Health Care Checkup: January 19, 2024

Health Care Checkup

January 19, 2023

THE BIG PICTURE: KEY CONGRESSIONAL & EXECUTIVE BRANCH DEVELOPMENTS

On Thursday, both the Senate and the House passed stopgap funding, known as a continuing resolution (CR), in a 77-18 vote in the Senate and a 314-108 vote in the House. The latest CR (H.R. 2872), the third since September, extends appropriations funding deadlines to March 1 and March 8, avoiding a partial government shutdown this weekend.

CMS finalized a rule Wednesday aimed at streamlining the use of prior authorization by Medicare Advantage, Medicaid, and Qualified Health Plan issuers. The rule would require Medicare Advantage organizations, Medicaid and other government-sponsored health programs, and QHP issuers to respond to prior authorization requests faster and include reasons for denying requests.

What to Expect Next Week:

The Senate is in session next week. Discussions concerning the security supplemental and border policy package continue, and Majority Leader Schumer has indicated he would like to see floor consideration as early as next week. The Senate Special Committee on Aging will hold a hearing on assisted living facilities and long-term care options for older adults on Thursday.

The House is in recess next week and will return to session on Monday, January 29.

DEEP DIVE

Congressional:

Congress Approves Stopgap Funding to Avert US Government Shutdown

Sen. Wyden and Rep. Smith Announce Tax Package with Tax Breaks for R&D

On Tuesday, Sen. Ron Wyden (D-OR) and Rep. Jason Smith (R-MO), who lead Congress’s two tax-writing panels, announced an agreement on an $80 billion package of breaks for R&D, business interest and equipment depreciation, and changes in the child tax credit. Pharmaceutical groups, among many other industries, have lobbied to reverse a provision of the 2017 tax law (PL 115-97) requiring companies to spread out domestic research and development deductions over five years and foreign deductions over 15 years, beginning in 2022. Previously, companies were allowed to claim research and development costs in full upfront. The legislation package retroactively delays the domestic portion from 2022 to 2026. Sen. Wyden and Rep. Smith are hoping to attach the bill to a broader legislative vehicle before the 2024 tax season. The package excluded other industry requests, including an increase in a tax credit for rare disease research and updating an excise tax that funds the Vaccine Injury Compensation Program. The deal is still far from finalized as neither House Ways and Means ranking member Richard Neal (D-MA) nor Senate Finance ranking member Mike Crapo (R-ID) have signed onto the framework. A markup of the legislation will be held on Friday, January 19, at 9:00 AM. Read the legislation package here.

Senate HELP Committee Holds Hearing Addressing the Impact of Long-COVID

On Thursday, the Senate Health, Education, Labor and Pensions Committee held a hearing on ways to accelerate long COVID research. The hearing featured patient advocates suffering from long COVID, epidemiologists, and other medical experts. During the hearing, the witnesses told senators they want more funding dedicated to studying the condition, with some stating they were not impressed with how the NIH has spent $1.15 billion in past appropriations and favored new approaches. Senator Roger Marshall (R-KS) stated, “The NIH’s Recover Initiative is focused on risk factors and root causes as opposed to diagnosis and treatment.” Sen. Marshall suggested that further funding should go to the Biomedical Advanced Research and Development Authority, an HHS agency. Committee Chairman Bernie Sanders (I-VT) said "all levels of government" need to do more to address the ongoing crisis. Sen. Tim Kaine (D-VA), advocated for legislation he introduced (S. 2560) to accelerate long COVID research and provide more information to patients and medical providers about long COVID, and (S. 801) to authorize the Agency for Healthcare Research and Quality to support research into long COVID treatments, which was included in the Senate's pandemic preparedness bill (S. 2333). The committee approved the pandemic preparedness bill in July, but the bill has not advanced since. Read more on the hearing here.

Senator Sanders Announces Vote to Subpoena Johnson & Johnson and Merck CEOs

On Thursday, the Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Berine Sanders (I-VT) announced the HELP Committee will vote on Jan. 31 to subpoena Johnson & Johnson CEO Joaquin Duato and Merck & Co. Inc., CEO Robert Davis for testimony on why the companies' drug prices are higher in the US than in other countries. Both companies make drugs that qualify for Medicare's new price negotiation initiative. On Nov. 21, 2023, Democratic members of the HELP committee sent letters to the CEOs of Johnson & Johnson, Merck, and Bristol Myers Squibb, inviting all three to a committee hearing to testify at a January, 25 hearing on the high cost of prescription drugs. Bristol Myers Squibb CEO Chris Boerner agreed to come forward "alongside at least one of the other pharmaceutical CEOs," the committee said. Johnson & Johnson wrote a letter to Sanders outlining concerns about the hearing. Read the press release here.

Senator Casey Launches Investigation into Assisted Living Workforce, Cost, and Quality of Care

On Tuesday, Senator Bob Casey (D-PA), chairman of the Senate Special Committee on Aging, sent letters to three of the largest owners of assisted living facilities in the U.S. asking for answers about high costs and low quality. The letters come ahead of a January 25, hearing on the "challenges faced by assisted living facility residents." In the letter, Casey pointed to a recent Washington Post article that found 2,000 assisted living residents have wandered away or been left unattended outside of their facilities since 2018, resulting in at least 98 deaths. While assisted-living facilities are not regulated by the federal government, Casey stated the committee has "the authority to examine private companies when concerns arise about potential health and safety, as well as financial risks posed to older adults." Read the press release and letter here.

