Weekly Health Care Policy Update – September 24, 2021

October 1, 2021

In this update: 

  • COVID-19 Response
    • FDA, CDC Approve Pfizer Boosters for 65+ and High-Risk Individuals
    • Biden Administration to Purchase 500 Million Vaccines for Global Distribution
    • Pfizer and BioNTech Release Results in Covid-19 Vaccine Trial for Kids 5 to 11
    • J&J Releases Vaccine and Booster Effectiveness Data
    • CMS Launches New Medicare.gov Feature to Compare Nursing Homes by Vaccination Rate
  • Legislative
    • Congress Continues Work on Reconciliation Bill; Shutdown, Debt Ceiling Deadlines Approach
    • Bipartisan Senate Finance Committee Chairs Request Input on Behavioral Health Legislation
  • Regulatory
    • CMS Finalizes Rule Governing Exchanges for 2022 and Beyond
    • CMS Grants Reporting Exceptions Due to Hurricane Ida
    • Treasury Opens Applications for Coronavirus Capital Projects Fund
    • CMS Awards $15 Million to 20 States for Mobile Crisis Intervention
    • HHS Announces $350 Million For Maternal and Child Health
    • HHS Announces Funding for Public Health IT Workforce Development
  • Other Updates
    • OIG Finds Some MA Plans Disproportionately Use Chart Reviews and HRAs to Increase Revenue
    • FAIR Health Reports Average Costs for Covid-19 Hospital Stays
  • Congressional Hearings
  • New York State
    • NYS Health Commissioner Howard Zucker Resigns
    • Governor Hochul Announces Additional Administration Appointments
    • DOH Proposes Enhanced Reimbursement Rates for CFTSS and Residential Treatment Services
    • DOH Publishes FAQ Regarding Covid-19 Vaccine Mandate

COVID-19 Response

FDA, CDC Approve Pfizer Boosters for 65+ and High-Risk Individuals
On September 22nd, the Food and Drug Administration (FDA) authorized Pfizer-BioNTech Covid-19 booster shots for people over 65, those at high risk of becoming severely ill with Covid-19, or those with frequent exposure at their jobs. The approval, given under Emergency Use Authorization, is for individuals at least six months after their second dose. The decision follows a September 17th meeting of an FDA advisory panel, which recommended an approval framework almost identical to FDA’s decision: Covid-19 vaccine booster shots only for people over 65 or those at “high risk” of severe Covid-19 who received their second dose at least six months ago.

Pfizer had asked the FDA to approve the third shot for all recipients of its vaccine 16 and older, and to grant full approval. However, by a vote of 16 to 2, the committee did not recommend booster shots for the general population, noting that the two-dose vaccine was sufficiently protective against severe disease or hospitalization, and that a third shot would not reduce viral transmission. The panel did not, however, specifically define what “high risk” means, nor was the FDA obligated to follow the Committee’s recommendation.

On September 23rd, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) met on the same topic. ACIP’s recommendations closely matched the FDA’s. Specifically, ACIP recommended that people over 65 and people between 50 and 64 with underlying medical conditions should receive booster shots, and that people between 18 and 49 with underlying medical conditions may receive them based on individual risks.

ACIP voted 9-6 not to recommend booster shots for adults between 18 and 64 considered at increased risk due to occupation or living situation. However, CDC Director Rochelle Walensky chose to overrule this recommendation, instead recommending that such individuals may receive a booster shot depending on individual risks. CDC otherwise endorsed the ACIP recommendations.

As a result, the Biden Administration is expected to make Pfizer booster shots available to these four populations starting shortly. FDA and CDC have not yet considered booster shots for the Moderna and Johnson & Johnson (J&J) vaccines.

Biden Administration to Purchase 500 Million Vaccines for Global Distribution
On September 22nd, at the virtual global Covid-19 summit, the White House announced plans to purchase 500 million additional vaccines to share with the world’s poorest countries. This will bring the total U.S. commitment to 1.1 billion doses. President Biden has set a deadline of September 2022 to vaccinate 70% of the world’s population, and it may take until that date to distribute all 500 million doses. Pfizer and BioNTech will provide the 500 million additional doses at an at-cost price, which is estimated to be roughly $3.5 billion.

