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 - MARCH 6, 2023

Senate Votes to Declassify COVID-19 Origin Information


The Senate voted unanimously last week to require Director of National Intelligence Avril Haines to declassify information about the origins of the coronavirus pandemic. Passage of the COVID-19 Origin Act (S. 619) follows a recent report from the Department of Energy which concluded with ‘low confidence’ that COVID-19 most likely originated from a lab leak in China. Director of the Federal Bureau of Investigation (FBI) Christopher Wray separately acknowledged on Tuesday the FBI’s determination that the pandemic had most likely come from a laboratory incident in Wuhan.


HELP Leadership Seek Information on Health Care Workforce Shortages


Senate Health, Education, Labor, and Pensions Committee (HELP) Chair Bernie Sanders (I-Vt.) and Ranking Member Bill Cassidy (R-La.) have sent a letter to health care stakeholders requesting input on the drivers of current health care workforce shortages and possible legislative solutions to the problem. HELP Committee leadership have repeatedly stated their intent to prioritize health care worker shortages as an area of bipartisan compromise, with the panel holding its first hearing of the 118th Congress on the subject last month. The letter states their plan to use the information received to draft bipartisan legislation to strengthen workforce capacity. Sanders and Cassidy request responses be sent to HealthWorkforceComments @help.senate.gov no later than Monday, March 20.


Hudson, Eshoo Release RFI on PAHPA Reauthorization


House Energy and Commerce Committee members Reps. Richard Hudson (R-N.C.) and Anna Eshoo (D-Calif.) have released a request for information (RFI) on improving the nation’s biosecurity and preparedness infrastructure. The RFI comes as the lawmakers begin work to reauthorize the Pandemic and All Hazards Preparedness Act (PAHPA). Current authority for the program expires on September 30. “As I lead the process with my colleague, Rep. Eshoo, to improve our preparedness, I am seeking feedback and suggestions on how our country can be better prepared, further equipped, more transparent, and fully accountable when taking on future emergencies,” Rep. Hudson stated. Responses to the RFI are due by Monday, March 13.


Ways and Means Republicans Release Oversight Priorities


House Committee on Ways and Means Chair Jason Smith (R-Mo.) released his priorities for oversight hearings and related activities that the committee and its subcommittees plan to conduct over the course of the 118th Congress. Matters under the committee’s health care jurisdiction include oversight of the No Surprises Act implementation, oversight of the implementation of prescription drug provisions in the Inflation Reduction Act, adequacy and appropriateness of Medicare provider reimbursements, oversight of graduate medical education policies, and oversight of existing and proposed health care price transparency requirements. The plan also highlights concerns related to the delivery of health services and Medicare reimbursement.


Oversight Panel Launches Investigation into Role of PBMs


The House Committee on Oversight and Accountability has launched an investigation into the business practices of pharmacy benefit managers (PBMs) and their impact on patients, the nation’s pharmaceutical market, and overall health care costs. “Pharmacy benefit managers’ anticompetitive tactics are driving up health care costs for Americans and harming patient care,” Chair James Comer (R-Ky.) stated. “Federal agencies administering health care programs for seniors, active-duty military, and federal employees rely on PBMs as middlemen to set drug prices, which opens the door to government waste at the expense of American taxpayers.” Comer has requested information from the Office of Personnel Management, Centers for Medicare and Medicaid Services, and the Defense Health Agency on how government- administered health programs are affected by PBMs. He has also requested information from the nation’s three largest PBMs – Express Scripts, CVS Caremark, and OptumRx, about their business practices, including details on the total rebates and fees collected by the companies.


Bipartisan Bill Reintroduced to Encourage Prescription Drug Competition


On March 1, Sens. Maggie Hassan (D-N.H.) and Mike Braun (R-Ind.), members of the Senate Health, Education, Labor, and Pensions (HELP) Committee, reintroduced the Prescription Drug Competition Act (S. 574). The Food and Drug Administration (FDA) may require drug manufacturers to have a Risk Evaluation and Mitigation Strategy (REMS) program to ensure the benefits of a drug with potential safety concerns outweigh the risks. However, as reported in the New York Times, drug manufacturers may patent their respective REMS programs and then leverage those patents to prevent alternative medications from entering the market. To address this, S. 574 would allow FDA to approve a generic medication immediately (avoiding the current 30-month stay) if the only impediment in the approval process is the reference product’s REMS patent. The legislation also includes provisions that would allow the continued sale of a generic medication facing litigation over a REMS patent. The legislation has been referred to the Senate HELP Committee.



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