Weekly Health Care Policy Update – October 17, 2022

October 24, 2022

In this update: 

  • Administration Updates
    • Biden Issues Executive Order Directing CMMI to Consider More Drug Pricing Models
  • Federal Agencies
    • HHS Extends Covid-19 Public Health Emergency
    • CMS Extends BPCI Advanced Model for Two Years
    • CMS Announces Medicare Drug Rebate and Negotiations Group
    • CMS Leadership Outlines Future Rulemaking on Expedited Medicare Coverage Pathway for Breakthrough Medical Devices
    • USPSTF Recommends Anxiety Screening for Kids 8 to 18
    • FDA Grants EUA for Pfizer-BioNTech and Moderna Bivalent Covid-19 Vaccines for Kids; CDC Adds Recommendation
    • HHS Report Says Covid-19 Vaccinations Resulted in More than 300,000 Fewer Deaths of Medicare Enrollees
  • Other Updates
    • Patent Office Releases Request for Comment on Patent Rights
  • New York State Updates
    • Governor Hochul Issues Executive Order 21.1 Continuing Polio Emergency
    • NYS Medicaid to Expand RPM Coverage for Maternal Care
    • NYS Medicaid to Begin Covering Gambling Disorder Treatment at OASAS-Certified Programs
    • DOH Issues Proposed Rule Updating Nursing Home Administrator Licensure Program
    • CMS Approves NYS SPA Eliminating the Nine-Dollar Family Premium Contribution for CHIP
  • Funding Opportunities
    • OPWDD Announces New Winter Funding Round for Integrated Supportive Housing Projects
    • U.S. DOL Announces Funding Opportunity for Nursing Expansion Grant Program
    • CMS Issues Funding Opportunity for Medicaid Outreach to American Indian/Alaska Native Children

Administration Updates

Biden Issues Executive Order Directing CMMI to Consider More Drug Pricing Models
On October 14th, the Biden Administration issued an Executive Order that takes “additional actions to complement the Inflation Reduction Act” (IRA) to lower prescription drug prices. The Order directs the Secretary of Health and Human Services (HHS) to consider selecting new health care payment and delivery models for testing through the Center for Medicare and Medicaid Innovation (CMMI) that would “lower drug costs and promote access to innovative drug therapies.” This could include models that lower cost-sharing for commonly used drugs, as the IRA does for insulin in Medicare.  
 
The Order directs the Secretary to produce a report on these models, with a plan and timeline for testing them, within 90 days. HHS may direct CMMI to begin implementation of selected models from the report. The report is likely to resemble documents previously released by HHS, including in the 2021 Comprehensive Plan for Reducing Drug Prices (here).
 
The Order is available here.

Federal Agencies

HHS Extends Covid-19 Public Health Emergency
On October 13th, HHS Secretary Xavier Becerra extended the federal Covid-19 Public Health Emergency (PHE) for an additional 90 days. The PHE was first declared on January 27, 2020 and has since been renewed 11 times, including this announcement. The extension continues the various temporary authorities provided by the PHE, including requirements for State Medicaid programs to provide continuous enrollment to continue receiving an increased federal medical assistance percentage (FMAP), waivers of Medicare telehealth restrictions, and more.
 
The PHE will now expire January 11, 2023, if not further extended. This means policies that end at the close of the year in which the PHE expires, such as the waiver allowing for virtual direct supervision in Medicare, will expire at the end of 2023.
 
The baseline budget forecast is understood to be that the PHE will end in July 2023, which would cause various telehealth and other flexibilities to expire in December 2023. End-of-year legislation could set a different date in statute for the end of the PHE. If the statutory end date for the PHE were to be sooner than July 2023, a budgetary savings would result.
 
The formal announcement is available here.
 
CMS Extends BPCI Advanced Model for Two Years
On October 13th, the Centers for Medicare and Medicaid Services (CMS) announced that the Bundled Payments for Care Improvement (BPCI) Advanced Model will be extended for two years. The Model originally launched on October 1, 2018 and was scheduled to end on December 31, 2023, but will now conclude on December 31, 2025.
 
