Health Care Checkup: December 1, 2023

Health Care Checkup

December 1, 2023

THE BIG PICTURE: KEY CONGRESSIONAL & EXECUTIVE BRANCH DEVELOPMENTS

Over the weekend, Former President Trump revived his calls to repeal and replace the Affordable Care Act if he wins the 2024 presidential election. In a Truth Social post, Trump stated he’s “seriously looking at alternatives” to replace ObamaCare, and that the failure to repeal the health law in 2017 while he was in office was “a low point for the Republican Party.”

Prior to Thanksgiving, Congress passed a two-step continuing resolution that extended government funding for some appropriations until January 19th and others through February 2nd. While Congress continues to work on passing fiscal year 2024 bills in the interim, work has been delayed as the House and Senate have been focused on a potential supplemental spending bill to provide aid for Israel, Ukraine, and Tawain, although there is disagreement on including Ukraine funding and border security measures.

What to Expect Next Week:

The Senate Finance Committee will hold a hearing next week on Tuesday to examine drug shortages from a federal health program perspective.

While Congress continues to work on passing fiscal year 2024 bills in the interim, work has been delayed as the House and Senate have been focused on a potential supplemental spending bill to provide aid for Israel, Ukraine, and Tawain, although there is disagreement on including Ukraine funding and border security measures. Conference talks on the National Defense Authorization Act (NDAA) will continue next week.

DEEP DIVE

Congressional:

House Energy and Commerce Health Subcommittee Holds Hearing on AI in Healthcare

On Wednesday, the House Energy and Commerce Health Subcommittee held a hearing on how artificial intelligence is changing health care. Witnesses included healthcare industry experts who talked about how AI is currently being used in healthcare and how potential regulation could impact the technology. There was broad bipartisan consensus from subcommittee members that AI has great potential to improve health outcomes and patient experiences while reducing administrative burdens for healthcare workers. Members echoed that the benefits of AI must be weighed carefully, and Congress must act quickly to establish guardrails to protect patient privacy, prevent biases in the AI models, and prevent unintended consequences. Committee leaders also agreed on the need for a national data privacy standard to protect patients and consumers. Read Mehlman’s hearing summary here.

CDC Director Testifies in Hearing Before House Energy and Commerce Oversight Subcommittee

On Thursday, the Centers for Disease Control and Prevention (CDC) Director Mandy Cohen testified before the House Energy and Commerce oversight panel in a hearing focused on trust in the CDC amid the respiratory illness season. The hearing was Cohen's first appearance in front of Congress, who asked subcommittee members several times for Congress to give the CDC more funds and flexibility to carry out its work, following the end of the COVID-19 public health emergency, where the agency lost much of its access to local public health data. House Republicans pressed Cohen on her stance on school closures and mask and vaccine mandates carried out during the Covid pandemic’s peak. Democrats generally asked Cohen what the agency needs to prevent the next pandemic and to prevent the spread of respiratory diseases. Committee Ranking Member Frank Pallone (D-NJ) said he was interested in reauthorizing the recently lapsed pandemic preparedness measure and ensuring the CDC has the resources to do its job. Read the witness testimony here.

House Energy and Commerce Republican Leadership Demands Transparency from CDC

On Wednesday, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Oversight Subcommittee Chair Morgan Griffith (R-VA), and Health Subcommittee Chair Brett Guthrie (R-KY) sent a letter to CDC Director Mandy Cohen ahead of Thursday’s hearing, demanding transparency from the CDC regarding the uptick of respiratory viruses in China. The World Health Organization (WHO) recently called on China to provide epidemiological information about reported pneumonia clusters among children. The WHO has stated the spike in illnesses is a result of kids not being exposed to pathogens during the pandemic but has asked for more information regardless. Read the press release and letter here.

Fauci to Interview with Select Subcommittee on the Coronavirus Pandemic

On Thursday, the Select Subcommittee on the Coronavirus Pandemic, Chairman Brad Wenstrup (R-OH), announced Anthony Fauci, the former director of the National Institute of Allergy and Infectious Diseases, will participate in a two-day transcribed interview in January with the Select Subcommittee on the Coronavirus Pandemic. The interview will take place on January 8 and 9, followed by a public hearing later in the year. The testimony is expected to last seven hours per day, according to a letter Wenstrup sent to Fauci. Wenstrup indicated the committee will ask Fauci about the gain-of-function research that occurred in Wuhan, China, prior to the COVID-19 pandemic and comments he has made rejecting theories that the virus leaked from a lab. Read the letter here.