Senator Cassidy Requests Information from Major Contract Pharmacies as Part of 340B Investigation

On Wednesday, Senator Bill Cassidy (R-LA), ranking member of the Senate Health, Education, Labor and Pensions (HELP) Committee, wrote letters to CVS Health and Walgreens seeking as part of his ongoing investigation into how health care entities use and generate revenue from the 340B Drug Pricing Program. Cassidy is requesting information to understand how these companies generate revenue from 340B, and how, or if, that revenue results in direct benefits for patients. Read the press release and letters here.

Notable Bills Introduced:

Senators Cortez Masto, Cornyn Introduce Bipartisan Legislation to Enhance Mental Health Care Emergency Services

On Thursday, Senators Catherine Cortez Masto (D-NV) and John Cornyn (R-TX) introduced the bipartisan Medicare Mobile Crisis Improvement Act to help more Americans access behavioral health crisis services. The legislation would make Medicare payment rates more robust for mental health services delivered by mobile units. Read the press release here and the bill here.

Reps. Bonamici, Joyce, Underwood, Kiggans Introduce Bipartisan Legislation to Address Nursing Shortage

On Thursday, Representatives Suzanne Bonamici (D-OR), David Joyce (R-OH), Lauren Underwood (D-IL), and Jennifer Kiggans (R-VA) introduced legislation to help address the nursing shortage by increasing the number of faculty at nursing schools. One of the primary reasons for faculty shortage is the pay disparity between practicing nurses and nurse educators. The median salary across advanced practice registered nurses is $120,000, but the average salary for a master’s-prepared professor in schools of nursing is $87,325. The Nurse Faculty Shortage Reduction Act, H.R. 7002, would create a grant program to help close this pay gap between clinical nursing and nurse faculty roles. Priority will be given to programs that serve vulnerable populations and recruit and retain faculty from underrepresented backgrounds. Read the press release here and the bill here.

Senators Durbin, Marshall Introduce Legislation to Bolster Public Health Efforts to Improve Dental Health

On Wednesday, Senate Majority Whip Dick Durbin (D-IL) and Senator Roger Marshall (R-KS) introduced bipartisan legislation, the Promoting Dental Health Act, to reauthorize funding the Centers for Disease Control and Prevention’s (CDC) Oral Health program for the next five years. The Oral Health program receives $20.5 million in annual funding for a range of public health activities to promote oral health. This funding is allocated to 20 states to prevent cavities, gum disease, and other painful and serious conditions, including by supporting dental education, data collection, school-based sealant care for low-income children, state fluoridation efforts, workforce development, and research into gaps in patient care. Read the press release here and the bill here.

Senators Welch, Braun, and Klobuchar Introduce Bipartisan Legislation to Streamline Drug Patent Litigation, Lower Cost of Prescription Drugs

Late last week, Senators Peter Welch (D-VT), Mike Braun (R-IN), and Amy Klobuchar (D-MN) introduced bipartisan, bicameral legislation to streamline drug patent litigation, encourage fair market competition, and lower prescription drug prices by making it easier for generic and biosimilar companies to enter the market. Rep. Jodey Arrington (R-TX), along with Reps. Lloyd Doggett (D-TX), August Pfluger (R-TX), Debbie Dingell (D-MI), Darrell Issa (R-OH), and Pramila Jayapal (D-WA) introduced companion legislation in the House. This bill codifies the practice that many federal district courts across the country already apply to limit the number of patents or patent claims a company can assert in litigation. Specifically, this bipartisan bill streamlines patent litigation by limiting to one, the number of patents per patent thicket a pharmaceutical company can assert in litigation. It would also prohibit a patent owner from asserting multiple patents from the same thicket in separate actions against the same alleged infringer to circumvent the intent of the law. Read the press release here and the bill here.

Reps. Matsui and Bucshon Introduce Bipartisan Bill to Prevent Drug Shortages by Addressing Vulnerabilities in the Pharmaceutical Supply Chain

Late last week, Representatives Doris Matsui (D-CA) and Larry Bucshon (R-IN) introduced the Mapping America’s Pharmaceutical Supply (MAPS) Act, a bill to help the federal government prepare for and mitigate future drug shortages by identifying pharmaceutical supply chain vulnerabilities. The MAPS Act would require the Department of Health and Human Services (HHS) to update its Essential Medicines List and create a database mapping the pharmaceutical supply chain. The database would include the country of origin, quantity manufactured, and other key information about critical drug products to identify supply chain weaknesses that could lead to shortages or other challenges in a future public health emergency. HHS could then use this information to predict future supply interruptions, helping to combat drug shortages and increase resiliency and readiness. Read the press release here and the bill here.

