Health Care Watch: May 20, 2023
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from May 14 – May 20. Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.
LEGISLATIVE UPDATE
House
On May 16, the Ways & Means Committee held a hearing entitled Health Care Price Transparency: A Patient’s Right to Know. The committee heard from witnesses who shared their firsthand experience of using price transparency to benefit patients seeking care or small businesses sponsoring insurance for their employees. Committee members asked that the Biden Administration fully enforce existing price transparency rules and that Congress look at more ways to empower patients to unleash price transparency through tools like modernized Health Savings Accounts to access quality, affordable health care.
On May 17, the Energy & Commerce Committee advanced a legislative package aimed at increasing transparency and competition in health care — particularly among hospitals, insurance companies and pharmacy benefit managers (PBMs). Collaboration between Committee Chair Cathy McMorris Rodgers (R-WA) and Ranking Member Frank Pallone (D-NJ) allowed for the passage of multiple pieces of legislation that included provisions codifying and enhancing rules that require hospitals and insurance companies to disclose the prices of their services.
On May 18, the Appropriations Agriculture, Rural Development, Food & Drug Administration Subcommittee advanced its FY 2024 spending bill by voice vote to the full committee. The bill, if passed as written, would provide the FDA with $3.5 billion, a number that would total $6.6 billion when user fees are added. President Joe Biden had asked Congress to boost the agency’s funding to $7.2 billion in FY 2024, an increase of $521 million over FY 2023.
Republican Leadership continues to negotiate with the White House on a package to raise the debt before June 1. While reports suggest the parties remain divided on the size and duration of discretionary spending caps, it is likely that a recission of roughly $60 billion in unspent COVID funds will be a part of a final deal. President Joe Biden and Speaker Kevin McCarthy (R-CA) are scheduled to meet again May 22.
On May 22, the House will consider the following legislation:
H.R. 1076: Preventing the Financing of Illegal Synthetic Drugs Act
H.R. 467: HALT Fentanyl Act
Senate
On May 15, Health, Education, Labor, & Pensions (HELP) Committee Chairman Bernie Sanders (I-VT) released a five-year, $190 billion plan to fund community health centers ($130 billion) and expand the health care workforce ($60 billion). HELP Ranking Member Bill Cassidy (R-LA) suggested these funding levels are unrealistic and inconsistent with their bipartisan talks.
On May 17, Sen. Sanders and Reps. Pramila Jayapal (D-WA) and Debbie Dingell (D-MI), reintroduced the Medicare for All Act. The legislation has amassed 14 cosponsors in the Senate and more than 110 in the House.
On May 17, the Homeland Security Investigations Subcommittee held a hearing entitled Examining Health Care Denials and Delays in Medicare Advantage. The committee announced that it will continue to investigate the frequency with which Medicare Advantage (MA) plans deny care for beneficiaries and followed up by sending letters to the three largest MA insurers — Humana, UnitedHealthcare and CVS — demanding records on the number of prior authorization requests and denials dating back to 2019. The letter also asked the companies for records outlining the role software algorithms play in turning down physicians’ prior authorization requests.
On May 18, Sen. Cassidy released draft legislation designed to improve care for dual eligibles though integrated care models, expanding the Program of All-Inclusive Care for the Elderly to Medicare beneficiaries under the age of 55, and a new risk adjustment model for integrated plans that cover duals. The legislation would also examine the hospital star rating program.
On May 18, HELP Chairman Bernie Sanders stated that he would not commit to voting to approve the White House’s nominee to lead the National Institutes of Health (NIH). Chairman Sanders sent a letter to the White House earlier this month saying he would not support Biden nominees who are “too soft” on prescription drug companies and has stated that he “has not heard one word from the administration on this.”
On May 18, Finance Committee Chairman Ron Wyden (D-OR) sent a letter to Department of Health & Human Services (HHS) Secretary Xavier Becerra and Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure asking CMS to provide prompt, clear, and publicly available information about how Medicare providers and patients can participate in a registry or submit data under the agency’s coverage with evidence development (CED) policy that allows Medicare to cover new Alzheimer’s medicines. The letter asks CMS to disclose a variety of information about its plans to release more details about how it will help Medicare beneficiaries and providers understand how to access new Alzheimer’s therapies that may receive full approval from FDA.
The Senate returns from its Memorial Day recess on May 30.
