79–006 

115TH CONGRESS REPORT " ! HOUSE OF REPRESENTATIVES 2d Session 115–730 

AMENDING TITLE XIX OF THE SOCIAL SECURITY ACT TO PROVIDE FOR 

MEDICAID COVERAGE PROTECTIONS FOR PREGNANT AND POSTPARTUM WOMEN WHILE RECEIVING INPATIENT TREATMENT FOR A 

SUBSTANCE USE DISORDER, AND FOR OTHER PURPOSES 

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. 5789] 

[Including cost estimate of the Congressional Budget Office] 

The Committee on Energy and Commerce, to whom was referred 

the bill (H.R. 5789) to amend title XIX of the Social Security Act 

to provide for Medicaid coverage protections for pregnant and postpartum women while receiving inpatient treatment for a substance 

use disorder, and for other purposes, having considered the same, 

report favorably thereon with amendments and recommend that 

the bill as amended do pass. 

CONTENTS 

Page 

Purpose and Summary ............................................................................................ 2 

Background and Need for Legislation .................................................................... 2 

Committee Action .................................................................................................... 5 

Committee Votes ...................................................................................................... 5 

Oversight Findings and Recommendations ........................................................... 5 

New Budget Authority, Entitlement Authority, and Tax Expenditures ............. 5 

Congressional Budget Office Estimate ................................................................... 5 

Federal Mandates Statement ................................................................................. 27 

Statement of General Performance Goals and Objectives .................................... 27 

Duplication of Federal Programs ............................................................................ 27 

Committee Cost Estimate ....................................................................................... 27 

Earmark, Limited Tax Benefits, and Limited Tariff Benefits ............................. 28 

Disclosure of Directed Rule Makings ..................................................................... 28 

Advisory Committee Statement .............................................................................. 28 

Applicability to Legislative Branch ........................................................................ 28 

Section-by-Section Analysis of the Legislation ...................................................... 28 

Changes in Existing Law Made by the Bill, as Reported ..................................... 28 

The amendments are as follows: 

Strike all after the enacting clause and insert the following: 

2 

1 Centers for Disease Control and Prevention. ‘‘Drug Overdose Death Data.’’ December 19, 

2017. Available at https://www.cdc.gov/drugoverdose/data/statedeaths.html. 

SECTION 1. GUIDANCE TO IMPROVE CARE FOR INFANTS WITH NEONATAL ABSTINENCE SYNDROME AND THEIR MOTHERS; GAO STUDY ON GAPS IN MEDICAID COVERAGE FOR 

PREGNANT AND POSTPARTUM WOMEN WITH SUBSTANCE USE DISORDER. 

(a) GUIDANCE.—Not later than one year after the date of the enactment of this 

Act, the Secretary of Health and Human Services shall issue guidance to improve 

care for infants with neonatal abstinence syndrome and their mothers. Such guidance shall include— 

(1) the types of services, including post-discharge services and parenting supports, for mothers and fathers of babies with neonatal abstinence syndrome that 

States may cover under the Medicaid program under title XIX of the Social Security Act; 

(2) best practices from States with respect to innovative or evidenced-based 

payment models that focus on prevention, screening, treatment, plans of safe 

care, and post-discharge services for mothers and fathers with substance use 

disorders and babies with neonatal abstinence syndrome that improve care and 

clinical outcomes; 

(3) recommendations for States on available financing options under the Medicaid program under title XIX of such Act and under the Children’s Health Insurance Program under title XXI of such Act for Children’s Health Insurance 

Program Health Services Initiative funds for parents with substance use disorders, infants with neonatal abstinence syndrome, and home visiting services; 

and 

(4) guidance and technical assistance to State Medicaid agencies regarding 

additional flexibilities and incentives related to screening, prevention, and postdischarge services, including parenting supports, under contracts with medicaid 

managed care organizations. 

(b) GAO STUDY.—Not later than one year after the date of the enactment of this 

Act, the Comptroller General of the United States shall conduct a study, and submit 

to Congress a report, addressing gaps in coverage for pregnant women with substance use disorder under the Medicaid program under title XIX of the Social Security Act, and gaps in coverage for postpartum women with substance use disorder 

who had coverage during their pregnancy under the Medicaid program under such 

title. 