BPCI Advanced is an Advanced Alternative Payment Model (APM) that encourages health care providers to invest in innovation and care coordination to lower costs and maintain or improve quality of care. More than 1.2 million Medicare beneficiaries have received care from participants in the model, which includes over 1,800 acute care hospitals and almost 70,000 physicians. CMS plans to announce a Request for Applications (RFA) in early 2023 to participate in the Model’s two-year extension. Participants must be Medicare-enrolled entities or Accountable Care Organizations (ACOs). Current model participants will be permitted to remain in the model during the extension years.
 
The announcement also included changes to the pricing methodology of the model. These changes include: 

  • Reducing the CMS Discount for medical Clinical Episodes from 3% to 2%;
  • Reducing the Peer Group Trend Factor Adjustment cap for all Clinical Episodes from 10% to 5%;
  • Making major joint replacement of the upper extremity a multi-setting Clinical Episode category by including outpatient total shoulder arthroplasty procedures in the model; and
  • Holding participants accountable for all Clinical Episodes in which the beneficiary has a Covid-19 diagnosis during the Clinical Episode.

More information is available here.

CMS Announces Medicare Drug Rebate and Negotiations Group
On October 14th, CMS published a notice in the Federal Register that it has established the Medicare Drug Rebate and Negotiations group within the Center for Medicare to implement the Drug Price Negotiation Program and the Inflation Rebate Program in Medicare Part B and Part D. The programs were authorized under the Inflation Reduction Act of 2022.
 
According to the notice in the Federal Register, under the Drug Price Negotiation Program, the new group will “negotiate drug prices with pharmaceutical manufacturers for certain Part B and Part D drugs” including identification of negotiation-eligible drugs, negotiation and establishment of agreements with manufacturers, calculation of ceiling and maximum fair prices, and publication of negotiation results. Under the Inflation Rebate Program, the new group will “identify the universe of rebatable drugs under Part B and part D; determine which drugs had price increases in excess of inflation; and computer; invoice; and collect rebates owned by manufacturers.”
 
The reorganization officially took effect on October 8th. The notice in the Federal Register is available here.
 
CMS Leadership Outlines Future Rulemaking on Expedited Medicare Coverage Pathway for Breakthrough Medical Devices
On October 12th, CMS leadership published an article in JAMA discussing the agency’s plans regarding expedited Medicare coverage of “breakthrough” medical devices designated by the Food and Drug Administration (FDA). Under the Trump Administration, CMS published a rule in January 2021 that would have automatically provided four years of Medicare coverage to all FDA-designated breakthrough medical devices. The Biden Administration rescinded this rule in November 2021, but now intends to return to the topic to establish a more limited pathway.
 
The article, by CMS Chief Operating Officer Jon Blum and CMS Chief Medical Officer Dr. Lee Fleischer, states that CMS is committed to establishing an accelerated coverage pathway that would be guided by the following principles: 

  1. The process would be voluntary for medical device manufacturers, and limited to those that are relevant to Medicare enrollees and covered by Medicare.
  2. CMS may conduct an early evidence review of a proposed device, before the device secures FDA market authorization, to help determine the appropriate Medicare coverage pathway.
  3. At the manufacturer’s request, CMS may also initiate the coverage review process before FDA market authorization. This could require developing an additional evidence development plan and confirming that there are appropriate safeguards and protections for Medicare beneficiaries.
  4. CMS is considering how to simplify and reduce the burdens of the coverage with evidence development (CED) pathway. For example, CMS is considering whether to establish a clear timeline for decisions requiring CED. CMS will consider factors such as “whether a device is associated with an overall improvement in health (benefits exceed any harms)” and whether evidence generated will help guide patients and clinicians in deciding whether to use new technologies.

CMS intends to continue working with stakeholders to develop the rule, including to develop a definition of emerging technologies and evidence standards.  

The JAMA article is available here.

