POLICY BRIEFINGS


Consideration of Endless Frontier Act Delayed


Committee consideration of Senate Majority Leader Chuck Schumer’s (D-N.Y.) Endless Frontier Act (S. 1260) has been delayed for several weeks. The bipartisan bill aims to respond to China’s economic, military, and technological advances. It includes more than $100 billion in funding for the National Science Foundation to support high-tech research and advanced manufacturing. The legislation was initially slated to be marked up by the Senate Commerce Committee last week but was pushed back for at least two weeks after more than 200 amendments were filed to the bill. Schumer intends to package the Endless Frontier Act with other China-related legislation prior to consideration on the Senate floor.


Dems Push Manufacturers to Expand International Access to COVID Vaccines


Agroup of Democratic senators are urging Pfizer, Moderna, and Johnson & Johnson to increase global access to their COVID-19 vaccines. The letters argue that expanded access is urgently needed to reduce human suffering and prevent unnecessary deaths in places like India, which recently set the record for reaching 400,000 new COVID-19 cases in a single day. Sens. Elizabeth Warren (D-Mass.), Ed Markey (D-Mass.), Tammy Baldwin (D-Wis.), Jeff Merkley (D-Ore.), and Chris Murphy (D-Conn.) suggest that the companies could voluntarily share their vaccine-related intellectual property and other technology with partner companies to expand vaccine development and access.


Warren Requests Investigation into Emergent Biosolutions CEO


Sen. Elizabeth Warren (D-Mass.) has sent a letter to Securities and Exchange Commission (SEC) Chair Gary Gensler urging him to open an investigation into potential insider trading done by the CEO of Emergent BioSolutions. The Washington Post recently reported that the company’s CEO Robert Kramer dumped $10 million in Emergent shares prior to the company disclosing problems with producing COVID-19 vaccine at its Baltimore facility. “Given my longstanding concerns about pandemic profiteering and the specific troubling new details about Emergent and Mr. Kramer’s sales of company stock amidst its vaccine production failures,” Warren writes, “I ask that the SEC open an investigation of this matter as rapidly as possible.”


Cheri Bustos to Retire from Congress


Rep. Cheri Bustos (D-Ill.) has announced that she will not run for reelection in 2022. Bustos is the former Democratic Congressional Campaign Committee (DCCC) chairwoman. She currently serves on the Agriculture and Appropriations committees. Her congressional district has shifted rightward in recent years.


GAO Releases New Report on Drug Pricing


The Government Accountability Office (GAO) has released a new report finding that retail drug prices are two to four times higher in the U.S. on average than drug prices in Australia, Canada, and France. GAO’s analysis examines 20 selected brand-name prescription drugs. The agency notes that while rebates and confidential discounts offered on some drugs were taken into account for U.S. prices, the publicly available prices for the comparison countries do not reflect such discounts.


CMS Proposed Payment Rule Includes Added GME Slots


The Centers for Medicare and Medicaid Services (CMS) released its fiscal year (FY) 2022 hospital inpatient prospective payment system proposed rule last week. The regulation would provide acute-care hospitals with a 2.8% increase in Medicare reimbursements and long-term care hospitals with a 1.4% bump. The rule would also implement the distribution of 1,000 more residency slots to qualifying hospitals in rural and underserved areas over the next five years – a provision enacted as part of the Consolidated Appropriations Act, 2021. CMS estimates that these additional graduate medical education (GME) slots will cost approximately $300 million a year.


Hart Health Strategies COVID-19 Resources


Hart Health Strategies Inc. continues to update the following resources related to the coronavirus pandemic. Please remember to clear your cache to ensure you download the most recent documents.


