Weekly Health Care Policy Update – September 17, 2021

September 22, 2021

In this update: 

  • COVID-19 Response
    • CDC Releases Three Studies on Vaccines and Delta Variant
    • FDA Vaccine Panel Considers Covid-19 Booster Shot Plan Today
    • NIH Awards $470 Million to NYU for RECOVER “Long Covid” Research Initiative
  • Legislative
    • House Committees Complete Markup of Build Back Better Act
  • Regulatory
    • CMS Administrator to Hold National Stakeholder Call Today (12:30pm)
    • HHS to Distribute $17 Billion through Phase 4 of PRF and Additional $8.5 Billion to Rural Providers
    • CMS Proposes to Repeal Rule Permitting Expedited Medicare Coverage for New Technologies
    • CMS Withdraws Funding Opportunity for ET3 Medical Triage Lines
    • Administration Issues Proposed Rules to Promote Transparency in Air Ambulance Costs, Agent and Broker Compensation
    • CMS Announces Community Health Access and Rural Transformation (CHART) Award Recipients
    • CMS Delays Enforcement of Payer Interoperability Provision
    • FTC Issues Policy Statement on Health Breach Notification Rule
    • Administration Issues Proposed Rules to Promote Transparency in Air Ambulance Costs, Agent and Broker Compensation
    • CMS Announces Community Health Access and Rural Transformation (CHART) Award Recipients
    • CMS Delays Enforcement of Payer Interoperability Provision
    • FTC Issues Policy Statement on Health Breach Notification Rule
  • Other
    • KFF Estimates Preventable Covid-19 Hospitalizations Have Cost Over $5 Billion
    • Census Releases Report on U.S. Health Coverage in 2020
  • Congressional Hearings
  • New York State
    • NYS Releases First Quarterly Update to FY 2022 Enacted Budget Financial Plan; State Hiring Freeze Lifted
    • Federal Judge Blocks DOH Exclusion of Religious Exemptions from Covid-19 Vaccine Mandate
    • Governor Hochul Announces Mask Requirements in Child Care Programs and Congregate Facilities, Authorizes EMTs to Administer Covid-19 Vaccinations
    • LOIs Due Today for OMH Peer-to-Peer Supported Transition Program (4pm)
    • New York State DOL Releases FAQ on HERO Act Employee Safety Requirements

COVID-19 Response

CDC Releases Three Studies on Vaccines and Delta Variant
On September 10th, the Centers for Disease Control and Prevention (CDC) issued three major studies on Covid-19 vaccines and the Delta variant: 

  • The first study showed that over the spring and summer of 2021, unvaccinated Americans were 5 times more likely to be infected with Covid-19 than unvaccinated Americans. Unvaccinated Americans were also 10 times more likely to be hospitalized and 11 times more likely to die of Covid-19 than fully-vaccinated Americans.
  • The second study showed that vaccine effectiveness against the Delta variant was significantly higher among Moderna vaccine recipients (95%) than among Pfizer-BioNTech (80%) or J&J (60%) vaccine recipients. The study included about 32,000 patients assessed between June and August 2021.
  • The third study showed that incident rate ratios (IRR) for hospitalization and death were relatively unchanged after the Delta variant reached predominance, even as case IRRs decreased. This result suggests that, despite reduced effectiveness for the prevention of any Covid-19 infection, vaccines continue to be effective against severe illness. This study included data on more than 600,000 Covid-19 cases from April to July 2021.

FDA Vaccine Panel Considers Covid-19 Booster Shot Plan
Today (September 17th), the Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee is meeting to consider whether to recommend booster shots of the Pfizer Covid-19 vaccine for all individuals 16 and older. The Biden Administration has publicly stated that it is preparing to provide booster shots to the general population, conditional on the recommendations of the FDA and of the CDC’s Advisory Committee on Immunization Practices (ACIP), which is scheduled to meet next week (September 22nd and 23rd).
 
The FDA meeting is occurring amidst controversy regarding booster shots. Notably, an article published in The Lanceton September 13th by several scientists, including the director and deputy director of FDA’s Office of Vaccines Research and Review, Dr. Marion Gruber and Dr. Philip Krause, asserted that the available data do not support booster shots for the general population as vaccine efficacy against severe disease remains high. The authors further assert that “current vaccine supplies could save more lives if used in previously unvaccinated populations than if used as boosters in vaccinated populations.” Dr. Gruber and Dr. Krause have announced that they are leaving the FDA later this year, reportedly over the issue of booster shots.
 
The meeting is being webcast live here.
 
