Weekly Health Care Policy Update – August 6, 2021

August 13, 2021

In this update: 

  • Administration
    • Biden Administration Announces Updates on COVID-19 Response 
      • U.S. Hits 70% Vaccination Goal
      • CDC Issues New Eviction Moratorium
  • Legislative
    • Senate Considers Infrastructure Bill; CBO Projects $256 Billion Impact on Deficit
    • Senate Finance Committee Leaders Issue Bipartisan Request for Input on Mental Health Legislation
  • Regulatory
    • CMS Issues Final FY 2022 Hospital Inpatient PPS Rule
    • CMS Releases Final FY 2022 IPF PPS Rule
    • CMS Finalizes Hospice Payment Rates for FY 2022
    • CMS Releases Final FY 2022 IRF Rule
    • CMS Releases Final FY 2022 SNF Rule
    • CMMI Issues 2020 Report to Congress
    • FDA Aims for Full Authorization for Pfizer-BioNTech Vaccine by Labor Day
    • SAMHSA Awards $250 Million to 100 Certified Community Behavioral Health Centers
    • HRSA Awards $90 Million for Substance Use and Maternal Care in Rural Areas
  • Other
    • WHO Calls for Halt on Boosters
    • Moderna Reports COVID-19 Vaccine Remains 93% Effective at Six Months
  • Congressional Hearings
  • New York State
    • PHHPC Reviews and Adopts COVID-19 Emergency Regulations
    • OMH Releases Statewide Youth ACT Team RFP
    • CMS Approves SPA to Eliminate Bed Reserve Days for Nursing Facility Services
    • OPWDD Issues Directive on Remote HCBS Delivery
    • Governor Cuomo Signs Legislation Regarding Residential Health Care Facility Transparency
    • DOH Submits Interim Evaluation Report on MLTC and 12-Month Continuous Eligibility

Administration Updates

Biden Administration Announces Updates on COVID-19 Response
This week, the Biden Administration announced new updates on the COVID-19 response: 

  • U.S. Hits 70% Vaccination Goal: On August 2nd, the U.S. reached the milestone of having 70% of eligible adults at least partially vaccinated against COVID-19. President Biden originally set a goal of reaching this milestone by the July 4thweekend, and did not set a new goal after that date was missed. The recent rise in cases attributable to the more contagious Delta variant has also led to a rise in vaccination rates in hard-hit areas like Arkansas, Missouri, Louisiana, and Florida.
  • CDC Issues New Eviction Moratorium: On August 3rd, Centers for Disease Control and Prevention (CDC) Director Dr. Rochelle Walensky issued a new order temporarily halting evictions in counties with heightened levels of COVID-19 community transmission. In its order, the CDC noted that evictions of tenants for failure to make rent or housing payments could be detrimental to public health control measures to slow the spread of COVID-19.  The order is in place until October 3, 2021, but is expected to face legal challenges, as at least five justices of the Supreme Court have indicated that they would strike down an eviction moratorium lasting beyond July 31st.

Legislative Updates

Senate Considers Infrastructure Bill; CBO Projects $256 Billion Impact on Deficit
This week, the Senate continued negotiations around the bipartisan infrastructure bill, whose text has now been released as Senate Amendment 2137 to H.R. 3684, the Infrastructure Investment and Jobs Act. The bill’s provisions regarding health care remain largely unchanged from last week, including a one-year extension of the Medicare sequester, a three-year delay of the Trump-era Part D Medicare drug rebate rule for three years, and savings related to rebates for unused doses of drugs in Medicare Part B, but no clawback from the Provider Relief Fund (PRF). On August 5th, the Congressional Budget Office released a projection that the bill would add $256 billion to the deficit over the ten-year legislative window. The Senate is expected to hold a special session on Saturday to advance the bill, although the House will not consider it until it returns from recess in September.
 
The CBO report is available here.
 
Senate Finance Committee Leaders Issue Bipartisan Request for Input on Mental Health Legislation
On August 5th, Senate Finance Committee Chairman Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) issued a letter to the rest of the Committee, outlining plans for and requesting input on a potential bipartisan legislative package to address barriers to mental health care. The Committee is initially seeking the “best policy ideas on methods for improving behavioral health care for Medicare, Medicaid, CHIP, and ACA marketplace beneficiaries” from the other 26 Senators on the Finance Committee. Ideas may pertain to areas including: 

  • Workforce and addressing the workforce shortage;
  • Integration, coordination, and access;
  • Mental health parity; and
  • Telehealth.

