Health Care Checkup
April 12, 2024
THE BIG PICTURE: KEY CONGRESSIONAL & EXECUTIVE BRANCH DEVELOPMENTS
Multiple Committees of jurisdiction held health hearings this week on looming Medicare issues. The House Energy and Commerce Committee held a hearing on expiring telehealth flexibilities, and the Senate Finance Committee held a hearing on the future of Medicare physician payments. The House Committee on Oversight and Accountability Committee also held a hearing with Food and Drug Administration (FDA) Commissioner Robert Califf to examine the FDA.

On Wednesday, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule updating Medicare payments and policies for inpatient hospitals and long-term care hospitals. The proposed increase in operating payment rates for certain acute care hospitals in FY 2025 is projected to be 2.6%. CMS also proposed a separate payment under the IPPS for small, independent hospitals to establish and maintain a buffer stock of essential medicines for use during future shortages.
What to Expect Next Week:

The House and Senate will hold multiple hearings on various healthcare topics.

On Tuesday, the House Energy and Commerce Committee will hold a hearing on cybersecurity following the Change Healthcare attack and a hearing on improper Medicare and Medicaid payments. The Committee on Education and the Workforce will also hold a hearing on ERISA.

Also, on Tuesday, the Senate Special Committee on Aging will hold a hearing addressing shortages in the long-term care workforce. 
DEEP DIVE
Congressional:

Sen. Cantwell, Rep. Rodgers Unveil Draft Data Privacy Bill
On Sunday, House Energy and Commerce Chair Cathy McMorris Rodgers (R-WA) and Senate Commerce Chair Maria Cantwell (D-WA) unveiled draft legislation to set a national data privacy standard. The American Privacy Rights Act would limit the type of data companies can collect and use, and allow for people to sue for privacy violations. The national law would preempt many existing state data privacy laws, making exemptions for certain health and consumer protection laws, according to a summary of the measure. The legislation would also allow people to sue data companies for privacy violations of their health information that is not protected by federal health privacy law. The House Energy and Commerce Subcommittee on Innovation, Data, and Commerce announced they will hold a hearing on Wednesday, April 17, to discuss the American Privacy Rights Act along with nine other pieces of legislation on data privacy proposals. Read the draft legislation here and more on the hearing here.

House Energy and Commerce Holds Hearing on Telehealth Bills Ahead of Policy Expirations
On Wednesday, the House Energy and Commerce Health Subcommittee held a hearing on expiring telehealth flexibilities, where Democrats and Republicans indicated support for maintaining expanded telehealth payment for Medicare beneficiaries. Issues around cost, impact, and preventing fraud and abuse were also raised. The cost of extending the flexibilities was a major concern for members, including whether virtual visits should be reimbursed at the same rate as in-person care. Health Subcommittee Chair Brett Guthrie (R-KY) stated, “Making these authorities permanent is likely to cost much more than a short-term extension, and we want to make sure that whatever we move out of committee is paid for.” Full committee Ranking Member Cathy McMorris Rodgers (R-WA) acknowledged that extending the rules would be a “significant investment” but stated, “We can’t afford to go backward.” Members also spoke of the need to ensure that changes to telehealth do not lead to decreased access to in-person care. Members also cautioned about the risk of fraud and abuse with telehealth. Subcommittee Ranking Member Anna Eshoo (D-CA) raised concerns about the industry “gaming” virtual care to make it into a “cash cow.” Read Mehlman’s hearing summary here.

Senate Finance Committee Holds Hearing on Physician Reimbursement
On Thursday, the Senate Finance Committee held a hearing on the future of Medicare physician payments. Members and witnesses discussed shifting from fee-for-service to alternative payment models (APMs) and the need for increased flexibilities in traditional Medicare due to the shift from acute illness to managing chronic conditions in the Medicare beneficiary population. They also expressed frustration with the increasing use of prior authorizations in Medicare Advantage (MA) plans. Committee Chair Ron Wyden (D-OR) stated that the committee is continuing with an investigation into the use of prior authorization by Medicaid Managed Care plans. Sen. Sheldon Whitehouse (D-RI) stated he is working on a bill that would waive prior authorization requirements for providers participating in advanced alternative payment models, aiming to save Medicare money while delivering high-quality, coordinated care. Witnesses testifying encouraged Congress to eliminate the Physician Fee Schedule budget neutrality requirement, incentivize value-based payment models, and address financial barriers that dissuade patients from accessing chronic care treatment. Read more on the hearing here.
 
House Oversight and Accountability Committee Holds Hearing Examining FDA
On Thursday, the House Committee on Oversight and Accountability Committee held a hearing with Food and Drug Administration (FDA) Commissioner Robert Califf testifying as part of Republicans' ongoing investigations into the agency. Califf faced questions from members on topics ranging from drug and infant formula shortages to marijuana and e-cigarettes. Chairman James Comer (R-KY) stated that the agency was "failing to do the bare minimum to carry out its core mission." House Oversight and Accountability Health Care and Financial Services Subcommittee Chairwoman Lisa McClain unveiled email correspondence between FDA and White House officials about the infant formula shortage in the days leading up to manufacturer Abbott's recall, and questioned why the Biden administration didn't act sooner. Read Califf’s testimony here.

