Weekly Health Care Policy Update – October 29, 2021

November 5, 2021

In this update: 

  • Covid-19 Updates
    • FDA Advisory Panel Supports Authorization of Covid-19 Vaccines for Kids Ages 5 to 11
    • HHS Invests $560 Million to Increase Availability of COVID-19 Tests
    • CDC Updates Booster Guidance for Immunocompromised Individuals
    • Covid-19 Health Equity Task Force to Hold Stakeholder Briefings on November 3rd
  • Legislative
    • Biden Announces Build Back Better Framework; House Releases Bill Text
  • Regulatory
    • HHS Proposes to Repeal Trump-Era SUNSET Rule
    • HHS Releases Strategic Plan for Health Workforce
    • CMS Announces Several Marketplace Quality Initiative Publications
    • FDA Issues Guiding Principles for Machine Learning in Medical Device Development
  • Other
    • CMS Releases Data on Covid-19 Services in Medicaid and CHIP
    • Nearly Half of All Hospitals Hit with Readmission Penalties
  • Congressional Hearings
  • New York State Updates
    • Governor Hochul Announces New Transparency Initiatives
    • Governor Hochul Extends Workforce Emergency
    • Governor Hochul Announces New Administration Nominations
    • PHHPC Extends Covid-19 Emergency Regulations
    • DOH Hosts Webinar for Adult BH HCBS Providers Regarding CORE Implementation
    • DOHMH Extends Vaccine Outreach and Counseling Program
    • OASAS Publishes Proposed Rule to Repeal and Replace 14 NYCRR Part 841
    • OPWDD Allows Remote Delivery of CSIDD
    • DOH Clarifies Proposed Rate Enhancements for ACT Programs, Proposes Additional Rate Enhancements for Substance Use Providers

COVID-19 Updates

FDA Advisory Panel Supports Authorization of Covid-19 Vaccines for Kids Ages 5 to 11
On October 26th, the Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee voted unanimously in favor of authorizing the Pfizer/BioNTech Covid-19 vaccine for children ages 5 to 11. In this age group, the vaccine would be delivered as two 10-microgram doses, or one-third the amount required for those over the age of 11. In Pfizer/BioNTech’s study of 1,518 children, vaccinated children were 90.7% less likely to develop symptomatic Covid-19 than those in the placebo group. The panel agreed that the benefit far outweighed the risk of myocarditis and pericarditis. These side effects have been observed in roughly one per 10,000 vaccinated boys and young men, though cases are milder and shorter than those that occur in non-vaccine circumstances. Pfizer/BioNTech’s application still requires review by the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) and a recommendation by the CDC Director.
 
According to a Kaiser Family Foundation poll, 27% of parents will seek vaccination right away, 33% will wait and see, and 30% will definitely not vaccinate. More detailed results from the poll are available here.
 
HHS Invests $560 Million to Increase Availability of COVID-19 Tests
On October 22nd, the Biden Administration announced that the Department of Health and Human Services (HHS) has invested more than $560 million in American Rescue Plan (ARP) funding to boost manufacturing of key products needed to increase the domestic Covid-19 testing supply. HHS, in partnership with the Department of Defense, has awarded this funding to over a dozen companies to support manufacturing of supplies like pipette tips, protective packaging, swabs, and reagents used to detect the virus in samples, with a focus on expanding domestic production capacity for essential components. These funds are intended to help meet the President’s goal of quadrupling the supply of at-home Covid-19 tests by December and increasing the number of no-cost testing sites.

The announcement, including a full description of each award, may be found here.

CDC Updates Booster Guidance for Immunocompromised Individuals
The Centers for Disease Control and Prevention (CDC) has updated its Covid-19 vaccine guidance for immunocompromised people. The guidance recommends a booster dose for those individuals at least six months after their primary vaccination series. In August, the CDC recommended that immunocompromised individuals who received either of the mRNA vaccines receive a third dose as part of their primary vaccination series, to raise their immunity levels to be comparable to those observed in non-immunocompromised people. The new recommendation would represent a fourth dose for many such recipients, intended to combat waning immunity. The booster dose may include any of the available vaccines (Pfizer/BioNTech, Moderna, or Johnson & Johnson). Roughly 2.7% of U.S. adults are considered immunocompromised.