Pfizer and BioNTech Release Results in Covid-19 Vaccine Trial for Kids 5 to 11
On September 20th, Pfizer and BioNTech announced results of their Covid-19 vaccine trial in children aged 5 to 11 years, showing it to be safe and effective in that age group. The trial included 2,268 children ages 5 to 11, two-thirds of whom received the two-dose vaccine, and one-third of whom received placebo. The 10-microgram vaccine is one-third the dose given to older children and adults, and produced an immune response comparable to those seen in trials of 16- to 25-year-olds. The companies did not include detailed review of the data from the trial and findings have not been peer reviewed nor published in a journal. Pfizer and BioNTech plan to apply to the FDA for authorization by the end of September. Results of a trial in children younger than five are expected later this year. Thirty thousand children were hospitalized for Covid-19 in August.

J&J Releases Vaccine and Booster Effectiveness Data
On September 21st, J&J released data from its 30,000 participant, two-shot Covid-19 trial, showing that the booster dose was 94% effective in preventing moderate to severe disease in the U.S. population when administered two months after the first dose. Globally, the two-dose regimen prevented 75% of moderate to severe cases, but was 100% effective against severe disease. The booster increased antibody levels by four to six times compared with one shot alone, and side effects were consistent with those seen after the first dose. However, very low numbers of Covid-19 cases were seen in both the experimental and placebo groups, raising questions about the study’s statistical validity.

J&J also released data from a real-world study of its single-dose vaccine, showing 79% efficacy at preventing Covid-19 infection and 81% efficacy against Covid-related hospitalizations, varying somewhat by age. The companies did not include detailed review of the data from the trial and findings have not been peer reviewed. The J&J single-dose vaccine has been administered to 14.8 million individuals across the U.S.

CMS Launches New Medicare.gov Feature to Compare Nursing Homes by Vaccination Rate
On September 23rd, the Centers for Medicare and Medicaid Services (CMS) announced the launch of a new feature on Medicare.gov to allow comparison of nursing homes by staff and resident vaccination rate. CMS and CDC will also use the data to monitor vaccine uptake among residents and staff, and to identify facilities that need additional resources for combatting the pandemic. Since May, Medicare and Medicaid-certified nursing homes have been required to report weekly vaccination rates for both residents and staff, and data has been posted on the Covid-19 Nursing Home Data website. This update provides a more user-friendly format. 

Legislative Updates

Congress Continues Work on Reconciliation Bill; Shutdown, Debt Ceiling Deadlines Approach
Congress continues to consider major infrastructure and reconciliation legislation proposals. The House is expected to compile proposals for the $3.5 trillion reconciliation bill from its various committees over the weekend for consideration by the Rules Committee and to pass them by next Wednesday, September 29th. These proposals are expected to be reduced significantly during negotiations with the Senate. The House also must still consider the Senate-passed $550 billion infrastructure bill. Speaker Pelosi promised centrist lawmakers a vote on that bill by Monday, September 27th, but progressive lawmakers have promised to oppose that bill unless the much larger reconciliation bill passes the Senate first. 
 
At the same time, Congress must address two high-stakes economic deadlines in the next several weeks. Funding for government operations expires on September 30th, forcing a government shutdown if Congress does not pass legislation providing additional funding before then. In addition, the government will reach the federal borrowing limit sometime in October, and the Treasury Department has warned of a potential economic crisis if Congress does not raise the debt ceiling.
 
On September 21st, the House passed a bill to fund the government through December 3rd, giving members more time to negotiate a longer-term funding bill, and to extend the debt ceiling until December 2022. Senate Republican leaders have voiced their opposition to the measure, which will require Republican support to pass the 50-50 Senate.
 
Bipartisan Senate Finance Committee Chairs Request Input on Behavioral Health Legislation
On September 21st, Senate Finance Committee Chairman Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) released a letter seeking stakeholder input on legislative proposals to improve access to care for people with behavioral health (BH) needs. The letter specifically identifies the following areas of focus:

  • Workforce;
  • Integration, coordination, and access to care;
  • BH parity;
  • Telehealth; and
  • BH care for children and young people.

The letter contains a list of specific questions within each area for consideration. The Committee will also accept input on reimbursement mechanisms and financing issues.
 
The full text of the letter is available here.

