POLICY BRIEFINGS

Hart Health Strategies provides a comprehensive policy briefing on a weekly basis. This in-depth health policy briefing is sent out at the beginning of each week. The health policy briefing recaps the previous week and previews the week ahead. It alerts clients to upcoming congressional hearings, newly introduced bills, regulatory announcements, and implementation activity related to the Patient Protection and Affordable Care Act (PPACA) and other health laws.


THIS WEEK'S BRIEFING - MAY 15, 2023

HELP Advances Drug Pricing Package


The Senate Health, Education, Labor and Pensions (HELP) Committee advanced four legislative proposals to strengthen generic drug competition and address pharmacy benefit manager (PBM) practices last week. The bills passed out of committee include:

  • The RARE Act (S. 1214), to codify that the scope of orphan drug exclusivity aligns with the approved use or indication of an orphan drug, rather than the disease or condition for which the drug received orphan drug designation.
  • The Ensuring Timely Access to Generics Act of 2023 (S. 1067), which would permit the Food and Drug Administration to deny a citizen petition submitted with the primary purpose of delaying the approval of a follow- on generic or biosimilar application, or if the petition does not raise valid scientific or regulatory issues.
  • The Expanding Access to Low-Cost Generics Act of 2023 (S. 1114), which aims to prevent a practice known as generic “parking” by allowing generic companies that are not first filers to enter the market if the first filer who otherwise received 180-day exclusivity has failed to come to market by 33 months since the date of submission of the application when there is another applicant who is otherwise ready to market their product.
  • The Pharmacy Benefit Manager Reform Act (S. 1339), to increase oversight and transparency of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. The bill would ban spread pricing and require PBMs to pass through all manufacturer rebates to insurance plans. The panel also adopted seven amendments to S. 1339, including an amendment to direct the Department of Labor to study PBMs.
Lawmakers will now work to compile a drug pricing package comprised of related legislation from the Senate Commerce, Judiciary, and Finance committees and potentially a measure to lower Americans’ out-of-pocket costs for insulin.


Ways and Means Republicans Push to Strengthen CMMI Oversight


The House Ways and Means Subcommittee on Health convened a hearing last week to consider policies that inhibit innovation and patient access. During the hearing Republicans called for increased oversight of the Center for Medicare and Medicaid Innovation (CMMI), criticizing a recent CMMI proposal to reduce Medicare reimbursement for drugs cleared via the Food and Drug Administration’s accelerated approval process. The agency believes the policy would incentivize manufacturers to complete confirmatory trials in a timelier manner, but Chairman Jason Smith (R-Mo.) argued that it would slow innovation and reduce access to life-saving therapies. Rep. Vern Buchanan (R-Fla.) has stated plans to introduce legislation on the issue. Lawmakers also questioned CMMI’s ability to evaluate new payment and service delivery models, highlighting that only six of the more than 50 models tested since the creation of CMMI have resulted in statistically significant savings.


HELP Holds Health Care Workforce Roundtable


The Senate Health, Education, Labor and Pensions (HELP) Committee convened a field roundtable last week to discuss health care provider shortages and ways to diversify the medical workforce. The event was held at Morehouse School of Medicine in Atlanta and featured leaders from Historically Black Colleges and Universities, who argued that physician shortages are particularly acute in minority communities and have an adverse impact on health outcomes. Witnesses expressed support for the Resident Physician Shortage Reduction Act (S. 1302/H.R. 2389), which would increase the number of Medicare-supported graduation medical education positions. Panelists also asked lawmakers to provide funding to strengthen the R&D infrastructure of academic health sciences centers at historically Black graduate institutions, and to address student debt and fair pay for medical residents.


IL Delegation Pushes for ARPA-H Hub


Sens. Tammy Duckworth (D-Ill.) and Dick Durbin (D-Ill.) have sent a letter to administration officials on behalf of the Illinois congressional delegation expressing support for the placement of an Advanced Research Projects Agency for Health (ARPA-H) hub in the Chicago area. The new biomedical innovation agency will be organized in a hub-and- spoke model comprised of three main hubs, with the first hub located in the Washington, D.C. area. The lawmakers argue “Chicago’s robust and diverse distribution networks, combined with an impressive and talented workforce, helps explain why the region has become home to a strong manufacturing sector, particularly pharmaceuticals and medical equipment manufacturing.”


Sen. Feinstein Returns to Washington


Sen. Dianne Feinstein (D-Calif.), 89, returned to D.C. last week for the first time since February when she was diagnosed with shingles and subsequently hospitalized. While her doctors have advised her to work on a lighter schedule now that she has returned to the Capitol, Feinstein’s presence restores Democrats’ one-seat advantage in the full chamber and their majority on the Judiciary Committee. Feinstein has come under criticism in recent weeks because of the impact of her extended absence on the ability of the Judiciary Committee to advance Biden administration nominees. With her return, the Judiciary Committee advanced three judicial nominees for consideration by the full Senate. Reps. Ro Khanna (D-Calif.), Alexandria Ocasio-Cortez (D-N.Y.), Rashida Tlaib (D-Mich.) and Dean Phillips (D-Minn.) previously called on her to resign, citing her inability to carry out her responsibilities as a senator. Feinstein, who is still experiencing some side effects from the shingles virus, announced earlier this year that she would not seek a sixth term in the Senate in 2024.


Upcoming Congressional Hearings and Markups


House Ways and Means Committee hearing “Health Care Price Transparency: A Patient’s Right to Know;” 10:00 a.m.; May 16

Senate Judiciary Subcommittee on Privacy, Technology, and the Law oversight hearing to examine A.I., focusing on rules for artificial intelligence; 10:00 a.m.; May 16

House Veterans’ Affairs Subcommittee on Disability Assistance and Memorial Affairs Oversight hearing “Reviewing VA’s Implementation of the PACT Act;” 10:30 a.m.; May 16

House Energy and Commerce Subcommittee on Oversight and Investigations hearing “Protecting Critical Infrastructure from Cyberattacks: Examining Expertise of Sector Specific Agencies;” 2:00 p.m.; May 16

Senate Health, Education, Labor, and Pensions Subcommittee on Primary Health and Retirement Security hearing to examine a crisis in mental health and substance use disorder care, focusing on closing gaps in access by bringing care and prevention to communities; 10:00 a.m.; May 17

House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic hearing “Like Fire Through Dry Grass: Nursing Home Mortality & COVID-19 Policies;” 10:00 a.m.; May 17

House Veterans’ Affairs Subcommittee on Health hearing “VHA Recruitment and Retention: Is Bureaucracy Holding Back a Quality Workforce?” 10:30 a.m.; May 17

Senate Committee on Homeland Security and Governmental Affairs business meeting to consider 15 bills including the Rural Hospital Cybersecurity Enhancement Act; 10:30 a.m.; May 17

House Ways and Means Subcommittee on Health hearing “Why Health Care is Unaffordable: Anticompetitive and Consolidated Markets;” 2:00 p.m.; May 17

Senate Homeland Security and Governmental Affairs Permanent Subcommittee on Investigations hearing to examine health care denials and delays in Medicare Advantage; 2:00 p.m.; May 17

Senate Finance Subcommittee on Health Care hearing to examine improving health care access in rural communities, focusing on obstacles and opportunities; 2:30 p.m.; May 17

Senate Special Committee on Aging hearing “Residents at Risk: The Strained Nursing Home Inspection System and the Need to Improve Oversight, Transparency, and Accountability;” 9:30 a.m.; May 18



May 15, 2023: | Page 1 Page 2 Page 3

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