Amend the title so as to read: 

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 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. 

PURPOSE AND SUMMARY

H.R. 5789 was introduced on May 15, 2018, by Rep. Bill Foster 

(D–IL). The bill requires the Secretary of Health and Human Services to issue guidance to improve care for infants with neonatal abstinence syndrome and their mothers. The bill also requires 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. 

BACKGROUND AND NEED FOR LEGISLATION

Deaths due to overdoses of opioids and other drugs have ravaged 

American communities. According to the Centers for Disease Control and Prevention (CDC), on average, 1,000 people are treated for 

opioid misuse in emergency departments per day, an average of 

115 Americans die per day, and opioid-related overdoses have increased steadily since 1999.1

While the impacts to Americans’ health outcomes are staggering, 

the opioid crisis has negatively impacted society in numerous ways. 

3 

2Dowell, D., Arias E., Kochanek K. et al. ‘‘Contribution of Opioid-Involved Poisoning to the 

Change in Life Expectancy in the United States, 2000–2015.’’ JAMA, September 2017. Available 

at https://jamanetwork.com/journals/jama/fullarticle/2654372. 3 American Action Forum. ‘‘The Labor Force and Output Consequences of the Opioid Crisis.’’ 

March 27, 2018. Available at https://www.americanactionforum.org/research/labor-force-outputconsequences-opioid-crisis/. 4 American Enterprise Institute. ‘‘The Geographic Variation in the Cost of the Opioid Crisis’’. 

Available at https://www.aei.org/wp-content/uploads/2018/03/Geographic_Variation_in_Cost_of_ Opioid_Crisis.pdf. 5Kaiser Family Foundation, ‘‘A Look at How the Opioid Crisis Has Affected People with Employer Coverage,’’ April 2018. Available online at: https://www.kff.org/health-costs/press-release/ 

analysis-cost-of-treating-opioid-addiction-rose-rapidly-for-large-employers-as-the-number-of-prescriptions-has-declined/. 6Government Accountability Office, ‘‘Medicaid: States Fund Services for Adults in Institutions 

for Mental Disease Using a Variety of Strategies,’’ GAO–17–652, August 2017. Available at 

https://www.gao.gov/assets/690/686456.pdf. 7Medicaid and CHIP Payment and Access Commission, ‘‘Medicaid and the Opioid Epidemic,’’ 

Chapter 2 in June 2017 Report to Congress on Medicaid and CHIP. Available at: https:// 

www.macpac.gov/wp-content/uploads/2017/06/Medicaid-and-the-Opioid-Epidemic.pdf. 8Kaiser Family Foundation. ‘‘Medicaid’s Role in Addressing the Opioid Epidemic.’’ Available 

at https://www.kff.org/infographic/medicaids-role-in-addressing-opioid-epidemic/. 9Kaiser Family Foundation. ‘‘Medicaid’s Role in Addressing the Opioid Epidemic.’’ Available 

at https://www.kff.org/infographic/medicaids-role-in-addressing-opioid-epidemic/. 10Medicaid and CHIP Payment and Access Commission, ‘‘Medicaid and the Opioid Epidemic,’’ 

Chapter 2 in June 2017 Report to Congress on Medicaid and CHIP. Available at: https:// 

www.macpac.gov/wp-content/uploads/2017/06/Medicaid-and-the-Opioid-Epidemic.pdf. 

The Centers for Disease Control and Prevention note that life expectancy dropped in 2015 and 2016 and that one of the reasons 

was an increase in unintentional injuries, a category that includes 

drug overdoses.2 The opioid crisis has also resulted in a contraction 

in the labor force by almost 1 million workers in the years between 

1999 and 2015, which resulted in a loss of $702 billion in real output.3 In 2015, the total economic burden of the opioid epidemic was estimated to be $504 billion.4 While all states were negatively impacted, there is geographic variation in the burden. West Virginia 

had the greatest loss per person ($4,378) and Nebraska had the 

lowest loss per person ($394).4 One recent analysis found that the 

annual cost for private sector employers for treating opioid addiction and overdoses has increased more than eight-fold since 2004, 

and more than one in five persons aged 55 to 64 had at least one 

opioid prescription in 2016.5

Medicaid is the largest source of federal funding for behavioral 

health services—mental health and substance use disorder services—with nearly $71 billion in projected 2017 spending.6 As the 