The full CDC guidance is available here.
 
Covid-19 Health Equity Task Force to Hold Stakeholder Briefings on November 3rd
On October 28th, the Presidential Covid-19 Health Equity Task Force held its final public meeting, during which it presented its Final Report, containing priority actions and recommendations to “disrupt the predictability of who is harmed first and harmed worst in times of national crisis.” The Task Force also released a proposed implementation plan and suggested accountability framework. It intends to hold a series of stakeholder briefings for various groups of interest to outline its recommendations and to provide an opportunity for questions. The Task Force will hold the following briefings: 

  • Essential Workers, Health Care Workers, and Providers (10am; registration here)
  • Congregate Settings (11am; registration here)
  • Black Community (12pm; registration here)
  • LGBTQIA+ Community (1pm; registration here)
  • AA and NHPI Communities (2pm; registration here)
  • Rural and Remote Communities (3pm; registration here)
  • Children, Youth, and Families (4pm; registration here)
  • Hispanic/Latino/Latinx Communities (5pm; registration here)
  • Chronic Health Conditions and People Living with Disabilities (6pm; registration here)
  • American Indian and Alaska Native (7pm; registration here).

Legislative Update

Biden Announces Build Back Better Framework; House Releases Bill Text
On October 28th, President Biden announced that an agreement has been reached among Congressional Democrats on a framework for the “Build Back Better” reconciliation bill. According to the framework, the bill would spend $1.75 trillion primarily on climate investments, child care and universal pre-K, child tax credits, housing, and home care, as well as a separate $100 billion investment in the immigration system. It would also contain up to $2 trillion of offsets, including tax increases on corporations and high earners, limits on deductions, additional IRS enforcement, and the repeal of the Trump Administration’s drug rebate rule. Concurrently, House Democrats released draft legislative text (H.R. 5376) of the bill, which will need to be considered and passed in both the House and Senate.
 
Major health care provisions, as contained in the House bill, are summarized below. A more detailed summary by SPG of the Medicaid HCBS provisions is available here.
 
Medicaid Home and Community-Based Services (HCBS): $150 billion
States who submit an HCBS Improvement Plan would be eligible for an indefinite 6 percentage point increase in their Federal Medical Assistance Percentage (FMAP) on Medicaid HCBS spending. States would also receive an 80 percent FMAP through October 1, 2031, for administrative costs related to enhancing HCBS, and an indefinite 80 percent FMAP for HCBS quality improvement and reporting activities. Finally, States may also choose to establish a program to facilitate self-directed HCBS care. Such States would be eligible to receive a further 2 percentage point increase in their FMAP for spending on HCBS for six quarters.
 
States must meet various requirements to remain eligible for the enhanced FMAP. In particular, states must: 

  • Supplement, not supplant, the level of State funding on HCBS;
  • Meet maintenance of effort requirements;
  • Carry out activities to improve HCBS access;
  • Strengthen and expand the HCBS workforce;
  • Designate an independent HCBS or long-term care ombudsman; and
  • Submit annual reporting on its activities.

ACA Exchanges and Medicaid Gap: $130 billion
The bill would continue the enhanced premium tax credits and cost-sharing reductions included in the ARP, including providing subsidies to unemployed individuals as if their income were 150% of the federal poverty line (FPL).
 
To address the Medicaid gap in non-expansion states, the bill would provide premium tax credits and cost-sharing reductions to individuals with incomes below 138% of FPL. It would also make $10 billion available per year for state reinsurance programs, and direct the Centers for Medicare and Medicaid Services (CMS) to operate such a program in non-expansion states. As a result, such individuals would be eligible for coverage with zero premiums.
 
Relatedly, for states that did accept Medicaid expansion, the FMAP for the Medicaid expansion population would be increased to 93%.
 