Reps. Brad Schneider and Troy E. Nehls Introduce the Bipartisan DOCTORS Act

Late last week, Representatives Troy E. Nehls (R-TX) and Brad Schneider (D-IL), along with 14 others, introduced the bipartisan Districting Our Country’s Transfer of Residency Slots (DOCTORS) Act, to help address nationwide physician shortages by reallocating unused waivers from the Conrad 30 waiver program to states who use their maximum number of waivers. Senators Joni Ernst (R-IA) and Amy Klobuchar (D-MN) introduced the Senate version of this legislation on September 5, 2023. The DOCTORS Act would require state agencies to report to the Secretary of State how many unused waivers they retained at the end of each fiscal year. The Secretary will calculate the total unused waivers and disburse those equally back to the states that used their maximum 30 slots in the previous fiscal year, divisible by three. Read the press release here and the bill here.

Reps. Eshoo, DeGette, Schrier Introduce Bill to Ensure Stable Supply of Pediatric Cancer Drugs

Late last week, Reps. Anna Eshoo (D-CA), Ranking Member of the Energy and Commerce Health Subcommittee, Diana DeGette (D-CO) and Kim Schrier (D-WA) introduced the Pediatric Cancer Drug Supply Act of 2024, legislation to ensure the United States maintains a stable supply of essential pediatric cancer drugs. The Pediatric Cancer Drug Supply Act of 2024 directs the U.S. Department of Health and Human Services (HHS) to establish a program to create a reserve supply of essential pediatric cancer drugs. Through this program, HHS will contract with eligible drug manufacturers to produce a stockpile of the most essential pediatric cancer drugs. As part of the contract, drug manufacturers would receive payments from HHS based on the quantity and cost of pediatric cancer drugs held in reserve. HHS would have authority to order manufacturers to distribute drugs from the buffer stocks into the commercial market to alleviate or prevent drug shortages. Read the press release here and the bill here.

Executive Branch:

CMS Announces New Model to Advance Integration in Behavioral Health

On Thursday, the Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), announced a new model to test approaches for addressing the behavioral and physical health, as well as health-related social needs, of people with Medicaid and Medicare. The Innovation in Behavioral Health (IBH) Model’s goal is to improve the overall quality of care and outcomes for adults with mental health conditions and/or substance use disorder by connecting them with the physical, behavioral, and social supports needed to manage their care. The model will also promote health information technology (health IT) capacity building through infrastructure payments and other activities. The IBH Model will be tested by the Center for Medicare and Medicaid Innovation (CMS Innovation Center). Under IBH, community-based behavioral health practices will form interprofessional care teams consisting of behavioral and physical health providers, as well as community-based supports. Read the press release here.

CMS Finalizes Rule to Expand Access to Health Information and Improve the Prior Authorization Process

On Wednesday, the Centers for Medicare & Medicaid Services (CMS) finalized the CMS Interoperability and Prior Authorization Final Rule. The rule sets requirements for Medicare Advantage (MA) organizations, Medicaid and the Children’s Health Insurance Program (CHIP) fee-for-service (FFS) programs, Medicaid managed care plans, CHIP managed care entities, and issuers of Qualified Health Plans (QHPs) offered on the Federally-Facilitated Exchanges (FFEs), to improve the electronic exchange of health information and prior authorization processes for medical items and services. Starting in 2026, Medicare Advantage and Medicaid plans will have 72 hours to answer urgent requests and seven days for a standard request, cutting current decision timeframes for standard decisions in half. The rule also requires all impacted payers to include a specific reason for denying a prior authorization request. Read the press release here and the final rule here.

Canada Holds Discussions with U.S. Officials on Bulk Importation of Drugs

On Tuesday, the Canadian government released a readout regarding the importation of Canadian prescription drugs to the US following the FDA approval in early January allowing Florida to import drugs from Canada. Canadian Health Minister Mark Holland spoke with HHS Secretary Xavier Becerra and U.S. Ambassador David Cohen earlier this week “to express Canada's disappointment with the FDA decision and to advise that Canada will take all necessary measures to protect the Canadian drug supply.” Ambassador Cohen confirmed that there is no desire or intent of the U.S. Government to create any challenges for Canada on drug access or shortages. Read the readout here.

Legal & Other:

Biden Administration Drops Appeal of Drug Copay Assistance Suit

On Tuesday, the Justice Department agreed to drop its appeal of a D.C. federal district court decision permitting the use of copay accumulator adjustment programs to help patients pay for their medicines. The Justice Department moved to withdraw its appeal of a recent decision by the US District Court for the District of Columbia in a case brought by the HIV & Hepatitis Policy Institute, overturning a Trump administration rule that allowed health insurers to avoid counting drug manufacturer copay assistance towards beneficiaries’ annual limits on deductible and out-of-pocket costs. The government’s action came after 19 senators sent a letter to the heads of the Departments of Health and Human Services, Labor, and Treasury calling on the administration to drop its appeal. The district court ruling in December 2023 leaves in effect the 2020 Notice of Benefit and Payment Parameters rule that requires health plans to count manufacturer copay assistance toward the annual limit on cost-sharing for drugs that don’t have a medically appropriate generic equivalent.