POLICY BRIEFINGS

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Grassley Asks FTC to Reconsider PBM Study

Sen. Chuck Grassley (R-Iowa) has sent a letter to Federal Trade Commission (FTC) Chair Lina Khan urging the agency to investigate pharmacy benefit managers (PBMs). Grassley argues that there is “widespread bipartisan support” for a probe into whether PBMs are “causing Americans to pay higher prices for prescription drugs.” The FTC recently deadlocked along party lines about whether to launch a study of U.S. PBMs. Republican commissioners voted against the proposal because, as drafted, it would not consider concerns with the impact of PBMs on out-of-pocket costs for consumers. Grassley encouraged FTC commissioners to find common ground on a meaningful study, pointing out that a more targeted focus “on the impact of PBMs on consumers and the out-of-pocket costs of their prescription drugs appears to be an area of agreement.” He also suggested that the FTC could study whether PBMs use formulary designs to depress the market share of low-cost prescription drugs.

Wyden Continues AbbVie Investigation

Senate Finance Committee Chair Ron Wyden (D-Ore.) has sent a letter to AbbVie Inc. demanding that the manufacturer explain the tax implications of having the company’s unit in Bermuda hold its intellectual property for the rheumatoid arthritis medication Humira. Wyden asserts that no Humira manufacturing, packaging, or distribution takes place in Bermuda. His letter states that AbbVie’s effective tax rate was 12.5%, compared to the 21% statutory corporate rate. “The lack of transparency into this arrangement raises important questions related to where income associated with the U.S. Humira net revenues is being recognized for tax purposes,” Wyden writes. The letter asks technical questions of the company about how it books revenue.

Lawmakers Request Money for Long COVID Research

Agroup of two dozen lawmakers in the House of Representatives wrote to Senate and House leadership urging the inclusion of funds for research on long-COVID in future COVID-19 relief packages. The letter cites estimates that 10% of documented COVID-19 survivors, 7.8 million people, are afflicted with long-COVID. “Congress must use every available tool to immediately respond to this crisis within a crisis,” the Democrats led by Rep. Ayanna Pressley (D-Mass.) wrote.

Democrats Push for Public Option in FY23 WH Budget

Sens. Sheldon Whitehouse (D-R.I.), Sherrod Brown (D-Ohio), Michael Bennet (D-Colo.), and Tim Kaine (D-Va.) have sent a letter to the White House urging the administration to include a proposal to add a publicly administered health insurance option to the Affordable Care Act’s (ACA) marketplaces in their fiscal year (FY) 2023 budget proposal. The letter cites data indicating that 31.1 million Americans remain uninsured, and that coverage disparities persist among Hispanic, Black, Asian, American Indian, and Alaska Native communities. “A public option would promote competition, improve health equity, and guarantee access to stable, low-cost, high-quality health insurance plans nationwide,” the lawmakers argue.

Lawmakers Push for Value-Based Care Incentives

Abipartisan group of lawmakers led by Reps. Suzan DelBene (D-Wash.), Markwayne Mullin (R-Okla.), Ami Bera, M.D. (D-Calif.), Mike Kelly (R-Pa.), Peter Welch (D-Vt.), Darin LaHood (R-Ill.), and Brad Wenstrup (R-Ohio) have sent a letter to the U.S. Department of Health and Human Services (HHS) calling on Secretary Xavier Becerra to deliver better health outcomes for Medicare beneficiaries and increase incentives for value-based care. The lawmakers ask Becerra to make modifications to the Medicare Shared Savings Program (MSSP) and implementation of the Medicare Access and CHIP Reauthorization Act (MACRA) that will increase provider participation in alternative payment models (APMs). “Adoption of value-based payments has played a critical role in slowing health care spending while improving quality over the last decade,” the letter states. “Moving forward, we must continue to prioritize policies that incentivize responsible cost- savings and advance quality care for seniors, as intended by Congress.” The letter was signed by 41 members of the House of Representatives.

E&C Members Request Information on COVID-19 and Mental Health

Abipartisan group of House Energy and Commerce Committee members is requesting information from the Substance Abuse and Mental Health Services Administration (SAMHSA) about the impact of the COVID-19 pandemic on the mental health and well-being of Americans. The letter cites data from various sources regarding increased levels of mental health issues in the United States since the start of the coronavirus pandemic. The lawmakers outline a list of questions to the agency about increased levels of distress, anxiety, and suicide-related behaviors, requesting a response by March 22.

