Weekly Health Care Policy Update – September 6, 2022

September 13, 2022

In this update: 

  • Administration Updates
    • Biden Administration Suspends Free Covid Test Distribution; Vaccine and Treatment Funding Projected to Run Out Next Year
  • Federal Agencies
    • CMS Proposes Rule to Streamline Medicaid, CHIP, and BHP Eligibility, Enrollment, and Renewals
    • CMS Announces 2021 Results for the Medicare Shared Savings Program
    • CMS Will Extend Deadline for Temporary Nursing Assistants to Be Certified
    • FDA Authorizes Pfizer-BioNTech and Moderna Bivalent Covid Vaccines
    • AHRQ-Funded Study Shows Medicare P4P Programs Not Linked to Consistent Quality/Safety Improvements
    • HHS Awards $79 Million in Overdose Grants
    • FDA Publishes Overdose Prevention Framework
    • HRSA Announces $20 Million in Maternal and Infant Health Funding
  • Other Updates
    • MedPAC Holds September Meeting
    • National Academies Announces Public Comment Session on Federal Policies that Contribute to Racial and Ethnic Inequities
  • New York State Updates
    • Governor Hochul Continues Statewide Disaster Emergency Due to Monkeypox
    • Governor Hochul Continues Statewide Disaster Emergency Due to Health Care Staffing Shortages; Ends Suspension of Utilization Review and Appeals Processes
    • DOH Further Delays NYIA Takeover of Expedited Assessments for Personal Care to December 1st
    • DFS Adopts Regulations Establishing Registration and Requirements for PBMs and Establishing the Pharmacy Benefits Bureau
  • Funding Opportunities
    • HUD Announces Older Adult Home Modification Program

Administration Updates

Biden Administration Suspends Free Covid Test Distribution; Vaccine and Treatment Funding Projected to Run Out Next Year
On August 28th, the Biden Administration announced it would suspend the free distribution of at-home Covid-19 tests as of September 2nd, due to insufficient funding. In addition, on August 30th, Assistant Secretary for Preparedness and Response Dawn O’Connell published a blog describing a meeting held that day with members of the Administration’s Covid-19 response team and drug manufacturers, state and local health departments, health care providers, and insurers to discuss transitioning the purchase of Covid-19 testing and therapeutics from the federal government to the commercial market. O’Connell noted that purchase of the monoclonal antibody treatment Bebtelovimab has already been transitioned to the commercial market.
 
As early as January 2023, the administration anticipates it will exhaust federal funding for the purchase and distribution of Covid-19 vaccines. The remaining federal supply of preventative treatment Evusheld is anticipated to be utilized by early 2023, with supplies of oral antiviral Lagevrio exhausted by the first or second quarter of 2023. When these federal funds and supplies are exhausted, the commercial market will need to assume responsibility for the purchase and distribution of Covid-19 vaccines and therapeutics.
 
O’Connell’s blog post is available here.

Federal Agencies

CMS Proposes Rule to Streamline Medicaid, CHIP, and BHP Eligibility, Enrollment, and Renewals
On August 31st, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule aimed at streamlining and simplifying processes for eligibility determination, enrollment, and renewal in Medicaid, the Children’s Health Insurance Program (CHIP), and Basic Health Programs (BHPs). The rule is issued in response to a pair of Executive Orders President Biden issued calling for expanded access to quality health care, particularly for individuals who qualify for Medicaid and CHIP and comes as states prepare to resume Medicaid eligibility determinations at the conclusion of the Covid-19 Public Health Emergency (PHE). Major provisions of the proposed rule include: 

  • For individuals who are exempt from the Modified Adjusted Gross Income (MAGI) counting rules: 
    • Limiting state eligibility renewals/redeterminations to once every 12 months;
    • Eliminating requirements for in-person interviews; and
    • Using prepopulated renewal forms.
  • Eliminating the requirement to apply for other benefits as a condition of Medicaid eligibility;
  • Ensuring automatic enrollment, with limited exceptions, of Supplemental Security Income (SSI) recipients into the Qualified Medicare Beneficiary (QMB) group;
  • Establishing specific guidelines for states to check available data before terminating eligibility when a beneficiary cannot be reached due to returned mail; and
  • Providing options for states to use available information to update a beneficiary’s address.

