of 
2017, would require states to suspend, rather than terminate, 
Medicaid eligibility for juvenile enrollees (generally under 21 
years of age) who become inmates of public correctional 
institutions. States also would have to redetermine those 
enrollees' Medicaid eligibility before their release and 
restore their coverage upon release if they qualify for the 
program. States would be required to process Medicaid 
applications submitted by or on behalf of juveniles in public 
correctional institutions who were not enrolled in Medicaid 
before becoming inmates and ensure that Medicaid coverage is 
provided when they are released if they are found to be 
eligible. On the basis of an analysis of juvenile incarceration 
trends and of the per enrollee spending for Medicaid foster 
care children, who have a similar health profile to 
incarcerated juveniles, CBO estimates that implementing the 
bill would cost $75 million over the 2019-2028 period.
    H.R. 4998, the Health Insurance for Former Foster Youth 
Act, would require states to provide Medicaid coverage to 
adults up to age 25 who had aged out of foster care in any 
state. Under current law, such coverage is mandatory only if 
the former foster care youth has aged out in the state in which 
the individual applies for coverage. The policy also would 
apply to former foster children who had been in foster care 
upon turning 14 years of age but subsequently left foster care 
to enter into a legal guardianship with a kinship caregiver. 
The provisions would take effect respect for foster youth who 
turn 18 on or after January 1, 2023. On the basis of spending 
for Medicaid foster care children and data from the Census 
Bureau regarding annual migration rates between states, CBO 
estimates that implementing the bill would cost $171 million 
over the 2019-2028 period.
    H.R. 5477, the Rural Development of Opioid Capacity 
Services Act, would direct the Secretary of HHS to conduct a 
five-year demonstration to increase the number and ability of 
providers participating in Medicaid to provide treatment for 
substance use disorders. On the basis of an analysis of federal 
and state spending for treatment of substance use disorders and 
the prevalence of such disorders, CBO estimates that enacting 
the bill would increase direct spending by $301 million over 
the 2019-2028 period.
    H.R. 5583, a bill to amend title XI of the Social Security 
Act to require States to annually report on certain adult 
health quality measures, and for other purposes, would require 
states to include behavioral health indicators in their annual 
reports on the quality of care under Medicaid. Although the 
bill would add a requirement for states, CBO estimates that its 
enactment would not have a significant budgetary effect because 
most states have systems in place for reporting such measures 
to the federal government.
    H.R. 5797, the IMD CARE Act, would expand Medicaid coverage 
for people with opioid use disorder who are in institutions for 
mental disease (IMDs) for up to 30 days per year. Under a 
current-law policy known as the IMD exclusion, the federal 
government generally does not make matching payments to state 
Medicaid programs for most services provided by IMDs to adults 
between the ages of 21 and 64. Recent administrative changes 
have made federal financing for IMDs available in limited 
circumstances, but the statutory prohibition remains in place. 
CBO analyzed several data sets, primarily those collected by 
the Substance Abuse and Mental Health Services Administration 
(SAMHSA), to estimate current federal spending under Medicaid 
for IMD services and to estimate spending under H.R. 5797. 
Using that analysis, CBO estimates that enacting H.R. 5797 
would increase direct spending by $991 million over the 2019-
2028 period.
    H.R. 5799, the Medicaid DRUG Improvement Act, would require 
state Medicaid programs to implement additional reviews of 
opioid prescriptions, monitor concurrent prescribing of opioids 
and certain other drugs, and monitor use of antipsychotic drugs 
by children. CBO estimates that the bill would increase direct 
spending by $5 million over 2019-2028 period to cover the 
administrative costs of complying with those requirements. On 
the basis of stakeholder feedback, CBO expects that the bill 
would not have a significant effect on Medicaid spending for 
prescription drugs because many of the bill's requirements 
would duplicate current efforts to curb opioid and 
antipsychotic drug use. (If enacted, H.R. 5799 also would 
affect spending subject to appropriation; CBO has not completed 
an estimate of that amount.)
    H.R. 5801, the Medicaid Providers Are Required To Note 
Experiences in Record Systems to Help In-Need Patients 
(PARTNERSHIP) Act, would require providers who are permitted to 
prescribe controlled substances and who participate in Medicaid 
to query prescription drug monitoring programs (PDMPs) before 
prescribing controlled substances to Medicaid patients. PDMPs 
are statewide electronic databases that collect data on 
controlled substances dispensed in the state. The bill also 
would require PDMPs to comply with certain data and system 
criteria, and it would provide additional federal matching 
funds to certain states to help cover administrative costs. On 
the basis of a literature review and stakeholder feedback, CBO 
estimates that the net budgetary effect of enacting H.R. 5801 
would be insignificant. Costs for states to come into 
compliance with the systems and administrative requirements 
would be roughly offset by savings from small reductions in the 
number of controlled substances paid for by Medicaid under the 
proposal. (If enacted, H.R. 5801 also would affect spending 
subject to appropriation; CBO has not completed an estimate of 
that amount.)
    H.R. 5808, the Medicaid Pharmaceutical Home Act of 2018, 
would require state Medicaid programs to operate pharmacy 
programs that would identify people at high risk of abusing 
controlled substances and require those patients to use a 
limited number of providers and pharmacies. Although nearly all 
state Medicaid programs currently meet such a requirement, a 
small number of high-risk Medicaid beneficiaries are not now 
monitored. Based on an analysis of information about similar 
state and federal programs, CBO estimates that net Medicaid 
spending under the bill would decrease by $13 million over the 
2019-2028 period. That amount represents a small increase in 
administrative costs and a small reduction in the number of 
controlled substances paid for by Medicaid under the proposal. 
(If enacted, H.R. 5808 also would affect spending subject to 
appropriation; CBO has not completed an estimate of that 
amount.)
    H.R. 5810, the Medicaid Health HOME Act, would allow states 
to receive six months of enhanced federal Medicaid funding for 
programs that coordinate care for people with substance use 
disorders. Based on enrollment and spending data from states 
that currently participate in Medicaid's Health Homes program, 
CBO estimates that the expansion would cost approximately $469 
million over the 2019-2028 period. The bill also would require 
states to cover all FDA-approved drugs used in medication-
assisted treatment for five years, although states could seek a 
waiver from that requirement. (Medication-assisted treatment 
combines behavioral therapy and pharmaceutical treatment for 
substance use disorders.) Under current law, states already 
cover most FDA-approved drugs used in such programs in some 
capacity, although a few exclude methadone dispensed by opioid 
treatment programs. CBO estimates that a small share of those 
states would begin to cover methadone if this bill was enacted 
at a federal cost of about $39 million over the 2019-2028 
period. In sum, CBO estimates that the enacting H.R. 5810 would 
increase direct spending by $509 million over the 2019-2028 
period.
    Legislation Primarily Affecting Medicare. The following ten 
bills would affect direct spending for the Medicare program.
    H.R. 3528, the Every Prescription Conveyed Securely Act, 
would require prescriptions for controlled substances covered 
under Medicare Part D to be transmitted electronically, 
starting on January 1, 2021. Based on CBO's analysis of 
prescription drug spending, spending for controlled substances 
is a small share of total drug spending. CBO also assumes a 
small share of those prescriptions would not be filled because 
they are not converted to an electronic format. Therefore, CBO 
expects that enacting H.R. 3528 would reduce the number of 
prescriptions filled and estimates that Medicare spending would 
be reduced by $250 million over the 2019-2028 period.
    H.R. 4841, the Standardizing Electronic Prior Authorization 
for Safe Prescribing Act of 2018, would require health care 
professionals to submit prior authorization requests 
electronically, starting on January 1, 2021, for drugs covered 
under Medicare Part D. Taking into account that many 
prescribers already use electronic methods to submit such 
requests, CBO estimates that enacting H.R. 4841 would not 
significantly affect direct spending for Part D.
    H.R. 5603, the Access to Telehealth Services for Opioid Use 
Disorders Act, would permit the Secretary of HHS to lift 
current geographic and other restrictions on coverage of 
telehealth services under Medicare for treatment of substance 
use disorders or co-occurring mental health disorders. Under 
the bill, the Secretary of HHS would be directed to encourage 
other payers to coordinate payments for opioid use disorder 
treatments and to evaluate the extent to which the 
demonstration reduces hospitalizations, increases the use of 
medication-assisted treatments, and improves the health 
outcomes of individuals with opioid use disorders during and 
after the demonstration. Based on current use of Medicare 
telehealth services for treatment of substance use disorders, 
CBO estimates that expanding that coverage would increase 
direct spending by $11 million over the 2019-2028 period.
    H.R. 5605, the Advancing High Quality Treatment for Opioid 
Use Disorders in Medicare Act, would establish a five-year 
demonstration program to increase access to treatment for 
opioid use disorder. The demonstration would provide incentive 
payments and funding for care management services based on 
criteria such as patient engagement, use of evidence-based 
treatments, and treatment length and intensity. Under the bill, 
the Secretary of HHS would be directed to encourage other 
payers to coordinate payments for opioid use disorder 
treatments and to evaluate the extent to which the 
demonstration reduces hospitalizations, increases the use of 
medication-assisted treatments, and improves the health 
outcomes of individuals with opioid use disorders during and 
after the demonstration. Based on historical utilization of 
opioid use disorder treatments and projected spending on 
incentive payments and care management fees, CBO estimates that 
increased use of treatment services and the demonstration's 
incentive payments would increase direct spending by $122 
million over the 2019-2028 period.
    H.R. 5675, a bill to amend title XVIII of the Social 
Security Act to require prescription drug plan sponsors under 
the Medicare program to establish drug management programs for 
at-risk beneficiaries, would require Part D prescription drug 
plans to provide drug management programs for Medicare 
beneficiaries who are at risk for prescription drug abuse. 
(Under current law, Part D plans are permitted but not required 
to establish such programs as of 2019.) Based on an analysis of 
the number of plans currently providing those programs, CBO 
estimates that enacting H.R. 5675 would lower federal spending 
by $64 million over the 2019-2028 period by reducing the number 
of prescriptions filled and Medicare's payments for controlled 
substances.
    H.R. 5684, the Protecting Seniors From Opioid Abuse Act, 
would expand medication therapy management programs under 
Medicare Part D to include beneficiaries who are at risk for 
prescription drug abuse. Because relatively few beneficiaries 
would be affected by this bill, CBO estimates that its 
enactment would not significantly affect direct spending for 
Part D.
    H.R. 5796, the Responsible Education Achieves Care and 
Healthy Outcomes for Users' Treatment Act of 2018, would allow 
the Secretary of HHS to award grants to certain organizations 
that provide technical assistance and education to high-volume 
prescribers of opioids. The bill would appropriate $100 million 
for fiscal year 2019. Based on historical spending patterns for 
similar activities, CBO estimates that implementing H.R. 5796 
would cost $100 million over the 2019-2028 period.
    H.R. 5798, the Opioid Screening and Chronic Pain Management 
Alternatives for Seniors Act, would add an assessment of 
current opioid prescriptions and screening for opioid use 
disorder to the Welcome to Medicare Initial Preventive Physical 
Examination. Based on historical use of the examinations and 
pain management alternatives, CBO expects that enacting the 
bill would increase use of pain management services and 
estimates that direct spending would increase by $5 million 
over the 2019-2028 period.
    H.R. 5804, the Post-Surgical Injections as an Opioid 
Alternative Act, would freeze the Medicare payment rate for 
certain analgesic injections provided in ambulatory surgical 
centers (ASCs). (For injections identified by specific billing 
codes, Medicare would pay the 2016 rate, which is higher than 
the current rate, during the 2020-2024 period.) Based on 
current utilization in the ASC setting, CBO estimates that 
enacting the legislation would increase direct spending by 
about $115 million over the 2019-2028 period. (If enacted, H.R. 
5804 also would affect spending subject to appropriation; see 
Table 3.)
    H.R. 5809, the Postoperative Opioid Prevention Act of 2018, 
would create an additional payment under Medicare for nonopioid 
analgesics. Under current law, certain new drugs and devices 
may receive an additional payment--separate from the bundled 
payment for a surgical procedure--in outpatient hospital 
departments and ambulatory surgical centers. The bill would 
allow nonopioid analgesics to qualify for a five-year period of 
additional payments. Based on its assessment of current 
spending for analgesics and on the probability of new nonopioid 
analgesics coming to market, CBO estimates that H.R. 5809 would 
increase direct spending by about $180 million over the 2019-
2028 period.
    Legislation Primarily Affecting the Food and Drug 
Administration. One bill related to the FDA would affect direct 
spending.
    H.R. 5333, the Over-the-Counter Monograph Safety, 
Innovation, and Reform Act of 2018, would change the way that 
the FDA regulates the marketing of over-the-counter (OTC) 
medicines, and it would authorize that agency to grant 18 
months of exclusive market protection for certain qualifying 
OTC drugs, thus delaying the entry of other versions of the 
same qualifying OTC product. Medicaid currently provides some 
coverage for OTC medicines, but only if a medicine is the least 
costly alternative in its drug class. On the basis of 
stakeholder feedback, CBO expects that delaying the 
availability of additional OTC versions of a drug would not 
significantly affect the average net price paid by Medicaid. As 
a result, CBO estimates that enacting H.R. 5333 would have a 
negligible effect on the federal budget. (If enacted, H.R. 5333 
also would affect spending subject to appropriation; see Table 
3.)
    Legislation with Revenue Effects. Two bills would affect 
revenues. However, CBO estimates that one bill, H.R. 5228, the 
Stop Counterfeit Drugs by Regulating and Enhancing Enforcement 
Now Act, would have only a negligible effect.
    H.R. 5752, the Stop Illicit Drug Importation Act of 2018, 
would amend the Federal, Food, Drug, and Cosmetic Act (FDCA) to 
strengthen the FDA's seizure powers and enhance its authority 
to detain, refuse, seize, or destroy illegal products offered 
for import. The legislation would subject more people to 
debarment under the FDCA and thus increase the potential for 
violations, and subsequently, the assessment of civil 
penalties, which are recorded in the budget as revenues. CBO 
estimates that those collections would result in an 
insignificant increase in revenues. Because H.R. 5752 would 
prohibit the importation of drugs that are in the process of 
being scheduled, it also could reduce amounts collected in 
customs duties. CBO anticipates that the result would be a 
negligible decrease in revenues. With those results taken 
together, CBO estimates, enacting H.R. 5752 would generate an 
insignificant net increase in revenues over the 2019-2028 
period.

