POLICY BRIEFINGS


E&C Advances 16 Bipartisan Health Care Bills


The House Energy and Commerce Committee advanced by voice votes the following 16 health care-related bills last week, including measures to combat drug overdose deaths, extend Medicaid funding, improve maternal health, increase access to childhood vaccines, and study the impact of social determinants of health:

  • H.R. 4369, National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act,
  • H.R. 654, Drug-Free Communities Pandemic Relief Act,
  • H.R. 2051, Methamphetamine Response Act of 2021,
  • H.R. 2379, State Opioid Response Grant Authorization Act of 2021,
  • H.R. 2364, Synthetic Opioid Danger Awareness Act,
  • H.R. 2355, Opioid Prescription Verification Act of 2021,
  • H.R. 4026, Social Determinants of Health Data Analysis Act of 2021,
  • H.R. 3743, Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act,
  • H.R. 550, Immunization Infrastructure Modernization Act,
  • H.R. 1550, Promoting Resources to Expand Vaccination, Education and New Treatments for (PREVENT) HPV Cancers Act of 2021,
  • H.R. 951, Maternal Vaccination Act,
  • H.R. 4387, Maternal Health Quality Improvement Act of 2021,
  • H.R. 3742, Vaccine INFO (Information for Nursing Facility Operators) Act,
  • H.R. 2347, Strengthening the Vaccines for Children Act,
  • H.R. 3894, Collecting and Analyzing Resources Integral and Necessary for Guidance (CARING) for Social Determinants Act of 2021, and
  • H.R. 4406, Supporting Medicaid in the U.S. Territories Act.


Oversight Committee Advances PPE Supply Chain Bill


The House Committee on Oversight and Reform advanced the Made in America Pandemic Preparedness Act (H.R. 4470) last week in a unanimous vote. The bill aims to increase preparedness for future pandemics by addressing shortages in the domestic personal protective equipment (PPE) supply chain. The legislation would create a requirement that all PPE in the Strategic National Stockpile (SNS) be produced domestically, unless an item cannot be manufactured to meet the nation’s demand for quality and quantity. The bill would also incentivize domestic manufacturing of PPE through a 20% tax credit to producers of equipment that qualifies for inclusion in the SNS.


E&C Leadership Seek Details on FDA Inspections


House Energy and Commerce Committee Chair Frank Pallone (D-N.J.) and Ranking Member Cathy McMorris Rodgers (R-Wash.) have sent a letter to the Food and Drug Administration (FDA) requesting information about the agency’s backlog of foreign inspections. The lawmakers express concerns that delays caused by the COVID-19 pandemic could impact the approval of new drug treatments and therapies. All non-critical, in-person inspections of foreign facilities were paused following the onset of the COVID-19 pandemic. While the FDA has resumed normal domestic inspections, foreign facilities are still being inspected via record reviews and remote evaluations. “One year into the pandemic, the strategy for resuming all inspections and addressing the backlog of delayed inspections remains unclear,” the letter states. The lawmakers ask for details regarding what actions the agency has taken, or plans to take, to mitigate experienced and potential delays of drug approval decisions.


Wyden, Grassley Urge Acceleration of OPO Enforcement


Abipartisan group of senators is urging the Biden administration to hasten reforms that would increase oversight of organ procurement organizations (OPOs). A recently finalized regulation entitled “Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations” aims to increase the accountability of OPOs but would not provide for the decertification of failing OPOs until 2026. The lawmakers argue that this protracted timeline for enforcement is problematic given the increase in the demand for transplants as a result of the COVID-19 pandemic. The letter to the Centers for Medicare and Medicaid Services (CMS) was led by Sens. Ron Wyden (D-Ore.) and Chuck Grassley (R-Iowa). The lawmakers highlight the particular impact of this issue on health equity, noting that “the failures of the current organ donation system disproportionately hurt patients of color.”


Lawmakers Seek Details on CHIRA Implementation


Sens. Patrick Leahy (D-Vt.) and Steve Daines (R-Mont.) are asking the Federal Trade Commission (FTC) and the Department of Justice (DOJ) for information regarding efforts to combat anti-competitive conduct in the health insurance sector following the enactment of the Competitive Health Insurance Reform Act (CHIRA) of 2020. “Not much is publicly known about what the DOJ or the FTC have done to exercise their expanded authorities under the law,” the lawmakers state. The letter argues that CHIRA’s enactment will help antitrust authorities promote competition and transparency in the health care industry by “actually empowering them to examine—and take action against, where justified—potentially anticompetitive practices by the health care, dental, and vision insurance companies.”


Caregivers Caucus Revived


Sens. Michael Bennet (D-Colo.) and Shelley Moore Capito (R-W.V.) are restarting the Assisting Caregivers Today (ACT) Caucus, with the support of AARP. The group will advocate on behalf of the work of family caregivers and provide education about the challenges that family caregivers face in supporting family members with physical or cognitive limits. According to Bennet and Capito, the estimated value of family caregivers’ unpaid work was $470 billion in 2016.


ARPA-H Listening Sessions


The National Institutes of Health (NIH) and the White House Office of Science and Technology Policy (OSTP) are holding listening sessions with patient advocacy groups, researchers, scientific societies, and other stakeholders to inform the development of the Advanced Research Projects Agency for Health (ARPA-H). More details and registration information can be found on the NIH events webpage. Materials from the listening sessions, including agendas, summaries, presentations, and videos, will also be posted where applicable.


HHS Extends COVID-19 Emergency Declaration


The U.S. Department of Health and Human Services (HHS) extended its declaration of the COVID-19 pandemic as a public health emergency (PHE) on July 19. The emergency declaration has been in place since January 27, 2020. This latest renewal will be effective for an additional 90 days.



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