Specifically for CHIP enrollment, the proposed rule would: 

  • Allow CHIP beneficiaries to remain enrolled or re-enroll without a lock-out period for failure to pay premiums;
  • Remove the option to allow a waiting period as a substitution of coverage prevention strategy; and
  • Prohibit annual and/or lifetime benefit limits.

Comments on the proposed rule, which is available here, are due November 9, 2022. A press release (here) and a fact sheet (here) are also available. The Executive Orders that the proposed rule responds to are available here (January 2021) and here (April 2022).
 
CMS Announces 2021 Results for the Medicare Shared Savings Program
On August 30th, CMS announced 2021 financial results for the Medicare Shared Savings Program (MSSP). The program reported its fifth consecutive year of savings, saving $1.66 billion relative to benchmarks in 2021. Savings were generated by 58% of participating accountable care organizations (ACOs). Nearly all ACOs (99%) met and reported the quality standard required to share in savings. As in previous years, ACOs with higher net savings tended to be low-revenue, meaning they were mainly comprised of physicians, included a small hospital, or served rural areas. ACOs comprised of 75% or more primary care clinicians had higher per capita net savings than ACOs with fewer primary care providers. These 2021 results are less robust than 2020 performance, when 67% of ACOs generated $1.9 billion in savings, although ACO results in 2020 were affected by Covid-19 adjustments. However, in a press release announcing the results, CMS reiterated its commitment to MSSP and its goal that 100% of people enrolled in traditional Medicare be part of an accountable care relationship by 2030.
 
CMS’s press release is available here and financial and quality data may be accessed here.
 
CMS Will Extend Deadline for Temporary Nursing Assistant to Be Certified
On August 29th, CMS issued guidance to nursing homes indicating that it would grant individual, statewide, and county waivers to facilities that have not yet certified Temporary Nursing Assistants (TNAs) that were hired under flexibilities available during the Covid-19 PHE.
 
Under previous guidance, TNAs needed to be certified by October 7th, a restoration of pre-pandemic rules. Nursing homes may now request a waiver with documentation proving that TNAs were either enrolled or signed up for training or testing, but were unable to be accommodated by the local Nurse Aide Training and Competency Evaluation Program (NATCEP). These waivers will last as long as the PHE remains in place, which is expected to be until at least January 2023.
 
FDA Authorizes Pfizer-BioNTech and Moderna Bivalent Covid Vaccines
On August 31st, the Food and Drug Administration (FDA) amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech Covid-19 vaccines to authorize bivalent formulations for use as single booster doses. The doses each contain two mRNA components of the SARS-CoV-2 virus—one of the original strain and one from the BA.4 and BA.5 lineages of the Omicron variant—and may be used at least two months following a primary or booster vaccination. The Moderna booster is authorized for individuals 18 years of age and older, while the Pfizer-BioNTech booster is authorized for individuals 12 years of age and older.
 
The booster shots were authorized without new human clinical trial data for this specific formulation. The authorization is based on mice data and the nation’s experience to-date with the mRNA vaccine platform. The strategy resembles the process FDA uses each year to approve new influenza vaccines. The approval follows a 19-2 FDA advisory panel vote in June recommending that the agency instruct manufacturers to create boosters containing a version of the Omicron strain. The World Health Organization recommended a vaccine with a BA.1 booster, believing that it would lead to broader protection, and this version will be distributed outside of the U.S. Human trial data is expected in November.
 
On September 1st, following the authorizations, the Center for Disease Control and Prevention’s  (CDC) Advisory Committee on Immunization Practices (ACIP) voted 13-1 to recommend the bivalent booster shots, and CDC Director Rochelle Walensky formally issued a positive recommendation hours later.
 
AHRQ-Funded Study Shows Medicare P4P Programs Not Linked to Consistent Quality/Safety Improvements
On August 30th, the Agency for Healthcare Research and Quality (AHRQ) announced the results of an AHRQ-funded study showing that Medicare’s three hospital pay-for-performance programs—the Hospital Readmission Reduction Program, the Hospital-Acquired Conditions Program, and the Hospital Value-Based Purchasing Program—were not associated with consistent improvements in quality or patient safety measures. Mortality rates also increased over the study period.
 
