Health Care Checkup: November 17, 2023

Health Care Checkup

November 17, 2023

THE BIG PICTURE: KEY CONGRESSIONAL & EXECUTIVE BRANCH DEVELOPMENTS

On Tuesday, the House passed a stopgap spending bill, or CR, in a 336-95 vote, averting a partial government shutdown and funding the government into January for four spending bills and February for the remaining eight. The Senate followed Wednesday night, passing the CR in an 87-11 vote, and President Biden signed it into law on Thursday.

What to Expect Next Week:

The Senate and House are both in recess next week and will reconvene on Monday, November 27 (Senate), and Tuesday, November 28 (House).

DEEP DIVE

Congressional:

President Biden Signs CR Into Law Funding Government into January

On Tuesday, the House passed a stopgap spending bill, or CR, in a 336-95 vote, averting a partial government shutdown and funding the government into January for some spending bills and February for others. The Senate followed Wednesday night, passing the CR in an 87-11 vote, and President Biden signed the CR into law on Thursday. The clean stopgap spending bill (H.R. 6363) sets a January 19 deadline for four bills (Agriculture-FDA, Energy and Water, Military Construction-VA, and Transportation-HUD) and a February 2 deadline for the remaining eight, including the Labor-HHS-Education bill. The CR also extends key farm bill programs that cover nutrition and agriculture policy for one year. The measure also would extend several programs that were set to expire on November 17, including:

Community health centers and pandemic preparedness authorities through January 19.
Delays an $8 billion cut to Medicaid disproportionate share hospital (DSH) payments through January 19.
The National Flood Insurance Program through February 2.
The Temporary Assistance for Needy Families (TANF) program through February 2.

The CR did not include supplemental funding requested by the Biden Administration for Israel, Ukraine, or border security.

House Republicans Postpone a Vote on Labor-HHS-Education Spending Bill

On Wednesday, House Republicans postponed a vote until after November 28 on their Labor-HHS-Education spending bill (H.R. 5894). Leaders put off the vote amid skepticism from conservative and moderate Republicans, with the bill proposing a 19 percent or $44 billion cut below the previous year. Prior to postponing the final passage of the bill, the House adopted 93 amendments to the bill, including proposals to increase funding for substance use prevention, medical research, and the healthcare workforce. The House also adopted proposals, including amendments that would block the use of fiscal 2024 funds to enforce a COVID-19 vaccine mandate in universities or to implement a mask mandate that would restrict certain research and grants related to gain-of-function research and bat coronavirus emergence.

House E&C Health Subcommittee Advanced21 Bills Focused on PBMs, Medicare

On Wednesday, the House Energy and Commerce Health Subcommittee approved 21 bills focused on reforming the practices of pharmacy benefit managers (PBMs), changing Medicare coverage rules, and reforming payments to physicians. While most of the legislation was bipartisan, disagreements remain between Republicans and Democrats on several bills. The committee advanced three bills related to PBMs, with H.R. 5393 mirroring legislation unanimously approved in the Senate Finance Committee markup last week, which would direct the Health and Human Services (HHS) secretary to establish standardized pharmacy performance metrics that PBMs participating in Part D and Medicare Advantage can use when determining how to pay pharmacies. On a 21-6 vote, the subcommittee advanced the Ensuring Patient Access to Critical Breakthrough Products Act of 2023 (H.R. 1691), which would require Medicare to cover medical devices approved under the Food and Drug Administration’s Breakthrough Devices Program for four years; codifying Trump-era rules that were walked back by the Biden administration. Read Mehlman’s markup summary here.

Senate Finance Subcommittee on Health Held a Hearing on Medicare Telehealth Flexibilities

On Tuesday, the Senate Finance Subcommittee on Health held a hearing on pathways to making Medicare telehealth flexibilities permanent. Telehealth flexibilities were temporarily granted under the COVID-19 pandemic and are set to expire on December 31, 2024. Witnesses, which included telehealth and policy experts, told the Healthcare Subcommittee panel that permanent, expanded Medicare telehealth services would improve access to health care in rural and underserved areas while making providers more effective and efficient. They also cautioned that discontinuing audio-only visits and reinstating limits on telehealth services to specific settings or designated rural areas would lead to a decline in coverage and reduce healthcare availability for these vulnerable populations. There was bipartisan agreement among the members present that these flexibilities should be made permanent. Read Mehlman’s hearing summary here.