All of these provisions will expire in 2025.
 
Medicare Hearing Benefit: $35 billion
Starting in 2024, Medicare would cover aural rehabilitation and treatment services provided by audiologists, and hearing assessment services provided by qualified hearing aid professionals. Medicare Part B would also cover the cost of hearing aids for individuals with severe or profound hearing loss, once every five years.
 
Other Provisions
The bill would also permanently authorize the Children’s Health Insurance Program (CHIP) and provide funding to various health care initiatives, including, among others: 

  • $1 billion to federally qualified health centers (FQHCs) for capital projects;
  • $1.1 billion for maternal care efforts;
  • $3.37 billion to teaching hospitals for graduate medical education;
  • Expansion and extension of the Certified Community Behavioral Health Care (CCBHC) program to be available to all states that apply;
  • Making the 85% FMAP option for Medicaid community-based mobile crisis intervention services, passed in the ARP but not yet implemented, permanent.

The framework also includes the repeal of the November 2020 final rule that required pharmacy benefit managers and insurers to pass on any manufacturer rebates on prescription drug prices to patients at the point of sale, raising $145 billion in revenue. Notably, the framework does not include any policies related to Medicare negotiation of prescription drug prices.
 
The White House summary of the framework is available here. The House Rules Committee’s section-by-section summary is here. The full text of the draft bill is available here.

Regulatory Updates

HHS Proposes to Repeal Trump-Era SUNSET Rule
On October 28th, the Department of Health and Human Services (HHS) issued a proposed rule that would repeal the “Securing Updated and Necessary Statutory Evaluations Timely” (SUNSET) rule published during the lame-duck period of the Trump Administration. The rule, originally finalized on January 19th, would require HHS to review all regulations periodically to extend their effectiveness, or else allow them to expire on the latest date of the following: 

  • Five calendar years after the year that the SUNSET rule first became effective;
  • Ten calendar years after the year of the regulation’s publication; or
  • Ten calendar years after the last year in which HHS conducted a detailed review or assessment of the regulation.

Previously, several litigants had challenged the SUNSET rule in court, and HHS had postponed the scheduled implementation date of the SUNSET rule by one year (to March 22, 2022). HHS now states that implementation of the rule would result in regulatory uncertainty, harm to public health, and the diversion of resources from existing regulatory programs. HHS proposes to withdraw the rule entirely but will accept comments on whether it should instead consider modifying the rule.
 
The proposed rule may be found here. Comments may be submitted through December 29th. The SUNSET final rule may be found here.
 
HHS Releases Strategic Plan for Health Workforce
This week, HHS formally released its Health Workforce Strategic Plan, as mandated by the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The plan focuses on four key goals: 

  • Expanding supply: expanding the health workforce to meet evolving community needs;
  • Ensuring equitable distribution: improving the distribution of the health workforce to reduce shortages;
  • Improving quality: enhancing health care quality through professional development, collaboration, and evidence-informed practice; and
  • Enhancing the use of data and evidence to improve program outcomes: developing and applying data and evidence to strengthen the health care workforce.

The plan will also “facilitate coordinated and intentional efforts to address long-standing barriers to strengthening the health workforce – barriers that have been amplified by ongoing crises” and will align with the White House’s National Strategy for the Covid-19 Response and Pandemic Preparedness,as well as with Presidential Executive Orders related to the pandemic. HHS will coordinate with other federal agencies that fund or administer health workforce development program to implement the plan.
 
The full plan can be found here.
 