The study, published in BMC Health Services Research, used AHRQ’s Healthcare Cost and Utilization Project State Inpatient Databases for 14 states. The study covered 2007 through 2016, capturing several years before and after introduction of program metrics. Over the study period, five patient safety indicators improved, five deteriorated, and three showed insignificant changes over time. The study authors suggest that, given this evidence, “the administrative cost of monitoring and enforcing penalties, and potential increase in mortality, CMS should consider redesigning their P4P programs before continuing to expand them.”
 
The abstract is available here.
 
HHS Awards $79 Million in Overdose Grants
On August 31st, the Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced the award of over $79 million in grants as part of President Biden’s National Drug Control Strategy. The grant include: 

  • $14.5 million for First Responders-Comprehensive Addiction and Recovery Support Services Act, which provides resources to first responders and others to train, carry and administer federally approved drugs and devices for emergency reversals of known or suspected opioid overdoses;
  • $7.1 million for Rural Emergency Medical Services Training Grants, which help rural areas recruit and train EMS personnel with a focus on addressing mental and substance use disorders;
  • $8.2 million for Targeted Capacity Expansion: Special Projects, to implement targeted strategies for the provision of substance use disorder or co-occurring disorder harm reduction, treatment, and/or recovery support services to support an under-resourced population or unmet need identified by the community;
  • $1.5 million for Provider’s Clinical Support System – Universities to provide resources to train graduate-level students in medical, physician assistant, nurse practitioner and other eligible nursing programs in treating opioid use disorders and in prescribing medications for opioid use disorder in office-based settings;
  • $12.1 million for Services Grant Program for Residential Treatment for Pregnant and Postpartum Women, which provides pregnant and postpartum women and their children with comprehensive substance-use treatment and recovery support services across residential and outpatient settings;
  • $3 million for the Strategic Prevention Framework for Prescription Drugs grant program, which provides funds for state agencies, territories and tribal entities to target prescription drug misuse;
  • $32.7 million for Medication-Assisted Treatment – Prescription Drug and Opioid Addiction, which provides resources to help expand and enhance access to medications for opioid use disorder and to decrease illicit opioid use and prescription opioid misuse.

Grant recipients in New York include Catholic Charities, the Erie County Department of Health, Federation of Organizations for the New York State Mentally Disabled, Gouverneur Volunteer Rescue Squad, Margaretville Memorial Hospital, New York City Health and Hospitals, Samaritan Daytop Village, and Services for the Underserved. More information is available here.
 
FDA Publishes Overdose Prevention Framework
On August 30th, the FDA introduced an Overdose Prevention Framework, the agency’s “vision to undertake impactful, creative action to prevent drug overdoses and reduce deaths.” The framework includes four priorities: 

  1. Supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing;
  2. Encouraging harm reduction through innovation and education;
  3. Advancing development of evidence-based treatments for substance use disorders; and
  4. Protecting the public from unapproved, diverted, or counterfeit drugs presenting overdose risks.

Within these categories, the FDA will mix existing activities with exploratory work to test new strategies. New potential work includes revised opioid analgesic prescriber education, new authorities for opioid approval standards, additional disposal options, stimulating the pipeline for non-opioid analgesics for acute pain, expanding the availability of of overdose reversal products including bringing novel and generic naloxone products to market, facilitating medical device innovation for addressing opioid use, and accelerating cross-agency efforts to address illicit sale of opioids and methamphetamine.
 
More information on the new framework is available here.
 
HRSA Announces $20 Million in Maternal and Infant Health Funding
On August 29th, the Health Resources and Services Administration (HRSA) announced more than $20 million in awards to improve maternal and infant health and advance the White House Blueprint for Addressing the Maternal Health Crisis. The funding is focused on reducing disparities in maternal and birth outcomes, expanding and diversifying the workforce of caregivers of pregnant and postpartum individuals, increasing access to obstetrics care in rural areas, and addressing inequities in maternal and infant health.
 