Spending subject to appropriation

    For this document, CBO has grouped bills with spending that 
would be subject to appropriation into four general categories:
           Bills that would have no budgetary effect,
           Bills with provisions that would authorize 
        specified amounts to be appropriated (see Table 2),
           Bills with provisions for which CBO has 
        estimated an authorization of appropriations (see Table 
        3), and
           Bills with provisions that would affect 
        spending subject to appropriation for which CBO has not 
        yet completed an estimate.
    No Budgetary Effect. CBO estimates that 6 of the 59 bills 
would have no effect on direct spending, revenues, or spending 
subject to appropriation.
    H.R. 3192, the CHIP Mental Health Parity Act, would require 
all Children's Health Insurance Program (CHIP) plans to cover 
mental health and substance abuse treatment. In addition, 
states would not be allowed to impose financial or utilization 
limits on mental health treatment that are lower than limits 
placed on physical health treatment. Based on information from 
the Centers for Medicare and Medicaid Services, CBO estimates 
that enacting the bill would have no budgetary effect because 
all CHIP enrollees are already in plans that meet those 
requirements.
    H.R. 3331, a bill to amend title XI of the Social Security 
Act to promote testing of incentive payments for behavioral 
health providers for adoption and use of certified electronic 
health record technology, would give the Center for Medicare 
and Medicaid Innovation (CMMI) explicit authorization to test a 
program offering incentive payments to behavioral health 
providers that adopt and use certified electronic health record 
technology. Because it is already clear to CMMI that it has 
that authority, CBO estimates that enacting the legislation 
would not affect federal spending.
    H.R. 5202, the Ensuring Patient Access to Substance Use 
Disorder Treatments Act of 2018, would clarify permission for 
pharmacists to deliver controlled substances to providers under 
certain circumstances. Because this provision would codify 
current practice, CBO estimates that H.R. 5202 would not affect 
direct spending or revenues during the 2019-2028 period.
    H.R. 5685, the Medicare Opioid Safety Education Act of 
2018, would require the Secretary of HHS to include information 
on opioid use, pain management, and nonopioid pain management 
treatments in future editions of Medicare & You, the program's 
handbook for beneficiaries, starting on January 1, 2019. 
Because H.R. 5685 would add information to an existing 
administrative document, CBO estimates that enacting the bill 
would have no budgetary effect.
    H.R. 5686, the Medicare Clear Health Options in Care for 
Enrollees Act of 2018, would require prescription drug plans 
that provide coverage under Medicare Part D to furnish 
information to beneficiaries about the risks of opioid use and 
the availability of alternative treatments for pain. CBO 
estimates that enacting the bill would not affect direct 
spending because the required activities would not impose 
significant administrative costs.
    H.R. 5716, the Commit to Opioid Medical Prescriber 
Accountability and Safety for Seniors Act, would require the 
Secretary of HHS on an annual basis to identify high 
prescribers of opioids and furnish them with information about 
proper prescribing methods. Because HHS already has the 
capacity to meet those requirements, CBO estimates that 
enacting that provision would not impose additional 
administrative costs on the agency.
    Specified Authorizations. Table 2 lists the ten bills that 
would authorize specified amounts to be appropriated over the 
2019-2023 period. Spending from those authorized amounts would 
be subject to appropriation.

          TABLE 2.--ESTIMATED SPENDING SUBJECT TO APPROPRIATION FOR BILLS WITH SPECIFIED AUTHORIZATIONS
----------------------------------------------------------------------------------------------------------------
                                                               By fiscal year, in millions of dollars----
                                                      ----------------------------------------------------------
                                                        2018    2019    2020    2021    2022    2023   2019-2023
----------------------------------------------------------------------------------------------------------------
                                 INCREASES IN SPENDING SUBJECT TO APPROPRIATION
 
H.R. 4684, Ensuring Access to Quality Sober Living
 Act:
    Authorization Level..............................       0       3       0       0       0       0         3
    Estimated Outlays................................       0       1       2       *       *       *         3
H.R. 5102, Substance Use Disorder Workforce Loan
 Repayment Act of 2018:
    Authorization Level..............................       0      25      25      25      25      25       125
    Estimated Outlays................................       0       9      19      23      25      25       100
H.R. 5176, Preventing Overdoses While in Emergency
 Rooms Act of 2018:
    Authorization Level..............................       0      50       0       0       0       0        50
    Estimated Outlays................................       0      16      26       6       2       1        50
H.R. 5197, Alternatives to Opioids (ALTO) in the
 Emergency Department Act:
    Authorization Level..............................       0      10      10      10       0       0        30
    Estimated Outlays................................       0       3       8      10       7       2        30
H.R. 5261, Treatment, Education, and Community Help
 to Combat Addiction Act of 2018:
    Authorization Level..............................       0       4       4       4       4       4        20
    Estimated Outlays................................       0       1       3       4       4       4        16
H.R. 5327, Comprehensive Opioid Recovery Centers Act
 of 2018:
    Authorization Level..............................       0      10      10      10      10      10        50
    Estimated Outlays................................       0       3       8      10      10      10        41
H.R. 5329, Poison Center Network Enhancement Act of
 2018:
    Authorization Level..............................       0      30      30      30      30      30       151
    Estimated Outlays................................       0      12      25      29      29      29       125
H.R. 5353, Eliminating Opioid-Related Infectious
 Diseases Act of 2018:
    Authorization Level..............................       0      40      40      40      40      40       200
    Estimated Outlays................................       0      15      34      38      39      40       166
H.R. 5580, Surveillance and Testing of Opioids to
 Prevent Fentanyl Deaths Act of 2018:
    Authorization Level..............................      30      30      30      30      30       0       120
    Estimated Outlays................................       0      11      25      29      29      19       113
H.R. 5587, Peer Support Communities of Recovery Act:
    Authorization Level..............................       0      15      15      15      15      15        75
    Estimated Outlays................................       0       5      13      14      15      15       62
----------------------------------------------------------------------------------------------------------------
Annual amounts may not sum to totals because of rounding. * = between zero and $500,000.

    H.R. 4684, the Ensuring Access to Quality Sober Living Act, 
would direct the Secretary of HHS to develop and disseminate 
best practices for organizations that operate housing designed 
for people recovering from substance use disorders. The bill 
would authorize a total of $3 million over the 2019-2021 period 
for that purpose. Based on historical spending patterns for 
similar activities, CBO estimates that implementing H.R. 4684 
would cost $3 million over the 2019-2023 period.
    H.R. 5102, the Substance Use Disorder Workforce Loan 
Repayment Act of 2018, would establish a loan repayment program 
for mental health professionals who practice in areas with few 
mental health providers or with high rates of death from 
overdose and would authorize $25 million per year over the 
2019-2028 period for that purpose. Based on historical spending 
patterns for similar activities, CBO estimates that 
implementing H.R. 5102 would cost $100 million over the 2019-
2023 period; the remaining amounts would be spent in years 
after 2023.
    H.R. 5176, the Preventing Overdoses While in Emergency 
Rooms Act of 2018, would require the Secretary of HHS to 
develop protocols and a grant program for health care providers 
to address the needs of people who survive a drug overdose, and 
it would authorize $50 million in 2019 for that purpose. Based 
on historical spending patterns for similar activities, CBO 
estimates that implementing H.R. 5176 would cost $50 million 
over the 2019-2023 period.
    H.R. 5197, the Alternatives to Opioids (ALTO) in the 
Emergency Department Act, would direct the Secretary of HHS to 
carry out a demonstration program for hospitals and emergency 
departments to develop alternative protocols for pain 
management that limit the use of opioids and would authorize 
$10 million annually in grants for fiscal years 2019 through 
2021. Based on historical spending patterns for similar 
programs, CBO estimates that implementing H.R. 5197 would cost 
$30 million over the 2019-2023 period.
    H.R. 5261, the Treatment, Education, and Community Help to 
Combat Addiction Act of 2018,  would direct the Secretary of 
HHS to designate regional centers of excellence to improve the 
training of health professionals who treat substance use 
disorders. The bill would authorize $4 million annually for 
grants to those programs over the 2019-2023 period. Based on 
historical spending patterns for similar activities, CBO 
estimates that implementing H.R. 5261 would cost $16 million 
over the 2019-2023 period; the remaining amounts would be spent 
in years after 2023.
    H.R. 5327, the Comprehensive Opioid Recovery Centers Act of 
2018, would direct the Secretary of HHS to award grants to at 
least 10 providers that offer treatment services for people 
with opioid use disorder, and it would authorize $10 million 
per year over the 2019-2023 period for that purpose. Based on 
historical spending patterns for similar activities, CBO 
estimates that implementing H.R. 5327 would cost $41 million 
over the 2019-2023 period; the remaining amounts would be spent 
in years after 2023.
    H.R. 5329, the Poison Center Network Enhancement Act of 
2018, would reauthorize the poison control center toll-free 
number, national media campaign, and grant program under the 
Public Health Service Act. Among other actions, H.R. 5329 would 
increase the share of poison control center funding that could 
be provided by federal grants. The bill would authorize a total 
of about $30 million per year over the 2019-2023 period. Based 
on historical spending patterns for similar activities, CBO 
estimates that implementing H.R. 5329 would cost $125 million 
over the 2019-2023 period; the remaining amounts would be spent 
in years after 2023.
    H.R 5353, the Eliminating Opioid Related Infectious 
Diseases Act of 2018, would amend Public Health Service Act by 
broadening the focus of surveillance and education programs 
from preventing and treating hepatitis C virus to preventing 
and treating infections associated with injection drug use. It 
would authorize $40 million per year over 2019-2023 period for 
that purpose. Based on historical spending patterns for similar 
activities, CBO estimates that implementing H.R. 5353 would 
cost $166 million over the 2019-2023 period; the remaining 
amounts would be spent in years after 2023.
    H.R. 5580, the Surveillance and Testing of Opioids to 
Prevent Fentanyl Deaths Act of 2018, would establish a grant 
program for public health laboratories that conduct testing for 
fentanyl and other synthetic opioids. It also would direct the 
Centers for Disease Control and Prevention to expand its drug 
surveillance program, with a particular focus on collecting 
data on fentanyl. The bill would authorize a total of $30 
million per year over the 2018-2022 period for those 
activities. Based on historical spending patterns for similar 
activities, CBO estimates that implementing H.R. 5580 would 
cost $113 million over the 2019-2023 period; the remaining 
amounts would be spent in years after 2023.
    H.R. 5587, Peer Support Communities of Recovery Act, would 
direct the Secretary of HHS to award grants to nonprofit 
organizations that support community-based, peer-delivered 
support, including technical support for the establishment of 
recovery community organizations, independent, nonprofit groups 
led by people in recovery and their families. The bill would 
authorize $15 million per year for the 2019-2023 period. Based 
on historical spending patterns for similar activities, CBO 
estimates that implementing H.R. 5587 would cost $62 million 
over the 2019-2023 period; the remaining amounts would be spent 
in years after 2023.
    Estimated Authorizations. Table 3 shows CBO's estimates of 
the appropriations that would be necessary to implement 19 of 
the bills. Spending would be subject to appropriation of those 
amounts.
    H.R. 449, the Synthetic Drug Awareness Act of 2018, would 
require the Surgeon General to report to the Congress on the 
health effects of synthetic psychoactive drugs on children 
between the ages of 12 and 18. Based on spending patterns for 
similar activities, CBO estimates that implementing H.R. 449 
would cost approximately $1 million over the 2019-2023 period.
    H.R. 4005, the Medicaid Reentry Act, would direct the 
Secretary of HHS to convene a group of stakeholders to develop 
and report to the Congress on best practices for addressing 
issues related to health care faced by those returning from 
incarceration to their communities. The bill also would require 
the Secretary to issue a letter to state Medicaid directors 
about relevant demonstration projects. Based on an analysis of 
anticipated workload, CBO estimates that implementing H.R. 4005 
would cost less than $500,000 over the 2018-2023 period.
    H.R. 4275, the Empowering Pharmacists in the Fight Against 
Opioid Abuse Act, would require the Secretary of HHS to develop 
and disseminate materials for training pharmacists, health care 
practitioners, and the public about the circumstances under 
which a pharmacist may decline to fill a prescription. Based on 
historical spending patterns for similar activities, CBO 
estimates that costs to the federal government for the 
development and distribution of those materials would not be 
significant.

          TABLE 3.--ESTIMATED SPENDING SUBJECT TO APPROPRIATION FOR BILLS WITH ESTIMATED AUTHORIZATIONS
----------------------------------------------------------------------------------------------------------------
                                                              By fiscal year, in millions of dollars--
                                                   -------------------------------------------------------------
                                                     2018   2019     2020     2021     2022     2023   2019-2023
----------------------------------------------------------------------------------------------------------------
                                 INCREASES IN SPENDING SUBJECT TO APPROPRIATION
 
H.R. 449, Synthetic Drug Awareness Act of 2018:
    Estimated Authorization Level.................      0       *        *        *        0        0         1
    Estimated Outlays.............................      0       *        *        *        0        0         1
 
H.R. 4005, Medicaid Reentry Act:
    Estimated Authorization Level.................      *       *        0        0        0        0         *
    Estimated Outlays.............................      *       *        0        0        0        0         *
 
H.R. 4275, Empowering Pharmacists in the Fight
 Against Opioid Abuse Act:
    Estimated Authorization Level.................      0       *        *        *        *        *         *
    Estimated Outlays.............................      0       *        *        *        *        *         *
 
H.R. 5009, Jessie's Law:
    Estimated Authorization Level.................      0       *        *        *        *        *         *
    Estimated Outlays.............................      0       *        *        *        *        *         *
 
H.R. 5041, Safe Disposal of Unused Medication Act:
    Estimated Authorization Level.................      0       *        *        *        *        *         *
    Estimated Outlays.............................      0       *        *        *        *        *         *
 
H.R. 5272, Reinforcing Evidence-Based Standards
 Under Law in Treating Substance Abuse Act of
 2018:
    Estimated Authorization Level.................      0       1        1        1        1        1         4
    Estimated Outlays.............................      0       1        1        1        1        1         4
 
H.R. 5333, Over-the-Counter Monograph Safety,
 Innovation, and Reform Act of 2018:a
    Food and Drug Administration:
        Collections from fees:
            Estimated Authorization Level.........      0     -22      -22      -26      -35      -42      -147
            Estimated Outlays.....................      0     -22      -22      -26      -35      -42      -147
        Spending of fees:
            Estimated Authorization Level.........      0      22       22       26       35       42       147
            Estimated Outlays.....................      0       6       17       30       44       41       137
        Net effect on FDA:
            Estimated Authorization Level.........      0       0        0        0        0        0         0
            Estimated Outlays.....................      0     -17       -6        4        9        *       -10
    Government Accountability Office:
        Estimated Authorization Level.............      0       0        0        0        0        *         *
        Estimated Outlays.........................      0       0        0        0        0        *         *
    Total, H.R. 5333:
        Estimated Authorization Level.............      0       0        0        0        0        *         *
        Estimated Outlays.........................      0     -17       -6        4        9        *       -10
 