Medicaid and CHIP Payment and Access Commission (MACPAC) 

stated in 2017, ‘‘the opioid epidemic, which has reached most communities across the U.S., disproportionately affects Medicaid beneficiaries.’’ 7 Of the two million non-elderly Americans with opioid 

addiction, Medicaid provides health coverage for an estimated 38 

percent of this population, which is the largest percentage of any 

insurer type.8 Medicaid provides care to 4 in 10 adults with opioid 

use disorder and compared to other insurance types, provides a significantly higher percentage of inpatient and outpatient substance 

use disorder treatment.9

MACPAC found that ‘‘Medicaid beneficiaries are prescribed pain 

relievers at higher rates than those with other sources of insurance. They also have a higher risk of overdose and other negative 

outcomes, from both prescription opioids and illegal opioids such as 

heroin and illicitly manufactured fentanyl.’’ 10 Not only are the 

number of Medicaid beneficiaries with opioid misuse disproportionately high, so too are the number of overdoses. Studies from North 

Carolina and Washington indicate high rates of opioid-related 

4 

11See SAMHSA website. Available at: https://www.samhsa.gov/medication-assisted-treatment. 12Medicaid and CHIP Payment and Access Commission, ‘‘Medicaid and the Opioid Epidemic,’’ 

Chapter 2 in June 2017 Report to Congress on Medicaid and CHIP. Available at: https:// 

www.macpac.gov/wp-content/uploads/2017/06/Medicaid-and-the-Opioid-Epidemic.pdf. 13Medicaid and CHIP Payment and Access Commission, ‘‘Medicaid and the Opioid Epidemic,’’ 

Chapter 2 in June 2017 Report to Congress on Medicaid and CHIP. Available at: https:// 

www.macpac.gov/wp-content/uploads/2017/06/Medicaid-and-the-Opioid-Epidemic.pdf. 14Medicaid and CHIP Payment and Access Commission, ‘‘Medicaid and the Opioid Epidemic,’’ 

Chapter 2 in June 2017 Report to Congress on Medicaid and CHIP. Available at: https:// 

www.macpac.gov/wp-content/uploads/2017/06/Medicaid-and-the-Opioid-Epidemic.pdf. 15 Jason, N., Gastonguay, M., Adeniyi-Jones, M. D., Susan, C., Moody, D. E., Kraft, M. D., & 

Walter, K. (2017). Population Pharmacokinetic and Pharmacodynamic Analysis of 

Buprenorphine for the Treatment of Neonatal Abstinence Syndrome. 16Winkleman, T.N, Villipiano, N., Davis, M.M., & Patrick, S.W. ‘‘Incidence and Costs of Neonatal Abstinence Syndrome among Infants with Medicaid: 2004–2014,’’ Pediatrics, April 2018, 

141(4), 2017–3520. 

deaths for the Medicaid population (33 percent and 45 percent, respectively). 

For treatment, Medicaid has several pharmacy and medical benefits for treating opioid use disorder that vary by state. A primary 

pharmaceutical treatment offered to patients with opioid abuse 

and/or substance use disorder is medication-assisted treatment 

(MAT). The Substance Abuse and Mental Health Services Administration (SAMHSA) describes MAT as ‘‘the use of FDA-approved 

medications, in combination with counseling and behavioral therapies, to provide a ‘‘whole-patient’’ approach to the treatment of substance use disorders.’’ 11

Non-pharmaceutical treatment of opioid use disorder in Medicaid 

occurs in inpatient, outpatient, residential, and community-based 

settings. MACPAC’s 2017 analysis found that ‘‘Medicaid is responding to the opioid crisis by covering treatment, innovating in the delivery of care, and working with other state agencies to reduce misuse of prescription opioids.’’ 12 State Medicaid programs adopt 

strategies and design their programs to meet the needs of their 

Medicaid beneficiaries resulting in variations in covered treatment 

services and settings. It is important state Medicaid programs provide a continuum of care to serve the needs of Medicaid beneficiaries. 