NIH Awards $470 Million to NYU for RECOVER “Long Covid” Research Initiative
On September 15th, the National Institutes of Health (NIH) announced that it awarded nearly $470 million to NYU Langone Health to serve as the Clinical Science Core for the NIH’s “Researching COVID to Enhance Recovery” (RECOVER) initiative. The RECOVER initiative will fund long-term studies of individuals recovering from Covid-19 with the goal of learning about “long Covid,” defined as prolonged or new symptoms that occur in Covid-19 patients after the acute phase of infection ends. A central component of the initiative will be the long-term tracking of the SARS-CoV-2 Recovery Cohort, a diverse population of tens of thousands of individuals who are recovering from Covid-19 (as well as a control group who is not). As the Clinical Science Core, NYU Langone will make subawards to more than 100 researchers at more than 30 institutions nationally and integrate their research activities.
 
The NIH press release is available here. An announcement by NYU is available here.

Legislative Updates

House Committees Complete Markup of Build Back Better Act
On September 3rd, the Biden Administration released a proposed Pandemic Preparedness Plan, which outlines $65 billion of investments over the next 7-10 years that the Administration believes are necessary to protect the United States from future pandemics. It outlines five major areas for legislative priorities, including: 

  • Bolstering vaccines, therapeutics, and diagnostics;
  • Promoting situational awareness about infectious disease threats;
  • Strengthening the public health system;
  • Improving strategic national stockpiles; and
  • Improving biosecurity and biosafety.

The plan is part of the response to Biden’s initial January 20th Executive Order requiring a whole-of-government review of national biopreparedness policies. The Administration plans to issue a full strategy document later this year.

Legislative Updates

House Committees Begin Considering Build Back Better Reconciliation Legislation
On September 15th, the House Ways and Means Committee and Energy and Commerce Committee completed markup of the Build Back Better Act and voted to approve their respective provisions. As passed, the Committees’ bills contain most of the health care provisions previously made public, including: 

  • Expanding Medicare coverage of hearing, vision, and dental services;
  • Closing the Medicaid coverage gap;
  • Extending enhanced premium tax credit subsidies; and
  • Offering additional funding for home and community-based services (HCBS)

Notably, the Energy and Commerce Committee did not approve language allowing Medicare to directly negotiate drug prices, with three Democrats voting against the provisions, resulting in a 29-29 tie. The Ways and Means Committee did approve similar language. Negotiations will continue in the Senate.
 
A press release from the Energy and Commerce Committee is available here, and a press release from the Ways and Means Committee is here.

Regulatory Updates

CMS Administrator to Hold National Stakeholder Call Today
Today at 12:30pm, CMS Administrator Chiquita Brooks-LaSure and other CMS leadership are holding a national stakeholder call to provide updates on their first 100 days in office.

Interested stakeholders may join here.

HHS to Distribute $17 Billion through Phase 4 of PRF and Additional $8.5 Billion to Rural Providers
On September 10th, the Department of Health and Human Services (HHS) announced that its Health Resources and Services Administration (HRSA) will make $17 billion available to providers affected by the COVID-19 pandemic through Phase 4 of the PRF. Providers may apply beginning September 29th.
 
As covered in the supplemental update SPG provided earlier this week, HHS intends to use a new methodology to allocate these funds to favor small- and medium-sized providers and providers who serve Medicare and Medicaid populations.

  • 75% of the allocation will be based on reported revenue losses and COVID-19-related expenses from July 1, 2020 to March 31, 2021. Providers will be separated into three groups: 
    • Large providers will receive a base reimbursement of a percentage of their losses and COVID-19 expenses.
    • Medium and small providers will receive this base reimbursement plus a supplement, which will be higher for small providers than medium providers.
    • HHS will determine the exact parameters of these payments after all applications are received. No provider should expect to receive more than 100% of their reported losses and COVID-19 expenses.
  • 25% of the allocation will be based on providers’ total amount and type of services provided to Medicare, Medicaid, and CHIP enrollees. 
    • The total amount of services will be calculated as a dollar figure, with all services priced at Medicare rates (except for some “services provided predominantly in Medicaid and CHIP”).
    • Eligible providers who serve any Medicare, Medicaid, or CHIP patients living in rural areas will receive a minimum payment.

HHS will also provide a separate $8.5 billion to rural providers, as allocated in the American Rescue Plan (ARP). These payments will be calculated similarly to the second allocation above, based on quantity and type of service provided to Medicare, Medicaid, and CHIP enrollees. The 2020 year-end Consolidated Appropriations Act (CAA) required HHS to disburse at least 85 percent of the remaining funds in the PRF through Phase 4, indicating that roughly $3 billion of unobligated PRF funds remain.
 