CMS Announces Several Marketplace Quality Initiative Publications
On October 25th, CMS announced the availability of several publications related to the 2022 plan year on the Marketplace Quality Initiative website, available here. These include: 

  • The Quality Rating System and Qualified Health Plan Enrollee Experience Survey: Technical Guidance for 2022, available here;
  • The updated version of the 2022 Quality Rating System Measure Technical Specifications, available here;
  • The Qualified Health Plan Enrollee Experience Survey: Technical Specifications for 2022, available here;
  • The Quality Rating Information Bulletin to announce guidance for public display of quality rating information by all Exchanges, available here;
  • The Plan Year 2022 Nationwide Quality Rating System Public Use File (PUF), available here, which outlines underlying measure data as well as star ratings for all eligible Qualified Health Plan (QHP) issuers, operating in all Exchange types, that received QRS star ratings for Plan Year 2022;
  • The Quality PUF for Plan Year 2022, available here, which includes star ratings assigned to plans that will be available on HealthCare.gov for Plan Year 2022;
  • A QHP Enrollee Survey PUF, available here, which includes QHP Enrollee Experience Survey results data for plans offered through Exchanges nationwide. (This file is new for the 2022 plan year); and
  • Results-At-A-Glance for the Plan Year 2022 QRS Program, available here, which summarizes the QRS ratings for the 2022 Plan Year, including a summary of QRS reporting and QRS eligibility for the 2022 Plan Year.

FDA Issues Guiding Principles for Machine Learning in Medical Device Development
On October 27th, the FDA, together with regulators in Canada and the United Kingdom, released a document outlining 10 shared guiding principles to “inform the development of Good Machine Learning Practice (GMLP).” The principles identify areas where international regulators could work to advance GMLP. Areas of collaboration would include research, educational resources, and harmonization of international standards. These guidelines are intended to encourage medical device producers to adopt good practices from other areas, tailor practices to be relevant to the health care sector, and create new practices specific to health care.
 
The document can be viewed here. FDA is accepting further feedback through the public docket here.

Other Updates

CMS Releases Data on Covid-19 Services in Medicaid and CHIP
On October 27th, CMS published an updated Medicaid and CHIP data snapshot on the impact of Covid-19 on beneficiaries and service utilization through February 2021. The data shows that over 103 million people were enrolled across all Medicaid programs for at least one day during the Covid-19 public health emergency (PHE). About 3% of all beneficiaries, or almost 3.2 million people, were treated for Covid-19 during the PHE, with 264,468 total hospitalizations (255 per 100,000 beneficiaries).
 
The data also show that child health prevention services have not returned to the pre-pandemic average, with fewer vaccinations for non-Covid-19 conditions, screening services, dental, and mental health services. Telehealth usage spiked in April 2020 and declined afterwards, but remained much higher than before the PHE.
 
The snapshot can be found here.
 
Nearly Half of All Hospitals Hit with Readmission Penalties
On October 28th, Kaiser Health News published an analysis of Hospital Readmission Reduction Program data released by CMS on October 20th as a supplement to the Inpatient Prospective Payment System (IPPS) final rule. The analysis found that 2,499 hospitals, or 47% of all hospitals, will have their Medicare payments reduced in FY 2022 due to excessive readmissions during the July 1, 2017 – December 1, 2019 performance period. Only 517 hospitals received no penalty, while the remaining 2,216 are specialty hospitals exempted from the program. The average penalty was a 0.64% reduction in payments for each Medicare discharge; 39 hospitals received the maximum payment reduction of 3%. In total, the penalties will reduce Medicare spending by $521 million during this fiscal year.
 
The Kaiser Health News analysis is available here, and the CMS data file is available here.

Congressional Hearings

Thursday, November 4th: 

  • At 10am, the Senate Health, Education, Labor, and Pensions committee will hold a hearing entitled “Next Steps: The Road Ahead for the COVID-19 Response.” More information is available here.

New York State Updates

Governor Hochul Announces New Transparency Initiatives
On October 28th, Governor Hochul announced the launch of several initiatives to increase transparency in state government. Initiatives include: 

  • Transparency plans published by over 70 State agencies and authorities, including all health and human services agencies. For example, the Department of Health (DOH) will consider publishing final audited Institutional Cost Reports (ICRs), underlying datasets supporting DOH reports.
  • Improvements to the process for fulfilling Freedom of Information Law (FOIL) requests. FOIL responses will no longer be reviewed by the Executive Chamber, but instead will be processed by the agency’s General Counsel. Agencies will also be required to take immediate steps to post frequently requested documents.
  • Issuance of Executive Order 10 (available here), which requires all state employees to complete a live ethics training course upon hiring and a refresher course once every three years (two years for employees of the Executive Chamber).
  • The release of recusal policies for the Governor, Lieutenant Governor, and Secretary to the Governor.

