Weekly Health Care Policy Update – October 23, 2023

October 30, 2023

In this update: 

  • Legislative Update
    • Senate HELP Committee Releases Majority Report on Nonprofit Hospitals
    • House E&C Subcommittee Holds Hearing on Physician Payments
  • Federal Agencies
    • CMS Releases 2024 MA-PD and PDP Star Ratings
    • FDA Seeks Nominations for Advisory Committee on Digital Technologies
    • CMS Releases 2024 Medicare A and B Premiums and Deductibles
    • CMMI Publishes One-Year Update on Prescription Drug Models
    • HHS Releases Guidance on Privacy and Telehealth for Patients and Providers
    • Project NextGen Selects Initial Vaccine Candidates
    • CMS Removes Limit on PET Scans for Alzheimer’s
    • HHS and Pfizer Agree to Plan for Paxlovid Market Transition, Price Increase
    • CDER Seeks Input on Clinical Trial Innovation
    • NIH Simplifies Grant Review Process to Focus on Scientific Merit, Reduce Bias
    • CMS to Hold November 15th Conference on Improving Patient Lives
  • Other Updates
    • KFF Releases Survey on Employer-Sponsored Insurance Premiums
  • New York State Updates
    • DOH Releases New Monthly Unwinding Dashboard Reports
    • DOH Releases Guidance and Instructions on MLTC Involuntary Disenrollment Process
    • DOH Hosts Monthly Managed Care Policy and Planning Meeting
    • OMH Issues Updated Billing Guidance for Using Interpreter Services in MHOTRS Clinics
  • Funding Opportunities
    • NYS Announces Eighth Round of Funding for Empire State Supportive Housing Initiative
    • OASAS Releases RFA for Harm Reduction Services
    • NYHealth Releases RFP to Support Healthy Food Interventions and Projects
    • OMH Releases RFA for One-Time Funding to Support MHOTRS Clinic Enhancement
    • NYC DOHMH Releases RFP for Operation of Strong Messenger Project

Legislative Update

Senate HELP Committee Releases Majority Report on Nonprofit Hospitals
On October 10th, Senator Bernie Sanders (I-VT), the Chairman of the Senate Health, Education, Labor, and Pensions Committee, released a Majority Staff Report on nonprofit hospitals. The report claims that many not-for-profit hospital systems are not providing affordable care, despite the tax benefits they receive. Nearly half of American hospitals are non-profit. The report finds that, in 2020, each non-profit hospital on average received an estimated $9.4 million in federal, state, and local tax benefits. The report examined 16 of the nation’s largest non-profit hospital systems and found that 12 dedicate less than 2% of total revenue to charity care. New York Presbyterian Hospital, Montefiore Medical Center, and Robert Wood Johnson Barnabas Health were included in this analysis. The report calls on Congress and the Internal Revenue Service (IRS) to reevaluate the tax-exempt status of not-for-profit hospitals.

The American Hospital Association (AHA) responded to the report in a blog post drawing attention to a new AHA report outlining the substantial community benefits beyond charity care that are provided by not-for-profit hospitals. According to AHA, not-for-profit hospitals delivered nearly $130 billion in total community benefits, or an average of 15.5% of total expenses.

Senator Sanders’s report is available here. The AHA blog post is available here.

House E&C Subcommittee Holds Hearing on Physician Payments
On October 19th, the House Energy & Commerce (E&C) Committee’s Health Subcommittee held a meeting entitled “What’s the Prognosis?: Examining Medicare Proposals to Improve Patient Access to Care & Minimize Red Tape for Doctors.” The hearing included an examination of 23 legislative proposals that may be introduced at some point during the 118th Congress, which include, among others: 

  • A bill to add an inflationary adjustment to the Physician Fee Schedule (PFS) every five years, based on the Medicare Economic Index (MEI), and to require updates to direct costs on the same timeline;
  • A bill to extend the 5% Advanced Alternative Payment Model (A-APM) bonus through 2026 and establish a five-year cap on receiving the bonus;
  • A bill exempting physicians participting in a Medicare Advantage (MA) APM from Merit-Based Incentive Payment System (MIPS) requirements; and
  • The Improving Seniors Timely Access to Care Act, which the House passed in 2022 but was not taken up by the Senate.

Although it is unlikely that any of these proposals will be included in a health package this year, this hearing sets the groundwork for the subcommittee’s work next year. A more detailed summary by SPG’s partners at Impact Health is available here.

