Weekly Health Care Policy Update – December 10, 2021

December 17, 2021

In this update: 

  • Covid-19 Updates
    • FDA Approves Pfizer Boosters for 16- and 17-Year-Olds
    • CDC Updates International Travel Guidance
    • Federal Judge Blocks Vaccine Mandate for Federal Contractors
    • FDA Approves AstraZeneca Antibody Drug
    • USAID Announces Global Vax Initiative
  • Legislative
    • Congress Delays Medicare Across-the-Board and Physician Cuts, Prepares to Raise Debt Limit
  • Agency
    • CMS Issues Guidance on Targeted Income and Resource Disregards for Medicaid HCBS
    • CMS Issues Guidance on Requirement for Medicaid to Cover Routine Clinical Trial Care
    • CMS Issues Guidance on Medicaid Supplemental Payment Reporting, DSH Limits
    • HHS Issues Report on Telehealth Usage During the Pandemic
    • OMB Issues Biden Administration’s Fall 2021 Unified Agenda
    • Rules Being Reviewed by OMB
  • Grants
    • SAMHSA Releases NOFO for Harm Reduction Program Grants
    • DOL Announces Availability of Funding for the YouthBuild Program
  • Other
    • Vice President Harris Announces Call to Action to Reduce Maternal Mortality and Morbidity
    • Providers Sue Biden Administration Over No Surprises Act Regulation
    • Study Shows $2 Million Lifetime Pay Gap for Female Physicians
  • Congressional Hearings
  • New York State Updates
    • NYC Mayor Announces Vaccine Mandate for Private Sector Workers
    • DOH Issues Guidance to Hospitals on Limits to Non-Essential Elective Procedures
    • CMS Approves New York State SPA Increasing Article 28 Hospital Inpatient Psychiatric Rates
    • DOH Issues Guidance on Children’s Waiver Amendment
    • DOH Releases Funding Opportunity for the Minority Male Wellness Screening Initiative

COVID-19 Updates

FDA Approves Pfizer Boosters for 16- and 17-Year-Olds
On December 9th, the Food and Drug Administration (FDA) issued an Emergency Use Authorization for booster shots of the Pfizer Covid-19 vaccine for 16- and 17-year-olds, at least six months after receiving their second dose. The FDA previously authorized boosters from Pfizer, Moderna, and J&J for all adults above this age group. Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky also quickly signed off on the expanded authorization, encouraging everyone to get booster shots.
 
CDC Updates International Travel Guidance
On December 2nd, the CDC updated its international travel guidance to require that, beginning December 6th, all incoming international air passengers, regardless of vaccination status, must show a negative Covid-19 test taken no more than one day before travel to the United States. The requirement applies to all travelers two years of age or older regardless of citizenship or immigration status. For individuals who recently recovered from Covid-19, travelers may show documentation of having recovered from Covid-19 in the past 90 days.
 
The amended order may be found here.
 
Federal Judge Blocks Vaccine Mandate for Federal Contractors
On December 7th, U.S. District Court Judge Stan Baker issued a stay to bar enforcement of the Biden Administration’s nationwide vaccine mandate for employees of federal contractors. The plaintiffs include seven states—Alabama, Georgia, Idaho, Kansas, South Carolina, Utah, and West Virginia—as well as several contractors, including a nationwide trade group, Associated Builders and Contractors. Given that the group’s members do business nationwide, the stay is applicable nationwide. Judge Baker concluded that the Biden Administration exceeded its constitutional authority in issuing the requirement. The ruling follows a stay by a federal judge last week in Kentucky, which only applied to Kentucky, Ohio, and Tennessee. 
 
FDA Approves AstraZeneca Antibody Drug
On December 8th, the Food and Drug Administration (FDA) cleared AstraZeneca’s COVID-19 antibody drug. This is the first COVID-19 antibody approved for long-term prevention of COVID-19 infection and is indicated for individuals age 12 and older with serious health problems or allergies who cannot get enough protection from vaccination alone. Eligible populations include cancer patients, organ transplant recipients, and others taking immunosuppressants. The two antibody injections may help prevent infection for up to six months.
 
USAID Announces Global Vax Initiative
On December 6th, U.S. Agency for International Development (USAID) Administrator Samantha Power announced the “U.S. Government’s Initiative for Global Vaccines,” or “Global VAX,” to “expand assistance and enhance international coordination to identify and rapidly overcome vaccine access barriers and save lives” with a specific emphasis on sub-Saharan Africa. The announcement included a new commitment of $400 million in American Rescue Plan Act (ARP) funds to bolster cold chain supply and logistics, service delivery, vaccine confidence and demand, human resources, data and analytics, local planning, and vaccine safety and efficacy.
 
More information on Global VAX can be found here.

