Weekly Health Care Policy Update – November 22, 2024

November 29, 2024

In this update: 

  • Administration Update
    • Trump Nominates Dr. Mehmet Oz for CMS Administrator
  • Legislative Update
    • Senator Bill Cassidy to Chair HELP Committee
  • Federal Agencies
    • DEA Extends Remote Prescribing of Controlled Substances
    • CMS Approves Five 1115 Waivers on Continuous Eligibility
  • Other Updates
    • Leapfrog Releases Fall 2024 Hospital Safety Grades
    • CVS, United, Cigna PBMs Sue FTC Over Insulin Prices
    • Commonwealth Fund Publishes Biennial 2024 Health Insurance Survey
  • New York State Updates
    • DOH Issues Notice to Hospitals Regarding Cybersecurity Requirements
    • DFS Issues Revised Proposed Regulations on Behavioral Health Network Adequacy and Access
    • DFS Adopts PBM Market Conduct Regulations
    • OMH Issues Guidance on Rights of Minors to Consent to Mental Health Treatment
    • CMS Approves New York SPA to Cover Certain Imported Drugs Under Medicaid
    • OMIG to Host Second Health Care Provider Engagement Forum

Administration Update

Trump Nominates Dr. Mehmet Oz for CMS Administrator 
On November 19th, President-elect Donald Trump announced his nomination of Dr. Mehmet Oz to serve as the Centers for Medicare and Medicaid Services (CMS) Administrator. Trump’s announcement stated that “Dr. Oz will work closely with Robert F. Kennedy Jr. to take on the illness industrial complex, and all the horrible chronic diseases left in its wake” and that “he will also cut waste and fraud.” Dr. Oz will need to advance through the Senate Finance Committee and be confirmed by the whole Senate.
 
A former TV personality and cardiothoracic surgeon, Dr. Oz’s record on health policy is relatively slim. During the passage of the Patient Protection and Affordable Care Act (ACA), Dr. Oz applauded the bill’s reduction in the number of uninsured Americans. During his 2022 Pennsylvania Senate campaign, however, he was critical of the ACA. Oz has consistently advocated for broader use of Medicare Advantage (MA) plans, authoring a “Medicare Advantage for All” plan with former Kaiser CEO George Halvorson, which included a 20% payroll tax to finance the plan.
 
Dr. Oz has both promoted and expressed skepticism about vaccines, while regularly touting unproven health treatments for various ailments, including hydroxychloroquine for Covid-19. His financial disclosures reveal wide investments across health care, including in pharmaceutical, device, retail, insurance, supplier, provider, and other businesses.

Legislative Update

Senator Bill Cassidy to Chair HELP Committee
On November 14th, Senator Bill Cassidy (R-LA) was officially selected to chair the Senate Health, Education, Labor, and Pensions (HELP) Committee for the 119th Congress, assuming the position from Senator Bernie Sanders (I-VT). Senator Cassidy, a gastroenterologist by training, is the first doctor to serve as the HELP chair since 1933. Key areas of focus for Senator Cassidy are prescription drug affordability, surprise medical bills, and mental health. The makeup of the full Committee is yet to be decided.
 
Chair Cassidy and the HELP Committee will hold at least one hearing to discuss Trump’s pick to lead the Department of Health and Human Services (HHS), Robert F. Kennedy Jr., though this position is ultimately confirmed by the Senate Finance Committee. In a press release, Chair Cassidy applauded RFK Jr.’s work with healthy foods and public health transparency, noting that he looks “forward to learning more about his other policy positions and how they will support a conservative, pro-American agenda.”
 
The announcement is available here.

Federal Agencies

DEA Extends Remote Prescribing of Controlled Substances
On November 19th, the Drug Enforcement Agency (DEA) and the Department of Health and Human Services (HHS) jointly issued a temporary rule extending pandemic-era telehealth flexibility on virtual prescribing of controlled substances through December 31, 2025. This is the third such temporary extension of telehealth prescribing flexibilities, which would otherwise have expired at the end of 2024. Under the extension, the pre-pandemic in-person evaluation requirement for controlled substance prescription is waived. 
 
The rule is available here.
 
CMS Approves Five 1115 Waivers on Continuous Eligibility 
On November 14th, the Department of Health and Human Services (HHS) announced the approval of five section 1115 demonstration amendments. Currently, all states are required to provide 12 months of continuous eligibility for children in Medicaid and the Children’s Health Insurance Program (CHIP). However, these waivers, in Colorado, Hawaii, Minnesota, New York, and Pennsylvania, will provide continuous eligibility for Medicaid and CHIP for children up to their third (CO) or sixth birthdays (HI, MN, NY, PA), with additional stipulations for continuous eligibility at other ages. Additionally, Colorado and Pennsylvania’s waivers allow for 12 months of continuous eligibility for adults (up to 65 years of age) leaving incarceration.
 