The Committee will accept ideas from Senators through August 31st. It will also issue a separate request for public and private-sector stakeholder input later this month. The full text of the letter is available here.

Regulatory Updates

CMS Issues Final FY 2022 Hospital Inpatient PPS Rule
On August 2nd, the Centers for Medicare and Medicaid Services (CMS) issued a final rule updating Medicare payment policies for hospitals under the Inpatient Prospective Payment System (IPPS) and the Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) for fiscal year (FY) 2022. For inpatient payments, standardized Medicare payments will increase by 2.5 percentage points, or $3.4 billion, for acute care hospitals that successfully participate in the Hospital Inpatient Quality Reporting (IQR) Program and are meaningful electronic health record (EHR) users. Combined with changes in uncompensated care payments, capital payments, and other changes, CMS projects total Medicare spending on inpatient hospital services and capital will increase by about $3.7 billion in FY 2022. CMS notes that it is using data from FY 2019 for this rate-setting process. Ordinarily, FY 2022 rate-setting would be expected to use FY 2020 data, but utilization and spending patterns in FY 2020 were markedly different due to the COVID-19 public health emergency (PHE).
 
Notably, the final rule does not address proposals included in the proposed rule related to payments to hospitals for direct graduate medical education (GME) and indirect medical education (IME), and to organ acquisition payment policy for transplant hospitals, donor community hospitals, and organ procurement organizations. CMS notes that due to the “number and nature” of comments on these proposals, they will be addressed in future rulemaking.
 
SPG’s full summary of this rule was sent out separately, and is available here. The final rule is available here. A fact sheet is available here.
 
CMS Releases Final FY 2022 IPF PPS Rule
On July 29th, CMS released the final FY 2022 inpatient psychiatric facility (IPF) prospective payment system (PPS) rule. The rule establishes final payment policies and rates for IPFs as well as updates to the IPF Quality Reporting Program (QRP). In FY 2022, CMS estimates that total payments to IPFs will increase by 2.0%, or $80 million, relative to estimated FY 2021 payments. CMS finalized changes to the IPF PPS teaching policy with respect to displaced residents from IPF hospital closures and closures of IPF teaching programs, to better align the policy with changes made in the FY 2021 IPPS final rule. CMS also finalized changes to the IPF Quality Reporting Program (QRP), which include the adoption of two new measures, the COVID-19 health care personnel vaccination rate and Follow-Up After Psychiatric Hospitalization, and the adoption of voluntary patient-level data reporting for chart abstracted measures for FY 2023 payment determination and mandatory reporting beginning with the FY 2024 payment determination.
 
This final rule takes effect October 1st, and is available here. A fact sheet is available here.
 
CMS Finalizes Hospice Payment Rates for FY 2022
On July 20th, CMS issued a final rule establishing Medicare hospice payments and finalizing changes to conditions of participation (CoPs) and the Hospice Quality Reporting Program (HQRP) for FY 2022. Hospices will receive a 2.0% payment increase for FY 2022, slightly lower than the 2.3% update included in the proposed rule. This will increase the statutory aggregate cap amount, which limits annual per patient payments to hospice providers, to $31,297.61. CMS estimates the payment updates will increase total payments to hospice providers by $480 million relative to FY 2021 payments. The final rule also rebases and revises the labor share for all four levels of hospice care, makes changes to hospice CoPs, including those regarding hospice aide competency evaluation standards, and makes permanent selected regulatory blanket waivers that were issued to Medicare-participating hospice agencies during the COVID-19 PHE. CMS also finalized several changes to the HQRP, including the addition of the claims-based Hospice Care Index measure and the Hospice Visits in the Last Days of Life measure for public reporting. CMS also summarizes comments related to two requests for information included in the proposed rule regarding the use of Fast Healthcare Interoperability Resources (FHIR)-based standards for digital hospice quality reporting and how to advance health equity with changes to the HQRP.
 
