Weekly Health Care Policy Update – October 22, 2021

October 29, 2021

In this update: 

  • COVID-19 Response
    • HHS Extends Public Health Emergency
    • FDA Issues EUA for Moderna and J&J Boosters; Allows “Mix and Match”
    • HRSA Seeks to Collect PRF Data Beyond PHE
  • Legislative
    • CBO Releases Estimates on Health Care Provisions of House Reconciliation Bill
  • Regulatory
    • CMS Posts State Spending Plans for Enhanced Medicaid HCBS Funding
    • CMMI Releases Strategy Refresh Website and White Paper
    • FDA Issues Proposed Rule on OTC Hearing Aids
    • CMS Extends Timeline for Rule on Medicare Advantage Risk Adjustment Data Validation Audits
    • HHS Proposes to Repeal Trump-Era Limits on Subregulatory Guidance
    • Department of Education Releases Report on Mental Health in Schools
    • Medicare Open Enrollment Period Begins
    • Rules Being Reviewed by OMB
  • Other
    • AHA Asks CMS to “Revise and Reissue” Trump-Era Prior Authorization Rule
  • Congressional Hearings
  • New York State
    • Governor Hochul Announces New Administration Nominations
    • OMH Extends Regulatory Waiver
    • PCDC Webinar on Integrated Care and Increasing Access to Behavioral Health
    • DOH Holds Webinar on Implementing the Medically Tailored Meals Pilot Program
    • DOH Releases Revised Medicaid Quality Strategy for Public Comment
    • DOH Posts Enhanced HCBS Spending Plan Quarterly Update
    • OMH and OASAS Announce Launch Date and Release Documents for Transition to CORE Services

COVID-19 Response

HHS Extends Public Health Emergency
On October 15th, Secretary of Health and Human Services (HHS) Xavier Becerra renewed the federal Public Health Emergency (PHE) declaration for COVID-19 under the Public Health Service Act for another 90 days. The PHE will now expire January 16, 2022 without further action. In the absence of legislative or other changes, this means the 6.2 percent enhanced Federal Medical Assistance Percentage (FMAP) for state Medicaid programs will continue through the first quarter of 2022. The declaration can be found here.
 
FDA Issues EUA for Moderna and J&J Boosters; Allows “Mix and Match”
On October 18th, the Food and Drug Administration (FDA) issued emergency use authorizations (EUAs) for booster doses of the Moderna and Johnson & Johnson (J&J) Covid-19 vaccines. A half-dose of the Moderna vaccine was approved for people fully vaccinated at least six months ago who are either at least 65 years old, or who are at least 18 years old and at high risk of severe Covid-19 or have frequent exposure to the virus through their work. The J&J booster was approved for anyone who received that vaccine at least two months ago. The FDA also included a revision to the previous authorization that allows individuals to get a booster that does not match their primary series (“mix and match”).
 
On October 21st, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) recommended the FDA’s booster strategy to CDC Director Rochelle Walensky, who endorsed the policy without changes.
 
The CDC’s booster eligibility expansion announcement can be found here.
 
HRSA Seeks to Collect PRF Data Beyond PHE
On October 20th, the Health Resources and Services Administration (HRSA) submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval, to enable further collection of reporting on the Provider Relief Fund (PRF) after the end of the federal Covid-19 PHE. The PRF has disbursed over $120 billion in attested funds out of a total of $186.5 billion allocated to eligible health care providers to support health care-related expenses or lost revenues attributable to the pandemic. Recipients are required to submit reports about their use of the funding through HRSA’s reporting portal, which currently operates under a PHE waiver but must be approved by OMB to continue afterwards. HRSA is not proposing changes to the process but will accept public feedback on whether the information is necessary for the agency, its estimated burden, and how it could make the information more usable.
 
The document is open for public comments here through November 19th.

Legislative Update

CBO Releases Estimates on Health Care Provisions of House Reconciliation Bill
On October 19th, the Congressional Budget Office (CBO) published estimates of the cost of health care provisions contained in the House version of President Biden’s Build Back Better agenda. The analyzed provisions include:

  • Extending the ARP’s enhanced premium tax credits (PTCs) for Marketplace coverage ($209.5 billion over ten years);
  • Filling the “Medicaid gap” in non-expansion states by expanding PTCs for Marketplace coverage from 2022 to 2024 and establishing a federal Medicaid program starting in 2025 ($323.1 billion over ten years); and
  • Extending the ARP’s Marketplace benefits for the unemployed and reducing the affordability threshold for employer-sponsored coverage through 2025 ($21.4 billion over ten years).