This announcement is part of HHS’s overall push to approve outstanding waiver applications before the end of President Biden’s Administration. While CMS does not discuss waiver applications, California (concerning mental and reproductive health infrastructure) and New York (concerning a managed care tax) have considerable requests pending.
 
The announcement is available here.

Other Updates

Leapfrog Releases Fall 2024 Hospital Safety Grades 
On November 15th, the Leapfrog Group released its Fall 2024 Hospital Safety Grades. Leapfrog uses 30 performance measures to assign each hospital an A through F grade. For the third year in a row, Utah ranks number one in percentage of “A” hospitals, followed by Virginia and Connecticut, North Carolina, New Jersey, California, Rhode Island, Idaho, Pennsylvania, Colorado and South Carolina.  There were no “A” hospitals in Iowa, North Dakota, South Dakota or Vermont. Leapfrog found that the rates of three critical hospital-associated infections (HAIs),central line-associated bloodstream infections, catheter-associated urinary tract infections, and methicillin-resistant Staphylococcus aureus, decreased by at least one-third.
 
The announcement is available here. Individual hospital ratings can be found here.
 
CVS, United, Cigna PBMs Sue FTC Over Insulin Prices
On November 19th, CVS Health, UnitedHealthcare, and Cigna sued the Federal Trade Commission (FTC) over the agency’s in-house case against pharmacy benefit managers (PBMs) over the cost of insulin. The PBMs are claiming this suit, which hinges on the FTC’s claim that PBMs use illegal rebate programs to raise the cost of insulin, is unconstitutional and violates the Due Process clause of the Fifth Amendment. The plaintiffs also argue that this case is not suited for in-house court and must be litigated in federal court. This suit is the latest in a string of actions related to the Biden Administration’s pursuit of more vigorous regulation of this industry, in the absence of Congressional action.
 
Commonwealth Fund Publishes Biennial 2024 Health Insurance Survey
On November 20th, the Commonwealth Fund published its 2024 biennial health insurance survey, “The State of Health Insurance Coverage in the U.S.” Overall in 2023, 26 million Americans, or 8% of the population, lacked health insurance coverage, roughly half the number who lacked insurance prior to passage of the Affordable Care Act. Still, 12% of working-age adults had a gap in coverage during 2023, and 23% were underinsured, without coverage that provided affordable access to health care. Almost 60% of underinsured adults said they avoided getting needed care due to cost, and 44% said they had medical or dental debt. Roughly 40% of adults who delayed care due to cost said the delay worsened an existing health condition. Among underinsured adults, 66% had coverage through an employer, 16% had coverage through Medicaid or Medicare, and 14% had a marketplace or individual market plan.
 
The full survey findings are available here.

New York State Updates

DOH Issues Notice to Hospitals Regarding Cybersecurity Requirements
On November 19th, the New York State (NYS) Department of Health (DOH) issued a notice to hospitals regarding the recently adopted cybersecurity regulations that became effective October 2, 2024 (details here). The regulations require hospitals to develop a cybersecurity program that designates a Chief Information Security Officer, includes policies for third-party services providers, and implements a cybersecurity awareness training program for personnel. Hospitals will be required to conduct an annual risk assessment to inform the design of its cybersecurity program.

Hospitals are required to report specific cybersecurity incidents to DOH within 72 hours, effectively immediately. Hospitals have one year from the effective date of the regulation (that is, until October 2, 2025) to comply with the remaining requirements.

The notice is available here. Questions may be submitted to cyberincident@health.ny.gov.

DFS Issues Revised Proposed Regulations on Behavioral Health Network Adequacy and Access
On November 20th, the NYS Department of Financial Services (DFS) issued revised proposed regulations that would establish network adequacy standards for behavioral health services for regulated commercial insurance plans. The Fiscal Year 2023-24 Enacted Budget required DOH, in consultation with the DFS, the Office of Mental Health (OMH), and the Office of Addiction Services and Supports (OASAS) to develop regulations by the end of last year on this topic. DOH has issued identical network adequacy proposed regulations, which are applicable to Medicaid managed care organizations (SPG’s summary is available here).

As with the DOH proposed regulations, the DFS regulations would require commercial insurance plans to ensure that its network has adequate capacity and availability to offer behavioral health services appointments within specified timeframes (i.e., within 10 business days for initial outpatient visits, and within 7 calendar days following a hospital discharge or emergency room visit). If the plan is not able to locate a participating provider within 3 business days of receipt of an access complaint, the plan must allow the member to receive services from an out-of-network provider and may not impose additional cost-sharing.

The regulations would allow health insurance plans to meet appointment wait time requirements using telehealth appointments, unless the patient specifically requests an in-person appointment. The proposed regulations also include provider directory requirements, reporting requirements, requirements for responding to complaints, and additional plan responsibilities regarding network adequacy and access.