Legislative Update

Congress Delays Medicare Across-the-Board and Physician Cuts, Prepares to Raise Debt Limit
On December 9th, the Senate passed legislation to delay various Medicare cuts scheduled to take effect January 1, 2022, sending the bill to President Biden, who is anticipated to sign it shortly. The legislation will:

  • Delay the resumption of the 2% across-the-board Medicare payment cut due to budget sequestration for three months. Congress had paused the sequestration cuts as part of its Covid-19 response. Starting in April, the sequester will phase back in with a 1% Medicare cut through June 30, 2022 and a 2% cut thereafter until sequestration expires.
  • Delay until 2023 a 4% Medicare pay cut that would have otherwise been required due to by budgetary rules to offset increases in the deficit due to the ARP.
  • Increase payments made under the Medicare Physician Fee Schedule (PFS) by 3%. Because PFS rates were increased by 3.75% under the 2020 year-end omnibus, this represents a 0.75% cut from current rates.

The bill also includes a bipartisan agreement that clears the way for Congress to raise the debt limit.

Agency Updates

CMS Issues Guidance on Targeted Income and Resource Disregards for Medicaid HCBS
On December 7th, the Centers for Medicare and Medicaid Services (CMS) issued a State Medicaid Director (SMD) letter on the “construction rule” passed in the Sustaining Excellence in Medicaid Act of 2019. This rule allows states to employ higher thresholds for income and resources in Medicaid eligibility standards targeted towards individuals seeking home and community-based services (HCBS) authorized under HCBS waiver authorities (1115, 1915(c), 1915(i), or 1915(k) waivers).
 
As such, states may choose to make certain populations eligible for Medicaid HCBS, even if their income or resources would make them ineligible to enroll in Medicaid. States may choose to employ the construction rule to be targeted to specific HCBS, e.g., only one 1915(c) waiver or only one 1915(i) service. Specific disregards, such as spousal resources, may also be targeted to individuals with HCBS. States must submit a State Plan Amendment to effectuate such provisions.
 
The SMD letter is available here.
 
CMS Issues Guidance on Requirement for Medicaid to Cover Routine Clinical Trial Care
On December 7th, CMS issued a second SMD letter on the new statutory requirement included in the 2020 year-end omnibus spending bill for Medicaid programs to cover routine patient costs associated with participation in qualifying clinical trials, starting January 1, 2022. Qualifying trials may include, among others, any study that is approved by the National Institutes of Health (NIH) or a number of other government entities, or that is conducted pursuant to an investigational new drug exemption. Historically, some states have deemed such services experimental, and therefore not covered by Medicaid.
 
Under the new guidance, “routine costs” include any item or service provided under the clinical trial, including any service that would treat potential complications, if that item would have been covered by Medicaid outside of the context of the trial, as well as any item or service required for the investigational service itself. Routine costs do not include items provided solely to satisfy data collection and analysis for the trial, unless the item is used in direct clinical management of the beneficiary.
 
The full guidance is available here.
 
CMS Issues Guidance on Medicaid Supplemental Payment Reporting, DSH Limits
On December 10th, CMS issued a SMD letter on new reporting requirements related to Medicaid supplemental payments. Supplemental payments in Medicaid are defined as any payment made to providers in addition to base payments, except for Disproportionate Share Hospital (DSH) payments. The 2020 year-end omnibus spending bill required CMS to establish a system for states to submit reports on their supplemental payments with each SPA that contains an authority for such a payment.
 
Under this system, states will be required to provide an explanation of each supplemental payment’s purpose, how the payment amounts are calculated, how provider eligibility is determined, and if applicable (e.g., to inpatient hospital providers), an assurance that the payment does not exceed the Upper Payment Limit (UPL). Supplemental payments made under demonstration authority, such as uncompensated care or Delivery System Reform Incentive Payments (DSRIP), will also be subject to these requirements.
 
The guidance also changes the calculation process for Medicaid DSH limits. Going forward, the Medicaid shortfall portion of each hospital’s DSH limit will only take into account costs and payments for whom Medicaid is the primary payer. As such, dual eligibles’ costs will no longer contribute to the hospital’s measured shortfall, although an exception is available for hospitals with exceptionally high usage by Medicare SSI beneficiaries.
 
The full guidance is available here.
 
HHS Issues Report on Telehealth Usage During the Pandemic
On December 3rd, the HHS Office of the Assistant Secretary for Planning and Evaluation published a report titled, “Medicare Beneficiaries’ Use of Telehealth in 2020: Trends by Beneficiary Characteristics and Location.” The report examines Medicare fee-for-service (FFS) Part B visits and use of telehealth during the Covid-19 Public Health Emergency by beneficiary characteristics, provider specialty, and location. The report showed that the number of Medicare FFS beneficiary telehealth visits increased 63-fold in 2020, from approximately 840,000 in 2019 to nearly 52.7 million in 2020, despite the fact that total utilization of all Medicare FFS Part B clinician visits declined about 11% over the same period. In 2020, telehealth increased to 8% of primary care visits, 3% of specialist visits, and to one-third of all behavioral health specialist visits. Black and rural beneficiaries had lower use of telehealth compared with White and urban beneficiaries, respectively, and the Northeast and West had higher usage than the Midwest and South.
 