Regulatory Updates

CMS Finalizes Rule Governing Exchanges for 2022 and Beyond
On September 17th, CMS released a final rule regarding changes to regulatory requirements for Exchanges and health insurance markets for 2022 and beyond (fact sheet). This rule finalizes several policies proposed in a June 2021 rule and marks the completion of rulemaking for the 2022 plan year. Finalized policies of importance to state-based exchanges include:

  • Extending annual open enrollment by one month – CMS finalized a proposal to extend the annual open enrollment period for the federally facilitated exchange, which currently runs from November 1 – December 15, by one month, ending on January 15. This change would be effective for the 2022 plan year and beyond and apply to individual plans sold on and off any Exchange.
  • New Special Enrollment Period (SEP) for low-income individuals – CMS finalized a proposal to create a new, monthly SEP for Advance Premium Tax Credit (APTC)-eligible individuals with  household income at or below 150% of the Federal Poverty Level (FPL). Issuers would not be required to offer this SEP off the Exchange (where applicants are unable to access the APTCs that, in part, trigger the proposed SEP). In a change from the proposed rule, this SEP will only be available when an eligible enrollee’s applicable percentage is set at zero, and individuals using the SEP to enroll dependents cannot use it to change to a new metal level.
  • Repeal of separate billing for abortion services – CMS finalized repeal of a Trump Administration provision requiring qualified health plans (QHPs) that offer abortion services to separately bill enrollees for such services, requiring enrollees to make two payments: one for abortion services and one for all other services. The “double billing” requirement had not yet taken effect and was vacated by a district court judge in July 2020. This rule proposes to eliminate the language from federal code.
  • Repeal of October 2018 Section 1332 waiver guidance – CMS finalized repeal of less stringent requirements for approval of 1332 waivers. Under Section 1332 of the Affordable Care Act, states may pursue changes to certain ACA requirements so long as the effect of such waivers will not limit coverage eligibility or make coverage less comprehensive and affordable. In October 2018, the Trump Administration proposed to loosen these waiver guardrails, encouraging states to pursue alternatives to QHPs, such as association health plans and short-term limited duration insurance, and focus on the coverage residents are offered rather than the coverage residents actually purchase. This final rule largely reinstates waiver requirements in place before October 2018.
  • Repeal of direct enrollment option – CMS finalized repeal of a recently-established direct enrollment option that would allow Exchanges to work directly with private sector entities to operate enrollment websites in lieu of government responsibility for Exchange operations. Direct enrollment activities are still permitted, but they must supplement, not replace, state or federal government Exchange activities.

CMS Grants Reporting Exceptions Due to Hurricane Ida
On September 20th, CMS announced that it would grant exceptions under certain Medicare quality reporting and value-based purchasing programs located in areas affected by Hurricane Ida and remnants of Hurricane Ida. This includes nine New York counties: Bronx, Kings, Nassau, New York, Queens, Richmond, Suffolk, Sullivan, and Westchester. The exception is intended to assist providers as they direct resources toward caring for patients and repairing structural damages to facilities, and applies to acute care hospitals, ambulatory surgical centers, Prospective Payment System-exempt Cancer Hospitals, inpatient psychiatric hospitals, inpatient rehabilitation facilities, Long-Term Care Hospitals, and skilled nursing facilities. The exception affects the following programs: 

  • Hospital Outpatient Quality Reporting (OQR) Program
  • Ambulatory Surgical Centers Quality Reporting (ASCQR) Program
  • Hospital Inpatient Quality Reporting (IQR) Program
  • Data Validation/ HAI Validation Templates
  • Data Validation/CMS Clinical Data Abstraction Center (CDAC) Record Requests
  • Hospital-Acquired Condition (HAC) Reduction Program
  • Inpatient Psychiatric Facility Quality Reporting (IPFQR) Program
  • PPS-Exempt Cancer Hospital Quality Reporting (PCHQR) Program
  • Post-Acute Care Quality Reporting Programs: IRFs, LTCHs, and SNFs
  • Merit-based Incentive Payment System (MIPS) Eligible Clinicians

Additional details, including specific measures affected, and applicable reporting periods, can be found here.
 
Treasury Opens Applications for Coronavirus Capital Projects Fund
On September 24th, the Department of the Treasury opened the application portal for states to apply for the $10 billion Coronavirus Capital Projects Fund. Part of the American Rescue Plan (ARP), this fund will provide capital funding for projects “directly enabling work, education, and health monitoring, including remote options” in response to Covid-19. Projects may be approved on a case-by-case basis, but must be general enough to facilitate all three of the outlined use cases. Presumptively eligible projects include: 

  • Broadband infrastructure projects;
  • Digital connectivity technology projects (i.e., purchasing public equipment such as laptops, tablets, etc. for communities where affordability is an issue); and
  • Multi-purpose community facility projects (i.e., building projects designed to directly enable work, education, and health monitoring in needy communities).