The Governor’s press release is available here. The website with the transparency plans for state agencies, including the plans for all health and human services agencies, is available here.
 
Governor Hochul Extends Workforce Emergency
On October 27th, Governor Hochul issued Executive Order 4.1 (available here), which extends the statewide disaster emergency due to health care staffing shortages that was declared in Executive Order 4. The Order continues the provisions in EO 4 that reinstated many workforce and scope of practice flexibilities that applied during the original New York State Covid-19 public health emergency. It also adds several modifications, including: 

  • Expanding the authorization for individuals who were temporarily authorized to perform Covid-19 testing to perform any clinical laboratory test, under appropriate supervision;
  • Permitting initial patient visits for home health to be made within 48 hours of acceptance of a community referral or return home from institutional placement;
  • Permitting home health agencies to conduct in-home supervision “as soon as practicable” or by telephone or video; and
  • Adding further flexibilities related to testing.

Governor Hochul Announces New Administration Nominations
On October 28th, Governor Hochul announced the following nominations to her administration: 

  • Kevin Law has been nominated as Director of the Urban Development Corporation (UDC) and will be designated Chair of the UDC. Law is a Partner and Executive Vice President at Tritec Real Estate Company and has been the co-chair of the Long Island Regional Economic Development Council for the past ten years.
  • Hope Knight has been nominated as Commissioner of the Department of Economic Development and President and CEO of Empire State Development. Knight has served as President and CEO of Greater Jamaica Development Corporation since 2015 and also serves as a Commissioner of the New York City Planning Commission.

The Governor’s press release is available here.
  
PHHPC Extends Covid-19 Emergency Regulations
On October 26th, the Public Health and Health Planning Council (PHHPC) voted to extend the following Covid-19 emergency regulations that were set to expire on October 31st: 

  • 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.
    • Note: DOH has removed the requirement for nursing homes and adult care facilities to certify on a weekly basis that the facility has complied with the regulation.
  • Covid-19 Confirmatory Testing (here): 
    • Requires hospitals and nursing homes to test patients and residents for Covid-19 if they are presenting symptoms or if they have been exposed to Covid-19.
    • Requires hospitals and nursing homes to test deceased patients and residents for Covid-19 within 48 hours after death if there is a clinical suspicion that Covid-19 was the cause of death and if no such test was performed in the 14 days prior to death.
    • Requires funeral directors, coroners, and medical examiners to administer tests for Covid-19 within 48 hours after death if there is a reasonable suspicion that Covid-19 was the cause of death and if no such test was performed in the 14 days prior to death.

The PHHPC meeting agenda is available here. Questions may be submitted to REGSQNA@health.ny.gov.

DOH Hosts Webinar for Adult BH HCBS Providers Regarding CORE Implementation
On October 22nd, the Office of Mental Health (OMH) and Office of Addiction Supports and Services (OASAS) held a webinar for current adult Behavioral Health Home and Community-Based Services (BH HCBS) providers regarding the implementation of the Community Oriented Recovery and Empowerment (CORE) service array. Last week, OMH and OASAS announced that the implementation will take place on February 1, 2022 and released several documents related to the transition, including the CORE operations manual and billing guidance. OMH and OASAS intend to host several additional provider and plan implementation webinars over the next few months.
 
The presentation slides are available here. SPG’s summary of the policies around the transition is available here.
 
DOHMH Extends Vaccine Outreach and Counseling Program
On October 27th, the New York City (NYC) Department of Health and Mental Hygiene (DOHMH) announced that the Vaccine Outreach and Counseling Program (VOCP), which reimburses primary care providers for counseling a target list of unvaccinated New Yorkers, has been extended through November 30th for all participating health plans and through December 31st for most plans. As of October 22nd, the participating plans include Healthfirst, Empire BCBS/HealthPlus, EmblemHealth/HIP, MetroPlus, UnitedHealth, and Amida Care.
 