Schultz, DeGette Urge FDA to Deny E-Cig Applications

Reps. Debbie Wasserman Schultz (D-Fla.) and Diana DeGette (D-Colo.) have sent a letter to the Food and Drug Administration (FDA) asking the agency to deny all e-cigarette applications for non-tobacco vapes. The letter was signed by more than 50 other lawmakers. It has been more than six months since the FDA’s deadline for completing pre- market tobacco reviews of e-cigarettes. Many of the product’s most popular brands remain on the market while awaiting the FDA’s decision.

DeLauro, Obama Announce Breakthrough COVID Cases

Rep. Rosa DeLauro (D-Conn.) announced that she has tested positive for COVID-19. DeLauro is vaccinated and boosted and stated that she is only experiencing mild symptoms. She plans to isolate and work remotely from her home in Connecticut for the time being. Former President Barack Obama announced that, despite being vaccinated and boosted, he has tested positive but has mild symptoms and otherwise feels fine. Obama says his wife, Michelle, has tested negative and calls on people to get vaccinated even as cases go down.

MDUFA V Framework Submitted to Congress

An agreement has been reached between the Food and Drug Administration (FDA) and the medical device industry on the framework for the latest Medical Device User Fee Agreement (MDUFA). The new five-year deal reportedly contains up to $1.9 billion in total revenue and would pave the way for a Total Product Life Cycle Advisory Program pilot funded through a combination of new money and MDUFA IV carryover funds. It also includes goals for increasing agency staffing. The full MDUFA V commitment letter was formally transmitted to lawmakers as the latest step in the reauthorization process last week, but the letter is not public. The agency and industry had missed the January 15 statutory deadline to submit an agreement to Congress. Congress must adopt the new user fee agreements spanning fiscal years (FY) 2023 through 2027 before the current deals expire on September 30.

OSHA to Increase Inspections of High Hazard Health Facilities

The Occupational Safety and Health Administration (OSHA) has announced an enforcement memorandum for a short- term increase in highly focused inspections directed at hospitals and skilled nursing care facilities that treat or handle COVID-19 patients. The goal of this effort is to control the spread of COVID-19 and future variants of the coronavirus and to protect the health and safety of workers who remain at heightened risk of contracting the virus. OSHA will expand its presence in high-hazard health care facilities between March 9 and June 9, 2022, working to verify readiness to address any ongoing or future COVID-19 surges. Follow-up inspections will be conducted at sites that were previously issued citations and where complaints were received but the agency did not conduct in-person inspections.

Moderna to Coordinate with COVAX to Supply Vaccine

Moderna stated last week that it does not have plans to ever enforce its COVID-19 vaccine patents against manufacturers based in or producing in 92 low- and middle-income countries. The nations covered are members of the Gavi COVAX Advance Market Commitment, which aims to secure financing for coronavirus vaccines in those nations. In other countries not covered by the commitment, “Moderna remains willing to license its technology for COVID-19 vaccines to manufacturers in these countries on commercially reasonable terms.”

Upcoming Congressional Hearings and Markups

Senate Health, Education, Labor, and Pensions Committee markup of the PREVENT Pandemics Act; 10:00 a.m.; March 15

Senate Finance Committee hearing “Prescription Drug Price Inflation: An Urgent Need to Lower Drug Prices in Medicare;” 10:00 a.m.; March 16

House Ways and Means Worker & Family Support Subcommittee hearing “Improving Family Outcomes through Home Visiting;” 10:00 a.m.; March 16

House Veterans’ Affairs Health Subcommittee hearing on H.R. 4993, the Veterans Emergency Care Reimbursement Act; H.R. 5738, Lactation Spaces for Veteran Moms Act; H.R. 5754, Patient Advocate Tracker Act; H.R. 5819, Autonomy for Disabled Veterans Act; H.R. 5941, Fairness for Rural Veterans Act; H.R. 6647, to make certain improvements relating to the eligibility of veterans to receive reimbursement for emergency treatment furnished through the Veterans Community Care program; H.R. 6823, Elizabeth Dole Home and Community Based Services for Veterans and Caregivers Act; Discussion Draft, Long-term Care Veterans Choice Act; 2:00 p.m.; March 16

Small Business Subcommittee on Oversight, Investigations, and Regulations hearing “An Empirical Review of the Paycheck Protection Program;” 10:00 a.m.; March 16

Senate Armed Services Subcommittee on Personnel hearing to receive testimony on the health effects of exposure to airborne hazards, including toxic fumes from burn pits; 3:00 p.m.; March 16

House Energy and Commerce Subcommittee on Health hearing “The Future of Medicine: Legislation to Encourage Innovation and Improve Oversight;” 10:30 a.m.; March 17

House Veterans’ Affairs Committee hearing “Building a Better VA: Addressing Healthcare Workforce Recruitment and Retention Challenges;” 2:00 p.m.; March 17

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