This final rule takes effect October 1st, and is available here. A fact sheet is available here.
 
CMS Releases Final FY 2022 IRF Rule
On July 29th, CMS issued a rule to finalize updates to the inpatient rehabilitation facility (IRF) payments under Medicare for FY 2022. Under the rule, IRF payments will be updated by 1.9 percent for FY 2022, slightly lower than the 2.2 percent increase originally proposed. After adjustments, the overall increase to IRF payments will be 1.5 percent, or roughly $130 million, over FY 2021. The rule also finalizes updates to the IRF Quality Reporting Program (QRP), including a requirement that IRFs report COVID-19 vaccinations among health care personnel in their facilities. CMS also finalized two policies related to the Medicare Durable Medical Equipment Prosthetics, Orthotics, and Supplies (DMEPOS): an exclusion from fee schedule adjustments for certain wheelchair accessories, and changes to the definition of “item” to exclude complex rehabilitative manual wheelchairs and certain manual wheelchairs from the DMEPOS Competitive Bidding Program.
 
This final rule takes effect October 1st, and is available here. The fact sheet is available here.
 
CMS Releases Final FY 2022 SNF Rule
On July 29th, CMS issued a rule to finalize updates to payments for skilled nursing facilities (SNF) under Medicare for FY 2022. Under the rule, SNF payments will be updated by 1.2 percent for FY 2022, a roughly $411 million increase over FY 2021. In addition, in order to improve accuracy, the rule rebases the SNF market basket to a 2018-based market basket rather than a 2014-based market basket. CMS finalized a proposal to require SNFs to report COVID-19 vaccination rates among health care personnel in their facilities, with the first reporting period beginning on October 1, 2021. The rule did not, however, recalibrate the patient-driven payment model’s (PDPM) parity adjustment to account for the effects of the pandemic. CMS noted that comments on the provision will be considered for the upcoming FY 2023 SNF PPS proposed rule. The rule also finalized a proposal to resume public reporting through the SNF Quality Reporting Program starting January 2022 after allowing exceptions for the first two calendar quarters of 2020.
 
This final rule takes effect October 1st, and is available here. The fact sheet is available here.
 
CMMI Issues 2020 Report to Congress
On August 4th, the Center for Medicare and Medicaid Innovation (CMMI) issued its 2020 Report to Congress. CMMI is required by statute to report on its activities to Congress at least every other year. The report covers CMMI’s activities between October 2, 2018 through September 30, 2020, which include 38 payment and service delivery models and initiatives, as well as six congressionally-mandated or authorized demonstration projects. CMS estimates that 528,000 providers and plans have participated in CMMI payment and service delivery models and initiatives, affecting the care of almost 28 million Americans.
 
The report highlights five CMMI models that have delivered statistically significant savings (the ACO Investment Model, the Home Health Value-Based Purchasing Model, the Maryland All-Payer Model, the Medicare Prior Authorization Model: Repetitive Scheduled Non-Emergent Ambulance Transport, and the Pioneer ACO Model), as well as two models that demonstrated significant improvements in quality (the Comprehensive End-Stage Renal Disease Care Model, and the Comprehensive Care for Joint Replacement Model). The report also highlights the modification or termination of models that did not meet CMMI’s goals, such as the Bundled Payments for Care Improvement (BPCI) Advanced Model.
 
FDA Aims for Full Authorization for Pfizer-BioNTech Vaccine by Labor Day
On August 3rd, the New York Times reported that the Food and Drug Administration aims to fully approve the Pfizer-BioNTech COVID-19 vaccine by Labor Day. The FDA noted in a statement that full approval might inspire more public confidence in the vaccine, as supported by a recent poll by the Kaiser Family Foundation which found that three in 10 unvaccinated Americans said that full authorization would make them more likely to get a vaccine. Many large public and private employers across the country have also stated that they will implement mandatory vaccination upon full authorization.
 
SAMHSA Awards $250 Million to 100 Certified Community Behavioral Health Centers
On July 29th, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced $250 million in grants t0 100 Certified Community Behavioral Health Centers through the Certified Community Behavioral Health Clinics (CCBHC) expansion grant program. The program aims to increase access to, and improve the quality of, community mental and substance use disorder treatment services. The funding includes $115 million in COVID-19 relief funds, $77 million in American Rescue Plan (ARP) funds, and $58 million in annual appropriations.
 