However, as MACPAC noted, ‘‘there are gaps in the continuum 

of care, and states vary in the extent to which they cover needed 

treatment.’’ 13 One of the barriers to appropriate treatment consistently identified by Medicaid directors and health policy experts is 

a statutory prohibition on federal Medicaid matching funds for paying for care for certain Medicaid beneficiaries in Institutions for 

Mental Diseases (IMD). As MACPAC has explained, ‘‘the Medicaid 

IMD exclusion acts a barrier for individuals with an opioid use disorder to receive residential treatment, which, depending on an individual’s treatment plan, may be the most appropriate setting for 

care.’’ 14 Given these and other findings, there continues to be an 

opportunity for Congress and state Medicaid programs to work to 

improve access to timely, high-quality treatment across the continuum of care. 

Neonatal Abstinence Syndrome (NAS) is a drug-withdrawal condition in newborns caused by prenatal exposure to addictive illegal 

or prescription drugs.15 Opioid dependence is often associated with 

maternal comorbidities of anxiety, depression and pain. From 2004 

to 2014, the rate of U.S. infants diagnosed with NAS increased 433 

percent, from 1.5 to 8.0 per 1,000 hospital births.16 This trend was 

more pronounced in Medicaid programs, where the rate increased 

5 

from 2.8 to 14.4 per 1,000 hospital births. In 2014, Medicaid covered 82 percent of NAS births nationwide. 

COMMITTEE ACTION

On April 11 and 12, 2018, the Subcommittee on Health held a 

hearing on a discussion draft entitled ‘‘To amend title XIX of the 

Social Security Act to provide for Medicaid coverage protections for 

pregnant and postpartum women while receiving inpatient treatment for a substance use disorder.’’ 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, Chief Executive Officer, Centerstone; 

• John Kravitz, Chief Information Officer, Geisinger Health 

System; and, 

• Sam Srivastava, Chief Executive Officer, Magellan Health. 

On April 25, 2018, the Subcommittee on Health met in open 

markup session and forwarded the discussion draft, without 

amendment, to the full Committee by a voice vote. On May 17, 

2018, the full Committee on Energy and Commerce met in open 

markup session and ordered H.R. 5789, as amended, favorably reported to the House by a voice vote. H.R. 5789 is similar to the discussion draft forwarded by the Subcommittee. 

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. 

5789 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. 5789 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: 

6 

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, payas-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 entiVerDate Sep 11 2014 09:30 Jun 16, 2018 Jkt 079006 PO 00000 Frm 00006 Fmt 6659 Sfmt 6602 E:\HR\OC\HR730.XXX HR730
7 

ties 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. 

8 

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 Medicaid Protection Act of 2017 ................... 0 * 5 5 5 10 10 10 10 10 10 25 75 H.R. 4998, Health Insurance for Former Foster Youth Act ...................... 0 0 0 0 0 * 10 21 33 46 61 * 171 H.R. 5477, Rural Development of Opioid Capacity Services Act ............ 0 13 35 58 68 83 27 9 3 3 3 256 301 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 ........................................................................ 0 * * * * * * * * * * * * 

H.R. 5797, IMD CARE Act ........................................................................ 0 38 158 251 265 279 0 0 0 0 0 991 991 H.R. 5799, Medicaid DRUG Improvement Act a ....................................... 0 * * 1 1 1 1 1 1 1 1 2 5 

H.R. 5801, Medicaid Providers Are Required To Note Experiences in 

Record Systems to Help In-Need Patients (PARTNERSHIP) Act a ........ 0 * * * * * * * * * * * * 

H.R. 5808, Medicaid Pharmaceutical Home Act of 2018 a ..................... 0 * ¥1 ¥1 ¥1 ¥1 ¥2 ¥2 ¥2 ¥2 ¥2 ¥4 ¥13 

H.R. 5810, Medicaid Health HOME Act .................................................... 0 94 58 62 56 52 48 43 38 32 25 323 509 

Legislation Primarily Affecting Medicare: 