Although a version of each of these proposals is expected to be included in a final version of the reconciliation legislation, these specific provisions will likely be altered and reduced in scope. The CBO has not yet completed an analysis of the full legislation.
 
The CBO analysis is available here.

Regulatory Updates

CMS Posts State Spending Plans for Enhanced Medicaid HCBS Funding
On October 21st, the Centers for Medicare and Medicaid Services (CMS) launched a website to provide stakeholders with information on all 51 spending plans to enhance home and community-based services (HCBS) under Section 9817 of the American Rescue Plan (ARP) submitted by State Medicaid agencies and the District of Columbia. Section 9817 offered states a 10 percentage point increase in their federal Medical Assistance Percentage (FMAP) for all Medicaid HCBS spending from April 1, 2021 through March 31, 2022, requiring that the funds be used to “enhance, expand or strengthen” HCBS. Of the plans:

  • Seven have been fully approved to claim the enhanced FMAP and to implement all activities;
  • 41 (including New York’s) have been approved to claim the FMAP and to implement some of the activities while awaiting further consideration of others; and
  • Three require revisions and will need to be resubmitted.

CMS also highlighted a range of “innovative and exciting” activities proposed, including: 

  • Implementing in-home and mobile Covid-19 vaccination programs for people with disabilities and older adults;
  • Developing deed-restricted accessible and affordable housing units for people with disabilities;
  • Building partnerships to increase access to housing and housing assistance;
  • Providing housing-related services and supports, such as accessibility modifications or supportive services; and
  • Implementing new behavioral health crisis response services.

The website can be found here.
 
CMMI Releases Strategy Refresh Website and White Paper
On October 20th, the Center for Medicare and Medicaid Innovation (CMMI) released a white paper on CMMI’s tenth anniversary, outlining its refreshed strategy and setting new goals for CMMI models in 2030. The white paper builds on an August 2021 blog that CMS leadership published in Health Affairs on lessons learned in the first 10 years of the Innovation Center. CMMI’s vision is to create “a health system that achieves equitable outcomes through high quality, affordable, person-centered care.”
 
CMMI will organize its work toward this goal around five strategic objectives, and has also set measurable objectives for each goal: 

  • Drive Accountable Care: Increase the number of beneficiaries in a care relationship with accountability for quality and total cost of care. 
    • All beneficiaries with Medicare Parts A and B will be in such a relationship by 2030.
  • Advance Health Equity: Embed health equity in every aspect of CMMI models and increase focus on underserved populations. 
    • All new models will require reporting demographic data, and, as appropriate, data on social needs and social determinants of health.
    • All new models will include patients from historically underserved populations and safety net providers.
    • CMMI will identify specific areas with inequities (e.g., avoidable admissions) and set reduction targets.
  • Support Care Innovations: Leverage a range of supports that enable integrated, person-centered care. 
    • CMMI will set improvement targets for patient experience measures (e.g., health and functional status; certain CAHPS measures).
    • All models will include patient-reported outcomes in performance measurement.
  • Improve Access by Addressing Affordability: Pursue strategies to address health care prices, affordability, and reduce unnecessary or duplicative care. 
    • CMMI will set a 2030 target to reduce the percentage of beneficiaries who forgo care due to cost.
    • All models will consider opportunities to improve affordability of high-value care.
  • Partner to Achieve Health System Transformation: Align priorities and policies across CMS and aggressively engage payers, purchasers, states, and beneficiaries 
    • All new models, if applicable, will have multi-payer alignment options by 2030.
    • All new models will collect patient perspectives across the life cycle.

CMMI will pursue stakeholder engagement on the strategy as well as on any revised or new models, including through listening sessions scheduled over the next several months. During a webinar on October 20th, CMMI Director Liz Fowler noted that the Innovation Center would not move to end any existing models early as a result of the refreshed strategy, but that existing models may be revised to bring them into alignment with the strategy.
 
The white paper is available here and the earlier blog post is available here. Additional information regarding CMMI’s strategy will be posted on a new website here.
 