The revised proposed regulations are available here. Compared to the initial proposed regulations, the revised regulations provide clarifying language and other changes to address many of the comments received by stakeholders. The comments received on the initial proposed regulations and associated DFS responses are available here. Public comment on the revised regulations may be submitted to HealthRegComments@dfs.ny.gov through January 4, 2025.

DFS Adopts PBM Market Conduct Regulations
On November 20th, DFS adopted final regulations that establish network contracting standards and consumer protections for Pharmacy Benefit Managers (PBMs) operating in New York, including minimum standards for market conduct practices, conflicts of interest, anti-competitive and unfair claims practices, and predatory audit practices. The regulations: 

  • Prohibit PBMs from barring any in-network pharmacies from providing mail order or delivery services;
  • Require PBMs to list formularies and pharmacy directories online and prohibit PBMs from penalizing consumers who rely on this information;
  • Require PBMs to post a telephone number and email address and provide timely responses to consumer inquiries;
  • Prohibit anti-competitive practices that steer consumers away from their community pharmacy to larger pharmacies affiliated with the PBM;
  • Prohibit retroactive denial or reduction of reimbursement to pharmacies, except in specific circumstances (e.g., fraud, pharmacy errors, or prior agreement);
  • Allow pharmacies to submit information to and receive information from PBMs electronically; and
  • Require PBMs to apply the same audit standards across all in-network pharmacies.

The DFS press release is available here. The adopted regulations are available here.

OMH Issues Guidance on Rights of Minors to Consent to Mental Health Treatment
On November 20th, OMH issued guidance to licensed outpatient and inpatient providers that clarifies the rights of minors (individuals under the age of 18) regarding their ability to consent for their own mental health treatment. Under Mental Hygiene Law 33.21, a minor may receive mental health outpatient services from OMH licensed providers if: 

  • The minor knowingly and voluntarily seeks such services; and
  • The services are clinically indicated and necessary to the minor’s well-being; and
    • A parent or guardian is not reasonably available;
    • Requiring parental or guardian consent or involvement would have a detrimental effect on the course of outpatient treatment; or
    • A parent or guardian has refused to give such consent, and a physician determines that treatment is necessary and in the best interests of the minor.

A minor may meet with a mental health practitioner without prior parental consent to determine whether the minor meets the above guidelines. If the above conditions are not met, consent from a parent or guardian is required for outpatient treatment. Additionally, in any outpatient circumstance in which psychotropic medication is recommended, the consent of the minor’s legal guardian is required.

Regarding inpatient care, a minor over the age of 16 can seek admission to a hospital, Comprehensive Psychiatric Emergency Program (CPEP), or a Residential Treatment Facility (RTF) without consent from a parent/guardian if the minor is voluntarily seeking treatment and the director of the facility is in agreement. If admitted, the minor 16 or over can consent to psychotropic medication without the consent of a parent or guardian if the following are met: 

  • A parent or guardian is not reasonably available, provided the treating physician determines that the minor had capacity and the medications are in the minor’s best interest;
  • Requiring consent of a parent or guardian would have a detrimental effect on the minor, provided that the treating physician and a second physician who specializes in psychiatry and is not an employee of the hospital determine that 1) such detrimental effect would occur; 2) the minor has capacity to consent; and 3) such medications are in the minor’s best interest; or
  • The parent or guardian has refused to give such consent, provided the treating physician and a second physician who specializes in psychiatry and is not an employee of the hospital determine that 1) the minor has capacity to consent; and 2) such medications are in the minor’s best interests. Notice of the decision to administer psychotropic medication should be provided to the parent or guardian. 

Youth who are parents of a child, emancipated, married, or on voluntary status on their own application under MHL 9.13 can consent to treatment without the consent of a parent or guardian.

The guidance is available here.

CMS Approves New York SPA to Cover Certain Imported Drugs Under Medicaid
On November 20th, CMS approved New York’s State Plan Amendment (SPA) to allow for the coverage of imported drugs in line with federal regulations. Effective August 1, 2024, the NYS Medicaid benefit will cover “certain imported drugs that are deemed medically necessary” per federal reimportation requirements.

In certain cases, the Food and Drug Administration (FDA) allows temporary importation of non-FDA approved drugs from other countries to mitigate the effects of drug shortages, such as the current shortage of long-acting penicillin. CMS encouraged states in its May 7thMedicaid call to consider submitting a SPA to cover such drugs if needed.

The SPA is available here. The CMS approval letter is available here.

OMIG to Host Second Health Care Provider Engagement Forum
On December 18th from 10:30am-12pm, the NYS Office of the Medicaid Inspector General (OMIG) will host a second health care provider forum in New York City. The session will provide updates on OMIG’s Medicaid program integrity efforts, on which participants may provide feedback and ask questions.

In-person attendance is available on a first-registered, first-served basis (registration here). Participants may also attend virtually (registration here and webcast will be available here). Providers interested in submitting input, questions, or recommendations prior to the session may complete the feedback form here. Questions about the event may be submitted to information@omig.ny.gov.