USPSTF Recommends Anxiety Screening for Kids 8 to 18
On October 11th, the United States Preventive Services Task Force (USPSTF) issued a new final recommendation that all children and adolescents aged 8 to 18 should be screened for anxiety (B grade). The Task Force noted a 2018-2019 survey that found that 7.8% of children aged 3 to 17 had an anxiety disorder, and that the incidence of anxiety has risen during the pandemic. The Affordable Care Act (ACA) requires most health insurers to cover preventive items and services with an A or B recommendation from the USPSTF without cost-sharing. However, this provision of the ACA is subject to ongoing litigation, with a Texas District Court Judge ruling the requirement unconstitutional last month. 
 
The recommendation falls short of the American Academy of Pediatrics’ recommendation, which is annual screening for behavioral, social, and emotional problems from birth to 21. This is the first time the USPSTF has recommended anxiety screening for children, but the final recommendation is consistent with a draft document released in April 2022.
 
The full recommendation is available here.
 
FDA Grants EUA for Pfizer-BioNTech and Moderna Bivalent Covid-19 Vaccines for Kids; CDC Adds Recommendation
On October 12th, the FDA amended the Emergency Use Authorizations (EUAs) for both the Moderna and Pfizer-BioNTech bivalent Covid-19 vaccines to include younger age groups. The Moderna vaccine is approved for use in children down to six years of age while the Pfizer-BioNTech vaccine is authorized for children down to five years of age, both at least two months following completion of primary or booster vaccination. The bivalent vaccines include components of both the original and omicron strains of Covid-19. The authorization means that the monovalent Pfizer-BioNTech Covid-19 vaccine is no longer authorized as a booster dose for individuals five through 11 years of age. Later in the day, Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky recommended use of the bivalent booster in the new age groups.
 
The FDA EUA amendment is available here. The CDC recommendation is available here.
 
HHS Report Says Covid-19 Vaccinations Resulted in More than 300,000 Fewer Deaths of Medicare Enrollees
On October 11th, HHS released a new report showing that Covid-19 vaccinations in 2021 were linked to 670,000 to 680,000 fewer Covid-19 hospitalizations and 330,000 to 370,000 fewer deaths among Medicare beneficiaries. This represents a 37-49% reduction in these outcomes. The reductions in hospitalization and deaths were also linked to $16 billion in direct medical cost savings for the Medicare program. The reductions were seen across all racial and ethic groups, and across all 50 states. As of today, over 90% of seniors are “fully-vaccinated” (one shot of J&J or two shots of Pfizer or Moderna) and over 70% have received a booster shot.
 
The full report is available here.

Other Updates

Patent Office Releases Request for Comment on Patent Rights
On October 4th, the U.S. Patent and Trademark Office (USPTO) released a request for comment (RFC) on “Initiatives to Ensure the Robustness and Reliability of Patent Rights.” The USPTO is specifically seeking comment on “initiatives directed at bolstering the robustness and reliability of patents to incentivize and protect new and nonobvious inventions while facilitating the broader dissemination of public knowledge to promote innovation and competition.” The RFC specifically seeks comment in the areas of: 

  • Prior art searching;
  • Support for claimed subject matter;
  • Request for continued examination practice;
  • Restriction practice; and
  • Patent thickets (as addressed in a June 2022 letter to the USPTO from Senators Leahy, Klobuchar, Braun, Blumenthal, Cornyn and Collins);

The RFC also seeks comment on issues laid out in a July 2022 letter from the USPTO to Food and Drug Administration Commissioner Dr. Robert Califf, which expresses concern that patent laws may have been misused to inhibit or delay competition from generic drugs and biosimilars, resulting in reduced access to low-cost drugs. The letter includes potential initiatives related to: 

  • Enhanced collaboration between USPTO and FDA (and other agencies) on pharmaceuticals and biologics;
  • Improved procedures for obtaining a patent;
  • Improved processes for challenging patients before the Patent Trial and Appeal Board;
  • Improved public participation; and
  • Considering new proposals for protecting the investment for bringing important drugs to market while minimizing unnecessary delay in bringing more affordable versions of such drugs to patients.