House Veterans’ Affairs Committee Held a Hearing on VA Electronic Health Records Stability

On Wednesday, at a House Veterans’ Affairs Hearing, members' patience with the VA’s troubled electronic health records (EHR) system transition waned. The Oracle Cerner EHR implemented for the VA went live three years ago. Rep. Matt Rosendale (R-MT), chair of the House Veterans’ Affairs subcommittee on technology modernization, argued that VA data on system performance was not showing the extent of the issues, pointing to information from health IT research firm KLAS showing user dissatisfaction with the system, and employees have stopped reporting glitches. Witness Kurt DelBene, the VA’s chief information officer, said contractor Oracle Cerner has met incident-free time requirements in only four of the 10 past months as of September. Read more on the hearing here.

Senators Warnock and Kennedy Release White Paper Examining Insulin Deserts

On Tuesday, Senators Raphael Warnock (D-GA) and John Kennedy (R-LA) released a new white paper analyzing county-level data across the country to examine counties with both high rates of uninsured people and high rates of diabetes, which the Senators have termed “Insulin Deserts.” The report concluded that 813 counties are Insulin Deserts, with most of these counties concentrated in the South and especially the Southeast. The report follows the legislation, the Affordable Insulin Now Act (S. 954), which the Senators are sponsoring, that would cap insulin copays at $35 a month and require the Department of Health and Human Services to reimburse doctors and pharmacists for providing insulin to the uninsured. Read the press release here and the report here.

Healthcare Groups Press Congress for Five-Year Pandemic Preparedness Reauthorization

On Tuesday, over 100 healthcare groups pressed House and Senate leadership to pass a bipartisan, five-year pandemic preparedness reauthorization before the end of the calendar year. The Pandemic and All-Hazards Preparedness Act expired on September 30. The current continuing resolution, which passed the House and Senate this week and is expected to be signed into law by the end of the week, extended the legislation through January 19. In the letter, the groups stated, "Failing to reauthorize PAHPA would have serious effects on our country's economic well-being, national security, and health security given the rapidly changing threat landscape.” In July, the House and Senate advanced long-term reauthorization measures, with the House version currently split into two bills (H.R. 4421 and H.R. 4420), which Democrats opposed due to the lack of language addressing prescription drug shortages. Read the letter here.

Notable Bills Introduced:

Senators Cortez Masto, Cassidy, Warren, and Blackburn Introduce Bipartisan Bill to Increase Transparency Over Medicare Advantage Health Plans

On Wednesday, Senators Catherine Cortez Masto (D-NV), Bill Cassidy (R-LA), Elizabeth Warren (D-MA) and Marsha Blackburn (R-TN) introduced bipartisan legislation to improve transparency of Medicare Advantage (MA) plans. The Encounter Data Enhancement Act would require Medicare Advantage plans to report important information about how much they are paying for patient services and how much patients are responsible for paying out-of-pocket. The legislation will help lawmakers conduct oversight of federal dollars going to Medicare Advantage plans, assess quality of care, and strengthen healthcare access for Medicare beneficiaries. Read the press release here and the bill here.

Senators Smith and Cotton Reintroduce Bipartisan Legislation to Boost U.S. Pharmaceutical Manufacturing

On Wednesday, Senators Tina Smith (D-MN) and Tom Cotton (R-AR) reintroduced bipartisan legislation to reduce dependence on foreign pharmaceutical manufacturing and boost production in the U.S. The American Made Pharmaceuticals Act would create federal incentives to onshore manufacturing of essential medicine, while taking steps to shore up links in the supply chain. Read the press release here and the bill here.

Senators Collins and Cardin Introduce Bill to Improve Seniors’ Access to Substance Use Treatment

On Thursday, Senators Susan Collins (R-ME) and Ben Cardin (D-MD) introduced the Supporting Seniors with Opioid Use Disorder Act. This bipartisan legislation would put into law the recommendations made by the Department of Health and Human Services (HHS) Office of Inspector General (OIG) regarding how to improve beneficiaries’ awareness of Medicare coverage for opioid use disorder treatment and how to identify gaps and opportunities to meet the needs of this unique population better. Read the press release here and the bill here.

Senators Peters, Collins, and Reps. Kelly, Kiggans Introduce Bipartisan, Bicameral Medical Nutrition Therapy Act

On Tuesday, Senators Susan Collins (R-ME) and Gary Peters (D-MI) introduced the Medical Nutrition Therapy Act, bipartisan legislation that would expand Medicare beneficiaries’ access to Medical Nutrition Therapy (MNT) for currently uncovered diseases or conditions, a cost-effective method to treat obesity, diabetes, hypertension, dyslipidemia, and other chronic conditions. Reps. Robin Kelly (D-IL) and Jen Kiggans (R-VA) introduced a companion bill in the House. Read the press release here and the bill here.