H.R. 5473, Better Pain Management Through Better
 Data Act of 2018:
    Estimated Authorization Level.................      0       *        *        *        *        0         1
    Estimated Outlays.............................      0       *        *        *        *        *         1
 
H.R. 5483, Special Registration for Telemedicine
 Clarification Act of 2018:
    Estimated Authorization Level.................      0       *        *        *        *        *         *
    Estimated Outlays.............................      0       *        *        *        *        *         *
 
H.R. 5554, Animal Drug and Animal Generic Drug
 User Fee Amendments of 2018:
    Collections from fees:
        Animal drug fees..........................      0     -30      -31      -32      -33      -34      -159
        Generic animal drug fees..................      0     -18      -19      -19      -20      -21       -97
            Total, Estimated Authorization Level..      0     -49      -50      -51      -53      -55      -257
            Total, Estimated Outlays..............      0     -49      -50      -51      -53      -55      -257
    Spending of fees:
        Animal drug fees..........................      0      30       31       32       33       34       159
        Generic animal drug fees..................      0      18       19       19       20       21        97
            Total, Estimated Authorization Level..      0      49       50       51       53       55       257
            Total, Estimated Outlays..............      0      39       47       51       52       54       243
    Net changes in fees:
        Estimated Authorization Level.............      0       0        0        0        0        0         0
        Estimated Outlays.........................      0     -10       -3        *        *        *       -14
    Other effects:
        Estimated Authorization Level.............      0       3        1        1        1        1         6
        Estimated Outlays.........................      0       2        1        1        1        1         6
    Total, H.R. 5554:
        Estimated Authorization Level.............      0       3        1        1        1        1         6
        Estimated Outlays.........................      0      -8       -2        1        *        *        -8
 
H.R. 5582, Abuse Deterrent Access Act of 2018:
    Estimated Authorization Level.................      0       0        *        0        0        0         *
    Estimated Outlays.............................      0       0        *        0        0        0         *
 
H.R. 5590, Opioid Addiction Action Plan Act:
    Estimated Authorization Level.................      *       *        *        *        *        *         2
    Estimated Outlays.............................      *       *        *        *        *        *         2
 
H.R. 5687, Securing Opioids and Unused Narcotics
 with Deliberate Disposal and Packaging Act of
 2018:
    Estimated Authorization Level.................      0       *        *        *        *        *         *
    Estimated Outlays.............................      0       *        *        *        *        *         *
 
H.R. 5715, Strengthening Partnerships to Prevent
 Opioid Abuse Act:
    Estimated Authorization Level.................      0       2        2        2        2        2         9
    Estimated Outlays.............................      0       2        2        2        2        2         9
 
H.R. 5789, a bill to require the Secretary of
 Health and Human Services to issue guidance to
 improve care for infants with neonatal abstinence
 syndrome and their mothers, and to require the
 Comptroller General of the United States to
 conduct a study on gaps in Medicaid coverage for
 pregnant and postpartum women with substance use
 disorder:
    Estimated Authorization Level.................      0       2        0        0        0        0         2
    Estimated Outlays.............................      0       2        0        0        0        0         2
 
H.R. 5795, Overdose Prevention and Patient Safety
 Act:
    Estimated Authorization Level.................      0       1        0        0        0        0         1
    Estimated Outlays.............................      0       1        0        0        0        0         1
 
H.R. 5800, Medicaid IMD ADDITIONAL INFO Act:
    Estimated Authorization Level.................      0       1        0        0        0        0         1
    Estimated Outlays.............................      0       *        *        0        0        0         1
 
H.R. 5804, Post-Surgical Injections as an Opioid
 Alternative Act:a
    Estimated Authorization Level.................      0       0        0        0        1        1         1
    Estimated Outlays.............................      0       0        0        0        1        1         1
 
H.R. 5811, a bill to amend the Federal Food, Drug,
 and Cosmetic Act with respect to postapproval
 study requirements for certain controlled
 substances, and for other purposes:
    Estimated Authorization Level.................      0       *        *        *        *        *         *
    Estimated Outlays.............................      0       *        *        *        *        *        *
----------------------------------------------------------------------------------------------------------------
Annual amounts may not sum to totals because of rounding. * = between -$500,000 and $500,000.
aThis bill also would affect mandatory spending (see Table 1).

    H.R. 5009, Jessie's Law, would require HHS, in 
collaboration with outside experts, to develop best practices 
for displaying information about opioid use disorder in a 
patient's medical record. HHS also would be required to develop 
and disseminate written materials annually to health care 
providers about what disclosures could be made while still 
complying with federal laws that govern health care privacy. 
Based on spending patterns for similar activities, CBO 
estimates that implementing H.R. 5009 would have an 
insignificant effect on spending over the 2019-2023 period.
    H.R. 5041, the Safe Disposal of Unused Medication Act, 
would require hospice programs to have written policies and 
procedures for the disposal of controlled substances after a 
patient's death. Certain licensed employees of hospice programs 
would be permitted to assist in the disposal of controlled 
substances that were lawfully dispensed. Using information from 
the Department of Justice (DOJ), CBO estimates that 
implementing the bill would cost less than $500,000 over the 
2019-2023 period.
    H.R. 5272, the Reinforcing Evidence-Based Standards Under 
Law in Treating Substance Abuse Act of 2018, would require the 
newly established National Mental Health and Substance Use 
Policy Laboratory to issue guidance to applicants for SAMHSA 
grants that support evidence-based practices. Using information 
from HHS about the historical cost of similar activities, CBO 
estimates that enacting this bill would cost approximately $4 
million over the 2019-2023 period.
    H.R. 5333, the Over-the-Counter Monograph Safety, 
Innovation, and Reform Act of 2018, would change the FDA's 
oversight of the commercial marketing of OTC medicines and 
authorize the collection and spending of fees through 2023 to 
cover the costs of expediting the FDA's administrative 
procedures for certain regulatory activities relating to OTC 
products. Under H.R. 5333, CBO estimates, the FDA would assess 
about $147 million in fees over the 2019-2023 period that could 
be collected and made available for obligation only to the 
extent and in the amounts provided in advance in appropriation 
acts. Because the FDA could spend those fees, CBO estimates 
that the estimated budget authority for collections and 
spending would offset each other exactly in each year, although 
CBO expects that spending initially would lag behind 
collections. Assuming appropriation action consistent with the 
bill, CBO estimates that implementing H.R. 5333 would reduce 
net discretionary outlays by $10 million over the 2019-2023 
period, primarily because of that lag. The bill also would 
require the Government Accountability Office to study exclusive 
market protections for certain qualifying OTC drugs authorized 
by the bill--a provision that CBO estimates would cost less 
than $500,000. (If enacted, H.R. 5333 also would affect 
mandatory spending; see Table 1.)
    H.R. 5473, the Better Pain Management Through Better Data 
Act of 2018, would require that the FDA conduct a public 
meeting and issue guidance to industry addressing data 
collection and labeling for medical products that reduce pain 
while enabling the reduction, replacement, or avoidance of oral 
opioids. Using information from the agency, CBO estimates that 
implementing H.R. 5473 would cost about $1 million over the 
2019-2023 period.
    H.R. 5483, the Special Registration for Telemedicine 
Clarification Act of 2018, would direct DOJ, within one year of 
the bill's enactment, to issue regulations concerning the 
practice of telemedicine (for remote diagnosis and treatment of 
patients). Using information from DOJ, CBO estimates that 
implementing the bill would cost less than $500,000 over the 
2019-2023 period.
    H.R. 5554, the Animal Drug and Animal Generic Drug User Fee 
Amendments of 2018, would authorize the FDA to collect and 
spend fees to cover the cost of expedited approval for the 
development and marketing of certain drugs for use in animals. 
The legislation would extend through fiscal year 2023, and make 
several changes to, the FDA's existing approval processes and 
fee programs for brand-name and generic veterinary drugs, which 
expire at the end of fiscal year 2018. CBO estimates that 
implementing H.R. 5554 would reduce net discretionary outlays 
by $8 million over the 2019-2023 period, primarily because the 
spending of fees lags somewhat behind their collection.
    Fees authorized under the bill would supplement funds 
appropriated to cover the FDA's cost of reviewing certain 
applications and investigational submissions for brand-name and 
generic drugs for use in animals. Those fees could be collected 
and made available for obligation only to the extent and in the 
amounts provided in advance in appropriation acts. Under H.R. 
5554, CBO estimates, the FDA would assess about $257 million in 
fees over the 2019-2023 period. Because the FDA could spend 
those funds, CBO estimates that budget authority for 
collections and spending would offset each other exactly in 
each year. CBO estimates that the delay between collecting and 
spending fees under the reauthorized programs would reduce net 
discretionary outlays by $14 million over the 2019-2023 period, 
assuming appropriation actions consistent with the bill.
    Enacting H.R. 5554 would increase the FDA's workload 
because the legislation would expand eligibility for 
conditional approval for certain drugs. The agency's 
administrative costs also would increase because of regulatory 
activities required by a provision concerning petitions for 
additives intended for use in animal food. H.R. 5554 also would 
require the FDA to publish guidance or produce regulations on a 
range of topics, transmit a report to the Congress, and hold 
public meetings. CBO expects that the costs associated with 
those activities would not be covered by fees, and it estimates 
that implementing such provisions would cost $6 million over 
the 2019-2023 period.
    H.R. 5582, the Abuse Deterrent Access Act of 2018, would 
require the Secretary of HHS to report to the Congress on 
existing barriers to access to ``abuse-deterrent opioid 
formulations'' by Medicare Part C and D beneficiaries. Such 
formulations make the drugs more difficult to dissolve for 
injection, for example, and thus can impede their abuse. 
Assuming the availability of appropriated funds and based on 
historical spending patterns for similar activities, CBO 
estimates that implementing the legislation would cost less 
than $500,000 over the 2019-2023 period.
    H.R. 5590, the Opioid Addiction Action Plan Act, would 
require the Secretary of HHS to develop an action plan by 
January 1, 2019, for increasing access to medication-assisted 
treatment among Medicare and Medicaid enrollees. The bill also 
would require HHS to convene a stakeholder meeting and issue a 
request for information within three months of enactment, and 
to submit a report to the Congress by June 1, 2019. Based on 
historical spending patterns for similar activities, CBO 
estimates that implementing H.R. 5590 would cost approximately 
$2 million over the 2019-2023 period.
    H.R. 5687, the Securing Opioids and Unused Narcotics with 
Deliberate Disposal and Packaging Act of 2018, would permit the 
FDA to require certain packaging and disposal technologies, 
controls, or measures to mitigate the risk of abuse and misuse 
of drugs. Based on information from the FDA, CBO estimates that 
implementing H.R. 5687 would not significantly affect spending 
over the 2019-2023 period. This bill would also require that 
the GAO study the effectiveness and use of packaging 
technologies for controlled substances--a provision that CBO 
estimates would cost less than $500,000.
    H.R. 5715, the Strengthening Partnerships to Prevent Opioid 
Abuse Act, would require the Secretary of HHS to establish a 
secure Internet portal to allow HHS, Medicare Advantage plans, 
and Medicare Part D plans to exchange information about fraud, 
waste, and abuse among providers and suppliers no later than 
two years after enactment. H.R. 5715 also would require 
organizations with Medicare Advantage contracts to submit 
information on investigations related to providers suspected of 
prescribing large volumes of opioids through a process 
established by the Secretary no later than January 2021. Based 
on historical spending patterns for similar activities, CBO 
estimates that implementing H.R. 5715 would cost approximately 
$9 million over the 2019-2023 period.
    H.R. 5789, a bill to require the Secretary of Health and 
Human Services to issue guidance to improve care for infants 
with neonatal abstinence syndrome and their mothers, and to 
require the Comptroller General of the United States to conduct 
a study on gaps in Medicaid coverage for pregnant and 
postpartum women with substance use disorder, would direct the 
Secretary of HHS to issue guidance to states on best practices 
under Medicaid and CHIP for treating infants with neonatal 
abstinence syndrome. H.R. 5789 also would direct the Government 
Accountability Office to study Medicaid coverage for pregnant 
and postpartum women with substance use disorders. Based on 
inforation from HHS and historical spending patterns for 
similar activities, CBO estimates that enacting H.R. 5789 would 
cost approximately $2 million over the 2019-2023 period.
    H.R. 5795, the Overdose Prevention and Patient Safety Act, 
would amend the Public Health Service Act so that requirements 
pertaining to the confidentiality and disclosure of medical 
records relating to substance use disorders align with the 
provisions of the Health Insurance Portability and 
Accountability Act of 1996. The bill would require the Office 
of the Secretary of HHS to issue regulations prohibiting 
discrimination based on data disclosed from such medical 
records, to issue regulations requiring covered entities to 
provide written notice of privacy practices, and to develop 
model training programs and materials for health care providers 
and patients and their families. Based on spending patterns for 
similar activities, CBO estimates that implementing H.R. 5795 
would cost approximately $1 million over the 2019-2023 period.
    H.R. 5800, Medicaid IMD ADDITIONAL INFO Act, would direct 
the Medicaid and CHIP Payment and Access Commission to study 
institutions for mental diseases in a representative sample of 
states. Based on information from the commission about the cost 
of similar work, CBO estimates that implementing H.R. 5800 
would cost about $1 million over the 2019-2023 period.
    H.R. 5804, the Post-Surgical Injections as an Opioid 
Alternative Act, would freeze the Medicare payment rate for 
certain analgesic injections provided in ambulatory surgical 
centers. The bill also would mandate two studies of Medicare 
coding and payments arising from enactment of this legislation. 
Based on the cost of similar activities, CBO estimates that 
those reports would cost $1 million over the 2019-2023 period. 
(If enacted, H.R. 5804 also would affect mandatory spending; 
see Table 1.)
    H.R. 5811, a bill to amend the Federal Food, Drug, and 
Cosmetic Act with respect to postapproval study requirements 
for certain controlled substances, and for other purposes, 
would allow the FDA to require that pharmaceutical 
manufacturers study certain drugs after they are approved to 
assess any potential reduction in those drugs' effectiveness 
for the conditions of use prescribed, recommended, or suggested 
in labeling. CBO anticipates that implementing H.R. 5811 would 
not significantly affect the FDA's costs over the 2019-2023 
period.
    Other Authorizations. The following nine bills would 
increase authorization levels, but CBO has not completed 
estimates of amounts. All authorizations would be subject to 
future appropriation action.
           H.R. 4284, Indexing Narcotics, Fentanyl, and 
        Opioids Act of 2017
           H.R. 5002, Advancing Cutting Edge Research 
        Act
           H.R. 5228, Stop Counterfeit Drugs by 
        Regulating and Enhancing Enforcement Now Act (see Table 
        1 for an estimate of the revenue effects of H.R. 5228)
           H.R. 5752, Stop Illicit Drug Importation Act 
        of 2018 (see Table 1 for an estimate of the revenue 
        effects of H.R. 5752)
           H.R. 5799, Medicaid DRUG Improvement Act 
        (see Table 1 for an estimate of the direct spending 
        effects of H.R. 5799)
           H.R. 5801, Medicaid Providers and 
        Pharmacists Are Required to Note Experiences in Record 
        Systems to Help In-Need Patients (PARTNERSHIP) Act (see 
        Table 1 for an estimate of the direct spending effects 
        of H.R. 5801)
           H.R. 5806, 21st Century Tools for Pain and 
        Addiction Treatments Act
           H.R. 5808, Medicaid Pharmaceutical Home Act 
        of 2018 (see Table 1 for an estimate of the direct 
        spending effects of H.R. 5808)
           H.R. 5812, Creating Opportunities that 
        Necessitate New and Enhanced Connections That Improve 
        Opioid Navigation Strategies Act (CONNECTIONS) Act
    Pay-As-You-Go considerations: The Statutory Pay-As-You-Go 
Act of 2010 establishes budget-reporting and enforcement 
procedures for legislation affecting direct spending or 
revenues. Twenty-two of the bills discussed in this document 
contain direct spending or revenues and are subject to pay-as-
you-go procedures. Details about the amount of direct spending 
and revenues in those bills can be found in Table 1.
    Increase in long-term direct spending and deficits: CBO 
estimates that enacting H.R. 4998, the Health Insurance for 
Former Foster Youth Act, would increase net direct spending by 
more than $2.5 billion and on-budget deficits by more than $5 
billion in at least one of the four consecutive 10-year periods 
beginning in 2029.
    CBO estimates that none of the remaining 58 bills included 
in this estimate would increase net direct spending by more 
than $2.5 billion or on-budget deficits by more than $5 billion 
in any of the four consecutive 10-year periods beginning in 
2029.
    Mandates: One of the 59 bills included in this document, 
H.R. 5795, would impose both intergovernmental and private-
sector mandates as defined in UMRA. CBO estimates that the 
costs of that bill's mandates on public and private entities 
would fall below UMRA's thresholds ($80 million and $160 
million, respectively, for public- and private-sector entities 
in 2018, adjusted annually for inflation).
    In addition, five bills would impose private-sector 
mandates as defined in UMRA. CBO estimates that the costs of 
the mandates in three of those bills (H.R. 5333, H.R. 5554, and 
H.R. 5811) would fall below the UMRA threshold. Because CBO 
does not know how federal agencies would implement new 
authority granted in the other two of those five bills, H.R. 
5228 and 5687, CBO cannot determine whether the costs of their 
mandates would exceed the threshold.
    For large entitlement grant programs, including Medicaid 
and CHIP, UMRA defines an increase in the stringency of 
conditions on states or localities as an intergovernmental 
mandate if the affected governments lack authority to offset 
those costs while continuing to provide required services. 
Because states possess significant flexibility to alter their 
responsibilities within Medicaid and CHIP, the requirements 
imposed by various bills in the markup on state administration 
of those programs would not constitute mandates as defined in 
UMRA.