FDA Issues Proposed Rule on OTC Hearing Aids
On October 19th, the FDA issued a proposed rule to improve access to and reduce the cost of hearing aid technology, implementing a provision of Over-the-Counter Hearing Aid Act as enacted in the FDA Reauthorization Act of 2017. The rule would establish a new category of over-the-counter (OTC) hearing aids, which would allow the devices to be sold directly to consumers in stores or online without a medical exam or a fitting by an audiologist. FDA stated that the rule is designed to increase competition in the market, while continuing ensuring safety and effectiveness. Safety and efficacy provisions in the rule include a maximum output limit for OTC hearing aids, distortion control limits, self-generated noise limits, latency limits, and insertion depth. FDA noted that hearing loss affects an estimated 30 million Americans, but only about one-fifth of people who could benefit from a hearing aid use one.
 
The proposed rule is available here and is open for public comment until January 18, 2022.
 
CMS Extends Timeline for Rule on Medicare Advantage Risk Adjustment Data Validation Audits
On October 21st, CMS published a notice in the Federal Register that it will extend its timeline to publish provisions of a rule to revise the Medicare Advantage Risk Adjustment Data Validation (RADV) regulations. The proposed rule, originally published in November 2018, would enable CMS to recover overpayments based on extrapolated audit findings through the use of statistically valid random sampling techniques, starting with payment year 2011 contract-level audits. It also proposed not to use a fee-for-service (FFS) adjuster to RADV overpayment determinations, which had been considered as a way to correct for errors in FFS claims data.
 
By statute, CMS must finalize rules within three years of publication, meaning this rule should be published by November 1st. However, CMS states that it is unable to meet this timeline due to extended comment periods which involved further public scrutiny of the FFS adjuster data, as well as delays related to the Covid-19 PHE. As a result, it is extending the timeline by one year, through November 1, 2022.
 
The notice is available here. The original proposed rule is available here.
 
HHS Proposes to Repeal Trump-Era Limits on Subregulatory Guidance
On October 19th, HHS announced a proposed rule seeking to repeal two rules issued at the end of the Trump administration that limit the power of its subregulatory guidance. The rules, entitled “HHS Good Guidance Practices” and “HHS Transparency and Fairness in Civil Administrative Enforcement Actions,” together prohibit HHS from penalizing individuals or organizations that do not comply with agency guidance documents. These rules in effect make formal regulations promulgated through notice-and-comment procedure the only binding, enforceable actions that HHS can take. The Biden Administration has revoked the Executive Orders underlying the original rules and argues that continuing to apply them would inappropriately constrict HHS’ ability to efficiently interpret and enforce regulations.
 
The proposed rule is available here and will be open for comment until November 19th.
 
Department of Education Releases Report on Mental Health in Schools
On October 19th, the Biden Administration released a fact sheet on “Improving Access and Care for Youth Mental Health and Substance Use Conditions,” accompanying the release of a Department of Education report on supporting children’s mental health needs. The report describes challenges in providing mental health support in schools, and includes seven recommendations for educators, staff, and providers to create an appropriate system of supports. The fact sheet also outlines the Administration’s other efforts to date to improve children’s access to health and behavioral health care.
 
The fact sheet is available here. The Department of Education Report is available here.
 
Medicare Open Enrollment Period Begins
The 2022 Medicare Open Enrollment period began on October 15th. During this period, beneficiaries have the opportunity to make changes to their health plans or prescription drug plans, pick a Medicare Advantage plan, or return to Original Medicare. The Medicare open enrollment period will run through December 7th, with enrollment changes taking effect January 1, 2022.
 
Rules Being Reviewed by OMB
The Office of Management and Budget (OMB) has received the following health care-related rules for final review before publication in the Federal Register:
 
Prescription Drugs

  • An interim final rule entitled “Prescription Drug and Health Care Spending,” expected to relate to provisions of the No Surprise Act around drugs.
  • A final rule titled “Establishing Minimum Standards in Medicaid State Drug Utilization Review and Supporting Value-Base Payments for Drugs Covered in Medicaid”.

 
Medicare Payment Policies

  • A final rule on the CY 2022 Hospital Outpatient Prospective Payment System (OPPS).
  • A final rule on the CY 2022 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS).
  • A final rule on the CY 2022 Home Health PPS.
  • A final rule on CY 2022 revisions to payment policies under the Physician Fee Schedule (PFS).
  • A final rule on Durable Medical Equipment (DME) Policy Issues.