An example of an acceptable project in the guidance is a community health center that engages in health monitoring, provides health education classes, and offers access to job counseling employment services. Hospital projects are not presumptively eligible, but will be reviewed individually for eligibility.

New York is eligible for up to $345.6 million through this program. Although the State itself must request funds, it may make subawards to private entities and nonprofits.Applications will be accepted through December 27th.

More information is available on Treasury’s website here.
 
CMS Awards $15 Million to 20 States for Mobile Crisis Intervention
On September 20th, CMS announced that it awarded $15 million in planning grants to 20 states to support expanding community-based mobile crisis intervention services for Medicaid beneficiaries. This funding, which is provided through the ARP, provides financial resources for state Medicaid agencies to assess community needs and develop programs to bring crisis intervention services directly to individuals who are experiencing a substance use-related or mental health crisis outside a hospital or facility setting. CMS hopes these services will help reduce reliance on law enforcement when people are experiencing a behavioral health crisis and also reduce unnecessary incarceration of individuals with serious mental illness and substance use disorders. The performance period for this grant will be from September 30, 2021 through September 29, 2022.
 
The list of states receiving awards, which does not include New York, can be found here.
 
HHS Announces $350 Million For Maternal and Child Health
On September 17th, the Health Resources and Services Administration (HRSA)
announced nearly $350 million in awards to every state to support safe pregnancies and healthy babies. The funds will be used to expand home visiting services to families in need, increase access to doulas, address health disparities in infant deaths, and improve data reporting on maternal mortality. HRSA is making the investments through four specific programs: 

New York State will receive $8,828,477 in Maternal, Infant, and Early Childhood Home Visiting awards. All Maternal, Infant, and Early Childhood Home Visiting awards may be found here, Healthy Start Initiative awards may be found here, and SSDI awards may be found here.
 
HHS Announces Funding for Public Health IT Workforce Development
On September 22nd, the HHS Office of the National Coordinator for Health Information Technology (ONC) awarded $73 million in cooperative agreements under the Public Health Informatics & Technology Workforce Development Program (PHIT Workforce Program). The program was created earlier this year and funded through the ARP. Its goals are to strengthen public health IT efforts, improve Covid-19 data collection, and increase involvement of underrepresented communities in public health IT efforts. The 10 awardees receiving funds as part of this announcement are focused on minority-serving institutions higher education. Dominican College of Blauvelt, Inc., in Orangeburg, NY, is the sole New York-based awardee.
 
A press release is available here.

Other Updates

OIG Finds Some MA Plans Disproportionately Use Chart Reviews and HRAs to Increase Revenue
On September 20th, the HHS Office of the Inspector General (OIG) released a report finding that some Medicare Advantage (MA) organizations disproportionately used chart reviews and Health Risk Assessments (HRAs) to drive increased revenue without associated services. Currently, CMS permits organizations to use diagnoses obtained during chart reviews and HRAs to inform risk adjustment, but OIG raised concerns that either beneficiaries may not be receiving required services or that improper payments are being made for invalid diagnoses.
 
OIG found that a specific set of 20 organizations out of 162 reviewed used these approaches to drive revenue. At those 20 organizations, 56% of beneficiaries had some diagnoses reported only on a chart review or HRA, compared to 32% at the other organizations. OIG also noted that one specific company generated 40% of all payments from such diagnoses, and 67 percent of payments driven specifically by in-home HRAs, even though it enrolled only 22% of all MA beneficiaries. Although OIG did not name specific companies in this report, the one company was identified by The Wall Street Journal as UnitedHealthcare.
 
The full report is available here.
 
FAIR Health Reports Average Costs for Covid-19 Hospital Stays
On September 21st, FAIR Health released an analysis showing the average billed charge for a complex Covid-19 hospitalization in the United States is $317,810. The estimated amount allowed (the actual amount paid by a plan and a patient) is $98,139. FAIR Health also reported that the average charge amount for a general Covid-19 hospitalization is $74,591 (average estimated allowed amount of $33,525). “Complex” hospitalizations generally included costs for inpatient durable medical equipment (such as ventilators) and blood and blood components, which regular hospitalizations did not. The average charge amount for Covid-19 non-hospitalization is $2,557 (average estimated allowed amount of $1,008). These non-hospitalization charges included costs for labs, radiology, office visits, and cardiography procedures. The data come from FAIR Health’s repository of national, private health care claims, and the cost estimates are based on a current, 12-month window of claims, refreshed twice yearly.