Federal Agencies

CMS Releases 2024 MA-PD and PDP Star Ratings
On October 13th, the Centers for Medicare and Medicaid Services (CMS) released the 2024 Star Ratings for Medicare Advantage (MA) and Medicare Part D plans. The Star Ratings score plans on a scale from one to five stars, based on the quality of health and drug services received by beneficiaries enrolled in the plan. The ratings are available to consumers through the Medicare Plan Finder Tool.

Based on the new star ratings, 42% of MA plans that offer prescription drug coverage (MA-PD) that will be offered in 2024 earned an overall rating of four stars or higher. As a result, approximately 74% of MA-PD enrollees are currently in contracts that will have four or more stars in 2024. Fewer than 6% of MA-PD plans earned a 5-star rating, while just under 10% of plans earned fewer than three stars.

The Star Ratings data show significant differences in for-profit versus non-profit MA-PD plans. While 34% of for-profit plans earned four stars or greater, over 56% of non-profit plans earned four stars or higher. This trend held for stand-alone prescription drug plans as well, with nearly 14% of for-profit plans earning four stars or higher, while 40% of non-profit plans earned four stars or higher.

Open enrollment for these plans began on October 15th and will end on December 7th. Changes made during this period will take effect on January 1, 2024. More information on the Star Ratings data is available here.

FDA Seeks Nominations for Advisory Committee on Digital Technologies 
On October 11th, the Food and Drug Administration (FDA) announced the creation of a new Digital Health Advisory Committee and requested nominations for the committee from the public. The Committee will guide the FDA’s navigation of emerging issues relating to digital health technologies, including: 

  • Artificial intelligence and machine learning;
  • Digital therapeutics; and
  • Remote patient monitoring software

The Committee will consist of nine permanent voting members (including a chairperson) as well as temporary non-voting members with expertise in particular topics, who may be consumer representatives or industry representatives. The nine permanent members themselves must have appropriate qualifications, including technical and scientific subject matter expertise. FDA plans for the Committee to be fully operational in 2024.

The FDA announcement is available here. Nominations will be accepted through December 11th. Individuals interested in applying to be a voting or non-voting member can submit nominations here.

CMS Releases 2024 Medicare A and B Premiums and Deductibles 
On October 12th, CMS announced the 2024 premiums, deductibles, and coinsurance amounts for Medicare Part A and Part B programs as well as the 2024 Medicare Part D monthly adjustment amounts. There were slight increases in the deductibles for all enrollees in Medicare Part A and Part B. The Inflation Reduction Act made modifications to the Medicare Savings Programs and the Low-Income Subsidy (LIS) program. Specific premium information for 2024 includes: 

  • The Medicare Part A inpatient hospital deductible will be $1,632 in 2024, an increase of $32 from $1,600 in 2023.
  • Beneficiaries must pay a coinsurance amount of $408 per day for the 61st through 90th day of a hospitalization ($400 in 2023) in a benefit period and $816 per day for lifetime reserve days ($800 in 2023).
  • For beneficiaries in skilled nursing facilities, the daily coinsurance for days 21 through 100 of extended care services in a benefit period will be $204.00 in 2024 ($200.00 in 2023).
  • The standard monthly premium for Medicare Part B enrollees will be $174.70 for 2024, an increase of $9.80 from $164.90 in 2023.
  • The annual deductible for all Medicare Part B beneficiaries will be $240 in 2024, an increase of $14 from the annual deductible of $226 in 2023.

The fact sheet is available here.

CMMI Publishes One-Year Update on Prescription Drug Models
On October 11th, the Center for Medicare and Medicaid Innovation (CMMI) published a one-year update on its progress towards implementing President Biden’s Executive Order 14087 on “Lowering Prescription Drug Costs for Americans.” In February, CMMI announced that it would test three new models in response to the Order (described in SPG’s February 22ndupdate here). The update includes new details on its progress towards implementing these three models.