Mandates Affecting Public and Private Entities

    H.R. 5795, the Overdose Prevention and Patient Safety Act, 
would impose intergovernmental and private-sector mandates by 
requiring entities that provide treatment for substance use 
disorders to notify patients of their privacy rights and also 
to notify patients in the event that the confidentiality of 
their records is breached. In certain circumstances, H.R. 5795 
also would prohibit public and private entities from denying 
entry to treatment on the basis of information in patient 
health records. Those requirements would either supplant or 
narrowly expand responsibilities under existing law, and 
compliance with them would not impose significant additional 
costs. CBO estimates that the costs of the mandates would fall 
below the annual thresholds established in UMRA.

Mandates Affecting Private Entities

    Five bills included in this document would impose private-
sector mandates:
    H.R. 5228, the Stop Counterfeit Drugs by Regulating and 
Enhancing Enforcement Now Act, would require drug distributors 
to cease distributing any drug that the Secretary of HHS 
determines might present an imminent or substantial hazard to 
public health. CBO cannot determine what drugs could be subject 
to such an order nor can it determine how private entities 
would respond. Consequently, CBO cannot determine whether the 
aggregate cost of the mandate would exceed the annual threshold 
for private-sector mandates.
    H.R. 5333, the Over-the-Counter Monograph Safety, 
Innovation, and Reform Act of 2018, would require developers 
and manufacturers of OTC drugs to pay certain fees to the FDA. 
CBO estimates that about $30 million would be collected each 
year, on average, for a total of $147 million over the 2019-
2023 period. Those amounts would not exceed the annual 
threshold for private-sector mandates in any year during that 
period.
    H.R. 5554, the Animal Drug and Animal Generic Drug User Fee 
Amendments of 2018, would require developers and manufacturers 
of brand-name and generic veterinary drugs to pay application, 
product, establishment, and sponsor fees to the FDA. CBO 
estimates that about $51 million would be collected annually, 
on average, for a total of $257 million over the 2019-2023 
period. Those amounts would not exceed the annual threshold for 
private-sector mandates in any year during that period.
    H.R. 5687, the Securing Opioids and Unused Narcotics with 
Deliberate Disposal and Packaging Act of 2018, would permit the 
Secretary of HHS to require drug developers and manufacturers 
to implement new packaging and disposal technology for certain 
drugs. Based on information from the agency, CBO expects that 
the Secretary would use the new regulatory authority provided 
in the bill; however, it is uncertain how or when those 
requirements would be implemented. Consequently, CBO cannot 
determine whether the aggregate cost of the mandate would 
exceed the annual threshold for private entities.
    H.R. 5811, a bill to amend the Federal Food, Drug, and 
Cosmetic Act with respect to postapproval study requirements 
for certain controlled substances, and for other purposes, 
would expand an existing mandate that requires drug developers 
to conduct postapproval studies or clinical trials for certain 
drugs. Under current law, in certain instances, the FDA can 
require studies or clinical trials after a drug has been 
approved. H.R. 5811 would permit the FDA to use that authority 
if the reduction in a drug's effectiveness meant that its 
benefits no longer outweighed its costs. CBO estimates that the 
incremental cost of the mandate would fall below the annual 
threshold established in UMRA because of the small number of 
drugs affected and the narrow expansion of the authority that 
exists under current law.
    None of the remaining 53 bills included in this document 
would impose an intergovernmental or private-sector mandate.
    Previous CBO estimate: On June 6, 2018, CBO issued an 
estimate for seven opioid-related bills ordered reported by the 
House Committee on Ways and Means on May 16, 2018. Two of those 
bills contain provisions that are identical or similar to the 
legislation ordered reported by the Committee on Energy and 
Commerce, and for those provisions, CBO's estimates are the 
same.
    In particular, five bills listed in this estimate contain 
provisions that are identical or similar to those in several 
sections of H.R. 5773, the Preventing Addiction for Susceptible 
Seniors Act of 2018:
           H.R. 5675, which would require prescription 
        drug plans to implement drug management programs, is 
        identical to section 2 of H.R. 5773.
           H.R. 4841, regarding electronic prior 
        authorization for prescriptions under Medicare's Part 
        D, is similar to section 3 of H.R. 5773.
           H.R. 5715, which would mandate the creation 
        of a new Internet portal to allow various stakeholders 
        to exchange information, is identical to section 4 of 
        H.R. 5773.
           H.R. 5684, which would expand medication 
        therapy management, is the same as section 5 of H.R. 
        5773.
           H.R. 5716, regarding prescriber 
        notification, is identical to section 6 of H.R. 5773.
    In addition, in this estimate, a provision related to 
Medicare beneficiary education in H.R. 5686, the Medicare Clear 
Health Options in Care for Enrollees Act of 2018, is the same 
as a provision in section 2 of H.R. 5775, the Providing 
Reliable Options for Patients and Educational Resources Act of 
2018, in CBO's estimate for the Committee on Ways and Means.
    Estimate prepared by: Federal Costs: Rebecca Yip (Centers 
for Disease Control and Prevention), Mark Grabowicz (Drug 
Enforcement Agency), Julia Christensen, Ellen Werble (Food and 
Drug Administration), Emily King, Andrea Noda, Lisa Ramirez-
Branum, Robert Stewart (Medicaid and Children's Health 
Insurance Program), Philippa Haven, Lara Robillard, Colin Yee, 
Rebecca Yip (Medicare), Philippa Haven (National Institutes of 
Health), Alice Burns, Andrea Noda (Office of the Secretary of 
the Department of Health and Human Services), Philippa Haven, 
Lori Housman, Emily King (Substance Abuse and Mental Health 
Services Administration, Health Resources and Services 
Administration); Federal Revenues: Jacob Fabian, Peter Huether, 
and Cecilia Pastrone; Fact Checking: Zachary Byrum and Kate 
Kelly; Mandates: Andrew Laughlin.
    Estimate reviewed by: Tom Bradley, Chief, Health Systems 
and Medicare Cost Estimates Unit; Chad M. Chirico, Chief, Low-
Income Health Programs and Prescription Drugs Cost Estimates 
Unit; Sarah Masi, Special Assistant for Health; Susan Willie, 
Chief, Mandates Unit; Leo Lex, Deputy Assistant Director for 
Budget Analysis; Theresa A. Gullo, Assistant Director for 
Budget Analysis.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

         Statement of General Performance Goals and Objectives

    Pursuant to clause 3(c)(4) of rule XIII, the general 
performance goal or objective of this legislation is to direct 
the Centers for Medicare and Medicaid Services to require e-
prescribing for coverage of prescribed controlled substances 
under the Medicare Part D program.

                    Duplication of Federal Programs

    Pursuant to clause 3(c)(5) of rule XIII, no provision of 
H.R. 3528 is known to be duplicative of another Federal 
program, including any program that was included in a report to 
Congress pursuant to section 21 of Public Law 111-139 or the 
most recent Catalog of Federal Domestic Assistance.

                        Committee Cost Estimate

    Pursuant to clause 3(d)(1) of rule XIII, the Committee 
adopts as its own the cost estimate prepared by the Director of 
the Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974.

       Earmark, Limited Tax Benefits, and Limited Tariff Benefits

    Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the 
Committee finds that H.R. 3528 contains no earmarks, limited 
tax benefits, or limited tariff benefits.

                  Disclosure of Directed Rule Makings

    Pursuant to section 3(i) of H. Res. 5, the following 
directed rule makings are contained in H.R. 3528:
           Section 2(a)(B): The Secretary shall, 
        pursuant to rulemaking, specify circumstances with 
        respect to which the Secretary may waive the 
        requirement under subparagraph (A), with respect to a 
        covered part D drug.
           Section 2(a)(D): The Secretary shall, 
        pursuant to rulemaking, have authority to enforce and 
        specify appropriate penalties for noncompliance with 
        the requirement under subparagraph (A).

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation


Section 1. Short title

    Section 1 provide that the Act may be cited as the ``Every 
Prescription Conveyed Securely Act.''

Section 2. Requiring E-prescribing for coverage of covered Part D 
        controlled substances

    Section requires prescriptions for a schedule II, III, IV, 
or V controlled substance covered under a part D prescription 
drug plan or MA-PD plan to be transmitted in accordance with an 
electronic prescription drug program by January 1, 2021. The 
Secretary may waive this requirement in certain defined cases, 
such as reasonable technological limitations.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (new matter is 
printed in italic and existing law in which no change is 
proposed is shown in roman):