Three New York organizations were funded to increase the availability of doula services in the communities they serve: the Albert Einstein College of Medicine received $180,000; the Northern Manhattan Perinatal Partnership received $125,000; and Public Health Solutions received $125,000.
 
HRSA’s press release is available here and the White House Blueprint is available here.

Other Updates

MedPAC Holds September Meeting
On September 1st and 2nd, the Medicare Payment Advisory Commission (MedPAC) held its monthly meeting. Commissioners discussed a number of agenda items, including: 

  • Context for Medicare policy, which focused on the financial status of the Medicare program and recommendations that the Commission will include in its March 2023 report to Congress;
  • Standardizing benefits in Medicare Advantage plans, during which Commissioners discussed potential options for simplifying plan choices, supporting plan competition, and streamlining future changes to the Medicare Advantage program;
  • Prices of Medicare Part B drugs, focused on new Part B drugs with limited clinical evidence, price competition for drugs with similar health effects, and financial incentives association with the percentage add-on to Medicare’s payment rate;

Commissioners also discussed the use of Medicare Advantage encounter data, which the Commission continues to monitor for accuracy and completeness following a June 2019 report that found significant errors and omissions in the data submitted by Medicare Advantage plans. Finally, the Commission discussed concerns with Medicare’s current wage index policies, which MedPAC identifies as inaccuracy, the circularity of hospital-reported data, the large volume or permitted exceptions, and administrative complexity. Staff presented and Commissioners discussed an alternative wage index calculation.
 
Brief descriptions of each session and slides presented by staff are available here. MedPAC’s next public meetings will be September 29th and 30th. The agenda for this meeting has not yet been posted.
 
National Academies Announces Public Comment Session on Federal Policies that Contribute to Racial and Ethnic Inequities
On September 9th from 2pm to 3:30pm ET, the National Academies of Sciences, Engineering, and Medicine (NASEM) will hold a public comment session on federal policies that contribute to “preventable and unfair differences in health status and outcomes experienced by all U.S. racial and ethnic minority populations.” The session will examine the following specific questions: 

  • What are examples of federal policies that create racial and ethnic inequities?
  • What are examples of federal policies that promote racial and ethnic health equity?
  • What are the most important considerations when prioritizing action regarding federal policies to advance racial and ethnic health equity?

Oral comments may be submitted by email with your name and affiliation to HealthEquityPolicies@nas.edu (each individual will have three minutes). Written comments may also be submitted for consideration by the study committee (as individuals or on behalf of an organization) via email to HealthEquityPolicies@nas.edu through September 30th.
 
Registration for the event is available here.

New York State Updates

Governor Hochul Continues Statewide Disaster Emergency Due to Monkeypox
On August 28th, Governor Hochul issued Executive Order 20.1, which extends through September 27th the statewide disaster emergency due to the ongoing spread of the monkeypox virus and the associated provisions of Executive Order 20. Additionally, the Order further suspends or modifies regulations to: 

  • Additionally require coverage without patient cost-sharing for the monkeypox virus immunization, including for patients who: 
    • Are covered by a grandfathered insurance plan;
    • Do not fall within the specific ACIP recommendation for monkeypox; or
    • Receives the immunization out-of-network.
  • Waive patient cost-sharing for: 
    • In-network laboratory testing to diagnose monkeypox virus; and
    • Visits to diagnose monkeypox virus at certain locations (including through telehealth).

However, co-payments, coinsurance, and annual deductibles may still be imposed for any follow-up care or treatment for the monkeypox virus, including through an inpatient hospital admission. Also, a deductible may be applied for individuals covered under a high deductible health plan if otherwise required by law.
 
The Order is available here. New York State Department of Financial Services (DFS) guidance for health plans on these requirements is available here. Questions may be submitted to health@dfs.ny.gov. 
 
Governor Hochul Continues Statewide Disaster Emergency Due to Health Care Staffing Shortages; Ends Suspension of Utilization Review and Appeals Processes
On August 28th, Governor Hochul issued Executive Order 4.12, which extends through September 27th the provisions in Executive Order 4 and its successors that reinstate many workforce and scope of practice flexibilities that applied during the original New York State Covid-19 public health emergency. However, the Order terminates the temporary suspension of certain utilization review requirements and appeal timeframes, and thereby resumes the following: 

  • Requirements for preauthorization review for scheduled surgeries;
  • Concurrent review for inpatient and outpatient hospital services;
  • Retrospective review for inpatient and outpatient hospital services at in-network hospitals; and
  • Statutory timeframes for hospitals to submit internal and external appeals.

