Weekly Health Care Policy Update – June 21, 2022

June 30, 2022

In this update: 

  • Covid-19 Updates
    • CDC, FDA Approve Covid-19 Vaccines for Kids as Young as Six Months
  • Administration Update
    • President Biden Issues Executive Order on LGBTQI+ Equality
  • Federal Legislature
    • Klobuchar and Porter Call for Investigation into Price Hikes
  • Federal Agencies
    • CMS Releases 2022 Strategic Framework Update
    • CMMI Adds Track 3 to Maryland Total Cost of Care Model
    • ONC Launches Adopted Standards Task Force
  • Other Federal Updates
    • SCOTUS Rules for Hospitals in 340B Case
    • MACPAC Issues Recommendations to Congress
    • MedPAC Publishes June 2022 Report
    • Commonwealth Fund Publishes 2022 State Scorecard
  • New York State Updates
    • Governor Hochul Extends NYS Covid-19 Emergency Declaration
    • DOH Delays NYIA Takeover of Expedited Assessments for Personal Care to October 1st
    • OPWDD Announces Schedule for 2023-2027 Draft Strategic Plan Regional Forums
    • Governor Hochul Signs Legislative Package on Abortion and Reproductive Rights
  • Funding Opportunities
    • OMH Releases HealthySteps RFA

Covid-19 Updates

CDC, FDA Approve Covid-19 Vaccines for Kids as Young as Six Months
On June 17th, the Food and Drug Administration (FDA) authorized emergency use of the Moderna and Pfizer-BioNTech Covid-19 vaccines for use in children as young as six months of age. The Moderna emergency use authorization (EUA) was amended to include the use of the vaccine in individuals six months through 17 years of age, while the Pfizer-BioNTech EUA was amended to include individuals six months through four years of age. On June 18th, Centers for Disease Control and Prevention (CDC) Director Dr. Rochelle Walensky endorsed the recommendation. As such, Covid-19 vaccines are now available for this age group.
 
Earlier in the week, on June 14th and 15th, the Food and Drug Administration (FDA)’s Vaccines and Related Biological Products Advisory Committee met to discuss these applications for authorizations. The panels unanimously supported the authorizations, but expressed significant concerns about public communication, because the vaccine will be authorized as a two-dose series, even though a third dose is needed to garner true protection from strains such as Omicron and its subvariants. The panel also express concerns about the different dosing regimens between Moderna and Pfizer: Moderna requires two 25-microgram doses four weeks apart, while Pfizer requires two 3-microgram doses three weeks apart, followed by a third dose at least eight weeks later. 

Administration Update


President Biden Issues Executive Order on LGBTQI+ Equality
On June 15th, President Biden issued an Executive Order (EO) on advancing equality for LGBTQI+ individuals. The EO includes several health care provisions, which include instructions to the Department of Health and Human Services (HHS) and other federal agencies to:

  • Encourage states to promote access to care for LGBTQI+ individuals through disseminating sample policies to states, seeking to expand access to family counseling through guidance and funding, and other approaches;
  • Investigate and prevent the use of so-called conversion therapy;
  • Publish a “Bill of Rights for LGBTQI+ Older Adults” and new guidance on the non-discrimination protections for older adults in long-term care settings;
  • Explore rulemaking to establish that LGBTQI+ individuals are included in the definition of populations of “greatest social need” under the Older Americans Act; and
  • Establish a new federal coordinating committee on sexual orientation and gender identity (“SOGI”) data, which will lead efforts across agencies to identify opportunities to strengthen SOGI data collection, while safeguarding privacy protections and civil rights for LGBTQI+ individuals.

A fact sheet on the Executive Order can be found here.

Federal Legislature

Klobuchar and Porter Call for Investigation into Price Hikes
On June 13th, Senator Amy Klobuchar (D-MN) and Representative Katie Porter (D-CA) sent a joint letter to Assistant Attorney General Jonathan Kantor and Federal Trade Commission Chair Lina Khan expressing their concern regarding Jansen Pharmaceuticals’ and Bristol-Myers Squibb/Pfizer’s parallel price increases for the anticoagulant drugs Xarelto and Eliquis. The letter notes that annual prices for the competing drugs have risen beyond the rate of inflation every year since they entered the market and suggests that the increases have been coordinated to “maintain pricing parity.” The letter expresses particular concern that the drugs, as part of the Part D benefit, require Medicare beneficiaries to pay an out-of-pocket percentage of the medication list price. In 2020, the drugs were both in the top three most costly for all of Medicare, with gross spending of nearly $15 billion combined. The letter encourages the evaluation of the “state of competition in this drug market and whether these companies’ pricing practices may have violated federal anti-trust laws.”
 