Since February, CMMI has been conducting targeted analysis to validate the feasibility of and effectiveness of each model, gathering input from internal and external parties, and identifying considerations for the implementation timeline. CMMI noted the following: 

  • Medicare $2 Drug List: This model will focus on generic medications already on lower-cost formulary tiers. This will include 150 drugs that offer a treatment option in over 90 percent of instances. CMMI found that currently, only about 20 percent of Part D beneficiaries are enrolled in a plan that offers a benefit similar to this model.
  • The Cell and Gene Therapy Access Model: This model would establish a multi-state approach for multiple Medicaid programs to structure outcomes-based arrangements to pay for new cell and gene therapies (CGT). CMMI notes that since the model was announced, the CGT pipeline has expanded rapidly, including new FDA approvals for several CGTs this year. As such, CMMI is accelerating the launch of this model to phase in during 2025, rather than 2026 as originally planned.
  • The Accelerating Clinical Evidence Model: Under this model, CMMI would make Part B payment adjustments to encourage the timely completion of trials for drugs that have received accelerated approval. CMMI notes that due to new FDA authorities for accelerated approval, additional review of the model will be needed.

CMMI’s announcement is available here.

HHS Releases Guidance on Privacy and Telehealth for Patients and Providers 
On October 18th, the Department of Health and Human Services (HHS) issued two resource documents to help explain the privacy and security risks to protected health information (PHI) when utilizing telehealth services. For patients, the resource includes information on personal cybersecurity and safety. For providers, HHS compiled an educational guide for providers to facilitate conversations with patients surrounding telehealth options offered, risks to PHI when using telehealth, the security practices of vendors, and applicability to civil rights law.

The guidance for patients is available here and the guide for providers is available here.

Project NextGen Selects Initial Vaccine Candidates
On October 13th, the Administration for Strategic Preparedness and Response (ASPR) at HHS announced the initial next-generation vaccine candidates and the accompanying awards for Project NextGen. The three vaccines selected are a vector-based intranasal vaccine (CastleVax), a live-attenuated intranasal vaccine (Codagenix), and a self-amplifying mRNA vaccine (Gritstone Bio). CastleVax, a recent offshoot of Mount Sinai, received $8.5 million for their Phase 2b clinical evaluation. Codagenix, another New York company, received $10 million. Accompanying awards include cold-chain and specimen management, genomic sequencing efforts, and the development of antibody test kits and monoclonal antibody treatments.

The announcement is available here.

CMS Removes Limit on PET Scans for Alzheimer’s
On October 13th, CMS announced its decision to remove the national coverage determination that restricted beneficiaries to one PET scan per lifetime. PET scans detect the presence of brain plaque, a prerequisite to be prescribed new Alzheimer’s drugs like Leqembi. CMS is leaving coverage determinations to regional contractors. With more accessible PET scans, many forecast an increase in prescriptions for this expensive class of drugs.

The decision is available here.

HHS and Pfizer Agree to Plan for Paxlovid Market Transition, Price Increase
On October 13th, HHS reached an agreement with Pfizer to maintain access to Paxlovid as the treatment transitions to the commercial market. One key feature of the agreement is an HHS-operated patient assistance program for individuals who are uninsured, on Medicare, or Medicaid. This program will transition to Pfizer management with time. Moreover, Pfizer will provide HHS with a stockpile of one million treatment courses. Lastly, Paxlovid will remain available for ordering from HHS through December 15th.

On October 18th, Pfizer announced it will list Paxlovid at a price of $1,390 for a 5-day course of treatment. HHS paid $529 for the treatment in their purchasing contract. The list price is not what patients pay, but it has an impact on how much insured patients pay out of pocket and can be a major barrier for uninsured patients.

The HHS announcement is available here.

CDER Seeks Input on Clinical Trial Innovation
On October 17th, the Center for Drug Evaluation and Research (CDER) within the FDA announced its solicitation of public comments to better understand the landscape of innovation in clinical design and conduct. CDER is particularly interested in the barriers and facilitators to incorporating these approaches into drug development programs. These comments will be accepted until April 19, 2024.

The announcement is available here.

NIH Simplifies Grant Review Process to Focus on Scientific Merit, Reduce Bias 
On October 19th, the National Institutes of Health (NIH) announced steps to simplify their process of assessing the scientific merit of research grant applications. These changes are also meant to reduce the potential for bias in review. The revisions include condensing five criteria for evaluation into three. The new criteria are: 

  • Importance of research (scored 1-9);
  • Rigor and feasibility (scored 1-9); and
  • Expertise and resources (evaluated as sufficient or not).

The announcement is available here.