The full report is available here.
 
OMB Issues Biden Administration’s Fall 2021 Unified Agenda
On December 10th, the Office of Management and Budget (OMB) published the Biden Administration’s Fall 2021 Unified Agenda. This document is generally released in the spring and fall, communicating an administration’s short- and long-term regulatory priorities.
 
Some notable new items included on the Fall 2021 agenda include: 

  • A proposed rule on transitional coverage for emerging technologies, replacing the Trump Administration’s rule which HHS has repealed;
  • A proposed rule entitled “Interoperability and Prior Authorization for MA Organizations, Medicaid and CHIP Managed Care and State Agencies, FFE QHP Issuers, MIPS Eligible Clinicians, Eligible Hospitals and CAHs”;
  • A proposed rule entitled “Medicare, Medicaid, and Health Insurance Exchanges Program Integrity”;
  • A proposed rule on requirements for Rural Emergency Hospitals; and
  • A proposed rule on updates to the rules implementing the Mental Health Parity and Addiction Equity Act.

The HHS Unified Agenda list is available here.
 
Rules Being Reviewed by OMB
The Office of Management and Budget (OMB) has received the following health care-related rules for final review before publication in the Federal Register:

  • The proposed Notice of Benefit and Payment Parameters (NBPP) for federally-facilitated exchanges for 2023;
  • The final rule on “Policy and Technical Changes to the Medicare Advantage Priogram and Medicare Prescription Drug Benefit Program; MOOP and Cost Sharing Limits”;
  • The final rule on the Hospital Inpatient Prospective Payment System (IPPS) and FY 2022 rates;
  • A final rule which is likely to repeal the Medicare Part B Most Favored Nation model, which was promulgated under the Trump Administration;
  • The proposed policy and technical changes rule for Medicare Advantage (MA) in 2023; and
  • Advance notice of methodological changes for calendar year 2023 for MA capitation rates and Part C and Part D payment policies.

Grant Updates

SAMHSA Releases NOFO forHarm ReductionProgram Grants
On December 8th, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a Notice of Funding Opportunity (NOFO) for the fiscal year (FY) 2022 Harm Reduction Program Grants. SAMHSA will award over $29 million in total funding across 25 awards during the three-year grant period to community-based overdose prevention programs, syringe services programs, and other harm reduction services to: 

  • Enhance overdose and other prevention activities for individuals with or at risk of developing substance use disorders;
  • Support distribution of opioid overdose reversal medication to individuals at risk of overdose;
  • Build connections for individuals to overdose education, counseling, and health education;
  • Refer individuals to treatment for infection diseases; and
  • Encourage individuals to take steps to reduce the negative personal and public health impacts of substance use or misuse.

The full NOFO is available here. Applications are due on February 7, 2022.  
 
DOL Announces Availability of Funding for the YouthBuild Program
On November 22nd, the U.S. Department of Labor (DOL) Employment and Training Administration announced a funding opportunity for eligible applicants to implement the YouthBuild program. The YouthBuild program model is a community-based alternative education program for youth ages 16-24 who left high school prior to graduation and who have disabilities, are experiencing housing instability, are aging out of foster care, and/or other disadvantaged youth populations.
 
DOL intends to provide approximately $90 million in total funding to support 75 projects nationwide during the 40-month grant period. Individual awards will range from $700,000 to $1.5 million and will require a 25 percent match from applicants using sources other than federal funding. Eligible applicants include public or private not-for-profit agencies.
 
Additional information is available here. Applications are due on January 21, 2022.

Other Updates

Providers Sue Biden Administration Over No Surprises Act Regulation
On December 9th, the American Hospital Association (AHA), the American Medical Association (AMA), and several other providers filed suit in the U.S. District Court for the District of Columbia against the Biden Administration over its proposals for surprise billing arbitration.
 
The suit seeks to block provisions of the Administration’s interim final rule regarding the arbitration process for determining fair payment for services by out-of-network providers, which directs arbitrators to begin with the presumption that the insurer’s median in-network rate in a given area is also the appropriate out-of-network amount. To deviate from this presumption, a party must clearly demonstrate why a service’s value is materially different. Plaintiffs argue that the No Surprises Act requires the consideration of other factors alongside the median in-network rate, and that the rule takes away discretion from the arbitrators and favors insurance plans.
 
A joint press release from the AHA and AMA is available here.
 