                          SOCIAL SECURITY ACT




           *       *       *       *       *       *       *
TITLE XVIII--HEALTH INSURANCE FOR THE AGED AND DISABLED

           *       *       *       *       *       *       *



Part D--Voluntary Prescription Drug Benefit Program

           *       *       *       *       *       *       *



Subpart 1--Part D Eligible Individuals and Prescription Drug Benefits

           *       *       *       *       *       *       *



    beneficiary protections for qualified prescription drug coverage

  Sec. 1860D-4. (a) Dissemination of Information.--
          (1) General information.--
                  (A) Application of ma information.--A PDP 
                sponsor shall disclose, in a clear, accurate, 
                and standardized form to each enrollee with a 
                prescription drug plan offered by the sponsor 
                under this part at the time of enrollment and 
                at least annually thereafter, the information 
                described in section 1852(c)(1) relating to 
                such plan, insofar as the Secretary determines 
                appropriate with respect to benefits provided 
                under this part, and including the information 
                described in subparagraph (B).
                  (B) Drug specific information.--The 
                information described in this subparagraph is 
                information concerning the following:
                          (i) Access to specific covered part D 
                        drugs, including access through 
                        pharmacy networks.
                          (ii) How any formulary (including any 
                        tiered formulary structure) used by the 
                        sponsor functions, including a 
                        description of how a part D eligible 
                        individual may obtain information on 
                        the formulary consistent with paragraph 
                        (3).
                          (iii) Beneficiary cost-sharing 
                        requirements and how a part D eligible 
                        individual may obtain information on 
                        such requirements, including tiered or 
                        other copayment level applicable to 
                        each drug (or class of drugs), 
                        consistent with paragraph (3).
                          (iv) The medication therapy 
                        management program required under 
                        subsection (c).
                          (v) The drug management program for 
                        at-risk beneficiaries under subsection 
                        (c)(5).
          (2) Disclosure upon request of general coverage, 
        utilization, and grievance information.--Upon request 
        of a part D eligible individual who is eligible to 
        enroll in a prescription drug plan, the PDP sponsor 
        offering such plan shall provide information similar 
        (as determined by the Secretary) to the information 
        described in subparagraphs (A), (B), and (C) of section 
        1852(c)(2) to such individual.
          (3) Provision of specific information.--
                  (A) Response to beneficiary questions.--Each 
                PDP sponsor offering a prescription drug plan 
                shall have a mechanism for providing specific 
                information on a timely basis to enrollees upon 
                request. Such mechanism shall include access to 
                information through the use of a toll-free 
                telephone number and, upon request, the 
                provision of such information in writing.
                  (B) Availability of information on changes in 
                formulary through the internet.--A PDP sponsor 
                offering a prescription drug plan shall make 
                available on a timely basis through an Internet 
                website information on specific changes in the 
                formulary under the plan (including changes to 
                tiered or preferred status of covered part D 
                drugs).
          (4) Claims information.--A PDP sponsor offering a 
        prescription drug plan must furnish to each enrollee in 
        a form easily understandable to such enrollees--
                  (A) an explanation of benefits (in accordance 
                with section 1806(a) or in a comparable 
                manner); and
                  (B) when prescription drug benefits are 
                provided under this part, a notice of the 
                benefits in relation to--
                          (i) the initial coverage limit for 
                        the current year; and
                          (ii) the annual out-of-pocket 
                        threshold for the current year.
                Notices under subparagraph (B) need not be 
                provided more often than as specified by the 
                Secretary and notices under subparagraph 
                (B)(ii) shall take into account the application 
                of section 1860D-2(b)(4)(C) to the extent 
                practicable, as specified by the Secretary.
  (b) Access to Covered Part D Drugs.--
          (1) Assuring pharmacy access.--
                  (A) Participation of any willing pharmacy.--A 
                prescription drug plan shall permit the 
                participation of any pharmacy that meets the 
                terms and conditions under the plan.
                  (B) Discounts allowed for network 
                pharmacies.--For covered part D drugs dispensed 
                through in-network pharmacies, a prescription 
                drug plan may, notwithstanding subparagraph 
                (A), reduce coinsurance or copayments for part 
                D eligible individuals enrolled in the plan 
                below the level otherwise required. In no case 
                shall such a reduction result in an increase in 
                payments made by the Secretary under section 
                1860D-15 to a plan.
                  (C) Convenient access for network 
                pharmacies.--
                          (i) In general.--The PDP sponsor of 
                        the prescription drug plan shall secure 
                        the participation in its network of a 
                        sufficient number of pharmacies that 
                        dispense (other than by mail order) 
                        drugs directly to patients to ensure 
                        convenient access (consistent with 
                        rules established by the Secretary).
                          (ii) Application of tricare 
                        standards.--The Secretary shall 
                        establish rules for convenient access 
                        to in-network pharmacies under this 
                        subparagraph that are no less favorable 
                        to enrollees than the rules for 
                        convenient access to pharmacies 
                        included in the statement of work of 
                        solicitation (#MDA906-03-R-0002) of the 
                        Department of Defense under the TRICARE 
                        Retail Pharmacy (TRRx) as of March 13, 
                        2003.
                          (iii) Adequate emergency access.--
                        Such rules shall include adequate 
                        emergency access for enrollees.
                          (iv) Convenient access in long-term 
                        care facilities.--Such rules may 
                        include standards with respect to 
                        access for enrollees who are residing 
                        in long-term care facilities and for 
                        pharmacies operated by the Indian 
                        Health Service, Indian tribes and 
                        tribal organizations, and urban Indian 
                        organizations (as defined in section 4 
                        of the Indian Health Care Improvement 
                        Act).
                  (D) Level playing field.--Such a sponsor 
                shall permit enrollees to receive benefits 
                (which may include a 90-day supply of drugs or 
                biologicals) through a pharmacy (other than a 
                mail order pharmacy), with any differential in 
                charge paid by such enrollees.
                  (E) Not required to accept insurance risk.--
                The terms and conditions under subparagraph (A) 
                may not require participating pharmacies to 
                accept insurance risk as a condition of 
                participation.
          (2) Use of standardized technology.--
                  (A) In general.--The PDP sponsor of a 
                prescription drug plan shall issue (and 
                reissue, as appropriate) such a card (or other 
                technology) that may be used by an enrollee to 
                assure access to negotiated prices under 
                section 1860D-2(d).
                  (B) Standards.--
                          (i) In general.--The Secretary shall 
                        provide for the development, adoption, 
                        or recognition of standards relating to 
                        a standardized format for the card or 
                        other technology required under 
                        subparagraph (A). Such standards shall 
                        be compatible with part C of title XI 
                        and may be based on standards developed 
                        by an appropriate standard setting 
                        organization.
                          (ii) Consultation.--In developing the 
                        standards under clause (i), the 
                        Secretary shall consult with the 
                        National Council for Prescription Drug 
                        Programs and other standard setting 
                        organizations determined appropriate by 
                        the Secretary.
                          (iii) Implementation.--The Secretary 
                        shall develop, adopt, or recognize the 
                        standards under clause (i) by such date 
                        as the Secretary determines shall be 
                        sufficient to ensure that PDP sponsors 
                        utilize such standards beginning 
                        January 1, 2006.
          (3) Requirements on development and application of 
        formularies.--If a PDP sponsor of a prescription drug 
        plan uses a formulary (including the use of tiered 
        cost-sharing), the following requirements must be met:
                  (A) Development and revision by a pharmacy 
                and therapeutic (p&t) committee.--
                          (i) In general.--The formulary must 
                        be developed and reviewed by a pharmacy 
                        and therapeutic committee. A majority 
                        of the members of such committee shall 
                        consist of individuals who are 
                        practicing physicians or practicing 
                        pharmacists (or both).
                          (ii) Inclusion of independent 
                        experts.--Such committee shall include 
                        at least one practicing physician and 
                        at least one practicing pharmacist, 
                        each of whom--
                                  (I) is independent and free 
                                of conflict with respect to the 
                                sponsor and plan; and
                                  (II) has expertise in the 
                                care of elderly or disabled 
                                persons.
                  (B) Formulary development.--In developing and 
                reviewing the formulary, the committee shall--
                          (i) base clinical decisions on the 
                        strength of scientific evidence and 
                        standards of practice, including 
                        assessing peer-reviewed medical 
                        literature, such as randomized clinical 
                        trials, pharmacoeconomic studies, 
                        outcomes research data, and on such 
                        other information as the committee 
                        determines to be appropriate; and
                          (ii) take into account whether 
                        including in the formulary (or in a 
                        tier in such formulary) particular 
                        covered part D drugs has therapeutic 
                        advantages in terms of safety and 
                        efficacy.
                  (C) Inclusion of drugs in all therapeutic 
                categories and classes.--
                          (i) In general.--Subject to 
                        subparagraph (G), the formulary must 
                        include drugs within each therapeutic 
                        category and class of covered part D 
                        drugs, although not necessarily all 
                        drugs within such categories and 
                        classes.
                          (ii) Model guidelines.--The Secretary 
                        shall request the United States 
                        Pharmacopeia to develop, in 
                        consultation with pharmaceutical 
                        benefit managers and other interested 
                        parties, a list of categories and 
                        classes that may be used by 
                        prescription drug plans under this 
                        paragraph and to revise such 
                        classification from time to time to 
                        reflect changes in therapeutic uses of 
                        covered part D drugs and the additions 
                        of new covered part D drugs.
                          (iii) Limitation on changes in 
                        therapeutic classification.--The PDP 
                        sponsor of a prescription drug plan may 
                        not change the therapeutic categories 
                        and classes in a formulary other than 
                        at the beginning of each plan year 
                        except as the Secretary may permit to 
                        take into account new therapeutic uses 
                        and newly approved covered part D 
                        drugs.
                  (D) Provider and patient education.--The PDP 
                sponsor shall establish policies and procedures 
                to educate and inform health care providers and 
                enrollees concerning the formulary.
                  (E) Notice before removing drug from 
                formulary or changing preferred or tier status 
                of drug.--Any removal of a covered part D drug 
                from a formulary and any change in the 
                preferred or tiered cost-sharing status of such 
                a drug shall take effect only after appropriate 
                notice is made available (such as under 
                subsection (a)(3)) to the Secretary, affected 
                enrollees, physicians, pharmacies, and 
                pharmacists.
                  (F) Periodic evaluation of protocols.--In 
                connection with the formulary, the sponsor of a 
                prescription drug plan shall provide for the 
                periodic evaluation and analysis of treatment 
                protocols and procedures.
                  (G) Required inclusion of drugs in certain 
                categories and classes.--
                          (i) Formulary requirements.--
                                  (I) In general.--Subject to 
                                subclause (II), a PDP sponsor 
                                offering a prescription drug 
                                plan shall be required to 
                                include all covered part D 
                                drugs in the categories and 
                                classes identified by the 
                                Secretary under clause (ii)(I).
                                  (II) Exceptions.--The 
                                Secretary may establish 
                                exceptions that permit a PDP 
                                sponsor offering a prescription 
                                drug plan to exclude from its 
                                formulary a particular covered 
                                part D drug in a category or 
                                class that is otherwise 
                                required to be included in the 
                                formulary under subclause (I) 
                                (or to otherwise limit access 
                                to such a drug, including 
                                through prior authorization or 
                                utilization management).
                          (ii) Identification of drugs in 
                        certain categories and classes.--
                                  (I) In general.--Subject to 
                                clause (iv), the Secretary 
                                shall identify, as appropriate, 
                                categories and classes of drugs 
                                for which the Secretary 
                                determines are of clinical 
                                concern.
                                  (II) Criteria.--The Secretary 
                                shall use criteria established 
                                by the Secretary in making any 
                                determination under subclause 
                                (I).
                          (iii) Implementation.--The Secretary 
                        shall establish the criteria under 
                        clause (ii)(II) and any exceptions 
                        under clause (i)(II) through the 
                        promulgation of a regulation which 
                        includes a public notice and comment 
                        period.
                          (iv) Requirement for certain 
                        categories and classes until criteria 
                        established.--Until such time as the 
                        Secretary establishes the criteria 
                        under clause (ii)(II) the following 
                        categories and classes of drugs shall 
                        be identified under clause (ii)(I):
                                  (I) Anticonvulsants.
                                  (II) Antidepressants.
                                  (III) Antineoplastics.
                                  (IV) Antipsychotics.
                                  (V) Antiretrovirals.
                                  (VI) Immunosuppressants for 
                                the treatment of transplant 
                                rejection.
                  (H) Use of single, uniform exceptions and 
                appeals process.--Notwithstanding any other 
                provision of this part, each PDP sponsor of a 
                prescription drug plan shall--
                          (i) use a single, uniform exceptions 
                        and appeals process (including, to the 
                        extent the Secretary determines 
                        feasible, a single, uniform model form 
                        for use under such process) with 
                        respect to the determination of 
                        prescription drug coverage for an 
                        enrollee under the plan; and
                          (ii) provide instant access to such 
                        process by enrollees through a toll-
                        free telephone number and an Internet 
                        website.
  (c) Cost and Utilization Management; Quality Assurance; 
Medication Therapy Management Program.--
          (1) In general.--The PDP sponsor shall have in place, 
        directly or through appropriate arrangements, with 
        respect to covered part D drugs, the following:
                  (A) A cost-effective drug utilization 
                management program, including incentives to 
                reduce costs when medically appropriate, such 
                as through the use of multiple source drugs (as 
                defined in section 1927(k)(7)(A)(i)).
                  (B) Quality assurance measures and systems to 
                reduce medication errors and adverse drug 
                interactions and improve medication use.
                  (C) A medication therapy management program 
                described in paragraph (2).
                  (D) A program to control fraud, abuse, and 
                waste.
                  (E) A utilization management tool to prevent 
                drug abuse (as described in paragraph (6)(A)).
        Nothing in this section shall be construed as impairing 
        a PDP sponsor from utilizing cost management tools 
        (including differential payments) under all methods of 
        operation.
          (2) Medication therapy management program.--
                  (A) Description.--
                          (i) In general.--A medication therapy 
                        management program described in this 
                        paragraph is a program of drug therapy 
                        management that may be furnished by a 
                        pharmacist and that is designed to 
                        assure, with respect to targeted 
                        beneficiaries described in clause (ii), 
                        that covered part D drugs under the 
                        prescription drug plan are 
                        appropriately used to optimize 
                        therapeutic outcomes through improved 
                        medication use, and to reduce the risk 
                        of adverse events, including adverse 
                        drug interactions. Such a program may 
                        distinguish between services in 
                        ambulatory and institutional settings.
                          (ii) Targeted beneficiaries 
                        described.--Targeted beneficiaries 
                        described in this clause are part D 
                        eligible individuals who--
                                  (I) have multiple chronic 
                                diseases (such as diabetes, 
                                asthma, hypertension, 
                                hyperlipidemia, and congestive 
                                heart failure);
                                  (II) are taking multiple 
                                covered part D drugs; and
                                  (III) are identified as 
                                likely to incur annual costs 
                                for covered part D drugs that 
                                exceed a level specified by the 
                                Secretary.
                  (B) Elements.--Such program may include 
                elements that promote--
                          (i) enhanced enrollee understanding 
                        to promote the appropriate use of 