CMS to Hold November 15th Conference on Improving Patient Lives 
On November 15th, from 9am to 4pm ET, CMS will host the 2023 CMS Conference on Optimizing Healthcare Delivery to Improve Patient Lives. The virtual conference will cover the following areas: 

  • Updates from CMS on agency efforts to reduce administrative burden;
  • Panel discussions on “Opportunities to Reduce Inequitable Outcomes and Improve Customer Experience” and “Connecting Patients and Care Providers across the Healthcare Enterprise”; and
  • Best practice presentations and discussion from leadership from the federal government, health provider organizations, and the patient advocacy community.

Registration is available here.

Other Updates

KFF Releases Survey on Employer-Sponsored Insurance Premiums 
On October 18th, the Kaiser Family Foundation (KFF) released the results of its annual survey of employer-sponsored health insurance costs, finding that premiums for family coverage increased to an average of nearly $24,000 annually, an increase of 7% over 2022. The overall increase is similar to the year-over-year increase in average worker wages (5.2%) and inflation (5.8%). These trends have also held over the past five years, with premiums increasing 22%, wages up 27%, and inflation up 21% since 2018. Workers’ 2023 contributions to their premium costs rose approximately $500, to $6,575 on average, while deductibles remained roughly stable for workers whose plans require them.
 
The survey is available here.

New York State Updates

DOH Releases Guidance and Instructions on MLTC Involuntary Disenrollment Process 
On October 18th, NYS DOH released guidance and instructions regarding the Managed Long Term Care (MLTC) Involuntary Disenrollment Process. Following the end of the Continuous Enrollment Condition authorized by the Families First Coronavirus Response Act, the State has begun its Public Health Emergency unwind process, which includes the resumption of the involuntary disenrollment of MLTC enrollees per the MLTC model contract requirements. As such, MLTC plans, including Partial Capitation, Programs of All-Inclusive Care for the Elderly (PACE), and Medicaid Advantage Plus (MAP) plans must follow the guidance for MLTC involuntary disenrollment effective November 1st.

The guidance covers mandatory vs. optional involuntary disenrollment, reasons for disenrollment, reasons for continuing enrollment following enrollee contact, the process for involuntary disenrollments, transition of care responsibilities, and DOH’s right to recover premiums. The guidance also includes templates for disenrollment letters and request forms. This policy does not include the involuntary disenrollments that result from a Medicaid discontinuance.

The guidance is available here.

DOH Hosts Monthly Managed Care Policy and Planning Meeting
On October 12th, DOH hosted its monthly Managed Care Policy and Planning Meeting, which provided updates on member enrollment statistics by plan and provider enrollment statistics. The webinar also provided updates on the Bureau of Managed Care fiscal oversight, Social Adult Day Care, implementation of the Independent Assessor Program, and dual eligible individuals during the PHE unwinding period.

The presentation is available here. The webinar also included an enrollment reconciliation update, which is available here.

OMH Issues Updated Billing Guidance for Using Interpreter Services in MHOTRS Clinics
On October 5th, the NYS Office of Mental Health (OMH) issued a memorandum to managed care plans and Mental Health Outpatient Treatment and Rehabilitative Services (MHOTRS) clinics regarding updated billing guidance for delivering interpreter services within MHOTRS programs. Effective October 1, 2023, the guidance has been updated as follows: 

  • Modifier U4, used for services delivered in a Language Other than English (LOE), may now only be used for reimbursement when the staff person is fluent in the enrollee’s preferred language and should not be used for interpreter services. The modifier will continue to pay a 10 percent rate enhancement for each eligible service.
  • OMH is implementing a new modifier combination of U1 and U7, which will provide a 35 percent rate enhancement for each eligible service when provided in an LOE with the translation assistance provided by a contracted vendor or a contracted translation professional other than the staff person (“LOE-Vendor”).

The memorandum is available here. Plan questions may be submitted to BHO@omh.ny.govand provider questions may be submitted to OMH-Managed-Care@omh.ny.gov.

Funding Opportunities

NYS Announces Eighth Round of Funding for Empire State Supportive Housing Initiative
On October 10th, New York State released a Request for Proposals (RFP) for the eighth round of funding for supportive housing units under the Empire State Supportive Housing Initiative (ESSHI). As part of the State’s plan to ensure that New Yorkers have access to affordable and safe housing, this RFP contributes to the goal of developing at least 20,000 supportive housing units over 15 years for individuals identified as homeless with special needs, conditions, or other life challenges.

This RFP will provide service and operating funding for 1,400 units of permanent supportive housing. Support services that accompany the housing units may include, but are not limited to, employment and training opportunities, parenting education, primary care, substance use disorder and mental health treatment, and child care. The State will provide up to $25,000 in services and operating funding annually for each unit. No capital funding is available through this RFP. Applicants are expected to secure capital funding sufficient to fully finance the proposed housing project within 24 months from the date of the ESSHI conditional funding award.

