Health Care Checkup
October 20, 2023
THE BIG PICTURE: KEY CONGRESSIONAL & EXECUTIVE BRANCH DEVELOPMENTS
On Friday, Representative Jim Jordan (R-OH) again failed to gain enough votes to become Speaker on the floor of the House of Representatives. This was the third round of voting where Jordan failed to win the required votes. Rep. Jordan has lost more votes in each round of voting, with the latest tally of 194 votes for Jordan. At this juncture, it is unclear whether Jordan will seek a fourth vote or if another member of the House Republican Conference will emerge as another candidate. Rep. Patrick McHenry (R-NC) continues to serve as the Speaker Pro Tempore. However, McHenry has limited powers to bring legislation to the floor, and an effort to change the House Rules to give him additional authority was met with Republican resistance this week.
 
The Senate will be in session next week and is expected to begin work on the $105 billion emergency supplemental funding request from President Biden to support war and humanitarian efforts in Israel and Ukraine, as well as US border security, childcare, and natural disaster emergency funding. Read the funding request here. In Biden’s speech last night, he stated his urgent budget request to Congress was “a smart investment that’s going to pay dividends for American security for generations.” The Senate stands adjourned until Tuesday next week and will convene at 10:00 AM to resume consideration of the nomination of Michael Whitaker to be FAA Administrator.
DEEP DIVE
Congressional:

Senate Finance Committee Holds Hearing on Medicare Advantage Practices
On Wednesday, the Senate Finance Committee held a hearing on Medicare Advantage (MA) marketing practices, which comes amid new, more stringent CMS marketing rules for plans. Committee Chairman Ron Wyden (D-OR) expressed interest in further regulating Medicare marketing tactics described as deceitful for Medicare Advantage (MA) plans, which Democratic Senators widely supported. Republican Senators focused on MA plans more generally, both increasing enrollee privacy and promoting competition. There was bipartisan support for increased MA plan transparency to provide enrollees with more information on coverage and provider and prescription drug costs. Most Senators stated MA plans are an essential option, increasing in popularity, and are here to stay due to the additional benefits they offer enrollees. Most also stressed the need for additional regulations and accountability for MA plan marketing tactics. Read Mehlman’s hearing summary here.
 
HELP Senators Question Biden NIH Nominee on Bertagnolli on Agency Priorities and Role in Drug Costs During Nomination Hearing
On Wednesday, President Joe Biden's nominee to lead the National Institutes of Health (NIH), Monica Bertagnolli, faced a series of detailed policy questions about drug costs and biomedical research at the Senate Health, Education, Labor and Pensions (HELP) Committee hearing. Democrats on the Committee quizzed the nominee on what she would do to lower drug costs, while Republicans focused on restoring public trust in the agency. The committee plans to hold a markup and vote on her nomination next week on Wednesday, October 25. Read the witness testimony here.
 
House Energy and Commerce Committee Holds Legislative Hearing on Strengthening Patient Access to Care in Medicare
On Thursday, the House Energy and Commerce Subcommittee on Health held a hearing to examine Medicare proposals to improve patient access to care and physician payment. Witnesses included CMS, the Government Accountability Office (GAO), and the Medicare Payment Advisory Commission (MedPAC). The hearing agenda featured 23 bills and draft legislation that included measures to extend bonuses for value-based care arrangements and allow for alternative performance measures that could boost physician scores under Medicare's payment program. Other drafts include a measure to exempt doctors from Medicare's payment program if they work in certain value-based arrangements through private Medicare Advantage plans and another to sub in performance measures used for hospitals in physician evaluations. Another would loosen restrictions around budget neutrality requirements, which require regulators to offset increases with cuts elsewhere in the program. Lawmakers signaled interest in strengthening physician payments under Medicare. Democrats criticized Republicans for excluding a number of their bills, while top committee Republicans voiced concerns about the toll inflation has taken on physicians. The timing for a markup is unclear. The agenda also included several small payment extenders typically rolled into an end-of-year omnibus. The staff hearing memo, legislation discussed, and witness testimonies can be found here.
 