                        medications by enrollees and to reduce 
                        the risk of potential adverse events 
                        associated with medications, through 
                        beneficiary education, counseling, and 
                        other appropriate means;
                          (ii) increased enrollee adherence 
                        with prescription medication regimens 
                        through medication refill reminders, 
                        special packaging, and other compliance 
                        programs and other appropriate means; 
                        and
                          (iii) detection of adverse drug 
                        events and patterns of overuse and 
                        underuse of prescription drugs.
                  (C) Required interventions.--For plan years 
                beginning on or after the date that is 2 years 
                after the date of the enactment of the Patient 
                Protection and Affordable Care Act, 
                prescription drug plan sponsors shall offer 
                medication therapy management services to 
                targeted beneficiaries described in 
                subparagraph (A)(ii) that include, at a 
                minimum, the following to increase adherence to 
                prescription medications or other goals deemed 
                necessary by the Secretary:
                          (i) An annual comprehensive 
                        medication review furnished person-to-
                        person or using telehealth technologies 
                        (as defined by the Secretary) by a 
                        licensed pharmacist or other qualified 
                        provider. The comprehensive medication 
                        review--
                                  (I) shall include a review of 
                                the individual's medications 
                                and may result in the creation 
                                of a recommended medication 
                                action plan or other actions in 
                                consultation with the 
                                individual and with input from 
                                the prescriber to the extent 
                                necessary and practicable; and
                                  (II) shall include providing 
                                the individual with a written 
                                or printed summary of the 
                                results of the review.
                        The Secretary, in consultation with 
                        relevant stakeholders, shall develop a 
                        standardized format for the action plan 
                        under subclause (I) and the summary 
                        under subclause (II).
                          (ii) Follow-up interventions as 
                        warranted based on the findings of the 
                        annual medication review or the 
                        targeted medication enrollment and 
                        which may be provided person-to-person 
                        or using telehealth technologies (as 
                        defined by the Secretary).
                  (D) Assessment.--The prescription drug plan 
                sponsor shall have in place a process to 
                assess, at least on a quarterly basis, the 
                medication use of individuals who are at risk 
                but not enrolled in the medication therapy 
                management program, including individuals who 
                have experienced a transition in care, if the 
                prescription drug plan sponsor has access to 
                that information.
                  (E) Automatic enrollment with ability to opt-
                out.--The prescription drug plan sponsor shall 
                have in place a process to--
                          (i) subject to clause (ii), 
                        automatically enroll targeted 
                        beneficiaries described in subparagraph 
                        (A)(ii), including beneficiaries 
                        identified under subparagraph (D), in 
                        the medication therapy management 
                        program required under this subsection; 
                        and
                          (ii) permit such beneficiaries to 
                        opt-out of enrollment in such program.
                  (E) Development of program in cooperation 
                with licensed pharmacists.--Such program shall 
                be developed in cooperation with licensed and 
                practicing pharmacists and physicians.
                  (F) Coordination with care management 
                plans.--The Secretary shall establish 
                guidelines for the coordination of any 
                medication therapy management program under 
                this paragraph with respect to a targeted 
                beneficiary with any care management plan 
                established with respect to such beneficiary 
                under a chronic care improvement program under 
                section 1807.
                  (G) Considerations in pharmacy fees.--The PDP 
                sponsor of a prescription drug plan shall take 
                into account, in establishing fees for 
                pharmacists and others providing services under 
                such plan, the resources used, and time 
                required to, implement the medication therapy 
                management program under this paragraph. Each 
                such sponsor shall disclose to the Secretary 
                upon request the amount of any such management 
                or dispensing fees. The provisions of section 
                1927(b)(3)(D) apply to information disclosed 
                under this subparagraph.
          (3) Reducing wasteful dispensing of outpatient 
        prescription drugs in long-term care facilities.--The 
        Secretary shall require PDP sponsors of prescription 
        drug plans to utilize specific, uniform dispensing 
        techniques, as determined by the Secretary, in 
        consultation with relevant stakeholders (including 
        representatives of nursing facilities, residents of 
        nursing facilities, pharmacists, the pharmacy industry 
        (including retail and long-term care pharmacy), 
        prescription drug plans, MA-PD plans, and any other 
        stakeholders the Secretary determines appropriate), 
        such as weekly, daily, or automated dose dispensing, 
        when dispensing covered part D drugs to enrollees who 
        reside in a long-term care facility in order to reduce 
        waste associated with 30-day fills.
          (4) Requiring valid prescriber national provider 
        identifiers on pharmacy claims.--
                  (A) In general.--For plan year 2016 and 
                subsequent plan years, the Secretary shall 
                require a claim for a covered part D drug for a 
                part D eligible individual enrolled in a 
                prescription drug plan under this part or an 
                MA-PD plan under part C to include a prescriber 
                National Provider Identifier that is determined 
                to be valid under the procedures established 
                under subparagraph (B)(i).
                  (B) Procedures.--
                          (i) Validity of prescriber national 
                        provider identifiers.--The Secretary, 
                        in consultation with appropriate 
                        stakeholders, shall establish 
                        procedures for determining the validity 
                        of prescriber National Provider 
                        Identifiers under subparagraph (A).
                          (ii) Informing beneficiaries of 
                        reason for denial.--The Secretary shall 
                        establish procedures to ensure that, in 
                        the case that a claim for a covered 
                        part D drug of an individual described 
                        in subparagraph (A) is denied because 
                        the claim does not meet the 
                        requirements of this paragraph, the 
                        individual is properly informed at the 
                        point of service of the reason for the 
                        denial.
                  (C) Report.--Not later than January 1, 2018, 
                the Inspector General of the Department of 
                Health and Human Services shall submit to 
                Congress a report on the effectiveness of the 
                procedures established under subparagraph 
                (B)(i).
          (5) Drug management program for at-risk 
        beneficiaries.--
                  (A) Authority to establish.--A PDP sponsor 
                may establish a drug management program for at-
                risk beneficiaries under which, subject to 
                subparagraph (B), the PDP sponsor may, in the 
                case of an at-risk beneficiary for prescription 
                drug abuse who is an enrollee in a prescription 
                drug plan of such PDP sponsor, limit such 
                beneficiary's access to coverage for frequently 
                abused drugs under such plan to frequently 
                abused drugs that are prescribed for such 
                beneficiary by one or more prescribers selected 
                under subparagraph (D), and dispensed for such 
                beneficiary by one or more pharmacies selected 
                under such subparagraph.
                  (B) Requirement for notices.--
                          (i) In general.--A PDP sponsor may 
                        not limit the access of an at-risk 
                        beneficiary for prescription drug abuse 
                        to coverage for frequently abused drugs 
                        under a prescription drug plan until 
                        such sponsor--
                                  (I) provides to the 
                                beneficiary an initial notice 
                                described in clause (ii) and a 
                                second notice described in 
                                clause (iii); and
                                  (II) verifies with the 
                                providers of the beneficiary 
                                that the beneficiary is an at-
                                risk beneficiary for 
                                prescription drug abuse.
                          (ii) Initial notice.--An initial 
                        notice described in this clause is a 
                        notice that provides to the 
                        beneficiary--
                                  (I) notice that the PDP 
                                sponsor has identified the 
                                beneficiary as potentially 
                                being an at-risk beneficiary 
                                for prescription drug abuse;
                                  (II) information describing 
                                all State and Federal public 
                                health resources that are 
                                designed to address 
                                prescription drug abuse to 
                                which the beneficiary has 
                                access, including mental health 
                                services and other counseling 
                                services;
                                  (III) notice of, and 
                                information about, the right of 
                                the beneficiary to appeal such 
                                identification under subsection 
                                (h) and the option of an 
                                automatic escalation to 
                                external review;
                                  (IV) a request for the 
                                beneficiary to submit to the 
                                PDP sponsor preferences for 
                                which prescribers and 
                                pharmacies the beneficiary 
                                would prefer the PDP sponsor to 
                                select under subparagraph (D) 
                                in the case that the 
                                beneficiary is identified as an 
                                at-risk beneficiary for 
                                prescription drug abuse as 
                                described in clause (iii)(I);
                                  (V) an explanation of the 
                                meaning and consequences of the 
                                identification of the 
                                beneficiary as potentially 
                                being an at-risk beneficiary 
                                for prescription drug abuse, 
                                including an explanation of the 
                                drug management program 
                                established by the PDP sponsor 
                                pursuant to subparagraph (A);
                                  (VI) clear instructions that 
                                explain how the beneficiary can 
                                contact the PDP sponsor in 
                                order to submit to the PDP 
                                sponsor the preferences 
                                described in subclause (IV) and 
                                any other communications 
                                relating to the drug management 
                                program for at-risk 
                                beneficiaries established by 
                                the PDP sponsor; and
                                  (VII) contact information for 
                                other organizations that can 
                                provide the beneficiary with 
                                assistance regarding such drug 
                                management program (similar to 
                                the information provided by the 
                                Secretary in other standardized 
                                notices provided to part D 
                                eligible individuals enrolled 
                                in prescription drug plans 
                                under this part).
                          (iii) Second notice.--A second notice 
                        described in this clause is a notice 
                        that provides to the beneficiary 
                        notice--
                                  (I) that the PDP sponsor has 
                                identified the beneficiary as 
                                an at-risk beneficiary for 
                                prescription drug abuse;
                                  (II) that such beneficiary is 
                                subject to the requirements of 
                                the drug management program for 
                                at-risk beneficiaries 
                                established by such PDP sponsor 
                                for such plan;
                                  (III) of the prescriber (or 
                                prescribers) and pharmacy (or 
                                pharmacies) selected for such 
                                individual under subparagraph 
                                (D);
                                  (IV) of, and information 
                                about, the beneficiary's right 
                                to appeal such identification 
                                under subsection (h) and the 
                                option of an automatic 
                                escalation to external review;
                                  (V) that the beneficiary can, 
                                in the case that the 
                                beneficiary has not previously 
                                submitted to the PDP sponsor 
                                preferences for which 
                                prescribers and pharmacies the 
                                beneficiary would prefer the 
                                PDP sponsor select under 
                                subparagraph (D), submit such 
                                preferences to the PDP sponsor; 
                                and
                                  (VI) that includes clear 
                                instructions that explain how 
                                the beneficiary can contact the 
                                PDP sponsor.
                          (iv) Timing of notices.--
                                  (I) In general.--Subject to 
                                subclause (II), a second notice 
                                described in clause (iii) shall 
                                be provided to the beneficiary 
                                on a date that is not less than 
                                30 days after an initial notice 
                                described in clause (ii) is 
                                provided to the beneficiary.
                                  (II) Exception.--In the case 
                                that the PDP sponsor, in 
                                conjunction with the Secretary, 
                                determines that concerns 
                                identified through rulemaking 
                                by the Secretary regarding the 
                                health or safety of the 
                                beneficiary or regarding 
                                significant drug diversion 
                                activities require the PDP 
                                sponsor to provide a second 
                                notice described in clause 
                                (iii) to the beneficiary on a 
                                date that is earlier than the 
                                date described in subclause 
                                (I), the PDP sponsor may 
                                provide such second notice on 
                                such earlier date.
                  (C) At-risk beneficiary for prescription drug 
                abuse.--
                          (i) In general.--For purposes of this 
                        paragraph, the term ``at-risk 
                        beneficiary for prescription drug 
                        abuse'' means a part D eligible 
                        individual who is not an exempted 
                        individual described in clause (ii) 
                        and--
                                  (I) who is identified as such 
                                an at-risk beneficiary through 
                                the use of clinical guidelines 
                                that indicate misuse or abuse 
                                of prescription drugs described 
                                in subparagraph (G) and that 
                                are developed by the Secretary 
                                in consultation with PDP 
                                sponsors and other 
                                stakeholders, including 
                                individuals entitled to 
                                benefits under part A or 
                                enrolled under part B, advocacy 
                                groups representing such 
                                individuals, physicians, 
                                pharmacists, and other 
                                clinicians, retail pharmacies, 
                                plan sponsors, entities 
                                delegated by plan sponsors, and 
                                biopharmaceutical 
                                manufacturers; or
                                  (II) with respect to whom the 
                                PDP sponsor of a prescription 
                                drug plan, upon enrolling such 
                                individual in such plan, 
                                received notice from the 
                                Secretary that such individual 
                                was identified under this 
                                paragraph to be an at-risk 
                                beneficiary for prescription 
                                drug abuse under the 
                                prescription drug plan in which 
                                such individual was most 
                                recently previously enrolled 
                                and such identification has not 
                                been terminated under 
                                subparagraph (F).
                          (ii) Exempted individual described.--
                        An exempted individual described in 
                        this clause is an individual who--
                                  (I) receives hospice care 
                                under this title;
                                  (II) is a resident of a long-
                                term care facility, of a 
                                facility described in section 
                                1905(d), or of another facility 
                                for which frequently abused 
                                drugs are dispensed for 
                                residents through a contract 
                                with a single pharmacy; or
                                  (III) the Secretary elects to 
                                treat as an exempted individual 
                                for purposes of clause (i).
                          (iii) Program size.--The Secretary 
                        shall establish policies, including the 
                        guidelines developed under clause 
                        (i)(I) and the exemptions under clause 
                        (ii)(III), to ensure that the 
                        population of enrollees in a drug 
                        management program for at-risk 
                        beneficiaries operated by a 
                        prescription drug plan can be 
                        effectively managed by such plans.
                          (iv) Clinical contact.--With respect 
                        to each at-risk beneficiary for 
                        prescription drug abuse enrolled in a 
                        prescription drug plan offered by a PDP 
                        sponsor, the PDP sponsor shall contact 
                        the beneficiary's providers who have 
                        prescribed frequently abused drugs 
                        regarding whether prescribed 
                        medications are appropriate for such 
                        beneficiary's medical conditions.
                  (D) Selection of prescribers and 
                pharmacies.--
                          (i) In general.--With respect to each 
                        at-risk beneficiary for prescription 