The list of grant recipients, including 10 grantees from New York State, can be found here.
 
HRSA Awards $90 Million for Substance Use and Maternal Care in Rural Areas
On August 5th, the Department of Health and Human Services (HHS) announced the award of $90 million to address opioid and other substance use disorder (OUD/SUD), maternal health, and other health care issues in rural health. Funds are being awarded through four programs operated by the Health Resources and Services Administration (HRSA)’s Office of Rural Health Policy: 

  • Rural Communities Opioid Response Program (Implementation) 
    • $78 million to 78 organizations for OUD/SUD prevention, treatment, and recovery services.
  • Rural Communities Opioid Response Program (Psychostimulant Support Program) 
    • $7.5 million to 15 rural consortia for services for individuals misusing psychostimulants.
  • Rural Maternity and Obstetrics Management Strategies Program 
    • $2.9 million to three recipients to test strategies (such as care coordination and telehealth) to address unmet maternal care needs in rural areas.
  • Rural Northern Border Region Planning Program
    • $760,000 to four community-based organizations to identify key rural health issues in the Northern Border Regional Commission service areas.

The press release, including lists of recipients, is available here.

Other Updates

WHO Calls for Halt on Boosters
On August 4th, the World Health Organization (WHO) called for a temporary moratorium on wealthy countries giving COVID-19 vaccine boosters to their citizens until at least the end of September or potentially later. The WHO said such a moratorium would not necessarily apply for select groups that might need additional protection, such as the immunocompromised, which several countries have already begun to administer. The goal of the moratorium is to get enough supply into COVAX, the international distribution system, to vaccinate 10% of the world’s population. More than 80% of the roughly 4 billion doses administered globally to date have gone to high-income countries.
 
Moderna Reports COVID-19 Vaccine Remains 93% Effective at Six Months
On August 5th, Moderna announced that its COVID-19 vaccine showed “durable efficacy” of 93% through six months after administration of the second dose, according to its final blinded analysis of Phase 3 study data. Moderna also released Phase 2 data indicating that booster shot candidates induced robust antibody responses against the currently known COVID-19 variants of concern, including Gamma, Beta, and Delta, and reported Phase 1 data on a next-generation COVID-19 mRNA vaccine that is potentially refrigerator-stable, facilitating easier distribution and administration.
 
The press release is available here.

Congressional Hearings

The House is in recess through August 30th. The Senate has not announced major health-related hearings next week.

New York State Updates

PHHPC Reviews and Adopts COVID-19 Emergency Regulations
On July 29th, the Public Health and Health Planning Council (PHHPC) reviewed and adopted several revised emergency regulations related to the COVID-19 pandemic. Of those regulations, the following were republished by the New York State Department of Health (DOH) with an effective date of July 30th. Revisions are noted in italics.

  • Hospital and Nursing Home Personal Protective Equipment (PPE) Supply (here): 
    • Requires hospitals and nursing homes to have a 60-day supply of PPE by August 31st (hospitals were previously required to have a 90-day stockpile)and authorizes the Commissioner of Health to increase the requirements to 90 days for hospitals during a state or local public health emergency.
  • Surge and Flex Health Coordination System (here): 
    • Establishes ongoing emergency planning requirements (“Surge and Flex Health Care Coordination System”) for facilities and agencies regulated by DOH and authorizes the Commissioner of Health to direct health care facilities to increase bed capacity by 50 percent (previously up to 100% within 30 days of emergency declaration) and to postpone all non-essential elective procedures.
  • COVID-19 Vaccinations of Nursing Home and Adult Care Facility Residents and Personnel (here) 
    • Requires adult care facilities (within 7 days) and nursing homes (within 14 days) to offer unvaccinated personnel and residents an opportunity to receive a first or second dose of the COVID-19 vaccine.

PHHPC also reviewed regulations related to personal and compassionate caregiving visitors in nursing homes and adult care facilities, reporting of communicable diseases, enforcement of social distancing measures, and COVID-19 confirmatory testing. The text of these regulations may be accessed here.
 