More information on Phase 4 is available here.
 
CMS Proposes to Repeal Rule Permitting Expedited Medicare Coverage for New Technologies
On September 13th, the Centers for Medicare and Medicaid Services (CMS) issued a ruleproposing to repeal a Trump-era final rule on coverage of breakthrough technologies in Medicare. The original rule, “Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary’,” was published in January and was scheduled to go into effect on December 15th. The original rule established a new Medicare coverage pathway to provide beneficiaries with faster access to medical devices designated as “breakthrough” by the FDA. Under the policy, devices would have been immediately covered by Medicare for up to four years upon FDA market authorization, unless CMS made a specific determination otherwise. The rule also proposed to codify a definition of “reasonable and necessary” which would include any items or services approved in the commercial market unless evidence indicates otherwise.
 
After several delays of the rule, CMS now proposes to repeal it. CMS stated that the MCIT pathway would provide “expedited, multiyear, national coverage” based on evidence that may be insufficient to demonstrate that coverage is reasonable and necessary, and that it would impede Medicare’s ability to make case-by-case determinations. CMS stated that “there are other ways to achieve our stated goals,” which may include existing pathways or future rulemaking.
 
Regarding the definition of “reasonable and necessary,” CMS stated that systematically approving items and services based on commercial insurer coverage would pose implementation challenges. CMS is seeking comment on this part of the proposal, including whether only the commercial insurance aspect should be repealed.
 
Public comments on the proposed rule are due to CMS within 30 days of publication (October 13th).
 
CMS Withdraws Funding Opportunity for ET3 Medical Triage Lines
On September 13th, CMS announced that it would not move forward with the Emergency Triage, Treat, and Transport (ET3) Model’s medical triage line component. CMS had issued a Notice of Funding Opportunity (NOFO) for medical triage lines in March, but received an insufficient number of applications, which would not have allowed CMS to perform a meaningful evaluation of quality improvement or spending reductions.
 
This decision does not affect other aspects of the ET3 model, including already-approved Participation Agreements related to the Transport to an Alternative Destination and facilitation of Treatment in Place ambulance payment component of the ET3 Model. It will also not affect an applicant’s ability to apply for any future NOFOs.
 
More information on ET3 is available on the CMS website here.

Administration Issues Proposed Rules to Promote Transparency in Air Ambulance Costs, Agent and Broker Compensation
On September 10th, HHS, the Department of Labor (DOL), and the Department of the Treasury, in partnership with the Office of Personnel Management (OPM), released a notice of proposed rulemaking (NRPM) entitled “Reporting Requirements Regarding Air Ambulance Services, Agent and Broker Disclosures, and Provider Enforcement.” The NPRM includes three major areas:

  • Air Ambulance Data Reporting: Plans, issuers, and providers of air ambulance services would be required to submit data for each air ambulance claim and transport for the two years covered by the reporting requirements in the No Surprises Act.
  • Disclosure and Reporting Requirements for Agent and Broker Compensation: Issuers offering individual health insurance coverage or short-term, limited-duration insurance (STLDI) would be required to disclose to policyholders the commission rates and compensation structure for other direct and indirect compensation provided by the issuers to an agent or broker associated with enrolling those individuals. This total amount of direct and indirect compensation would also have to be reported to HHS. 
  • Enforcement of PHS Act Requirements: The NPRM would extend CMS’s existing processes for determining whether a state is not substantially enforcing Public Health Service (PHS) Act requirements to such requirements related to providers, facilities, and providers of air ambulance services; create a process for initiating investigations and determining that a provider, facility, or provider of air ambulance services is in violation of a PHS Act requirement; and codify the processes for imposing civil monetary penalties of up to $10,000 per violation. 

The NPRM is open for comment through October 18th.  

CMS Announces Community Health Access and Rural Transformation (CHART) Award Recipients
On September 10th, CMS announced it will award up to $20 million to entities in four states to improve health care in rural areas as part of the Community Health Access and Rural Transformation (CHART) Model. The CHART Model is intended to implement health care delivery system redesign “on a broad scale” in rural communities, with the goals of improving access and sustainability. These awards comprise the Community Transformation Track of CHART, which is intended to test the effectiveness of a capitated alternative payment model (APM), offering upfront funding and operational flexibilities, in a defined rural community. The other component of CHART, the Accountable Care Organization (ACO) Track, has been delayed until spring 2022.