Covid-19

  • An interim final rule entitled “Omnibus Covid-19 Health Care Staff Vaccination”.
  • An emergency rule from the Occupational Safety and Health Administration (OSHA) on Covid-19 vaccination and testing, expected to implement vaccine mandates on workplaces.
  • Rules relating to CDC requirements around the safe resumption of global travel and pre-flight Covid-19 testing.

Other Updates

AHA Asks CMS to “Revise and Reissue” Trump-Era Prior Authorization Rule
​​On October 18th, the American Hospital Association (AHA) sent a letter to CMS Administrator Chiquita Brooks-LaSure recommending that CMS “revise and reissue” the Trump-era proposed rule on prior authorization. The proposed rule was intended to reduce the time that prior authorization takes by standardizing related processes, including: 

  • Identifying whether a procedure is subject to prior authorization;
  • Submitting prior authorization and supporting documentation; and
  • Receiving a determination from the health insurer.

The Biden administration froze implementation of many Trump-era rules, including the prior authorization rule, in January. The AHA proposes the following revisions to the rule: 

  • Medicare Advantage (MA) Organizations should be required to adhere to the same requirements as other plans.
  • MA Organizations should be required to automatically consider a service authorized when the provider for that service has a history of prior authorization of 90% or greater.
  • All plans should be required to deliver prior authorization responses within 72 hours for standard, non-urgent services and 24 hours for urgent services.

The letter can be found here.

Congressional Hearings

Tuesday, October 26th:

  • At 10:15am, two House Education and Labor subcommittees (the Subcommittee on Civil Rights and Human Services and the Subcommittee on Workforce Protections) will hold a joint hearing entitled “Protecting Lives and Livelihoods: Vaccine Requirements and Employee Accommodations.” More information is available here. 
  • At 10:30am, the House Energy and Commerce Subcommittee on Health will hold a hearing entitled “Caring for America: Legislation to Support Patients, Caregivers, and Providers” that will examine 7 bills, including the Alzheimer’s Caregiver Support Act (H.R.1474), the Allied Health Workforce Diversity Act of 2021 (H.R.3320), and the Enhancing the Community Health Workforce Act (H.R.5594). More information is available here. 

Wednesday, October 27th:

  • At 10am, the House Appropriations Subcommittee on State, Foreign Operations, and Related Programs will hold a hearing entitled “United States Global COVID-19 Response: Actions Taken and Future Needs.” More information is available here.

New York State Updates

Governor Hochul Announces New Administration Nominations
On October 21st, Governor Hochul announced the following appointments, nominations, and recommendations to her administration:

  • Jeanette M. Moy has been nominated as Commissioner of the Office of General Services (OGS). Moy most recently served as the Executive Vice President and COO of Public Health Solutions, the contracting arm of the New York City Department of Health and Mental Hygiene (DOHMH).
  • Maria Imperial has been nominated as Commissioner of the Division of Human Rights (DHR).
  • Jackie Bray has been nominated as Commissioner of the New York State Division of Homeland Security and Emergency Services (DHSES). Bray previously served as the Deputy Executive Director of NYC Test and Trace Corps and as a senior advisor for the City’s vaccination campaign.
  • Lucy Lang has been appointed Inspector General of the State of New York. Lang most recently served as Director of the Institute for Innovation in Prosecution.
  • Gaurav Vasisht has been recommended to be appointed Executive Director of the New York State Insurance Fund. Vasisht most recently served as Executive Deputy Superintendent of the Department of Financial Services.

The Governor’s press release is available here.
 
OMH Extends Regulatory Waiver
Effective October 23rd, the New York State Office of Mental Health (OMH) has extended the current Commissioner’s regulatory waiver for an additional 60 days to continue various Covid-19-related flexibilities. The waiver provides temporary relief from various requirements of Title 14 of the New York Codes, Rules, and Regulations (NYCRR), which was initially granted for a 60-day period on June 25, 2021 following the end of New York State’s Covid-19 disaster emergency declaration.
 
The waived provisions that will continue include: 

  • Regulations around the provision of telemental health services, including temporary approvals, expanded practitioner types, and audio-only services.
  • Requirements continuing the reduction of minimum service durations and allowing rounding up of service times.
  • Requirements to waive timeframes around treatment planning reviews and to waive initial in-person assessment requirements.

The extension will remain in effect for another 60-day period (through December 22nd), unless otherwise modified or suspended by the OMH Commissioner, or if federal matching funds become unavailable during that period.
 
The waiver extension can be found here.
 