                        drug abuse enrolled in a prescription 
                        drug plan offered by such sponsor, a 
                        PDP sponsor shall, based on the 
                        preferences submitted to the PDP 
                        sponsor by the beneficiary pursuant to 
                        clauses (ii)(IV) and (iii)(V) of 
                        subparagraph (B) (except as otherwise 
                        provided in this subparagraph) select--
                                  (I) one, or, if the PDP 
                                sponsor reasonably determines 
                                it necessary to provide the 
                                beneficiary with reasonable 
                                access under clause (ii), more 
                                than one, individual who is 
                                authorized to prescribe 
                                frequently abused drugs 
                                (referred to in this paragraph 
                                as a ``prescriber'') who may 
                                write prescriptions for such 
                                drugs for such beneficiary; and
                                  (II) one, or, if the PDP 
                                sponsor reasonably determines 
                                it necessary to provide the 
                                beneficiary with reasonable 
                                access under clause (ii), more 
                                than one, pharmacy that may 
                                dispense such drugs to such 
                                beneficiary.
                        For purposes of subclause (II), in the 
                        case of a pharmacy that has multiple 
                        locations that share real-time 
                        electronic data, all such locations of 
                        the pharmacy shall collectively be 
                        treated as one pharmacy.
                          (ii) Reasonable access.--In making 
                        the selections under this 
                        subparagraph--
                                  (I) a PDP sponsor shall 
                                ensure that the beneficiary 
                                continues to have reasonable 
                                access to frequently abused 
                                drugs (as defined in 
                                subparagraph (G)), taking into 
                                account geographic location, 
                                beneficiary preference, impact 
                                on costsharing, and reasonable 
                                travel time; and
                                  (II) a PDP sponsor shall 
                                ensure such access (including 
                                access to prescribers and 
                                pharmacies with respect to 
                                frequently abused drugs) in the 
                                case of individuals with 
                                multiple residences, in the 
                                case of natural disasters and 
                                similar situations, and in the 
                                case of the provision of 
                                emergency services.
                          (iii) Beneficiary preferences.--If an 
                        at-risk beneficiary for prescription 
                        drug abuse submits preferences for 
                        which in-network prescribers and 
                        pharmacies the beneficiary would prefer 
                        the PDP sponsor select in response to a 
                        notice under subparagraph (B), the PDP 
                        sponsor shall--
                                  (I) review such preferences;
                                  (II) select or change the 
                                selection of prescribers and 
                                pharmacies for the beneficiary 
                                based on such preferences; and
                                  (III) inform the beneficiary 
                                of such selection or change of 
                                selection.
                          (iv) Exception regarding beneficiary 
                        preferences.--In the case that the PDP 
                        sponsor determines that a change to the 
                        selection of prescriber or pharmacy 
                        under clause (iii)(II) by the PDP 
                        sponsor is contributing or would 
                        contribute to prescription drug abuse 
                        or drug diversion by the beneficiary, 
                        the PDP sponsor may change the 
                        selection of prescriber or pharmacy for 
                        the beneficiary without regard to the 
                        preferences of the beneficiary 
                        described in clause (iii). If the PDP 
                        sponsor changes the selection pursuant 
                        to the preceding sentence, the PDP 
                        sponsor shall provide the beneficiary 
                        with--
                                  (I) at least 30 days written 
                                notice of the change of 
                                selection; and
                                  (II) a rationale for the 
                                change.
                          (v) Confirmation.--Before selecting a 
                        prescriber or pharmacy under this 
                        subparagraph, a PDP sponsor must notify 
                        the prescriber and pharmacy that the 
                        beneficiary involved has been 
                        identified for inclusion in the drug 
                        management program for at-risk 
                        beneficiaries and that the prescriber 
                        and pharmacy has been selected as the 
                        beneficiary's designated prescriber and 
                        pharmacy.
                  (E) Terminations and appeals.--The 
                identification of an individual as an at-risk 
                beneficiary for prescription drug abuse under 
                this paragraph, a coverage determination made 
                under a drug management program for at-risk 
                beneficiaries, the selection of prescriber or 
                pharmacy under subparagraph (D), and 
                information to be shared under subparagraph 
                (I), with respect to such individual, shall be 
                subject to reconsideration and appeal under 
                subsection (h) and the option of an automatic 
                escalation to external review to the extent 
                provided by the Secretary.
                  (F) Termination of identification.--
                          (i) In general.--The Secretary shall 
                        develop standards for the termination 
                        of identification of an individual as 
                        an at-risk beneficiary for prescription 
                        drug abuse under this paragraph. Under 
                        such standards such identification 
                        shall terminate as of the earlier of--
                                  (I) the date the individual 
                                demonstrates that the 
                                individual is no longer likely, 
                                in the absence of the 
                                restrictions under this 
                                paragraph, to be an at-risk 
                                beneficiary for prescription 
                                drug abuse described in 
                                subparagraph (C)(i); and
                                  (II) the end of such maximum 
                                period of identification as the 
                                Secretary may specify.
                          (ii) Rule of construction.--Nothing 
                        in clause (i) shall be construed as 
                        preventing a plan from identifying an 
                        individual as an at-risk beneficiary 
                        for prescription drug abuse under 
                        subparagraph (C)(i) after such 
                        termination on the basis of additional 
                        information on drug use occurring after 
                        the date of notice of such termination.
                  (G) Frequently abused drug.--For purposes of 
                this subsection, the term ``frequently abused 
                drug'' means a drug that is a controlled 
                substance that the Secretary determines to be 
                frequently abused or diverted.
                  (H) Data disclosure.--
                          (i) Data on decision to impose 
                        limitation.--In the case of an at-risk 
                        beneficiary for prescription drug abuse 
                        (or an individual who is a potentially 
                        at-risk beneficiary for prescription 
                        drug abuse) whose access to coverage 
                        for frequently abused drugs under a 
                        prescription drug plan has been limited 
                        by a PDP sponsor under this paragraph, 
                        the Secretary shall establish rules and 
                        procedures to require the PDP sponsor 
                        to disclose data, including any 
                        necessary individually identifiable 
                        health information, in a form and 
                        manner specified by the Secretary, 
                        about the decision to impose such 
                        limitations and the limitations imposed 
                        by the sponsor under this part.
                          (ii) Data to reduce fraud, abuse, and 
                        waste.--The Secretary shall establish 
                        rules and procedures to require PDP 
                        sponsors operating a drug management 
                        program for at-risk beneficiaries under 
                        this paragraph to provide the Secretary 
                        with such data as the Secretary 
                        determines appropriate for purposes of 
                        identifying patterns of prescription 
                        drug utilization for plan enrollees 
                        that are outside normal patterns and 
                        that may indicate fraudulent, medically 
                        unnecessary, or unsafe use.
                  (I) Sharing of information for subsequent 
                plan enrollments.--The Secretary shall 
                establish procedures under which PDP sponsors 
                who offer prescription drug plans shall share 
                information with respect to individuals who are 
                at-risk beneficiaries for prescription drug 
                abuse (or individuals who are potentially at-
                risk beneficiaries for prescription drug abuse) 
                and enrolled in a prescription drug plan and 
                who subsequently disenroll from such plan and 
                enroll in another prescription drug plan 
                offered by another PDP sponsor.
                  (J) Privacy issues.--Prior to the 
                implementation of the rules and procedures 
                under this paragraph, the Secretary shall 
                clarify privacy requirements, including 
                requirements under the regulations promulgated 
                pursuant to section 264(c) of the Health 
                Insurance Portability and Accountability Act of 
                1996 (42 U.S.C. 1320d-2 note), related to the 
                sharing of data under subparagraphs (H) and (I) 
                by PDP sponsors. Such clarification shall 
                provide that the sharing of such data shall be 
                considered to be protected health information 
                in accordance with the requirements of the 
                regulations promulgated pursuant to such 
                section 264(c).
                  (K) Education.--The Secretary shall provide 
                education to enrollees in prescription drug 
                plans of PDP sponsors and providers regarding 
                the drug management program for at-risk 
                beneficiaries described in this paragraph, 
                including education--
                          (i) provided by Medicare 
                        administrative contractors through the 
                        improper payment outreach and education 
                        program described in section 1874A(h); 
                        and
                          (ii) through current education 
                        efforts (such as State health insurance 
                        assistance programs described in 
                        subsection (a)(1)(A) of section 119 of 
                        the Medicare Improvements for Patients 
                        and Providers Act of 2008 (42 U.S.C. 
                        1395b-3 note)) and materials directed 
                        toward such enrollees.
                  (L) Application under ma-pd plans.--Pursuant 
                to section 1860D-21(c)(1), the provisions of 
                this paragraph apply under part D to MA 
                organizations offering MA-PD plans to MA 
                eligible individuals in the same manner as such 
                provisions apply under this part to a PDP 
                sponsor offering a prescription drug plan to a 
                part D eligible individual.
                  (M) CMS compliance review.--The Secretary 
                shall ensure that existing plan sponsor 
                compliance reviews and audit processes include 
                the drug management programs for at-risk 
                beneficiaries under this paragraph, including 
                appeals processes under such programs.
          (6) Utilization management tool to prevent drug 
        abuse.--
                  (A) In general.--A tool described in this 
                paragraph is any of the following:
                          (i) A utilization tool designed to 
                        prevent the abuse of frequently abused 
                        drugs by individuals and to prevent the 
                        diversion of such drugs at pharmacies.
                          (ii) Retrospective utilization review 
                        to identify--
                                  (I) individuals that receive 
                                frequently abused drugs at a 
                                frequency or in amounts that 
                                are not clinically appropriate; 
                                and
                                  (II) providers of services or 
                                suppliers that may facilitate 
                                the abuse or diversion of 
                                frequently abused drugs by 
                                beneficiaries.
                          (iii) Consultation with the 
                        contractor described in subparagraph 
                        (B) to verify if an individual 
                        enrolling in a prescription drug plan 
                        offered by a PDP sponsor has been 
                        previously identified by another PDP 
                        sponsor as an individual described in 
                        clause (ii)(I).
                  (B) Reporting.--A PDP sponsor offering a 
                prescription drug plan (and an MA organization 
                offering an MA-PD plan) in a State shall submit 
                to the Secretary and the Medicare drug 
                integrity contractor with which the Secretary 
                has entered into a contract under section 1893 
                with respect to such State a report, on a 
                monthly basis, containing information on--
                          (i) any provider of services or 
                        supplier described in subparagraph 
                        (A)(ii)(II) that is identified by such 
                        plan sponsor (or organization) during 
                        the 30-day period before such report is 
                        submitted; and
                          (ii) the name and prescription 
                        records of individuals described in 
                        paragraph (5)(C).
                  (C) CMS compliance review.--The Secretary 
                shall ensure that plan sponsor compliance 
                reviews and program audits biennially include a 
                certification that utilization management tools 
                under this paragraph are in compliance with the 
                requirements for such tools.
          (6) Providing prescription drug plans with parts a 
        and b claims data to promote the appropriate use of 
        medications and improve health outcomes.--
                  (A) Process.--Subject to subparagraph (B), 
                the Secretary shall establish a process under 
                which a PDP sponsor of a prescription drug plan 
                may submit a request for the Secretary to 
                provide the sponsor, on a periodic basis and in 
                an electronic format, beginning in plan year 
                2020, data described in subparagraph (D) with 
                respect to enrollees in such plan. Such data 
                shall be provided without regard to whether 
                such enrollees are described in clause (ii) of 
                paragraph (2)(A).
                  (B) Purposes.--A PDP sponsor may use the data 
                provided to the sponsor pursuant to 
                subparagraph (A) for any of the following 
                purposes:
                          (i) To optimize therapeutic outcomes 
                        through improved medication use, as 
                        such phrase is used in clause (i) of 
                        paragraph (2)(A).
                          (ii) To improving care coordination 
                        so as to prevent adverse health 
                        outcomes, such as preventable emergency 
                        department visits and hospital 
                        readmissions.
                          (iii) For any other purpose 
                        determined appropriate by the 
                        Secretary.
                  (C) Limitations on data use.--A PDP sponsor 
                shall not use data provided to the sponsor 
                pursuant to subparagraph (A) for any of the 
                following purposes:
                          (i) To inform coverage determinations 
                        under this part.
                          (ii) To conduct retroactive reviews 
                        of medically accepted indications 
                        determinations.
                          (iii) To facilitate enrollment 
                        changes to a different prescription 
                        drug plan or an MA-PD plan offered by 
                        the same parent organization.
                          (iv) To inform marketing of benefits.
                          (v) For any other purpose that the 
                        Secretary determines is necessary to 
                        include in order to protect the 
                        identity of individuals entitled to, or 
                        enrolled for, benefits under this title 
                        and to protect the security of personal 
                        health information.
                  (D) Data described.--The data described in 
                this clause are standardized extracts (as 
                determined by the Secretary) of claims data 
                under parts A and B for items and services 
                furnished under such parts for time periods 
                specified by the Secretary. Such data shall 
                include data as current as practicable.
  (d) Consumer Satisfaction Surveys.--In order to provide for 
comparative information under section 1860D-1(c)(3)(A)(v), the 
Secretary shall conduct consumer satisfaction surveys with 
respect to PDP sponsors and prescription drug plans in a manner 
similar to the manner such surveys are conducted for MA 
organizations and MA plans under part C.
  (e) Electronic Prescription Program.--
          (1) Application of standards.--As of such date as the 
        Secretary may specify, but not later than 1 year after 
        the date of promulgation of final standards under 
        paragraph (4)(D), prescriptions and other information 
        described in paragraph (2)(A) for covered part D drugs 
        prescribed for part D eligible individuals that are 
        transmitted electronically shall be transmitted only in 
        accordance with such standards under an electronic 
        prescription drug program that meets the requirements 
        of paragraph (2).
          (2) Program requirements.--Consistent with uniform 
        standards established under paragraph (3)--
                  (A) Provision of information to prescribing 
                health care professional and dispensing 
                pharmacies and pharmacists.--An electronic 
                prescription drug program shall provide for the 
                electronic transmittal to the prescribing 
                health care professional and to the dispensing 
                pharmacy and pharmacist of the prescription and 
                information on eligibility and benefits 
                (including the drugs included in the applicable 
                formulary, any tiered formulary structure, and 
                any requirements for prior authorization) and 
                of the following information with respect to 
                the prescribing and dispensing of a covered 
                part D drug:
                          (i) Information on the drug being 
                        prescribed or dispensed and other drugs 
                        listed on the medication history, 
                        including information on drug-drug 
                        interactions, warnings or cautions, 
                        and, when indicated, dosage 
                        adjustments.
                          (ii) Information on the availability 
                        of lower cost, therapeutically 
                        appropriate alternatives (if any) for 
                        the drug prescribed.
                  (B) Application to medical history 
                information.--Effective on and after such date 
                as the Secretary specifies and after the 
                establishment of appropriate standards to carry 
                out this subparagraph, the program shall 
                provide for the electronic transmittal in a 
                manner similar to the manner under subparagraph 
                (A) of information that relates to the medical 
                history concerning the individual and related 
                to a covered part D drug being prescribed or 
                dispensed, upon request of the professional or 
                pharmacist involved.