REGULATORY UPDATE
On May 15, the United States Court of Appeals for the Fifth Circuit issued a temporary administrative stay in the case Braidwood Management v. Becerra. This follows an earlier ruling by a district court judge in Texas that struck down the Affordable Care Act requirement that health plans must cover certain preventive services (including preexposure prophylaxis for HIV – the subject of the Texas case) without cost-sharing for patients. Under the administrative stay, the government can continue enforcing the preventive services requirement while the Fifth Circuit considers the Department of Justice’s motion for a stay pending appeal.
On May 15, the Supreme Court stated that it would not consider arguments from Teva Pharmaceuticals over “skinny labeling” for generic products. Skinny labeling allows generic drugs to come to market for some — but not all — indications of patented drugs. Teva has argued that a lower court’s ruling in GSK’s favor could hurt future generic drugs. In March, the Biden administration urged the Supreme Court to take the case.
On May 15, CMS announced that it will begin its Inpatient Rehabilitation Facility (IRF) Review Choice Demonstration program for IRF services in Alabama beginning August 21, 2023. IRF providers can select pre-claim review or postpayment review beginning July 7 through August 6.
On May 15, 2023, CMS announced that it will host a webinar entitled FY 2024 SNF PPS Proposed Rule Overview on May 24 at 2 PM EST. The educational webinar will provide an overview of the major proposals for the SNF VBP Program in the FY 2024 SNF PPS Proposed Rule. Registration can be found here.
On May 16, the Federal Trade Commission (FTC) announced a lawsuit against the biotech companies Amgen and Horizon Therapeutics to block their $27.8 billion merger. The FTC argues the deal would harm competition in the pharmaceutical market by crippling innovation and slowing down drug development. The lawsuit, filed in federal court in Chicago, says the deal would allow Amgen to entrench its monopoly in certain orphan drugs through rebates paid to PBMs.
On May 16, CMS announced that it is offering a virtual training program that provides instruction on the updated guidance for the Skilled Nursing Facility Minimum Data Set (MDS) 3.0 Resident Assessment Instrument (RAI) v1.18.11 Manual and Item Set.
On May 18, the Department of Education (DOE) issued a proposed rule under the Individuals with Disabilities Education Act that would streamline consent provisions when billing for Medicaid services provided through a student’s individualized education program. If finalized, the rule would result in a uniform process applicable to all Medicaid-enrolled children, regardless of disability. Comments on the rule are due by August 1. On the same day, CMS also released a comprehensive guide for Medicaid school-based services to make it easier for schools to deliver and receive payment for healthcare services to millions of eligible students. A fact sheet on the guide can be found here.
On May 18, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend that FDA approve the first vaccine that protects infants against respiratory syncytial virus (RSV). Advisers voted 14-0 that Pfizer’s vaccine candidate, administered to pregnant individuals in their second or third trimester, demonstrated that it would effectively protect infants from severe cases of the disease. In late-stage clinical trials, the vaccine was more than 80% effective at preventing severe RSV in newborns up to three months old and about 70% effective at preventing severe disease in babies up to six months old.
On May 18, the FTC issued a proposed rule on the Health Breach Notification Rule and how FTC intends to apply the rule to health apps and other digital health tools that do not fall under HIPAA. A press release on the rule can be found here.
WHITE HOUSE UPDATE
On May 15, President Biden announced his intent to nominate Dr. Monica Bertagnolli as Director of the National Institutes of Health (NIH). Dr. Bertagnolli is currently Director of the National Cancer Institute (NCI), the first woman to serve as NCI Director. She previously served as the Richard E. Wilson Professor of Surgery in the field of surgical oncology at Harvard Medical School, a surgeon at Brigham and Women’s Hospital, and a member of the Gastrointestinal Cancer Treatment and Sarcoma Centers at Dana-Farber Cancer Institute.
On May 15, the Biden Administration announced that it is summoning naloxone manufacturers for a discussion on the medication’s price. Director of the White House Office of National Drug Control Policy Rahul Gupta made the announcement amid continued criticism of pricing strategies from Emergent BioSolutions (which aims to price a two-pack of Narcan at $50) and other naloxone manufacturers.