PCDC Webinar on Integrated Care and Increasing Access to Behavioral Health
On October 27th at 1pm, the Primary Care Development Corporation (PCDC), in collaboration with Mount Sinai Health System and Headway, creator of a software-enabled national network of therapists, will host a webinar discussing integrated care and opportunities to increase access to behavioral health through partnerships. The webinar will feature: 

  • Dr. Anitha Iyer, Director of Behavioral Health Population Management at Mount Sinai Health Partners
  • Scott Munro, Head of Physician Partnerships at Headway
  • Dr. Andrew Philip, Senior Director at PCDC

Registration for the webinar is available here.
 
DOH Holds Webinar on Implementing the Medically Tailored Meals Pilot Program
On October 13th, the New York State Department of Health (DOH) hosted a webinar for Medicaid managed care plans (MCOs) outlining the in-lieu-of services (ILS) request form procedure for medically tailored meals (MTM). The New York State FY 2020-21 Enacted Budget established three pilot programs to promote social determinant of health interventions, including a pilot to provide MTM to high-need individuals, as identified by MCOs.
 
MCOs that apply and receive approval to offer MTM as ILS may identify eligible members and refer them to MTM providers as a substitute for one of the following: 

  • Personal Care Aide (PCA) services; or
  • Hospital inpatient stays and/or emergency department visits.

MCOs will authorize up to three meals per day for six months, with the ability to reauthorize based on member reassessment and need. Members opting in to MTM will receive a reduction in the number of PCA hours they receive.
 
The webinar presentation is available here and the request form is available here. The launch date for ILS MTM services is January 1, 2022 and applications will be accepted on a rolling basis. Completed request forms may be sent to ILS@health.ny.gov and SDH@health.ny.gov.
 
DOH Releases Revised Medicaid Quality Strategy for Public Comment
On October 20th, DOH posted a notice in the State Register (available here) announcing the 30-day public comment period for the revised Medicaid Quality Strategy for New York State for the 2020-2022 period (available here). Periodic updates to the Medicaid Quality Strategy are required by Federal Medicaid regulations. The Strategy provides an overview of the efforts of New York’s Medicaid program and its contracted managed care plans to assess the quality of care that members receive and to establish goals and targets for improvement.
 
Questions and comments may be submitted to 1115waivers@health.ny.gov with the subject line “Quality Strategy” through November 19th.
 
DOH Posts Enhanced HCBS Spending Plan Quarterly Update
On October 20th, DOH posted the first quarterly update to its enhanced Home and Community-Based Services (HCBS) spending plan under the American Rescue Plan (ARP). In this update, DOH estimates that it will be directly eligible for $2.248 billion in state share savings through this program, up from $2.146 billion in the original spending plan. As these funds may be additionally used as state matching funds to receive additional federal financial participation of at least the same amount, the original plan estimated a total of $5.4 billion in expenditures, a figure which has not yet been revised in the quarterly update.
 
SPG has updated its reference guide to the proposals, including the State’s status updates on each proposal, which is available here. The full quarterly report can be viewed here, and a revised budget projection is available here.
 
OMH and OASAS Announce Launch Date and Release Documents for Transition to CORE Services
On October 19th, the New York State Office of Mental Health (OMH) and Office of Addiction Services and Supports (OASAS) announced that implementation of the Community Oriented Recovery and Empowerment (CORE) service array will take place on February 1, 2022. CORE services are an array of community-based behavioral health supports that will be available to all Health and Recovery Plan (HARP), HIV Special Needs Plan (SNP), and Medicaid Advantage Plus (MAP) members meeting HARP eligibility criteria. Unlike the adult BH HCBS services, CORE services do not require an independent eligibility assessment or Level of Service Determination. Instead, CORE services may be provided to any eligible beneficiary upon recommendation by a Licensed Practitioner of the Healing Arts (LPHA). 
 
OMH and OASAS released the following accompanying documents: 

  • CORE Operations Manual for Designated Providers (here)
  • Policy Regarding Provider Transition to CORE Services and Provisional/Full Designation (here)
  • CORE Benefit and Billing Guidance (here)
  • CORE LPHA Memo and Recommendation Form (here)
  • CORE Services Initiation Notification Template (here)
  • CORE Services Fee Schedule (here)

Additional guidance, including CORE Staff Training and Incident Reporting and Management Guidance, will be available in the coming weeks. 
 
SPG’s summary of the policies around the transition is available here.