Congressional Hearings

Tuesday, September 28th:

  • At 10:15am, two House Education and Labor subcommittees (the Subcommittee on Civil Rights and Human Services and the Subcommittee on Health, Employment, Labor, and Pensions) will hold a joint hearing entitled “How to Save a Life: Successful Models for Protecting Communities from COVID-19.” More information is available here. 
  • At 10am, the Senate Banking, Housing, and Urban Affairs Committee will hold a hearing entitled “CARES Act Oversight of the Treasury and Federal Reserve: Supporting an Equitable Pandemic Recovery.” More information is available here. 

Wednesday, September 29th:

  • At 2pm, the House Select Subcommittee on the Coronavirus Crisis will hold a hybrid hearing entitled “Upgrading Public Health Infrastructure: The Need to Protect, Rebuild, and Strengthen State and Local Public Health Departments.” More information is available here. 

 Thursday, September 30th:

  • At 10am, the House Financial Services Committee will hold a hearing on the oversight of the Treasury Department’s and Federal Reserve’s pandemic response. More information is available here. 
  • At 10am, the House Transportation and Infrastructure Committee will hold a hearing to assess the impacts of the federal government’s COVID-19 relief and response efforts. More information is available here. 

New York State Updates

NYS Health Commissioner Howard Zucker Resigns
On September 23rd, New York State Health Commissioner Howard Zucker submitted his resignation letter to Governor Kathy Hochul. Zucker will continue to serve as Commissioner until a replacement is appointed, at which point he will assist with the transition.
 
The resignation letter is available here.
 
Governor Hochul Announces Additional Administration Appointments
On September 22nd, Governor Hochul announced the following appointments to her administration:

  • Robin Chappelle Golston has been appointed Executive Deputy Secretary. Golston most recently served as President and CEO of Planned Parenthood Empire State Acts and previously served as vice president of corporate relations and government affairs at EmblemHealth.
  • Julie Wood has been appointed Communications Director. Wood was previously the Senior Director of Communications for Lyft, and also worked as Press Secretary for the Bloomberg 2020 presidential campaign and as a senior spokesperson for the Clinton 2016 presidential campaign.
  • Marty Mack has been appointed Appointment Secretary. Mack was the mayor of Cortland, New York and served as Executive Deputy Attorney General for New York State.
  • Sita Fey has been appointed Deputy Appointments Secretary. Fey was most recently the Director of Policy at the Department of Agriculture and Markets and previously served as a senior advisor to then-Lieutenant Governor Hochul.
  • Byran Lesswing has been appointed Senior Advisor to the Governor. Lesswing most recently served as Communications Director for Hochul’s Lieutenant Governor’s office.

The Governor’s press release is available here.
 
DOH Proposes Enhanced Reimbursement Rates for CFTSS and Residential Treatment Services
On September 15th, the New York State Department of Health (DOH) posted a notice in the State register (available here) outlining its intent to increase reimbursement rates for Children and Family Treatment and Support Services (CFTSS) by an additional 14 percent from October 1, 2021 through March 31, 2022 to help providers recover from the Covid-19 pandemic. The State also intends to increase reimbursement rates for preventive and rehabilitative residential treatment services by an additional 25 percent from October 1, 2021 through March 31, 2022.
 
These proposed rate enhancements are contingent upon CMS approval of the State’s spending plan for the enhanced Federal Medical Assistance Percentage (FMAP) for home and community-based services (HCBS) contained in the ARP. Stakeholders may submit public comments on these proposed rate enhancements via email to spa_inquiries@health.ny.gov. 

DOH Publishes FAQ Regarding Covid-19 Vaccine Mandate
On September 20th, DOH published a frequently asked questions (FAQ) document regarding the emergency regulation issued on August 26th that requires certain covered health care entities to ensure that personnel are vaccinated against Covid-19. The FAQ outlines the covered entities and personnel, compliance dates, medical exemptions, and documentation requirements. As previously noted, a federal judge issued a temporary restraining order preventing DOH from preventing organizations from offering religious exemptions to the vaccine mandate. The temporary restraining order was recently extended to October 12th.   
 
The FAQ is available here and the emergency regulation is available here.