The full letter is available here. 

Federal Agencies

CMS Releases 2022 Strategic Framework Update
On June 8th, the Centers for Medicare and Medicaid Services (CMS) released a 2022 update to its Strategic Framework. The document reiterates the six strategic pillars that CMS laid out last year in the original strategic plan (available here), which promote the agency’s broad programmatic goals. The framework then summarizes CMS’s current efforts to implement cross-cutting initiatives across the agency. These initiatives include:

  • Stakeholder engagement;
  • Behavioral health, through the CMS Behavioral Health Strategy;
  • Drug affordability;
  • Maternity care, including the development of a “coordinated maternity care strategy”;
  • Benefit expansion, defined as “opportunities to expand access to […] underused high-value services”;
  • Rural health;
  • Preparing the health care system for the post-pandemic world through updated guidance for regulations after the end of the public health emergency (PHE);
  • Ensuring that as many people as possible maintain coverage during the coverage transition after the end of the PHE;
  • The CMS National Quality Strategy;
  • Nursing homes and choice in long-term care;
  • The use of data to drive decision making; and
  • Integrating Medicare, Medicaid and CHIP, and the Marketplace, through “new internal approaches” to create continuity of care.

The full 2022 update to the CMS Strategic Framework is available here.
 
CMMI Adds Track 3 to Maryland Total Cost of Care Model
On June 13th, the CMS Innovation Center (CMMI) announced the addition of a new payment model to the Maryland Total Cost of Care Model’s primary component, the Maryland Primary Care Program (MDPCP). Under the MDPCP, participating primary care practices in Maryland are paid a per-member per-month (PMPM) care management fee for attributed patients, and are rewarded or penalized based for their performance on the cost and quality of care for this population. The MDPCP is part of the Maryland Total Cost of Care Model, which sets a per capita limit on Medicare total cost of care in Maryland.
 
Currently, MDPCP has two “tracks” that have different payment models. Track 1 allows practices to continue receiving standard Medicare fee-for-service (FFS) reimbursement (at Medicare Physician Fee Schedule rates) alongside the PMPM fee, while Track 2 blends FFS payment with a prospective PMPM payment (at least 40% of the payment by a practice’s third year). The new track, Track 3, is based on the current Primary Care First (PCF) model. Under Track 3, provider reimbursement will not include any standard Medicare FFS component. Instead, they will receive a flat per-visit fee for certain primary care services and a prospective population-based PMPM payment, adjusted based on performance.
 
Effective January 1, 2023, CMS will retire Track 1 and begin accepting practices into Track 3. All participants will be transitioned into either Tracks 2 and 3 by January 1, 2024, and these will be the payment options under the model for the remainder of its current approval period, through December 31, 2026.
 
More information is available here.
 
ONC Launches Adopted Standards Task Force
On June 16th, the HHS Office of the National Coordinator for Health IT (ONC) launched the Health Information Technology Advisory Committee (HITAC) Adopted Standards Task Force. The Task Force has been formed to meet a requirement in the 21st Century Cures Act, which requires ONC to review existing adopted standards and implementation specifications and recommend whether to maintain their use every three year. The members of the Task Force include representatives from HIT developers, providers, clinicians, and public health officials, among others. It will be co-chaired by Hans Buitendijk of Oracle Cerner and Steven Eichner of the Texas Department of State Health Services.
 
More information is available on ONC’s website here. 

Other Federal Updates

SCOTUS Rules for Hospitals in 340B Case
On June 15th, the Supreme Court ruled unanimously that HHS does not have the authority to change provider reimbursement rates for drugs under the 340B program without having conducted a survey of hospitals’ acquisition costs. In 2018, CMS cut 340B payments by nearly 30% using a methodology based on the “average price” for drugs, not actual drug acquisition costs, and redistributed the savings through non-drug items and services. The Court’s decision, authored by Justice Kavanaugh, states that HHS cannot vary reimbursement rates by hospital group, and that HHS must “set uniform reimbursement rates for all hospitals for each covered drug.”
 