The full RFP is available here. SPG’s summary of the opportunity is available here. Applications are due on December 5th.

OASAS Releases RFA for Harm Reduction Services
On October 12th, the NYS Office for Addiction Services and Supports (OASAS) released a Request for Applications (RFA) that will provide funding to support community-based providers with the delivery of harm reduction services. OASAS will provide $4.5 million in total funding to 15 providers to develop/continue harm reduction service projects statewide. Funding may be used for increasing access to treatment and recovery support, reducing stigma, overdose prevention and education, outreach and engagement services, and capacity development.

Eligible applicants are not-for-profit organizations that are currently engaged in harm reduction activities with People Who Use Drugs (PWUD). Organizations must have a total revenue of less than $1 million annually in their current or immediate prior year. Organizations that are not OASAS-certified or funded must provide a detailed account of their harm reduction experience with PWUD. Each awarded organization will receive up to $100,000 in annual funding over the three-year contract period.

The RFA is available here. Applications are due on December 4th. Questions may be submitted to grants@oasas.ny.gov with the subject line “RFA 22110” through October 30th.

NYHealth Releases RFP to Support Healthy Food Interventions and Projects 
The New York Health Foundation (NYHealth) has released an RFP that will fund projects to: 

  • Promote “Food Is Medicine” interventions, such as medically tailored meals/groceries and produce prescription programs; or
  • Support healthier, culturally responsive food purchasing, such as hosting community workshops and creating opportunities for farmers/suppliers with small operations to compete for institutional contracts at health systems.

NYHealth will award 8-10 organizations with grants of up to $50,000 each. Projects may last for up to two years in duration. Funding may not be used for general operating support, capital expenses, or lobbying. Eligible applicants are NYS-based not-for-profit organizations. Priority will be given to organizations led by and directly supporting people of color.

The RFP is available here. FAQs are available here. Letters of Intent must be submitted by October 23rd. Selected applicants will be invited to submit a full proposal, which will be due on January 17th. Final grant decisions will be made in March 2024. Questions may be submitted to HFHLequityrfp2023@nyhealthfoundation.org.

OMH Releases RFA for One-Time Funding to Support MHOTRS Clinic Enhancement
On October 18th, OMH released a Request for Applications (RFA) for one-time funding to support providers with expanding access to specialized interventions in Mental Health Outpatient Treatment Rehabilitative Services (MHOTRS) programs (formerly known as Article 31 clinics). Through this RFA, OMH will provide a total of $4 million in funding across 80 awards.

OMH will provide one-time funding of $49,500 to eligible agencies that apply to: 

  • Establish or enhance mechanisms for increased engagement and service coordination;
  • Enhance program capacity to provide effective group intervention; or
  • Expand or create a fast-track for access or a behavioral health urgent care model to support timely access to in-person and telehealth MHOTRS programming for individuals with significant needs.

Eligible applicants are existing OMH-licensed MHOTRS providers that have existed for at least one year and that are in good standing with OMH.

The RFA is available here and SPG’s summary is available here. Applications are due on December 20th.

NYC DOHMH Releases RFP for Operation of Strong Messenger Project
On October 16th, the New York City (NYC) Department of Health and Mental Hygiene (DOHMH) releases a Request for Proposals (RFP) seeking a qualified organization to operate the Strong Messenger Project (SMP). The SMP is an enhancement to the City’s “Cure Violence (CV)” prevention program model that provides therapeutic support to direct CV staff. The awarded contractor will provide direct therapeutic services to over 250 direct-care staff at 31 CV sites citywide.

Applicants should have at least three years of experience providing community-level therapeutic services and support to community health workers, engaging and providing clinical therapeutic group sessions, and providing workshops centered on therapeutic support and wellness of BIPOC communities. DOHMH will award $820,000 in annual funding over the six-year contract period. The payment structure will be fee-for-service. Contracts are expected to begin on April 1, 2024.

Additional details are available here. Applications are due on November 30th. There will be an optional pre-proposal conference on October 30th at 11am. Interested parties may RSVP to RFP@health.nyc.gov with “81624P0002-PPC” in the subject line by October 28th. Questions may be submitted to the email address above with “81624P0002-Question” in the subject line by November 6th.