Study Shows $2 Million Lifetime Pay Gap for Female Physicians
On December 6th, Health Affairs published a study showing that over the course of a simulated forty-year career, female physicians earned 24.6% less than male physicians. This amounted to an average adjusted gross income of $8,307,327 for male physicians and $6,263,446 for female physicians. The differential was largest for surgical specialists, then nonsurgical specialists, and smallest for primary care physicians. The study used earnings data from 80,432 full-time U.S. physicians and adjusted for factors such as hours worked, clinical revenue, practice type, and specialty.
 
The study can be found here.

Congressional Hearings

Tuesday, December 14th:

  • At 10am, the Senate Health, Education, Labor, and Pensions Committee will hold a hearing on the nomination of Dr. Robert Califf to be FDA Commissioner. More information is available here.
  • At 2pm, the House Select Subcommittee on the Coronavirus Crisis will hold a hearing entitled “A Global Crisis Needs a Global Solution: The Urgent Need to Accelerate Vaccinations Around the World.” More information is available here.

New York State Updates

NYC Mayor Announces Vaccine Mandate for Private Sector Workers
On December 6th, New York City Mayor Bill de Blasio announced a Covid-19 vaccine mandate for private-sector workers. Effective December 27th, private-sector workers will be required to have received at least one Covid-19 vaccine dose to work in person with colleagues, and the City does not intend to include an option for weekly testing in lieu of the vaccine. Remote employees and locations with only one staff member will be excluded. Mayor-elect Eric Adams has not yet confirmed how his administration will pursue the mandate.
 
The Mayor’s press release is available here. Additional guidance on enforcement and reasonable accommodations and resources to support small businesses with implementation will be issued by December 15th.
 
DOH Issues Guidance to Hospitals on Limits to Non-Essential Elective Procedures
On December 3rd, the New York State Department of Health (DOH) issued guidance (available here) to hospital leadership regarding the Governor’s recent Executive Order authorizing DOH to limit non-essential elective procedures at hospitals or health systems with limited capacity. The guidance includes a framework detailing when facilities must, upon DOH review and determination, limit non-essential elective procedures and/or implement other actions to address potential capacity constraints. In general, hospitals in regions in which at least 15% of staffed bed capacity is available will not be subject to limitations, even if they are below 10% of staffed bed capacity individually.
 
The guidance does not apply to single specialty facilities (e.g., cancer treatment facility), non-hospital owned ambulatory surgery centers, office-based surgery practices, or free-standing diagnostic and treatment centers.
 
The framework is effective immediately. Initial determinations were issued to facilities on December 6th and apply to procedures scheduled to occur on or after December 9th. As of December 6th, it was reported that 32 hospitals statewide were directed by DOH to cease non-essential elective procedures. Questions may be submitted to hospinfo@health.ny.gov.
 
CMS Approves New York State SPA Increasing Article 28 Hospital Inpatient Psychiatric Rates
On December 8th, CMS approved New York State’s State Plan Amendment (SPA) to increase the fee-for-service reimbursement for Article 28 hospital inpatient psychiatric services by 9.86 percent. The rate increase is effective August 1, 2021.
 
The SPA is available here and the CMS approval letter is available here.
 
DOH Issues Guidance on Children’s Waiver Amendment
On December 3rd, DOH released guidance for Medicaid Managed Care Plans, HIV Special Needs Plans, Health Homes Serving Children, and Children’s HCBS providers regarding changes to the Children’s 1915(c) Waiver. CMS approved an amendment to the Children’s Waiver effective December 1, 2021, that includes the following three changes to HCBS: 

  • Families of children/youth who pass away who are enrolled in the Children’s Waiver at the time of their passing may receive six months of bereavement counseling;
  • After the passing of a child/youth enrolled in the Children’s Waiver and in a Health Home, families may continue to receive Health Home care management services for one additional month; and
  • The service descriptions of Caregiver/Family Support and Services and Community Self-Advocacy and Training and Supports are now the same, and the types of practitioners who can provide the services has been expanded.

The guidance is available here. Questions may be submitted to BH.Transition@health.ny.gov.
 
DOH Releases Funding Opportunity for the Minority Male Wellness Screening Initiative
On December 3rd, DOH announced the availability of funds to support the Minority Male Wellness Screening Initiative. This initiative provides services to reduce disparities in Covid-19 vaccination rates by addressing concerns about vaccine safety/efficacy and reducing barriers to accessing the vaccine among racial and ethnic minority males or individuals who identify as male. DOH intends to award one organization with $26,950 in total funding to support this program. Contracts will last for one year starting on May 1, 2022.
 
Eligible applicants for funding are not-for-profit 501(c)(3) organizations with a minimum of three years of experience working with vulnerable populations and/or minority populations. Applicants must also be located in and/or provide services to the target population within one of the designated minority areas (available here).
 
Additional information is available here. Applications are due on January 14, 2022. Questions may be submitted to Joyce Meadows at omhhdp@health.ny.gov through December 14th.