DOHMH will host a webinar for NYC health care providers to discuss VOCP on November 3rd from 1pm-2pm, which will cover how to obtain patient lists from participating plans, how to bill for the counseling, and other details about the program.
 
Webinar registration is available here. Further details on the program are available here.
 
OASAS Publishes Proposed Rule to Repeal and Replace 14 NYCRR Part 841
On October 27th, OASAS published a proposed rule in the State Register (available here) that proposes to repeal and replace 14 NYCRR Part 841, which establishes standards for reimbursement and participation in Medicaid for OASAS-certified addiction services providers. The updated regulation removes outdated language to reflect an updated State Plan Amendment that eliminates cost-based rates and uses the same fee methodology for all providers within a given space. Accordingly, the updated regulation includes the following new sections: 

  • Provisions applicable to all eligible providers;
  • Medical assistance payments for inpatient substance use disorder withdrawal and stabilization services;
  • Medical assistance payments and utilization review for substance use disorder residential rehabilitation services for youth;
  • Medical assistance payments for substance use disorder inpatient rehabilitation services;
  • Medical assistance payments for residential services;
  • Medical assistance payments for substance use disorder outpatient programs;
  • Medical assistance payments for children and family treatment and support services; and
  • Utilization review.

The proposed regulations are available here. Public comments may be submitted to kelly.grace@oasas.ny.gov through January 25, 2022.
 
OPWDD Allows Remote Delivery of CSIDD
On October 27th, the New York State Office for People with Developmental Disabilities (OPWDD) posted a public notice in the State Register (available here) announcing that, effective November 1st, it will allow reimbursement for the remote delivery of Crisis Services for Individuals with Intellectual and/or Developmental Disabilities (CSIDD). Remote delivery may include telephonic (audio-only) technology in accordance with New York State and federal regulations.
 
Public comment may be submitted to spa_inquiries@health.ny.gov.
 
DOH Clarifies Proposed Rate Enhancements for ACT Programs, Proposes Additional Rate Enhancements for Substance Use Providers
On October 27th, DOH posted a public notice in the State Register (available here) clarifying its intent to increase rates for Assertive Community Treatment (ACT) services, as follows:  

  • Permanently increase rates by 5 percent, effective October 7th. Rates will be increased by an additional 5.4 percent (previously 5 percent) for a total increase of 10.4 percent (previously 10 percent) from October 7th through March 31, 2022. On April 1, 2022, rates will be reduced by 5.4 percent.
  • Increase rates by an additional 8.5 percent (previously 8.2 percent) from October 7th through March 31, 2022, to allow providers to increase recruitment and retention through loan forgiveness, tuition reimbursement, and signing bonuses, among other initiatives.
  • Increase rates by an additional 50 percent for 10 newly licensed Youth ACT teams serving individuals up to age 21 from October 7th through March 31, 2022.
  • Increase rates by an additional 50 percent for Young Adult ACT teams from October 7th through March 31, 2022.

DOH also proposes to: 

  • Increase reimbursement rates for State Plan-approved private duty nursing (PDN) services for members 23 years of age and older by an additional 60 percent from November 1st through March 31, 2022.
  • Increase recovery oriented residential offerings by incorporating the residential reintegration services into the Medicaid benefit package and enhance the reimbursement rate through March 31, 2024. Rates will initially be increased by 50 percent from November 1st through December 31st.
  • Increase reimbursement rates for state-plan approved residential addiction rehabilitation services, outpatient addiction rehabilitation services, and addiction services by 10 percent from November 1st through December 31st.

The proposed changes are contingent upon CMS approval of the State’s spending plan for the enhanced FMAP for HCBS contained in the ARP. Stakeholders may submit public comments on the proposed training enhancements via email to spa_inquiries@health.ny.gov.