The full RFC can be found here. The June 2022 Senate letter can be found here. The USPTO letter to the FDA can be found here. The RFC will remain open for 90 days.

New York State Updates

Governor Hochul Issues Executive Order 21.1 Continuing Polio Emergency
On October 9th, Governor Hochul issued Executive Order 21.1, which extends the State Disaster Emergency due to the emerging poliovirus outbreak through November 8th. The Order also modifies the provisions contained in Executive Order 21 to: 

  • Allow emergency medical technicians-paramedics and advanced Emergency Medical Services (EMS) providers to also administer polio vaccinations that contain tetanus, pertussis, hepatitis B, and Hib vaccines;
  • Allow midwives to also administer polio vaccinations that contain diphtheria, tetanus, pertussis, hepatitis B, and Hib vaccines;
  • Allow pharmacists to administer polio vaccinations pursuant to a patient specific order;
  • Allow pharmacists to administer polio vaccinations that contain tetanus, pertussis, hepatitis B, and Hib vaccines pursuant to a non-patient specific and patient specific order;
  • Allow physicians and certified nurse practitioners to also issue non-patient specific regimen to administer polio vaccinations that contain diphtheria, tetanus, pertussis, hepatitis B, and Hib vaccine, and also to issue patient specific orders to licensed pharmacists for administration of polio vaccinations (including those that contain diphtheria, tetanus, pertussis, hepatitis B, and Hib vaccine).

The Executive Order is available here.
 
NYS Medicaid to Expand RPM Coverage for Maternal Care
Effective October 1st for Medicaid fee-for-service and December 1st for Medicaid managed care plans, the New York State (NYS) Medicaid program will expand coverage for remote patient monitoring (RPM) services during pregnancy and up to 84 days postpartum. This expansion of coverage, implemented as part of the NYS 2022-23 Enacted Budget, includes the following additional fees specific to maternal care that may be billed in addition to RPM CPT Code 99091 (fee = $48.00): 

  • CPT Code 99453 with “HD” modifier may be billed once per patient per pregnancy for the initial set-up of the RPM device/equipment (fee = $14.85); and
  • CPT code 99454 with “HD” modifier may be billed once monthly for continuous RPM medical device supply and patient monitoring (fee = $43.23).

Existing rules and regulations for the provision of RPM in the NYS Medicaid program apply. Providers in contract with Medicaid managed care plans should consult the individual plan to determine how this policy will be implemented.
 
Additional details are available in the September Medicaid update here. Questions may be submitted to FFSMedicaidPolicy@health.ny.gov.
 
NYS Medicaid to Begin Covering Gambling Disorder Treatment at OASAS-Certified Programs
Effective January 1, 2023, NYS Medicaid fee-for-service and Medicaid managed care will begin covering Gambling Disorder treatment provided at the following Office of Addiction Services and Supports (OASAS)-certified programs: 

  • Part 822 Outpatient Clinic Programs, with a problem gambling designation;
  • Part 825 Integrated Outpatient Services programs, with the OASAS gambling designation;
  • Part 818 Inpatient Rehabilitation Programs; and
  • Part 820 Residential Treatment Programs.

Services may be delivered onsite, via telehealth, or in the community. Outpatient programs will submit claims using the 837I claim form, which is the same as the prevailing outpatient substance use disorder treatment reimbursement and follows the Ambulatory Patient Group (APG) methodology.
 
Additional details are available in the September Medicaid update here. Questions may be submitted to picm@oasas.ny.gov.
 
DOH Issues Proposed Rule Updating Nursing Home Administrator Licensure Program
On October 12th, the NYS Department of Health (DOH) issued a proposed rule in the State Register clarifying and updating the nursing home administrator licensure program. Revisions include, but are not limited to: 

  • Allowing candidates to attempt the Nursing Home Administrator examination up to four times in an annual period, instead of three attempts in a five-year period; and
  • Removing the requirement that a training site have at least 80 beds, allowing nursing homes that are also providers with multiple levels of care (such as independent living communities and assisted living beds) to qualify as training sites.