The decision means that HHS’s 2018 and 2019 reimbursement rates for 340B hospitals will need to be adjusted. Collectively, hospitals would have been paid an additional $1.6 billion during those years under the previous methodology. However, because 2020 and later reimbursements were performed after a hospital survey, it is not clear if HHS will have to make any further adjustments or to revert its methodology going forward.
 
The full ruling is available here.
 
MACPAC Issues Recommendations to Congress
On June 15th, the Medicaid and CHIP Payment and Access Commission (MACPAC) released its June 2022 report to Congress. The report makes the following key recommendations: 

  • CMS should develop a new system for monitoring access to care for Medicaid beneficiaries that is transparent, involves stakeholder input, and allows for comparisons across states and delivery systems.
  • CMS should make more information available on managed care directed payment approval documents, rate certifications, and evaluation, collect new provider-level data on directed payment spending, and require more explanation from states on how these payments relate to program goals.
  • CMS should provide guidance for more meaningful, multi-year assessments of directed payments and improving coordination among managed care payment review processes.
  • CMS should make coverage of recommended vaccines a mandatory benefit for all adult Medicaid beneficiaries, promulgating regulations for vaccine payment, and encouraging the broad use of Medicaid providers in administering vaccines.
  • The Secretary of HHS should direct a coordinated effort to improve vaccine outreach and education to Medicaid and State Children’s Health Insurance Program (CHIP) beneficiaries, as well as improving immunization information systems and providing funding to support these efforts.
  • CMS should issue guidance to help states use Medicaid authorities and other federal resources to promote behavioral health IT adoption.
  • The Office of the National Coordinator for Health Information Technology and the Substance Abuse and Mental Health Services Administration should work together to develop voluntary standards that would encourage health IT uptake appropriate for behavioral health.
  • Congress should require all states to develop an integrated care strategy within two years, addressing the integration approach, eligibility and benefits covered, enrollment plan, beneficiary protections, data analytics, quality measurement, and be structured to promote health equity.

The full MACPAC report is available here.
 
MedPAC Publishes June 2022 Report
On June 15th, the Medicare Payment Advisory Commission (MedPAC) published its June 2022 report to Congress. The report does not contain new recommendations but presents analyses and suggestions on various topics. Some notable topics include:

  • Streamlining Medicare’s portfolio of alternative payment models (APMs): MedPAC suggests that CMS should reduce its portfolio of population-based payment models, like Accountable Care Organizations (ACOs), by offering tracks that vary only based on the provider’s size (i.e., an upside-only model for small practices), or by offering only a single track with varying risk-sharing based on the provider’s capacity. It also suggests that ACO benchmarks should no longer be rebased based on actual spending.
  • Analysis of utilization by duals and others: MedPAC presents analysis of Medicare beneficiaries’ service utilization, grouped by dual eligible status, geography (urban/rural), and number of chronic conditions.
  • Safety Net Index for hospitals: MedPAC presents a new measure it developed to measure hospitals’ share of services for underserved populations, the Safety Net Index (SNI).
  • Removing outliers from MA risk adjustment: MedPAC analysis finds that removing outliers from Medicare Advantage risk adjustment substantially improved its predictive accuracy.
  • Site-neutral payments: MedPAC presents an analysis of a proposal to establish site-neutral ambulatory payments for an additional 57 ambulatory payment classifications, and finds that it would have reduced Medicare program spending by $6.6 billion in 2019.

The report is available here.
 
Commonwealth Fund Publishes 2022 State Scorecard
On June 15th, the Commonwealth Fund published its annual Scorecard on State Health System Performance. The annual survey assesses states on metrics such as access to care, getting the right care at the right time, getting care in the right setting, and overall health. This year, the Commonwealth Fund also measured states’ responses to the Covid-19 pandemic, including seven Covid-specific measures to reflect state progress in vaccinating residents, Covid-related hospitalization rates and health system stress, and Covid-related mortality through the end of March 2022. States that historically performed well on the State Scorecard also performed well as the pandemic unfolded, both on Commonwealth’s usual set of health system measures and the new Covid-19-specific measures.
 
The full report is available here. New York’s Scorecard is available here. 

New York State Updates

Governor Hochul Extends NYS Covid-19 Emergency Declaration
On June 14th, Governor Hochul issued Executive Order 11.7 (available here), which extends New York’s second Covid-19 State Disaster Emergency declaration through July 14th. The Order continues the implementation of the State’s Comprehensive Emergency Management Plan and the “Surge and Flex” system, which allows the Department of Health (DOH) to limit non-essential elective procedures at health systems with limited capacity. Limited capacity is defined as having below 10% staffed bed capacity available, or as otherwise determined by DOH. The Order also continues the waiver of certain State Finance Law provisions around procurement to expedite purchasing of pandemic-related supplies.   
 