OMH Releases Statewide Youth ACT Team RFP
On August 4th, the New York State Office of Mental Health (OMH) released a Request for Proposals (RFP) for the expansion of Youth Assertive Community Treatment (ACT) teams throughout New York State. The Youth ACT teams will serve children and youth (ages 10-21) with Serious Emotional Disturbance (SED) who: 

  • Are returning home from inpatient settings or residential services;
  • Are at risk of entering such settings; or
  • Have not adequately engaged or responded to treatment in more traditional community-based settings.

OMH will provide 10 awards across five regions statewide as outlined in the RFP. Youth ACT teams will be funded through Medicaid and net deficit funding, in addition to $425,000 in start-up and transition/ramp-up funding. Contracts will last for five years.
 
The full RFP is available here. Applications are due on September 28th. SPG will shortly distribute a full summary of the RFP. 
 
CMS Approves SPA to Eliminate Bed Reserve Days for Nursing Facility Services
On August 2nd, CMS approved a State Plan Amendment (SPA) submitted by New York to eliminate payment for bed reserve days for hospitalizations for all residents over 21 years of age, except for individuals on hospice and therapeutic leave. Additionally, the amendment specifies the following: 

  • Payments for patients on hospice will be made at 50 percent of the Medicaid rate (payment may not exceed 14 days in any 12-month period);
  • Payments for patients on therapeutic leave will be made at 95 percent of the Medicaid rate (payment may not exceed 10 days in a 12-month period); and
  • Reserved bed days provided on behalf of individuals under 21 years of age will continue to be made at 100 percent of the Medicaid rate.

These changes are effective January 1, 2019. The CMS approval letter is available here.
 
OPWDD Issues Directive on Remote HCBS Delivery
On July 28th, the New York State Office for People with Developmental Disabilities (OPWDD) released an administrative directive memorandum (ADM) regarding the ability to use technology to remotely deliver Home and Community Based Services (HCBS), including: 

  • Day Habilitation;
  • Community Habilitation;
  • Prevocational Services;
  • Supported Employment (SEMP);
  • Pathway to Employment;
  • Support Broker; and
  • Respite Services.

For these services, face-to-face service delivery requirements may be met using remote technology in accordance with the guidelines outlined in the ADM. The guidelines outlined in the ADM include the definition of remote service delivery, requirements for care planning and ensuring individual choice to receive remote services, instructions for in-person support, and requirements for service documentation and billing.
 
The provisions of this ADM will take effect upon conclusion of the COVID-19 Appendix K authority and associated telehealth waivers, which will be no later than six months following the end of the federal COVID-19 Public Health Emergency.
 
The ADM is available here. Questions may be sent to peoplefirstwaiver@opwdd.ny.gov.
 
Governor Cuomo Signs Legislation Regarding Residential Health Care Facility Transparency
On August 2nd, Governor Cuomo signed legislation (S3185/A5848) that requires residential health care facilities to provide potential residents and their families with a document outlining how they can find information on complaints, citations, inspections, enforcement actions, and penalties taken against the facility. This information should include the address for the DOH nursing home profiles website and the federal Department of Health and Human Services nursing home compare website, as applicable.
 
DOH Submits Interim Evaluation Report on MLTC and 12-Month Continuous Eligibility
On August 3rd, DOH submitted an independent evaluation of the State’s 1115 Medicaid Redesign Team Waiver to CMS. Conducted by RAND Corporation, the evaluation assessed the following two components of the Waiver: 

  • The Managed Long Term Care (MLTC) program; and
  • The MLTC 12-month continuous eligibility policy.

The report examined whether these two initiatives have: 

  • Expanded access to long-term services and supports (LTSS);
  • Improved patient safety, quality of care, and consumer satisfaction; and
  • Reduced enrollment gaps and increased enrollment duration.

The report found that the MLTC program increased access to LTSS and did not lead to a significant change in patient safety or quality of care. The report also found that the 12-month continuous eligibility policy was associated with statistically significant increases in enrollment duration and outpatient visits and decreases in inpatient admissions and per member per month (PMPM) cost, leading to a net increase in total Medicaid cost.
 
The interim report is available here.