Executive Branch:

HHS Finalizes Rule to Enhance Nursing Home Ownership Data

On Wednesday, the Centers for Medicare & Medicaid Services (CMS) finalized a rule proposed in February to help define whether nursing homes are owned by private equity groups or real estate trusts. The rule is part of a broader administrative effort to crack down on poor nursing home management. Nursing homes currently must report certain ownership and management data to CMS as part of the Medicare and Medicaid enrollment processes, but the administration says the additional data required by the new rule will give CMS and states a "more complete background on the organizations and individuals that own, oversee, and facilitate the operations of nursing homes." Read the rule here and the fact sheet here.

CMS Announces Proposed Rule for 2025 Health Exchange

On Wednesday, the Centers for Medicare and Medicaid Services released its proposed standards for the 2025 health insurance exchanges. The annual proposed rule proposes allowing states to add routine dental benefits to their Essential Health Benefit, something that was previously prohibited. Additionally, CMS proposes allowing issuers to offer additional non-standardized plans beyond the two-plan limit if they demonstrate that these additional plans have reduced cost-sharing of 25 percent or more for benefits pertaining to the treatment of chronic and high-cost conditions. The agency stated the proposal could help reduce health disparities as many people with chronic and high-cost conditions struggle to find health coverage. CMS also proposes that state marketplaces establish network adequacy standards related to time and distance that are at least as stringent as the federal marketplaces. The proposal establishes marketplace call center standards and proposes state open enrollment periods for the states that are not using HealthCare.gov to extend their open enrollments into January. Read the fact sheet here.

Funding Opens for States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model

On Thursday, CMS announced the first of two Notice of Funding Opportunities (NOFOs) for the States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model. In September, CMS announced a new voluntary, state total cost of care model: the States Advancing All-Payer Health Equity Approaches and Development Model (“States Advancing AHEAD” or “AHEAD” Model). CMS’s goal in the AHEAD Model is to collaborate with states to curb healthcare cost growth, improve population health, and advance health equity by reducing disparities in health outcomes. States interested in participating in the model should submit their applications by Monday, March 18, 2024, for Cohorts 1 and 2, and Monday, August 12, 2024, for Cohort 3. Read the NOFO here and the press release here.

President Biden Intends to Appoint Dr. W. Kimryn Rathmell as Director of the National Cancer Institute

On Friday, President Joe Biden announced his intent to appoint Dr. W. Kimryn Rathmell as the 17^th Director of the National Cancer Institute (NCI), the federal government's principal agency for cancer research and training and the largest funder of cancer research in the world. Dr. W. Kimryn Rathmell is an accomplished physician-scientist and internationally recognized cancer expert who will work towards achieving the goals the President set for the Biden Cancer Moonshot as part of his Unity Agenda. Read the press release here.

Biden Administration Announces White House Initiative on Women’s Health Research

On Monday, the Biden administration announced a new White House initiative on women’s health research led by First Lady Jill Biden. As part of the initiative, President Joe Biden has tasked federal agencies with delivering recommendations within 45 days on what actions the federal government can take to advance women’s health research. Those agencies include the Departments of Health and Human Services, Veterans Affairs and Defense, the Advanced Research Projects Agency for Health, and the National Institutes of Health. The administration aims to close research gaps in women’s health, including how to manage and treat conditions like endometriosis and why women make up most cases of autoimmune diseases like rheumatoid arthritis. Read the fact sheet here.

HHS Secretary Forms Public Advisory Panel to Address Long Covid

On Thursday, the Department of Health and Human Services (HHS) announced the establishment of the Secretary’s Advisory Committee on Long COVID to study and advise treatment for Americans suffering from lingering disease symptoms. Health and Human Services Secretary Xavier Becerra invited nominations for his Secretary’s Advisory Committee on Long Covid, a panel consisting of individuals from outside the government who will assist in defining research priorities that will help inform the HHS’s response to tackling long Covid. Read the press release here.

Legal & Other:

Home Health Agencies Ask Court to Scrap 2023 Medicare Pay Rule

Late last week, attorneys representing the National Association for Home Care & Hospice filed a motion seeking summary judgment in their lawsuit against Department of Health and Human Services Secretary Xavier Becerra over methodology the agency uses to determine Medicare payment rates. In the filing in the US District Court for the District of Columbia, the association claims Medicare’s 2023 home health payment rule is “unlawful and should be set aside,” in part, because it violates a directive from Congress to “determine the impact on expenditures resulting from differences between assumed and actual behavior changes” of home health agencies. The motion also claims the final rule violates federal budget neutrality requirements and “Congress’s command to remove therapy thresholds as a factor that influences payment.” The outcome of the case could drastically reshape the payment landscape for Medicare home health providers and affect the availability and viability of the popular benefit. Read the court docket here.