Senator Cassidy Objects to HELP Chairman Sanders’ Field Hearing on Hospital Staffing
Late last week, Sen. Bernie Sanders (I-VT), Chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, announced that the Committee would hold a field hearing in New Brunswick, New Jersey, entitled “Overworked and Undervalued: Is the Severe Hospital Staffing Crisis Endangering the Well-Being of Patients and Nurses?” The field hearing comes as healthcare workers around the country have gone on strike, including 1,700 nurses at Robert Wood Johnson University Hospital in New Brunswick. Ranking Member Cassidy (R-LA), has objected to the hearing, raising concerns that Sanders is using committee resources to support unions during a labor dispute, which Cassidy said in a letter Friday is a violation of Senate rules. Read Sanders’ statement here and Cassidy’s statement and letter here.
 
Senators Padilla, Tillis, Smith, Ernst Launch Bipartisan Mental Health Caucus
On Tuesday, Senators Alex Padilla (D-CA), Thom Tillis (R-NC), Tina Smith (D-MN), and Joni Ernst (R-IA) announced the launch of their bipartisan Senate Mental Health Caucus. The Senate Mental Health Caucus will serve as a forum for Senators to collaborate on and promote bipartisan legislation and solutions, hold events to raise awareness of critical mental health issues, and destigmatize mental health. The caucus will work to improve prevention and early intervention efforts, expand the mental health professional workforce, enhance crisis response services, and increase access to evidence-based mental health treatment and common-sense solutions. Senators Cory Booker (D-NJ), Shelley Moore Capito (R-WV), Susan Collins (R-ME), John Fetterman (D-PA), Amy Klobuchar (D-MN), and Lisa Murkowski (R-AK) are also members of the caucus. Read the press release here.

Notable Bills Introduced:

Key Senators Introduce Bill to Improve Health Care Access, Protect Seniors from Unexpected Costs
On Thursday, Senators Michael Bennet (D-CO), Thom Tillis (R-NC), Ron Wyden (D-OR) introduced the Requiring Enhanced & Accurate Lists of (REAL) Health Providers Act, which would ensure Medicare Advantage plans maintain accurate provider directories and protect seniors from unexpected health care costs. The legislation would also ensure patients do not pay out-of-network costs for appointments with providers that were incorrectly listed in their plan’s provider directory as in-network; and direct CMS to publish guidance for plans to maintain accurate provider directories. Read the press release here, and a summary of the bill here.
 
Senators Thune, Hassan, Blackburn Introduce the SAVE IMD Options ACT
On Thursday, Senators John Thune (R-SD), Maggie Hassan (D-NH), and Marsha Blackburn (R-TN) introduced the Securing Advances and a Variety of Evidence-Based (SAVE) Institutions for Mental Disease (IMD) Options Act. The bipartisan legislation would establish a permanent state plan option in Medicaid that allows states to provide patients between the ages of 21 to 64 with substance use disorder treatment in IMD. Read the press release here and the bill here.
 
Senators Duckworth, Murkowski Reintroduce Bipartisan Bill to Expand Medicare Coverage for Breast Cancer Patients and Survivors
On Wednesday, Senators Tammy Duckworth (D-IL) and Lisa Murkowski (R-AK) re-introduced legislation to ensure breast cancer patients and survivors who have experienced a mastectomy are able to access custom breast prosthetics under Medicare. The Breast Cancer Patient Equity Act would provide coverage for custom fabricated breast prostheses, not currently covered by Medicare, to the more than 100,000 women who undergo mastectomies annually. Read the press release here, and the bill text here.
 
Representatives Spanberger, Nunn Introduce Bipartisan Bill to Disclose Drug Prices in Ads, Increase Price Transparency for Consumers
Late last week, Representatives Abigail Spanberger (D-VA) and Zach Nunn (R-IA) introduced the bipartisan Drug-Price Transparency for Consumers Act, which would require that direct-to-consumer advertisements for pharmaceuticals include a disclosure of pricing information. Specifically, the legislation would amend the Social Security Act to allow the Secretary of the Department of Health and Human Services (HHS) to require that pharmaceutical advertisements disclose the wholesale cost for a 30-day supply or typical course of treatment of the drug, clearly present the price information, and explain that pricing may vary depending on insurance coverage. Additionally, the bill would subject advertisers to a penalty of up to $100,000 for each violation. Read the press release here and the bill here.