CMS will award up to $5 million each through cooperative agreements with the following four entities:

  • University of Alabama Birmingham
  • State of South Dakota Department of Social Services
  • Texas Health and Human Services Commission
  • Washington State Health Authority 

Together, these recipients represent approximately 300,000 Medicare fee-for-service beneficiaries in rural communities.

CMS Delays Enforcement of Payer Interoperability Provision
On September 15th, CMS announced it would delay enforcement of an interoperability provision governing how payers exchange data from the May 2020 Interoperability and Patient Access final rule. The provision would have required insurance companies that do business with CMS to exchange data at a patient’s request, and to incorporate data from other payers into a beneficiary’s health record. The provision did not, however, establish technical specifications for such data exchange, leading insurance companies to express concern about increased administrative burden and poor data quality. CMS will therefore promulgate additional regulations before it enforces the payer interoperability provision. Implementation timelines for other provisions of the May 2020 Interoperability and Patient Access final rule are unaffected by this delay. 

FTC Issues Policy Statement on Health Breach Notification Rule
On September 15th, the Federal Trade Commission (FTC) issued a policy statement affirming that health apps and connected devices that collect or use consumers’ health information must comply with the Health Breach Notification Rule. This rule, originally adopted in 2009 as directed by statute, requires that vendors of personal health records and related entities notify consumers, the FTC, and (in some cases) the media when that data is disclosed or acquired without the consumers’ authorization. This rule includes entities not covered by the Health Insurance Portability and Accountability Act (HIPAA) and, when breached, may subject companies to civil monetary penalties of more than $40,000 per day.

The FTC expressed concern that health apps and other connected devices that collect personal health data have increased in use during the pandemic, and they are “targets ripe for scammers and other cyber hacks.” The policy statement was adopted by the Commission by a 3-2 vote.

Other Updates

KFF Estimates Preventable Covid-19 Hospitalizations Have Cost Over $5 Billion
On September 14th, the Kaiser Family Foundation (KFF) released an issue brief estimating that Covid-19-related hospitalizations of unvaccinated individuals cost more than $5 billion between June and August of this year. KFF defines hospitalizations in this three-month window as preventable because they occurred in unvaccinated people after vaccines were widely available in the U.S. The study omits outpatient costs, uses a conservative estimate of $20,000 for each hospitalization, and does not consider possible effects of rare breakthrough cases. As such, KFF considers it to be an underestimate of the total costs of preventable Covid-19-related health care for unvaccinated individuals.
 
Census Releases Report on U.S. Health Coverage in 2020
On September 14th, the Census Bureau released a report on health insurance coverage in the United States in 2020. The report found that the uninsured rate, defined as individuals who had no health insurance at any point during the year, was 8.6 percent, which has remained roughly steady over the last three years. During that period, the rate of private health insurance decreased slightly, from 67.3 percent to 66.5 percent (0.8 percent decrease), while the rate of public coverage increased slightly, from 34.4 percent to 34.8 percent (0.4 percent increase). One notable change over the period was the uninsured rate of among children (under 19) in poverty, which rose from 7.8 percent in 2018 to 9.3 percent in 2020.
 
The full report is available here. 

Congressional Hearings

Tuesday, September 21st: 

  • At 2:45pm, the Senate Finance Subcommittee on Social Security, Pensions, and Family Policy will hold a hearing on policy options for improving the Supplemental Security Income (SSI) program. More information is available here.  

Wednesday, September 22nd: 

  • At 10:30am, the House Energy and Commerce Subcommittee on Oversight and Investigations will hold a hearing entitled “Putting Kids First: Addressing COVID-19’s Impacts on Children.” More information is available here. 
  • At 2pm, the House Select Subcommittee on the Coronavirus Crisis will hold a hearing entitled “Recognizing and Building on the Success of Pandemic Relief Programs.” More information is available here. 

New York State Updates

NYS Releases First Quarterly Update to FY 2022 Enacted Budget Financial Plan; State Hiring Freeze Lifted
On September 15th, Governor Hochul announced the release of the first quarterly update to the New York State (NYS) Fiscal Year (FY) 2022 Enacted Budget Financial Plan, which shows the state’s fiscal forecast continuing to improve, with the projected four-year budget gap now totaling less than $1.5 billion (down from $3.4 billion). In the update, the Division of the Budget (DOB) estimates that the General Fund will remain balanced this year and during FY 2023, while the projected gaps in the following two years have decreased by roughly $1 billion each. DOB attributes the change to an estimated increase of $2.1 billion in personal income tax collections in each of the four years of the plan. The revenue surplus will fund future labor settlements, critical agency operating expenses, and deposits to general reserves, including $1.1 billion to be placed in reserves and $650 million to support reduced borrowing for capital projects.
 