Senator Sanders Unveils $10 Billion Long COVID Proposal
On Tuesday, Senate Health, Education, Labor and Pensions Committee Chairman Bernie Sanders (I-VT) released a draft proposal for $10 billion in mandatory funding over ten years for the National Institutes of Health for long COVID research and implement a new grant process. The legislation would also establish a centralized coordinating entity at NIH that includes long COVID patients, along with a dedicated advisory board and a research database. Sanders is requesting public feedback on the proposal until April 23. Read the press release and request for input here.

Notable Bills Introduced:

Reps. Mike Carey, Danny K. Davis Introduces Legislation to Expand Access to Breakthrough Medical Treatments
On Thursday, Reps. Mike Carey (R-OH) and Danny Davis (D-IL) introduced bipartisan legislation that would simplify regulations to allow Medicare beneficiaries access to breakthrough medical treatments. The Patient Access to Innovative New Technologies Act creates new deadlines to expand the availability of cutting-edge medical treatments that have been approved or cleared by the Food and Drug Administration (FDA) through the Breakthrough Device Program. Specifically, the legislation requires the Centers for Medicare and Medicaid to expand the NTAP conditional approval pathway to include all technologies approved or cleared by the FDA through the Breakthrough Device Program and create one single deadline for alternative pathway products. Read the press release here and the bill here.
 
Sens. Mullin, Sinema, Tillis Introduce Bill to Increase Rural Access to Specialty Care Providers
On Tuesday, Senator Markwayne Mullin (R-OK), along with Senators Kyrsten Sinema (I-AZ) and Thom Tillis (R-NC), introduced the Ensuring Access to Specialty Care Everywhere (EASE) Act to increase access to specialty care providers for rural communities. The EASE Act would authorize the Center for Medicare and Medicaid Innovation (CMMI) to use its demonstration authority to create a virtual specialty care provider network that rural and underserved patients can access through telehealth. The House companion of this bipartisan bill was introduced by Reps. Michelle Steel (R-CA) and Susie Lee (D-NV). Read the press release here and the bill here.

Sens. Manchin, Capito, & Reps. Miller Caraveo Introduce the Preserving Emergency Access in Key Sites Act
On Wednesday, Senators Joe Manchin (D-WV) and Shelley Moore Capito (R-WV) and Representatives Carol Miller (R-WV) and Yadira Caraveo (D-CO), introduced the Preserving Emergency Access in Key Sites Act (PEAKS Act). The legislation would allow Critical Access Hospitals (CAHs) in rural, mountainous areas to be able to operate ambulatory services under a special enhanced Medicare payment model. The bill would also help to preserve the CAH model in mountainous areas by providing more flexible requirements for these hospitals. Specifically, the legislation would correct that error and reimburse CAHs for ambulatory services when there is no other ambulatory base within 15 miles of the facility to help ensure CAHs are not operating at a financial loss or struggling to support the flow or transportation of patients in their hospitals. Read the press release here and the bill here.
 
Senator Scott, Warner Introduce Prevent Diabetes Act During Minority Health Month
On Wednesday, Senators Tim Scott (R-S.C.) and Mark Warner (D-Va.), along with Representatives Gus Bilirakis (R-Fla.-12) and Diana DeGette (D-Colo.-01), introduced the PREVENT DIABETES Act. The legislation works to increase access to the Medicare Diabetes Prevention Program (MDPP) Expanded Model by allowing CDC-recognized virtual suppliers to participate in the program. Read the press release here and the bill here.

Reps. Steel, Bilirakis, Lee Introduce Bill to Expand Language Access to Telehealth
Late last week, Reps. Michelle Steel (R-CA), Gus Bilirakis (R-FL), and Susie Lee (D-NV) introduced the Expanding Language Access in Telehealth Act. The legislation seeks to improve access to telehealth services by directing the Secretary of Health and Human Services to develop best practices to improve language access for patients with Limited English Proficiency, specifically when seeking behavioral health care via video-based and audio-only telehealth. Read the press release here and the bill here. 

Executive Branch:

Eight Governors Sign Letter Urging President Biden to Disavow Bulletin Policies
On Thursday, eight governors sent a letter to President Biden asking his Administration to reconsider and immediately disavow the Medicaid finance policies set forth in the February 2023 Informational Bulletin and May 2023 proposed rule. The letter states the changes are overly prescriptive, administratively burdensome, and contrary to the interests of the Medicaid beneficiaries and warns that if the policies are implemented, “Medicaid funding could be reduced by $48 billion each year, impacting 49 states that rely on provider taxes to bolster their Medicaid programs.” The letter also states that these policies “run counter to decades of agency conduct, and to the statements of two agency employees who—more than 10 years apart—affirmed that the policies in the Bulletin were not the law.” The governors advocate for adherence to law and to continued state flexibility, so state leaders can assure their citizens have access to high-quality health care. Read the letter here.