As such, DFS issued guidance to health plans regarding the resumption of utilization review and the restarting of appeal timeframes. The guidance indicates that, when resuming utilization review, insurance plans may request information to perform a retrospective review, reconcile claims, and make any payment adjustments. However, insurance plans should ensure that documentation requirements are reasonable and should take into account that hospitals may not be able to provide the typical level of documentation or may incur delays in furnishing the requested documentation as a result of staffing shortages.
 
The statutory timeframes are reset for any appeals pending or in progress at the time the tolling provisions of Executive Order 4 took effect. Hospitals have 45 days to submit an internal appeal or 60 days to submit an external appeal, starting from August 28th.
 
The Order is available here. The DFS guidance is available here. Questions may be submitted to health@dfs.ny.gov. 
 
DOH Further Delays NYIA Takeover of Expedited Assessments for Personal Care to December 1st
On August 30th, DOH announced that the implementation of the Independent Assessor (NYIA) for expedited assessments of individuals seeking personal care services (PCS) or consumer-directed personal assistance services (CDPAS) will be further delayed from October 1st to a new implementation date of December 1st. As part of the second Medicaid Redesign Team’s recommendations, Medicaid managed care plans will no longer conduct assessments for individuals seeking PCS or CDPAS. Instead, the NYIA will assess the individuals and determine their eligibility for these services, and plans will use the NYIA-produced Community Health Assessment to create a person-centered plan of care, which may include PCS, CDPAS, and other services. Plans remain ultimately responsible for service authorization, including service hours.
 
This process was effective starting May 16th for individuals 18 and over who are newly seeking services, except for requests made on an expedited basis, which were originally scheduled to become the NYIA’s responsibility on July 1st. For individuals who are being reassessed and children aged 4 to 17, plans will continue to conduct assessments until further notice.
 
DOH’s guidance is available here. Questions may be submitted to independent.assessor@health.ny.gov.
 
DFS Adopts Regulations Establishing Registration and Requirements for PBMs and Establishing the Pharmacy Benefits Bureau
On August 31st, DFS posted Notices of Adoption in the State Register of regulations that: 

  • Establish registration and annual reporting requirements for Pharmacy Benefit Managers (PBMs); and
  • Establish the Pharmacy Benefits Bureau and revise the rules for the Drug Accountability Board.

The Bureau will be tasked with licensing and supervising the PBM industry in New York, including receiving the disclosure and transparency submissions that required under new laws enacted in January. The Bureau will also take over DFS’s current functions in investigating drug price spikes. The 2022-2023 Enacted Budget allocates $5 million to fund and staff the new bureau. As the program develops, the State intends for costs to be offset through the application of fees, assessments, and penalties imposed directly on the PBM industry.
 
The Notices of Adoption are available here.

Funding Opportunities

HUD Announces Older Adult Home Modification Program
On August 29th, the U.S. Department of Housing and Urban Development (HUD) announced the availability of funding for the Older Adult Home Modification Program. This opportunity aims to support not-for-profit organizations, state and local governments, and public housing authorities with programs that make safety and functional repairs and renovations to meet the needs of low-income, elderly adult homeowners. Such programs should implement low-cost, high-impact home modifications to reduce the risk of falls, improve general safety, increase accessibility, and improve functional abilities, allowing older adults to “age in place” rather than move to nursing homes or other assisted care facilities.
 
HUD will provide $15 million in total funding across 20 awards during the three-year program period, at least $5 million of which will be awarded to grantees that serve communities with substantial rural populations. Individual awards will range from $500,000 to $1.25 million. Eligible applicants include not-for-profit 501(c)(3) organizations that have at least three years of experience providing services to elderly adults.
 
Additional information is available here. Applications are due on October 13th. Questions may be submitted to Dr. Taneka Blue at Taneka.M.Blue@hud.gov.