Health Policy Report (6/21)

House lawmakers will reconvene this afternoon to consider a bipartisan package of bills that seek to improve behavioral health treatment and increase access to substance use disorder (SUD) care. The Restoring Hope for Mental Health and Well Being Act (H.R. 7666TRP analysis) includes several policies that would, among other things: (1) reauthorize several grant programs at the Substance Abuse and Mental Health Services Administration (SAMHSA) and Health Resources and Services Administration (HRSA); (2) provide support for the new 9-8-8 suicide prevention hotline launching next month; and (3) promote and support behavioral health integration and workforce needs. While the legislation is expected to pass with bipartisan support next week, timing in the Senate is unclear due to competing legislative priorities.

Additionally, House lawmakers are scheduled to take up an Energy and Commerce Committee bill that would establish the Advanced Research Projects Agency for Health (ARPA-H) — a new agency within the Department of Health and Human Services (HHS) that focuses on innovation in health and medicine. Members will also consider legislation that would: (1) bolster mental health and suicide prevention efforts for veterans (H.R. 6411); (2) require the collection of voluntary, self-disclosed information on sexual orientation and gender identity in certain federal surveys (H.R. 4176); and (3) address mental health, addiction, and suicide on college campuses.

Meanwhile, in the upper chamber, the bipartisan gun safety group is pushing to finalize legislative text of their recently-announced agreement, but senators remain stuck on two key points of contention that have delayed progress on producing the bill. Specifically, the group has reached an impasse on efforts to prevent domestic abusers from purchasing firearms, as well as incentives for states to establish “red flag” laws. While Sens. Chris Murphy (D-CT) and John Cornyn (R-TX) were originally pushing to produce a formal bill by the end of last week, the timeframe for introduction — as well as the first vote series — is poised to shift as the group continues negotiations.

Senate HELP Committee Marks Up FDA User Fee Bill

On Tuesday, the Senate Committee on Health, Education, Labor, and Pensions (HELP) conducted a markup of five bills including the Food and Drug Administration (FDA) Safety and Landmark Advancements (FDASLA) Act (S. 4348). Notably, FDASLA would reauthorize the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), Biosimilar User Fee Act (BsUFA III), and the Medical Device User Fee Amendments (MDUFA V). The bill outlines a sizable increase in estimated fees for fiscal year (FY) 2023 in comparison to the first year of the most recent UFA reauthorization in 2018. The bill also included provisions related to rare disease therapies development, generic drug labeling, and foreign drug provisions, such as drug importation. 

It passed out of committee on a 13-9 vote, with 8 of 11 Republicans voting against. Next up, the Senate and House will hammer out their differences with an eye towards passing a consensus bill in July.

FTC Votes to Issue Statement on Anti-Competitive PBM Practices

On Thursday afternoon, the Federal Trade Commission (FTC) held a meeting (agenda) to discuss the impacts of drug fees and rebates — namely from pharmacy benefit managers (PBM) — on lowering drug costs. Notably, the Commission voted unanimously to issue a policy statement signaling its intent to study drug fees and rebates paid by manufacturers to PBMs and other intermediaries in the pharmaceutical supply chain, with each Commissioner discussing their views on the statement. Notably, FTC Chair Lina Khan explained that cost of medicines has “soared,” even for those developed decades ago, such as insulin. She added that insulin can cost upwards of $500 per month for the uninsured or those on high-deductible health plans (HDHP), resulting in patients forgoing their medications to save money. She said that the Commission is focused especially on rebates paid from manufacturers to PBMs, which she said encourages “ever-increasing” list prices and rebates. She suggested that the FTC may be able to block some rebates where they are used as an anti-competitive tool.

Senate Finance Releases Discussion Draft of Legislation to Address Youth Mental Health

A bipartisan group of senators on the Finance Committee unveiled a discussion draft (TRP analysis; press release) of the youth mental health provisions to be included as a part of the Committee’s broader legislative effort to improve mental health care for Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) beneficiaries. Policy proposals within the discussion draft pertain to: (1) updating Medicaid guidance to states to clarify that school mental health services qualify as an allowable payment; (2) allowing providers to receive same-day reimbursement for behavioral and primary care services; (3) improving the enforcement and oversight of Medicaid’s Early and Periodic Screening, Diagnostic and Treatment (EPSDT) benefit; (4) streamlining enrollment for out-of-state providers in another state’s Medicaid program; (5) providing guidance to states on how they can cover treatment family care services for foster youth in Medicaid; and (6) providing an option for states to provide Medicaid services for inmates, pending disposition, under the age of 18 years. 

As stated in the accompanying press release, other discussion drafts may be released prior to a committee markup to be held at a later date. Once a draft bill is marked up in the Finance Committee, it is expected to be formally introduced as amended into a single legislative package. Notably, the bill’s authors emphasized their intent to fully pay for the package through “bipartisan, consensus-driven” offsets, though such offsets are unknown at this time.

MACPAC Releases June 2022 Report to Congress

The Medicaid and CHIP Payment and Access Commission (MACPAC) released its June 2022 Report to Congress (TRP summary; report; press release), capping off its 2021-2022 cycle. The report is comprised of six chapters that discuss monitoring access to care, bolstering oversight of managed care payments, enhancing access to adult vaccines, encouraging behavioral health providers to utilize health information technology (IT), mandating integrated care for dually-eligible Medicare and Medicaid beneficiaries, and improving health equity in Medicaid.

While the Commission did not make formal recommendations regarding health equity, the report asserts that Medicaid “can and should” work to advance health equity. It also draws attention to other marginalized groups of beneficiaries due to sex, gender identity, geography, and other factors. Additionally, the report discusses an array of approaches that states are implementing to address disparities in Medicaid. The recommendations that MACPAC formally submitted to Congress last week were approved during the Commission’s April 2022 meeting (TRP summary). Regarding a new system for Medicaid access monitoring, the Commission made several recommendations to create a system that would allow for the interstate comparison of delivery systems.

FTC, DOJ Host Workshop in Antitrust Enforcement in Pharma Industry

Last week, the Federal Trade Commission (FTC) and the Department of Justice (DOJ) completed their two-dayworkshop (TRP summary) entitled “The Future of Pharmaceuticals: Examining the Analysis of Pharmaceutical Mergers.” The workshop is a culmination of efforts on behalf of the Multilateral Pharmaceutical Task Force, formed by then-Acting FTC Chair Rebecca Kelly Slaughter, to address various concerns stemming from mergers and acquisitions (M&A) within the industry. The first panel discussion focused on concentration levels within the pharmaceutical sector, primarily focusing on improving the standard review process, scrutinizing companies’ relationships with pharmacy benefit managers (PBM), and promoting quality and competition within the generic drug and pharmaceutical ingredient sectors of the industry.

The second panel touched largely on the role and effectiveness of divestiture remedies in the pharmaceutical context. During the third panel, experts discussed the relationship between M&As and innovation competition. After establishing this relationship, the panelists outlined their respective organization’s analytical approaches to considering the impact of M&As on innovation competition. The fourth panel considered the utility of examining prior bad conduct when determining the anticompetitive intent of a merger. Additionally, the panelists discussed a proposed analytical framework that would consider pharmaceutical firms’ bargaining power over PBMs, as well as ways to ensure generics increase competition.