CMS Proposes Rate Increases Under the Inpatient & Long-Term Care Hospitals Payment Rules
On Wednesday, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule updating Medicare payments and policies for the fiscal year (FY) 2025 Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS). The proposed increase in operating payment rates for general acute care hospitals paid under the IPPS that successfully participate in the Hospital Inpatient Quality Reporting (IQR) program and are meaningful electronic health record (EHR) users is projected to be 2.6%. For Long-Term Care Hospitals (LTCHs), CMS proposes to increase the LTCH PPS standard federal payment rate by 2.8%. In addition, CMS is proposing a separate payment under the IPPS for small, independent hospitals to establish and maintain a buffer stock of essential medicines for use during future shortages. Read the press release here and the fact sheet here. 
 
Biden-Harris Administration Finalizes Rule Expanding Access to Care and Increasing Protections for People with Medicare Advantage and Medicare Part D
Late last week, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), finalized policies that continue to strengthen enrollee protections and guardrails to ensure Medicare Advantage and Medicare Part D (Part D) prescription drug plans best meet the needs of people with Medicare. The Contract Year (CY) 2025 Medicare Advantage and Part D final rule builds on existing CMS policies to promote competition, increase access to care, including important behavioral health services, and protect individuals from inappropriate marketing and prior authorization. CMS is establishing a set amount a plan can compensate an agent or broker will protect Medicare Advantage and Part D plan enrollees, and prospective enrollees, from anti-competitive steering. In addition, CMS is codifying a provision prohibiting personal beneficiary data collected by Third Party Marketing Organizations (TPMOs), for marketing or enrolling a person into a Medicare Advantage or Part D plan, from being shared with another TPMO unless prior express written consent is given by the Medicare enrollee. CMS is also requiring that Medicare Advantage plans include an expert in health equity on their utilization management committees and for the committees to conduct an annual health equity analysis of the plans’ prior authorization policies and procedures. Read the press release here and the fact sheet here.

CDC Warns Doctors and State Health Departments to Watch Out for Bird Flu
Late last week, the Centers for Disease Control and Prevention issued a Health Action Network Advisory warning physicians of the highly pathogenic avian flu virus circulating the U.S. and the possibility of human infection. A farm worker in Texas reported an infection last week, marking the second case of the H5N1 strain of the bird flu in the U.S. The agency also asks state health departments to alert the federal government of any cases of avian flu. Read the press release here. 

Legal & Other:

Advocacy Groups Urge Biden Administration to Lower Cost of Prostate Cancer Drug
On Tuesday, a trio of advocacy groups urged the Biden administration to license patents for a costly cancer treatment to other manufacturers to lower prices. The prostate cancer drug, Xtandi, is currently sold in the U.S. by Pfizer and Astellas, where it is priced up to six times higher than in other developed nations. The three groups, Knowledge Ecology International, Universities Allied for Essential Medicines and Union for Affordable Cancer Treatment, argue in the letter to the Centers for Medicare and Medicaid Services (CMS) that the federal government could use two different laws to provide contracts to qualified companies to supply generic versions of Xtandi to patients in federal programs like Medicare and Medicaid. The groups stated that because the drug was developed with federal funding, the administration could directly lower costs. Last year, the Biden administration denied a petition to use so-called march-in rights to lower the cost of Xtandi. In December, the administration announced a plan for using march-in rights to lower drug costs, but it has faced industry pushback. Read the letter here. 
CONGRESSIONAL HEARINGS & EVENTS
House & Senate Hearings and Markups:

House:
 
House Energy and Commerce, Subcommittee on Health - Hearing
“Examining Health Sector Cybersecurity in the Wake of the Change Healthcare Attack.”
Tuesday, April 16, at 10 AM
 
Committee on Education and the Workforce, Subcommittee on Health, Employment, Labor, and Pensions - Hearing
"ERISA's 50th Anniversary: the Path to Higher Quality, Lower Cost Health Care"
Tuesday, April 16, at 10:15 AM
 
House Energy and Commerce, Oversight and Investigations Subcommittee – Hearing
“Examining How Improper Payments Cost Taxpayers Billions and Weaken Medicare and Medicaid.”
Tuesday, April 16, at 10:30 AM
 
House Energy and Commerce, Subcommittee on Health - Hearing
“Fiscal Year 2025 Department of Health and Human Services Budget.”
Wednesday, April 17, at 2:00 PM
 
Committee on Appropriations, Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies – Hearing
“Fiscal Year 2025 Budget Request for the Food and Drug Administration”
Thursday, April 18, at 9:00 AM
 
Senate:
 
Senate Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies – Hearing
“A Review of the President’s Fiscal Year 2025 Budget Request for the Department of Health and Human Services”
Tuesday, April 16, at 10:00 AM

Senate Special Committee on Aging – Hearing
“The Long-Term Care Workforce: Addressing Shortages and Improving the Profession”
Tuesday, April 16, at 10:00 AM
 
Senate Health, Education, Labor and Pensions Committee, Subcommittee on Primary Health And Retirement Security – Hearing
“Feeding a Healthier America: Current Efforts and Potential Opportunities for Food is Medicine”
Wednesday, April 17th, at 2:30 PM
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