On May 18, the Biden Administration announced additional actions to advance the President’s mental health strategy across its three key objectives: strengthening the mental health workforce and system capacity, connecting more Americans to care, and creating a continuum of support. Actions include increasing the size and diversity of the behavioral health workforce, enhancing crisis response, and expanding proven models of care.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
CMS
Medicare Secondary Payer and Certain Civil Money Penalties (CMS-6061); Final Rule; 3/1/22
Treatment of Medicare Part C Days in the Calculation of a Hospital's Medicare Disproportionate Patient Percentage (CMS-1739); Final Rule; 4/6/23
CY 2024 Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Medicare; Proposed Rule; 4/18/23
Short-Term Limited Duration Insurance; Update (CMS-9904); Proposed Rule; 4/20/23
CY 2024 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1786); Proposed Rule; 4/20/23
CY 2024 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1782); Proposed Rule; 4/21/23
CY 2024 Home Health Prospective Payment System Rate Update and Home Infusion Therapy Services Payment Update (CMS-1780); Proposed Rule; 4/24/23
Transitional Coverage for Emerging Technologies (CMS-3421); Notice; 4/24/23
Omnibus COVID-19 Health Care Staff Vaccination (CMS-3415); Final Rule; 5/2/23
OS
Health Resources Priority and Allocations System (HRPAS); Proposed Rule; 5/16/23
IHS
Catastrophic Health Emergency Fund (CHEF); Proposed Rule; 3/21/23
REPORTS
Office of Inspector General (OIG)
On May 16, OIG released a report examining the risk of misuse and diversion of buprenorphine for opioid use disorder for Medicare Part D beneficiaries. OIG found that almost all Medicare Part D enrollees who received buprenorphine to treat their opioid use disorder received the recommended amounts. Most enrollees received buprenorphine-naloxone combination products, which have a reduced risk of misuse or diversion; however, 16% of enrollees received buprenorphine monoproducts. Only a small number of enrollees received very high amounts of buprenorphine or received buprenorphine at the same time as they received high amounts of opioids indicated for pain. Most prescribers ordered buprenorphine for only a limited number of enrollees, which could provide an opportunity to increase access. Further, very few prescribers had patterns that raise concern. Only 35 prescribers ordered buprenorphine for multiple Part D enrollees who either received very high levels of buprenorphine or received buprenorphine at the same time as they received high amounts of opioids. OIG recommends that CMS: 1) monitor the use of buprenorphine and share information, as appropriate, with Departmental partners; 2) inform providers about buprenorphine use and the low risk of diversion to encourage providers to treat more Part D enrollees who have opioid use disorder; 3) take steps to inform providers about the availability of buprenorphine combination products in Part D, which can minimize the risk of misuse and diversion; and 4) follow up on the prescribers with concerning patterns identified in this report.
Government Accountability Office (GAO)
On May 17, GAO released “priority recommendations” for HHS. In May 2022, GAO identified 56 priority recommendations for the Department of Health and Human Services (HHS). Since then, HHS has implemented 12 of those recommendations. In April 2023, GAO identified four additional priority recommendations, bringing the total number of open priority recommendations to 45. These recommendations involve the following seven areas: 1) COVID-19 response and other public health emergency preparedness; 2) public health and human services program oversight; 3) Food and Drug Administration oversight; 4) Medicaid program; 5) Medicare program; 6) improper payments in Medicaid and Medicare; and 7) health information technology and cybersecurity.
Centers for Disease Control & Prevention
On May 15, the Centers for Disease Control and Prevention (CDC) released provisional data that found 109,680 people in the U.S. died from drug overdoses in 2022. This is a slight increase over the 2021 figure: 109,179.
On May 18, the CDC released new mpox data that found a significant benefit from a two-shot series. The study finds that two doses of the mpox vaccine Jynneos provide better protection against contracting the disease than one. The vaccine was, on average, 66% effective in preventing mpox in people who had received two doses and only 35.8% effective in people who received only one.
UPCOMING CONGRESSIONAL HEARINGS
House
Oversight and Accountability Committee
May 13; 10:00 AM; 2154 Rayburn
OTHER POLICY NEWS
On May 18, a group of 39 attorneys general sent a letter to congressional leaders asking for more to be done to combat the rise of xylazine, a horse sedative also known as Tranq. The bipartisan group of state officials asked lawmakers to pass the Combating Illicit Xylazine Act, which would classify the substance as a Schedule III drug, enabling the Drug Enforcement Agency (DEA) to track its manufacturing and require additional data on the drug’s risks.