Notable Bills Introduced:

Senators Murray, Collins, and Baldwin Introduce Bipartisan Legislation to Reauthorize Substance Use Disorder Prevention Programs for Pregnant and Postpartum Women

On Thursday, Senators Patty Murray (D-WA), Susan Collins (R-ME), and Tammy Baldwin (D-WI) introduced the Promoting Maternal and Child Health Through Substance Use Prevention Act. The bill will reauthorize key prenatal and postnatal health initiatives established in the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act, which was passed in 2018 to help address the root causes and ripple effects of the opioid crisis. The legislation includes a five-year extension of programs carried out by the Centers for Disease Control and Prevention (CDC) to research and prevent substance use disorder among pregnant and postpartum women. Read the press release here and the bill here.

Reps. Salinas and Harshbarger Introduce Bipartisan Bill to Expand Telehealth Services for Rural Americans

On Thursday, Representatives Andrea Salinas (D-OR) and Diana Harshbarger (D-TN) introduced the bipartisan Home-Based Telemental Health Care Act, legislation that would expand access to remote mental health and substance use services in rural America, especially for individuals working in the farming, fishing, and forestry industries. U.S. Senators Mike Rounds (R-UT) and Tina Smith (D-MN) are leading a companion bill in the Senate. The legislation would direct the Secretary of Health and Human Services, in coordination with the Rural Health Liaison of the Department of Agriculture, to award grants to entities to establish mental health and substance use services for rural Americans in their homes, particularly those working in farming, fishing, and forestry occupations. It would also authorize up to $10 million for each fiscal year through 2027 using current funds. Read the press release here and the bill here.

Reps. Ruiz and Bacon Introduce Legislation to Address the Health Disparities in Native American Communities

On Thursday, Representatives Raul Ruiz (D-CA) and Don Bacon (R-NE) introduced a bipartisan bill, the Urban Indian Health Parity Act, that addresses the healthcare gaps for urban American Indian and Alaska Native Medicaid. The legislation would expand the Federal Medical Assistance Percentage (FMAP) measures to Urban Indian Organizations at a 100 percent reimbursement rate. Read the press release here and the bill here.

Rep. Murphy Introduces Bipartisan Legislation to Eliminate Costly Health Care Fees

On Tuesday, Rep. Gregory Murphy (R-NC), along with co-sponsors Reps. Morgan Griffith (R-VA), Mariannette Miller-Meeks (R-IA), Derek Kilmer (D-WA), Ami Bera (D-CA), and Kim Schrier (D-WA), introduced the No Fees for EFTs Act, bipartisan legislation to protect health care providers and patients from unnecessary fees associated with electronic fund transfers and payment transactions. Under the Affordable Care Act, health plans are required to offer medical practices the option to receive reimbursements electronically, with insurers frequently imposing charges between 2-5% on health care providers for electronic fund transfers (EFTs). Read the press release here and the bill here.

Reps. Kamlager-Dove, Bacon, and Evans Introduce Bipartisan Legislation to Expand Medicaid Eligibility for Foster Youth

On Tuesday, Reps. Sydney Kamlager-Dove (D-CA), Don Bacon (R-NE), and Dwight Evans (D-PA) introduced the bipartisan Expanding Coverage for Former Foster Youth Act to expand Medicaid eligibility for foster youth. This is companion legislation to the Senate bill introduced by Senator Bob Casey (D-PA). The legislation would eliminate the limitation that youth must be enrolled in Medicaid while they were in the system to qualify for Medicaid to age 26, and expand eligibility for Medicaid to coverage to former foster youth who were in the system but exited foster care to a legal guardianship with a kinship caregiver. Read the press release here and the bill here.

Executive Branch:

Team Biden-Harris Launches New Ad Highlighting President Biden’s Work To Lower Health Care Costs

On Thursday, Team Biden-Harris launched a new ad, “Your Family,” focused on President Biden's work to lower healthcare costs and the costs of prescription drugs. The new ad features a pediatric nurse in Las Vegas sharing her experience on how the health care system “has become a business” and highlighting Biden’s actions to lower prescription drug costs. The one-minute ad will run in swing states, airing in major cities in Arizona, Georgia, Michigan, Nevada, North Carolina, Pennsylvania and Wisconsin. The campaign is targeting the ad to air during shows such as The Voice and Survivor, as well as high-rated sports and national cable news programming.

Biden Releases Statement on North Carolina’s Implementation of Medicaid Expansion

On Friday, President Biden released a statement on North Carolina’s implementation of Medicaid expansion, the 40th state in the country to expand Medicaid. In his statement, Biden praised North Carolina for their work and cited the threat of “MAGA Republicans” repealing the Affordable Care Act (ACA). He called for strengthening the ACA and reducing healthcare and prescription drug costs and stated he would not let the ACA be repealed during his time in office. Read the statement here.