H.R. 3528, Every Prescription Conveyed Securely Act ............................. 0 0 0 ¥24 ¥35 ¥33 ¥30 ¥33 ¥32 ¥31 ¥32 ¥92 ¥250 

H.R. 4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 ............................................................................ 0 0 0 * * * * * * * * * * H.R. 5603, Access to Telehealth Services for Opioid Use Disorders Act 0 2 * * * 1 1 1 2 2 2 3 11 H.R. 5605, Advancing High Quality Treatment for Opioid Use Disorders 

in Medicare Act .................................................................................... 0 0 0 15 26 24 23 23 10 1 * 65 122 

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 ... 0 0 0 ¥6 ¥7 ¥7 ¥7 ¥8 ¥9 ¥9 ¥11 ¥20 ¥64 

H.R. 5684, Protecting Seniors From Opioid Abuse Act ............................ 0 0 0 * * * * * * * * * * H.R. 5796, Responsible Education Achieves Care and Healthy Outcomes for Users’ Treatment Act of 2018 ............................................ 0 10 25 50 10 5 0 0 0 0 0 100 100 H.R. 5798, Opioid Screening and Chronic Pain Management Alternatives for Seniors Act ........................................................................ 0 0 * 1 1 1 1 1 1 1 1 2 5 H.R. 5804, Post-Surgical Injections as an Opioid Alternative Act a ....... 0 0 25 30 25 20 10 5 0 0 0 100 115 

H.R. 5809, Postoperative Opioid Prevention Act of 2018 ........................ 0 0 0 0 10 15 20 25 30 35 45 25 180 

Legislation Primarily Affecting the Food and Drug Administration: 

9 

H.R. 5333, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 a ............................................................................... 0 0 * * * * * * * * * * * 

INCREASES OR DECREASES (¥) IN REVENUES b

H.R. 5752, Stop Illicit Drug Importation Act of 2018 ............................. 0 * * * * * * * * * * * * 

Annual amounts may not sum to totals because of rounding. * = between ¥$500,000 and $500,000. Budget authority is equivalent to outlays. a This bill also would affect spending subject to appropriation. b One additional bill, H.R. 5228, the Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act, would have a negligible effect on revenues. 

10 

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 fedVerDate Sep 11 2014 09:30 Jun 16, 2018 Jkt 079006 PO 00000 Frm 00010 Fmt 6659 Sfmt 6602 E:\HR\OC\HR730.XXX HR730
11 

eral 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 highrisk 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.) 

12 

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 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 demonstraVerDate Sep 11 2014 09:30 Jun 16, 2018 Jkt 079006 PO 00000 Frm 00012 Fmt 6659 Sfmt 6602 E:\HR\OC\HR730.XXX HR730
13 

tion 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 Opiod 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 

14 

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, 

15 

• 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, 

16 

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 

17 

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 

18 

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. 

19 

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 ¥40 ¥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 

20 

TABLE 3.—ESTIMATED SPENDING SUBJECT TO APPROPRIATION FOR BILLS WITH ESTIMATED 

AUTHORIZATIONS—Continued 

By fiscal year, in millions of dollars— 

2018 2019 2020 2021 2022 2023 2019– 

2023 

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. a This 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. 

21 

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 

22 

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– 

23 

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 

24 

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 

25 

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 

26 

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. 

27 

• 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 require the Secretary of 

Health and Human Services to issue guidance to improve care for 

infants with neonatal abstinence syndrome and their mothers. 

DUPLICATION OF FEDERAL PROGRAMS

Pursuant to clause 3(c)(5) of rule XIII, no provision of H.R. 5789 

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. 

28 

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. 5789 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 Committee finds that 

H.R. 5789 contains no directed rule makings. 

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. Guidance to improve care for infants with neonatal abstinence syndrome and their mothers; GAO study on gaps in medicaid coverage for pregnant and postpartum women with substance use disorder 

Section 1 requires the Secretary of Health and Human Services 

to issue guidance to improve care for infants with neonatal abstinence syndrome and their mothers not later than one year after enactment. The bill also requires 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 not 

later than one year after enactment. 

CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED

This legislation does not amend any existing Federal statute. 

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