The proposed rule is available here. Public comment may be submitted to regsqna@health.ny.gov through December 11th.
 
CMS Approves NYS SPA Eliminating the Nine-Dollar Family Premium Contribution for CHIP
On October 3rd, CMS approved the NYS’s State Plan Amendment (SPA) eliminating the Child Health Insurance Program (CHIP) nine-dollar family premium contribution for children in households with income under 222 percent of the federal poverty level (FPL). The amendment is effective October 1, 2022.
 
The SPA is available here and the CMS approval letter is available here.

Funding Opportunities

OPWDD Announces New Winter Funding Round for Integrated Supportive Housing Projects
On October 13th, the NYS Office for People with Developmental Disabilities (OPWDD) announced that it will be issuing a second application round for its Integrated Supportive Housing (ISH) program. The ISH program encourages and supports the development of new housing opportunities for people with intellectual and/or developmental disabilities (I/DD) who can benefit from an independent, non-certified community-integrated residential settings.
 
However, unlike the annual funding opportunity, this second application round will not include a capital funding option and will only offer Letters of Support for Housing Subsidy Commitments. Letters of Support will be intended for projects seeking capital funding from the New York City Homes and Community Renewal (HCR) and that intend to set aside units for individuals with I/DD. Moving forward, OPWDD intends to hold two Integrated Supportive Housing funding rounds each year, with one in the late spring that will include a capital funding option and one in the winter that will generally only offer Letters of Support for Housing Subsidy commitments.
 
The next OPWDD funding round will be announced by the end of this calendar year. Questions may be submitted to housing.initiatives@opwdd.ny.gov.  
 
U.S. DOL Announces Funding Opportunity for Nursing Expansion Grant Program
On October 6th, the U.S. Department of Labor (DOL) announced a funding opportunity for the DOL Nursing Expansion Grant Program. Through this opportunity, DOL will award approximately $80 million in total funding across 15-25 grantees during the five-year program. The program aims to address nurse staffing shortages and to expand and diversify the pipeline of qualified nursing professionals who can fill jobs through two training tracks: 

  • Nurse Education Professional Track (individuals grants between $2 million and $6 million); and
  • Nursing Career Pathways Track (individuals grants between $1 million and $3 million).

The Nurse Education Professional Track will increase the number of nursing instructors and educators by training new or upskilling current or former nurses (including retired nurses) into advanced postsecondary credentialing necessary to become instructors and educators. The Nursing Career Pathways Track will train and support participants in attaining postsecondary credentials needed for middle- to high-skilled nursing occupations.
 
Eligible applicants include not-for-profit health care organizations affiliated with hospitals and other medical facilities, trade/employer associations, education/training providers, community-based organizations, and labor-management organizations, among others. Applicants may only submit one application that proposes to address only one of the training tracks. Applicants must provide cash or in-kind matching contributions equal to 20 percent of the total federal share of costs.
 
Additional details are available here. Applications are due on January 6, 2023. 
 
CMS Issues Funding Opportunity for Medicaid Outreach to American Indian/Alaska Native Children
On October 17th, CMS issued a funding opportunity for the 2023 Connecting Kids to Coverage program for American Indian/Alaska Native (AI/AN) Outreach and Enrollment. This program, authorized by the HEALTHY KIDS Act of 2017, provides funding to enroll eligible AI/AN children in Medicaid and the Children’s Health Insurance Program (CHIP) and to improve retention of AI/AN children who are already enrolled.
 
Under this opportunity, eligible entities will enact innovative outreach strategies tailored to AI/AN communities, including enlisting tribal and other community leaders. Eligible entities include Indian Health Service providers, Indian tribes or tribal consortia, or Urban Indian organizations, or coalitions headed by such entities.
 
The full funding opportunity is available here. Applications are due December 20th.