On September 16th, the Governor made an announcement (available here) that due to the improved fiscal forecast, the State would suspend its hiring freeze, originally implemented in April 2020, through the end of the fiscal year (in March 2022). Agencies will now be able to hire staff without obtaining a waiver from DOB. The freeze had resulted in an attrition-driven decrease of total staff in Executive Agencies from 118,000 to about 107,500.
 
The updated Financial Plan is available here. The Governor’s press release on the Financial Plan is available here.
 
Federal Judge Blocks DOH Exclusion of Religious Exemptions from Covid-19 Vaccine Mandate
On September 14th, U.S. District Judge David N. Hurd of the Northern District of New York granted a temporary restraining order (available here) that prevents the New York State Department of Health (DOH) from preventing organizations from offering religious exemptions in its recent Covid-19 vaccination mandate for health care workers. Although DOH is barred from interfering with employers that seek to grant religious exemptions, the order does not require that an employer offer a religious exemption.
 
The vaccination mandate is effective on September 27th for hospital and nursing home personnel and on October 7th for personnel at Article 28 facilities, home care providers, hospices, and adult care facilities. The State will have the opportunity to present oral arguments on September 28th against converting the temporary restraining order to a preliminary injunction.
 
Governor Hochul Announces Mask Requirements in Child Care Programs and Congregate Facilities, Authorizes EMTs to Administer Covid-19 Vaccinations
On September 15th, Governor Hochul announced new mask requirements to address the recent surge of Covid-19 infections statewide. The State will require face coverings for anyone able to medically tolerate wearing a mask, regardless of vaccination status, at the following settings:

  • OCFS licensed and registered child care centers, home-based group family and family child care programs, after-school child care programs, and enrolled legally exempt group programs; and
  • Congregate programs and facilities licensed, registered, operated, certified, or approved by OMH, OASAS, OPWDD, OCFS, and OTDA, including residential/day programs, inpatient/outpatient mental health facilities, substance use programs, and congregate foster care programs, among others.

The Governor also directed DOH to authorize basic emergency medical technicians (EMTs) to administer Covid-19 vaccinations. EMTs were previously authorized to administer vaccinations under the original New York State Covid-19 emergency declaration, but they became ineligible when Governor Cuomo ended the declaration on June 24th. Governor Hochul stated that this will reactivate 2,000 EMTs who are already trained in vaccine administration immediately and allow up to 50,000 EMTs to potentially become trained.
 
The Governor’s press release regarding mask requirements is available here and the Governor’s press release regarding vaccination efforts is available here.
 
LOIs Due Today for OMH Peer-to-Peer Supported Transition Program
As a reminder, letters of interest (LOIs) for the expansion of Peer-to-Peer Supported Transition programs are due today at 4pm. The Office of Mental Health (OMH) released a Solicitation of Interest for this program, funded through supplemental Community Mental Health Block Grant funding as provided in the 2020 year-end Consolidated Appropriations Act (CAA), to award one-time funding to providers licensed, funded, or overseen by OMH and entities that provide training and technical assistance.
 
Funding will assist individuals and their chosen support group/family in creating a time-limited, successful, and sustainable transition from a higher intensity treatment setting into lower levels of care in the community. Specifically, programs funded through this initiative should aim to: 

  • Develop and provide relevant workbooks, marketing materials, web-based and/or in-person trainings, Train-the-Trainers, and other supports;
  • Develop Regional Learning Collaboratives or group networking opportunities for trainees, inclusive of those who are geographically isolated and in need of supports (with both web-based and in-person supports);
  • Train geographically, culturally, and linguistically appropriate staff that work with individuals who have serious mental illness/serious emotional disturbance and their families/chosen support groups, including staff in rural areas of the state; and
  • Collect data (to be reported quarterly to OMH) to ensure program integrity.

Interested organizations should send an indication of interest to Carol Swiderski at carol.swiderski@omh.ny.gov by 4pm. Additional information is available in the New York State Contract Reporter here.
 
New York State DOL Releases FAQ on HERO Act Employee Safety Requirements
On September 9th, the New York State Department of Labor (DOL) released a document (available here) that includes a timeline and frequently asked questions (FAQ) regarding implementation of the HERO Act. Last week, the State designated Covid-19 as an airborne infectious disease that presents serious risk of harm to the public health in New York State, triggering the HERO Act that requires all employers to implement workforce safety plans to protect employees against exposure and disease. The document outlines which businesses are covered by the Act, the obligations for employers regarding safety plans, requirements for joint labor-management workplace safety committees, and enforcement mechanisms for violations of the law, among other issues.