Biden-Harris Administration Announces Actions to Bolster Medical Supply Chain

On Monday, as part of the inaugural meeting of the White House Council on Supply Chain Resilience, President Biden and Secretary of Health and Human Services Xavier Becerra announced new efforts to bolster the domestic supply chain for essential medicines and medical countermeasures. President Biden will issue a Presidential Determination broadening HHS’s authorities under Title III of the Defense Production Act (DPA) to enable investment in domestic manufacturing of essential medicines, medical countermeasures, and other critical inputs that have been deemed by the President as essential to the national defense. In addition, HHS will designate a new Supply Chain Resilience and Shortage Coordinator for efforts to strengthen the resilience of critical medical product and food supply chains, and to address related shortages. HHS has identified $35 million for investments in domestic production of key starting materials for sterile injectable medicines. Read the press release here.

President Biden Presses Congress to Approve More Funding and Pass Law to Block Fentanyl Trafficking

Last week, On Tuesday, November 21, President Joe Biden pressed Congress to approve more funding and tighten laws to help block fentanyl trafficking, following his agreement with Chinese President Xi Jinping to crack down on the deadly drug. Biden heralded an agreement with Xi, who pledged during their summit last week to carry out a law-enforcement campaign against Chinese fentanyl components, and his talks with Mexican President Andres Manuel Lopez Obrador on stopping the flow of drugs across the southwest border. A White House emergency funding request included $1.2 billion for the Department of Homeland Security to counter fentanyl trafficking. But the package has been held up in Congress over disagreements about Ukraine assistance and immigration policy. Biden also urged lawmakers to list fentanyl on Schedule I, a Drug Enforcement Administration list of highly abused substances.

New GAO Study on Cost of Oral Medications for End-Stage Renal Disease Covered Under Medicare Part B

On Thursday, a Government Accountability Office study found the Centers for Medicare & Medicaid Services (CMS) plan to begin covering oral phosphate binders, medications for end-stage renal disease (ESRD), under Medicare Part B starting in 2025 has dialysis centers anticipating they will require extensive staffing and infrastructure overhauls. The plan will entail a two-year transition period in which the CMS will pay dialysis organizations 100% of the average sales price of phosphate binders. Representatives from large and small dialysis centers surveyed by the GAO said the transition to a bundled coverage model will require significant investment to meet the capacity demands needed to dispense high volumes of phosphate binders in-house. In response to the study, CMS acknowledged that dialysis organizations would need to adjust operations to dispense phosphate binders, but the agency expects it will ultimately be feasible for organizations to develop needed capacity. Read the study here.

FDA Finalizes Rule on Radio and TV Prescription Drug Advertisements

Last week, on Tuesday, November 21, the Food and Drug Administration (FDA) finalized a rule Tuesday requiring radio and TV ads selling prescription drugs to provide information on side effects and contraindications in a more consumer-friendly manner. The rule builds upon previous regulations requiring the ads to include information on a drug’s risks by creating standards for what qualifies as a “clear, conspicuous, and neutral” presentation of risks. The standards include displaying information, such as side effects, on a TV ad so it can be read easily and gives consumers sufficient time to read it. The FDA stated that drug makers face having the FDA put limits on how they can be sold if they fail to follow these rules. Read the final rule here.

Legal & Other:

Trump States he is ‘Seriously’ Looking at ObamaCare Alternatives

Over the weekend, Former President Trump revived his calls to repeal and replace the Affordable Care Act if he wins the 2024 presidential election. In a Truth Social post, the leading GOP presidential candidate claimed he’s “seriously looking at alternatives” to replace ObamaCare, and that the failure to repeal the health law in 2017 while he was in office was “a low point for the Republican Party.” Dean Rosen, a Republican lobbyist at Mehlman Consulting and former chief health care adviser to former Sen. Majority Leader Bill Frist (R-TN), suggested Trump and other GOP candidates move on from the matter, stating, “history has not been kind to politicians who have tried to radically remake the health system or take away people’s coverage — no matter how imperfect.”

Biden HHS to Appeal Judge’s Order to Scrap Trump-Era Drug Rule

On Tuesday, the Health and Human Services (HHS) department filed a notice of appeal to the US Court of Appeals for the District of Columbia Circuit in the US District Court for the District of Columbia on behalf of the HHS, HHS Secretary Xavier Becerra, the Centers for Medicare & Medicaid Services, and CMS Administrator Chiquita Brooks-LaSure. HHS plans to appeal a federal judge’s order to withdraw a Trump-era rule on copay assistance programs that were opposed by drug industry-backed patient groups. In September, US District Judge John D. Bates wrote in an order that the CMS rule (RIN 0938-AT98) appears to conflict with the definition of “cost-sharing” in the Affordable Care Act and federal regulations. The 2020 rule said pharmacy benefit managers do not have to count drugmaker copay assistance toward patients’ out-of-pocket costs.