Upcoming Congressional Hearings and Markups


House Oversight Subcommittee on Economic and Consumer Policy hearing “The Urgent Need to Reform the Organ Transplantation System to Secure More Organs for Waiting, Ailing, and Dying Patients;” 11:00 a.m.; May 4

House Energy and Commerce Subcommittee on Health hearing “Negotiating a Better Deal: Legislation to Lower the Cost of Prescription Drugs;” 11:30 a.m.; May 4

House Veterans’ Affairs Committee hearing on various legislation related to health care; 10:00 a.m.; May 5

House Education & Labor Subcommittee on Health, Employment, Labor, and Pensions hearing “Lower Drug Costs Now: Expanding Access to Affordable Health Care;” 12:00 p.m.; May 5

House Committee on Oversight and Reform hearing “Birthing While Black: Examining America’s Black Maternal Health Crisis;” 11:00 a.m.; May 6

House Science, Space, & Technology Subcommittee on Research and Technology hearing “National Science Foundation: Advancing Research for the Future of U.S. Innovation Part II;” 11:00 a.m.; May 6


Recently Introduced Health Legislation


S.1362 — A bill to amend title XVIII of the Social Security Act to provide for coverage under the Medicare program of pharmacist services; Sponsor: Sen. Grassley, Chuck [R-IA]; Committees: Senate – Finance

S.1366 — A bill to secure the supply of drugs in the United States, and for other purposes; Sponsor: Sen. Warren, Elizabeth [D-MA]; Committees: Senate - Health, Education, Labor, and Pensions

S.1367 — A bill to require a report on foreign investment in the pharmaceutical industry of the United States; Sponsor: Sen. Warren, Elizabeth [D-MA]; Committees: Senate - Banking, Housing, and Urban Affairs

H.R.2831 — To amend the Federal Food, Drug, and Cosmetic Act to provide for the prompt approval of drugs when safety information is added to labeling, and for other purposes; Sponsor: Rep. Barragan, Nanette Diaz [D-CA-44]; Committees: House - Energy and Commerce

H.R.2843 — To amend subsection (q) of section 505 of the Federal Food, Drug, and Cosmetic Act to clarify the process for denying certain petitions whose primary purpose is to delay the approval of an application submitted under subsection (b)(2) or (j) of such section 505, and for other purposes; Sponsor: Rep. Levin, Andy [D-MI-9]; Committees: House - Energy and Commerce

H.R.2846 — To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes; Sponsor: Rep. McKinley, David B. [R-WV-1]; Committees: House - Energy and Commerce; Ways and Means

H.R.2853 — To amend the Federal Food, Drug, and Cosmetic Act, with respect to eligibility for approval of a subsequent generic drug, to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval, and for other purposes; Sponsor: Rep. Schrader, Kurt [D-OR-5]; Committees: House - Energy and Commerce

H.R.2855 — To amend title XVIII of the Social Security Act to require the Secretary of Health and Human Services to add a new set of measures to the 5-star rating system under the Medicare Advantage program in order to encourage increased access to biosimilar biological products; Sponsor: Rep. Tonko, Paul [D-NY-20]; Committees: House - Energy and Commerce; Ways and Means

S.1374 — A bill to direct the Director of the National Science Foundation to support STEM education and workforce development research focused on rural areas, and for other purposes; Sponsor: Sen. Wicker, Roger F. [R-MS]; Committees: Senate - Commerce, Science, and Transportation

S.1383 — A bill to amend the Public Health Service Act to direct the Secretary of Health and Human Services to develop best practices for the establishment and use of behavioral intervention teams at schools, and for other purposes; Sponsor: Sen. Cornyn, John [R-TX]; Committees: Senate - Health, Education, Labor, and Pensions

S.1388 — A bill to require the Federal Trade Commission to study the role of intermediaries in the pharmaceutical supply chain and provide Congress with appropriate policy recommendations, and for other purposes; Sponsor: Sen. Grassley, Chuck [R-IA]; Committees: Senate – Judiciary

S.1390 — A bill to amend the Elementary and Secondary Education Act of 1965 to improve mental health services for students, and for other purposes; Sponsor: Sen. Kennedy, John [R-LA];Committees: Senate - Health, Education, Labor, and Pensions



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SERVICES




BRIEFING ARCHIVE


 -  2021


 +  2020


 +  2019


 +  2018