Executive Branch:

Alzheimer’s Brain Scans to Get Broader Coverage Under Medicare
Late last week, CMS removed a policy that limited the number of PET scans Medicare would cover for a person with Alzheimer’s disease. The agency said in a memo it had lifted a policy dating back to 2013 that limited the imaging scan, which can identify early indicators of the disease in the brain, to once in a patient’s lifetime. CMS will leave it to Medicare contractors to make the actual coverage decisions, which could cause confusion and may force the agency to revisit its decision. Read the memo here.

HHS and Pfizer Reach Agreement to Increase Patient Access to Paxlovid
Late last week, the Department of Health and Human Services (HHS), announced that HHS and Pfizer have reached an agreement that extends patient access to Paxlovid, maximizes taxpayer investment, and begins Paxlovid’s transition to the commercial market in November 2023. Individuals on Medicare, Medicaid, and those who are uninsured will continue to be able to access HHS-procured Paxlovid for free through the end of 2024 via a patient assistance program. From 2025-2028, Pfizer will continue to run a patient assistance program for individuals who are uninsured or underinsured with HHS-procured Paxlovid. In parallel, Pfizer will operate a copay assistance program for individuals with commercial insurance through 2028. Read the press release here.

FDA Moves to Boost Blood Supply by Easing Donation Guidelines
On Tuesday, the Food and Drug Administration (FDA) published final industry guidance to bolster the nation’s blood supply by easing some requirements for establishments that collect blood and blood components, including source plasma. The FDA stated in the guidance that it does not intend to take regulatory action for a blood establishment’s failure to comply with certain requirements in the agency’s regulations regarding donation suitability, donor eligibility, and quarantine hold for source plasma. The agency said it expects this compliance policy will increase the availability of blood and blood components, including source plasma while maintaining the health of blood donors and the safety of blood and blood components. Read the guidance here.

Legal & Other:

NCPA Launches Company to Assist Pharmacies with Litigation Against PBMs over DIR Fees
On Monday, the National Community Pharmacists Association (NCPA) announced the launch of Trust LLC, a limited liability company that will investigate the use of direct and indirect remuneration (DIR) fees on behalf of community pharmacies. Should it be necessary, Trust will also litigate or arbitrate for the pharmacies, according to the announcement. TRUST will investigate claims from individual pharmacies, which NCPA said typically do not have the resources to take PBMs to court.
CONGRESSIONAL HEARINGS & EVENTS
House Hearings:

House Select Subcommittee on the Coronavirus Pandemic - Hearing
"Reforming the WHO: Ensuring Global Health Security and Accountability"
Tuesday, October 24, at 10:00 AM
 
Committee on Oversight and Accountability, Subcommittee on Government Operations and the Federal Workforce, and the Subcommittee on Health Care and Financial Services - Joint Hearing “Oversight of the Internal Revenue Service.”
Tuesday, October 24, at 2:00 PM
 
Committee on Energy and Commerce, Subcommittee on Health - Hearing The hearing is entitled “Supporting Access to Long-Term Services and Supports: An Examination of the Impacts of Proposed Regulations on Workforce and Access to Care.”
Wednesday, October 25, at 2:00 PM

Senate Hearings:

Senate Health, Education, Labor, and Pensions Committee - Markup
“To consider the nominations of Monica M. Bertagnolli, of Massachusetts, to be Director of the National Institutes of Health, Department of Health and Human Services, Charlotte A. Burrows, of the District of Columbia, to be a Member of the Equal Employment Opportunity Commission, Erika L. McEntarfer, of the District of Columbia, to be Commissioner of Labor Statistics, Department of Labor, Amanda Wood Laihow, of Maine, to be a Member of Occupational Safety and Health Review Commission, and other pending calendar business.”
Wednesday, October 25, at 10:00 AM
 
Senate Veterans' Affairs Committee - Hearing
“VA Accountability and Transparency: A Cornerstone of Quality Care and Benefits for Veterans”
Wednesday, October 25, at 3:30 PM
ADMINISTRATION ANNOUNCEMENTS
Centers for Medicare & Medicaid Services
Food and Drug Administration
Guidance Documents from the Centers for Disease Control and Prevention
National Institutes of Health
1341 G Street NW
Washington, DC 20005
202-585-0258