DOH Delays NYIA Takeover of Expedited Assessments for Personal Care to October 1st
On June 17th, DOH announced that the implementation of the Independent Assessor (NYIA) for expedited assessments of individuals seeking personal care services (PCS) or consumer-directed personal assistance services (CDPAS) will be delayed by three months, until October 1st. As part of the second Medicaid Redesign Team’s recommendations, Medicaid managed care (MMC) plans will no longer conduct assessments for individuals seeking PCS or CDPAS. Instead, the NYIA will assess the individuals and determine their eligibility for these services, and plans will use the NYIA-produced Community Health Assessment to create a person-centered plan of care, which may include PCS, CDPAS, and other services. Plans remain ultimately responsible for service authorization, including service hours.
 
This process was effective starting May 16th for individuals 18 and over who are newly seeking services, except for requests made on an expedited basis, which were originally scheduled to become the NYIA’s responsibility on July 1st. For individuals who are being reassessed and children aged 4 to 17, plans will continue to conduct assessments until further notice.
 
DOH’s guidance is available here.
 
OPWDD Announces Schedule for 2023-2027 Draft Strategic Plan Regional Forums
The New York State Office for People with Developmental Disabilities (OPWDD) has released the schedule of in-person regional forums for the 2023-2027 draft Strategic Plan. The draft Strategic Plan is currently open for public comment and the in-person forums provide an opportunity for stakeholders to provide verbal comments. Pre-registration is not required but is strongly encouraged.
 
The Strategic Plan is available here. The schedule and registration for the in-person forums are available here.
 
Governor Hochul Signs Legislative Package on Abortion and Reproductive Rights
This week, Governor Hochul signed a six-bill legislative package to protect abortion access and reproductive rights. Since the New York legislative session adjourned June 4th, no further action on legislation is expected this year. The package includes the following bills: 

  • S9384A/A9818A allows reproductive health care providers and their immediate family members, employees, volunteers, and patients to enroll in the State’s address confidentiality program.
  • S9079B/A9687B prohibits professional misconduct charges against health care providers on the basis that such provider, acting within their scope of practice, performed, recommended, or provided reproductive health care services for a patient who resides in a state where such services are illegal.
  • S9080B/A9718B prohibits medical malpractice insurance companies from taking any adverse action against an abortion or reproductive health care provider who performs an abortion or provides health care that is legal in New York State for someone who is from out of the state, including the prescription of abortion medication to out-of-state patients via telehealth.
  • S9077A/A10372A provides certain legal protections for abortion service providers, including protection from extradition, arrest, and legal proceedings in other states relating to abortions legally performed in New York State.
  • S470/A5499 authorizes the Commissioner of Health to conduct a study and issue a report examining the unmet health and resource needs facing pregnant individuals in New York State.
  • S9039A/A10094A establishes a cause of action for unlawful interference with protected rights, allowing individuals to bring a claim against someone who has sued them or brought charges against them for facilitating, aiding, or obtaining reproductive health or endocrine care services.

The Governor’s press release is available here.

Funding Opportunities

OMH Releases HealthySteps RFA
On June 15th, the New York State Office of Mental Health (OMH) released a Request for Applications (RFA) for funding to support the implementation of HealthySteps at new sites statewide. HealthySteps is an evidence-based program that serves young children (0-3) and their families in a pediatric health care setting. Through this RFA, OMH will award over $27.3 million in total funding to up to 57 awardees during the five-year program. Sites will be required to hire and maintain a HealthySteps Specialist for the duration of funding, who will be responsible for supporting the health care team and promoting the child’s developmental, social-emotional, and behavioral health.
 
Eligible applicants are pediatric or family medical practices (including Federally Qualified Health Centers) that serve children ages 0-3 and that have the potential to deliver well-child visits. Applicants must be not-for-profit practices with a payer mix of at least 50% Medicaid and/or Child Health Plus. HealthySteps sites previously funded by OMH at the same location are not eligible to apply; however, up to three applications from the same organization may apply to establish a new site at a different location.
 
The full RFA is available here. Applications are due on August 24th. Questions may be submitted to through July 12th.