                  (C) Limitations.--Information shall only be 
                disclosed under subparagraph (A) or (B) if the 
                disclosure of such information is permitted 
                under the Federal regulations (concerning the 
                privacy of individually identifiable health 
                information) promulgated under section 264(c) 
                of the Health Insurance Portability and 
                Accountability Act of 1996.
                  (D) Timing.--To the extent feasible, the 
                information exchanged under this paragraph 
                shall be on an interactive, real-time basis.
          (3) Standards.--
                  (A) In general.--The Secretary shall provide 
                consistent with this subsection for the 
                promulgation of uniform standards relating to 
                the requirements for electronic prescription 
                drug programs under paragraph (2).
                  (B) Objectives.--Such standards shall be 
                consistent with the objectives of improving--
                          (i) patient safety;
                          (ii) the quality of care provided to 
                        patients; and
                          (iii) efficiencies, including cost 
                        savings, in the delivery of care.
                  (C) Design criteria.--Such standards shall--
                          (i) be designed so that, to the 
                        extent practicable, the standards do 
                        not impose an undue administrative 
                        burden on prescribing health care 
                        professionals and dispensing pharmacies 
                        and pharmacists;
                          (ii) be compatible with standards 
                        established under part C of title XI, 
                        standards established under subsection 
                        (b)(2)(B)(i), and with general health 
                        information technology standards; and
                          (iii) be designed so that they permit 
                        electronic exchange of drug labeling 
                        and drug listing information maintained 
                        by the Food and Drug Administration and 
                        the National Library of Medicine.
                  (D) Permitting use of appropriate 
                messaging.--Such standards shall allow for the 
                messaging of information only if it relates to 
                the appropriate prescribing of drugs, including 
                quality assurance measures and systems referred 
                to in subsection (c)(1)(B).
                  (E) Permitting patient designation of 
                dispensing pharmacy.--
                          (i) In general.--Consistent with 
                        clause (ii), such standards shall 
                        permit a part D eligible individual to 
                        designate a particular pharmacy to 
                        dispense a prescribed drug.
                          (ii) No change in benefits.--Clause 
                        (i) shall not be construed as 
                        affecting--
                                  (I) the access required to be 
                                provided to pharmacies by a 
                                prescription drug plan; or
                                  (II) the application of any 
                                differences in benefits or 
                                payments under such a plan 
                                based on the pharmacy 
                                dispensing a covered part D 
                                drug.
          (4) Development, promulgation, and modification of 
        standards.--
                  (A) Initial standards.--Not later than 
                September 1, 2005, the Secretary shall develop, 
                adopt, recognize, or modify initial uniform 
                standards relating to the requirements for 
                electronic prescription drug programs described 
                in paragraph (2) taking into consideration the 
                recommendations (if any) from the National 
                Committee on Vital and Health Statistics (as 
                established under section 306(k) of the Public 
                Health Service Act (42 U.S.C. 242k(k))) under 
                subparagraph (B).
                  (B) Role of ncvhs.--The National Committee on 
                Vital and Health Statistics shall develop 
                recommendations for uniform standards relating 
                to such requirements in consultation with the 
                following:
                          (i) Standard setting organizations 
                        (as defined in section 1171(8))
                          (ii) Practicing physicians.
                          (iii) Hospitals.
                          (iv) Pharmacies.
                          (v) Practicing pharmacists.
                          (vi) Pharmacy benefit managers.
                          (vii) State boards of pharmacy.
                          (viii) State boards of medicine.
                          (ix) Experts on electronic 
                        prescribing.
                          (x) Other appropriate Federal 
                        agencies.
                  (C) Pilot project to test initial 
                standards.--
                          (i) In general.--During the 1-year 
                        period that begins on January 1, 2006, 
                        the Secretary shall conduct a pilot 
                        project to test the initial standards 
                        developed under subparagraph (A) prior 
                        to the promulgation of the final 
                        uniform standards under subparagraph 
                        (D) in order to provide for the 
                        efficient implementation of the 
                        requirements described in paragraph 
                        (2).
                          (ii) Exception.--Pilot testing of 
                        standards is not required under clause 
                        (i) where there already is adequate 
                        industry experience with such 
                        standards, as determined by the 
                        Secretary after consultation with 
                        effected standard setting organizations 
                        and industry users.
                          (iii) Voluntary participation of 
                        physicians and pharmacies.--In order to 
                        conduct the pilot project under clause 
                        (i), the Secretary shall enter into 
                        agreements with physicians, physician 
                        groups, pharmacies, hospitals, PDP 
                        sponsors, MA organizations, and other 
                        appropriate entities under which health 
                        care professionals electronically 
                        transmit prescriptions to dispensing 
                        pharmacies and pharmacists in 
                        accordance with such standards.
                          (iv) Evaluation and report.--
                                  (I) Evaluation.--The 
                                Secretary shall conduct an 
                                evaluation of the pilot project 
                                conducted under clause (i).
                                  (II) Report to congress.--Not 
                                later than April 1, 2007, the 
                                Secretary shall submit to 
                                Congress a report on the 
                                evaluation conducted under 
                                subclause (I).
                  (D) Final standards.--Based upon the 
                evaluation of the pilot project under 
                subparagraph (C)(iv)(I) and not later than 
                April 1, 2008, the Secretary shall promulgate 
                uniform standards relating to the requirements 
                described in paragraph (2).
          (5) Relation to state laws.--The standards 
        promulgated under this subsection shall supersede any 
        State law or regulation that--
                  (A) is contrary to the standards or restricts 
                the ability to carry out this part; and
                  (B) pertains to the electronic transmission 
                of medication history and of information on 
                eligibility, benefits, and prescriptions with 
                respect to covered part D drugs under this 
                part.
          (6) Establishment of safe harbor.--The Secretary, in 
        consultation with the Attorney General, shall 
        promulgate regulations that provide for a safe harbor 
        from sanctions under paragraphs (1) and (2) of section 
        1128B(b) and an exception to the prohibition under 
        subsection (a)(1) of section 1877 with respect to the 
        provision of nonmonetary remuneration (in the form of 
        hardware, software, or information technology and 
        training services) necessary and used solely to receive 
        and transmit electronic prescription information in 
        accordance with the standards promulgated under this 
        subsection--
                  (A) in the case of a hospital, by the 
                hospital to members of its medical staff;
                  (B) in the case of a group practice (as 
                defined in section 1877(h)(4)), by the practice 
                to prescribing health care professionals who 
                are members of such practice; and
                  (C) in the case of a PDP sponsor or MA 
                organization, by the sponsor or organization to 
                pharmacists and pharmacies participating in the 
                network of such sponsor or organization, and to 
                prescribing health care professionals.
          (7) Requirement of e-prescribing for controlled 
        substances.--
                  (A) In general.--Subject to subparagraph (B), 
                a prescription for a covered part D drug under 
                a prescription drug plan (or under an MA-PD 
                plan) for a schedule II, III, IV, or V 
                controlled substance shall be transmitted by a 
                health care practitioner electronically in 
                accordance with an electronic prescription drug 
                program that meets the requirements of 
                paragraph (2).
                  (B) Exception for certain circumstances.--The 
                Secretary shall, pursuant to rulemaking, 
                specify circumstances with respect to which the 
                Secretary may waive the requirement under 
                subparagraph (A), with respect to a covered 
                part D drug, including in the case of--
                          (i) a prescription issued when the 
                        practitioner and dispenser are the same 
                        entity;
                          (ii) a prescription issued that 
                        cannot be transmitted electronically 
                        under the most recently implemented 
                        version of the National Council for 
                        Prescription Drug Programs SCRIPT 
                        Standard;
                          (iii) a prescription issued by a 
                        practitioner who has received a waiver 
                        or a renewal thereof for a specified 
                        period determined by the Secretary, not 
                        to exceed one year, from the 
                        requirement to use electronic 
                        prescribing, pursuant to a process 
                        established by regulation by the 
                        Secretary, due to demonstrated economic 
                        hardship, technological limitations 
                        that are not reasonably within the 
                        control of the practitioner, or other 
                        exceptional circumstance demonstrated 
                        by the practitioner;
                          (iv) a prescription issued by a 
                        practitioner under circumstances in 
                        which, notwithstanding the 
                        practitioner's ability to submit a 
                        prescription electronically as required 
                        by this subsection, such practitioner 
                        reasonably determines that it would be 
                        impractical for the individual involved 
                        to obtain substances prescribed by 
                        electronic prescription in a timely 
                        manner, and such delay would adversely 
                        impact the individual's medical 
                        condition involved;
                          (v) a prescription issued by a 
                        practitioner allowing for the 
                        dispensing of a non-patient specific 
                        prescription pursuant to a standing 
                        order, approved protocol for drug 
                        therapy, collaborative drug management, 
                        or comprehensive medication management, 
                        in response to a public health 
                        emergency, or other circumstances where 
                        the practitioner may issue a non-
                        patient specific prescription;
                          (vi) a prescription issued by a 
                        practitioner prescribing a drug under a 
                        research protocol;
                          (vii) a prescription issued by a 
                        practitioner for a drug for which the 
                        Food and Drug Administration requires a 
                        prescription to contain elements that 
                        are not able to be included in 
                        electronic prescribing, such as a drug 
                        with risk evaluation and mitigation 
                        strategies that include elements to 
                        assure safe use; and
                          (viii) a prescription issued by a 
                        practitioner for an individual who--
                                  (I) receives hospice care 
                                under this title; or
                                  (II) is a resident of a 
                                skilled nursing facility (as 
                                defined in section 1819(a)), or 
                                a medical institution or 
                                nursing facility for which 
                                payment is made for an 
                                institutionalized individual 
                                under section 1902(q)(1)(B), 
                                for which frequently abused 
                                drugs are dispensed for 
                                residents through a contract 
                                with a single pharmacy, as 
                                determined by the Secretary in 
                                accordance with this paragraph.
                  (C) Dispensing.--Nothing in this paragraph 
                shall be construed as requiring a sponsor of a 
                prescription drug plan under this part, MA 
                organization offering an MA-PD plan under part 
                C, or a pharmacist to verify that a 
                practitioner, with respect to a prescription 
                for a covered part D drug, has a waiver (or is 
                otherwise exempt) under subparagraph (B) from 
                the requirement under subparagraph (A). Nothing 
                in this paragraph shall be construed as 
                affecting the ability of the plan to cover or 
                the pharmacists' ability to continue to 
                dispense covered part D drugs from otherwise 
                valid written, oral or fax prescriptions that 
                are consistent with laws and regulations. 
                Nothing in this paragraph shall be construed as 
                affecting the ability of the beneficiary 
                involved to designate a particular pharmacy to 
                dispense a prescribed drug to the extent 
                consistent with the requirements under 
                subsection (b)(1) and under this paragraph.
                  (D) Enforcement.--The Secretary shall, 
                pursuant to rulemaking, have authority to 
                enforce and specify appropriate penalties for 
                non-compliance with the requirement under 
                subparagraph (A).
  (f) Grievance Mechanism.--Each PDP sponsor shall provide 
meaningful procedures for hearing and resolving grievances 
between the sponsor (including any entity or individual through 
which the sponsor provides covered benefits) and enrollees with 
prescription drug plans of the sponsor under this part in 
accordance with section 1852(f).
  (g) Coverage Determinations and Reconsiderations.--
          (1) Application of coverage determination and 
        reconsideration provisions.--A PDP sponsor shall meet 
        the requirements of paragraphs (1) through (3) of 
        section 1852(g) with respect to covered benefits under 
        the prescription drug plan it offers under this part in 
        the same manner as such requirements apply to an MA 
        organization with respect to benefits it offers under 
        an MA plan under part C.
          (2) Request for a determination for the treatment of 
        tiered formulary drug.--In the case of a prescription 
        drug plan offered by a PDP sponsor that provides for 
        tiered cost-sharing for drugs included within a 
        formulary and provides lower cost-sharing for preferred 
        drugs included within the formulary, a part D eligible 
        individual who is enrolled in the plan may request an 
        exception to the tiered cost-sharing structure. Under 
        such an exception, a nonpreferred drug could be covered 
        under the terms applicable for preferred drugs if the 
        prescribing physician determines that the preferred 
        drug for treatment of the same condition either would 
        not be as effective for the individual or would have 
        adverse effects for the individual or both. A PDP 
        sponsor shall have an exceptions process under this 
        paragraph consistent with guidelines established by the 
        Secretary for making a determination with respect to 
        such a request. Denial of such an exception shall be 
        treated as a coverage denial for purposes of applying 
        subsection (h).
  (h) Appeals.--
          (1) In general.--Subject to paragraph (2), a PDP 
        sponsor shall meet the requirements of paragraphs (4) 
        and (5) of section 1852(g) with respect to benefits 
        (including a determination related to the application 
        of tiered cost-sharing described in subsection (g)(2)) 
        in a manner similar (as determined by the Secretary) to 
        the manner such requirements apply to an MA 
        organization with respect to benefits under the 
        original medicare fee-for-service program option it 
        offers under an MA plan under part C. In applying this 
        paragraph only the part D eligible individual shall be 
        entitled to bring such an appeal.
          (2) Limitation in cases on nonformulary 
        determinations.--A part D eligible individual who is 
        enrolled in a prescription drug plan offered by a PDP 
        sponsor may appeal under paragraph (1) a determination 
        not to provide for coverage of a covered part D drug 
        that is not on the formulary under the plan only if the 
        prescribing physician determines that all covered part 
        D drugs on any tier of the formulary for treatment of 
        the same condition would not be as effective for the 
        individual as the nonformulary drug, would have adverse 
        effects for the individual, or both.
          (3) Treatment of nonformulary determinations.--If a 
        PDP sponsor determines that a plan provides coverage 
        for a covered part D drug that is not on the formulary 
        of the plan, the drug shall be treated as being 
        included on the formulary for purposes of section 
        1860D-2(b)(4)(C)(i).
  (i) Privacy, Confidentiality, and Accuracy of Enrollee 
Records.--The provisions of section 1852(h) shall apply to a 
PDP sponsor and prescription drug plan in the same manner as it 
applies to an MA organization and an MA plan.
  (j) Treatment of Accreditation.--Subparagraph (A) of section 
1852(e)(4) (relating to treatment of accreditation) shall apply 
to a PDP sponsor under this part with respect to the following 
requirements, in the same manner as it applies to an MA 
organization with respect to the requirements in subparagraph 
(B) (other than clause (vii) thereof) of such section:
          (1) Subsection (b) of this section (relating to 
        access to covered part D drugs).
          (2) Subsection (c) of this section (including quality 
        assurance and medication therapy management).
          (3) Subsection (i) of this section (relating to 
        confidentiality and accuracy of enrollee records).
  (k) Public Disclosure of Pharmaceutical Prices for Equivalent 
Drugs.--
          (1) In general.--A PDP sponsor offering a 
        prescription drug plan shall provide that each pharmacy 
        that dispenses a covered part D drug shall inform an 
        enrollee of any differential between the price of the 
        drug to the enrollee and the price of the lowest priced 
        generic covered part D drug under the plan that is 
        therapeutically equivalent and bioequivalent and 
        available at such pharmacy.
          (2) Timing of notice.--
                  (A) In general.--Subject to subparagraph (B), 
                the information under paragraph (1) shall be 
                provided at the time of purchase of the drug 
                involved, or, in the case of dispensing by mail 
                order, at the time of delivery of such drug.
                  (B) Waiver.--The Secretary may waive 
                subparagraph (A) in such circumstances as the 
                Secretary may specify.
  (l) Requirements with Respect to Sales and Marketing 
Activities.--The following provisions shall apply to a PDP 
sponsor (and the agents, brokers, and other third parties 
representing such sponsor) in the same manner as such 
provisions apply to a Medicare Advantage organization (and the 
agents, brokers, and other third parties representing such 
organization):
          (1) The prohibition under section 1851(h)(4)(C) on 
        conducting activities described in section 1851(j)(1).
          (2) The requirement under section 1851(h)(4)(D) to 
        conduct activities described in section 1851(j)(2) in 
        accordance with the limitations established under such 
        subsection.
          (3) The inclusion of the plan type in the plan name 
        under section 1851(h)(6).
          (4) The requirements regarding the appointment of 
        agents and brokers and compliance with State 
        information requests under subparagraphs (A) and (B), 
        respectively, of section 1851(h)(7).

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