Weekly Health Care Policy Update – March 14, 2022

March 21, 2022

In this update: 

  • Covid-19 Updates
    • HHS Launches “Test to Treat” Initiative to Combine Covid-19 Testing and Antiviral Treatment 
  • Federal Legislature
    • Congress Passes Omnibus Spending Bill Without Covid-19 Funding
  • Federal Administration
    • Biden Nominates Roselyn Tso to Lead Indian Health Service
  • Federal Agencies
    • CMS Issues Guidance to States Regarding Medicaid Coverage Redeterminations
    • CMS Opens ACO REACH Applications
    • CMMI to Hold Roundtable on Safety Net Provider Participation on March 16th
    • PTAC Requests Input on Population-Based Total Cost of Care Models
    • CMS Updates Covid-19 Medicaid and CHIP Data, Showing Continuing Shortfalls in Mental Health Services
    • OSHA Begins Three-Month Initiative of Focused Covid-19 Safety Inspections
  • Other
    • MACPAC Holds March Meeting
    • Carin Alliance Launches “Digital Identity” Partnership with HHS and Other Stakeholders
  • Legislative Hearings
  • New York State Updates
    • Governor Hochul Extends Statewide Disaster Emergency Due to Health Care Staffing Shortages
    • OMH Publishes Revised Crisis Stabilization Center Regulations
    • NYS OMH Releases Memo on Mask Requirements in School-Based Settings and Updates Infection Control Guidance
    • DOH Submits Interim Evaluation Reports on HARP and SDC to CMS
    • DOH Outlines Implementation Timeline for PCS/CDPAS Regulatory Changes

COVID-19 Updates

HHS Launches “Test to Treat” Initiative to Combine Covid-19 Testing and Antiviral Treatment
On March 8th, the Department of Health and Human Services (HHS) announced the launch of a nationwide Test to Treat Initiative. Under this initiative, starting March 7th, HHS began directly providing pharmacies, federally qualified health centers (FQHCs), and long-term care facilities with supplies Covid-19 antiviral treatments, including molnupravir and Paxlovid. Patients will be able to receive Covid-19 testing or bring in an outside test result and, if appropriate, have an antiviral prescription filled during one visit. The Biden Administration plans to launch a website listing all Test to Treat sites in mid-March.
 
The announcement is available here.

Federal Legislature

Congress Passes Omnibus Spending Bill Without Covid-19 Funding
On March 10th, the Senate passed the Consolidated Appropriations Act 2022 (H.R. 2471), an omnibus spending package for federal fiscal year (FY) 2022, by a vote of 68-31. President Biden is expected to sign the bill this week.
 
The bill is the first such package under the Biden Administration and sets new spending levels, including a 7 percent increase for non-defense discretionary spending (to $730 billion) and a 6 percent increase to defense spending (to $782 billion). The bill did not, however, include additional funding for the Covid-19 pandemic response. A proposed $15.6 billion that had been included in a draft version of the bill was pulled before the bill hit the House floor as Democrats failed to reach consensus on how to offset these costs
 
Notable items from the bill include: 

  • An extension of pandemic-related telehealth services in Medicare. The bill extends, for 151 days following the end of the Covid-19 public health emergency (PHE), the expansion of Medicare coverage of telehealth services that has been in place during the PHE. During this period: 
    • The lifting of the rural geographic restriction on Medicare telehealth will remain in effect.
    • Medicare will continue to reimburse FQHCs and rural health clinics will for services provided through telehealth.
    • Medicare will continue to pay for audio-only telehealth and physical, occupational, and speech therapy services delivered through telehealth.
    • Medicare will continue not to enforce the requirement that beneficiaries receiving telehealth for mental health services must be seen in person by their provider within six months of starting treatment, and every year thereafter.
    • Prescription of controlled substances will not be allowed via telehealth.
  • Funding of $1 billion for the Advanced Research Projects Agency for Health (ARPA-H). This amount is significantly below the Biden Administration’s original request of $6.5 billion. Bipartisan legislation to establish ARPA-H as an independent entity within the National Institutes of Health (NIH) has been introduced in the Senate.
  • Total funding of $45 billion for the NIH, including a minimum increase of 3.4% for each Institute and Center.
  • Maternal care-related provisions, including: 
    • The Maternal Health Quality Improvement Act, which authorizes several grant programs for innovative maternal care models and training in reduction of maternal mortality;
    • The Rural Maternal and Obstetric Modernization of Services (MOMS) Act, which seeks to expand access to rural maternity care through telehealth, new regional obstetric networks, and training programs; and
    • A total of $177 million (an increase of $109 million) for the NIH, the Health Resources and Services Administration (HRSA), and the Centers for Disease Control and Prevention (CDC) for work in maternal health.
  • A number of new investments in public health capacity and infrastructure, including public health data and surveillance, workforce, and preparedness cooperative agreements.

The bill did not include health care provisions such as a further delay to the Medicare sequester, which is scheduled to resume in the form of across-the-board payment cuts of 1% on April 1st and 2% on July 1st, or additional provider relief. It also omitted the proposed supplemental $15.6 billion Covid-19 funding package, which would provide additional funds for the purchase of Covid-19 vaccines, therapies, and care for the uninsured, due to Democratic members’ objections to paying for it with unused state Covid-19 relief funds. The House released a standalone bill (H.R. 7007) including nearly $10 billion in additional pandemic funding without any offsets, which it plans to vote on this week. However, there is no clear legislative path forward in the Senate.  
 
The omnibus bill text is available here and a summary is available here.

Federal Administration

Biden Nominates Roselyn Tso to Lead Indian Health Service
On March 9th, President Biden announced he would nominate Roselyn Tso to serve as Director of the Indian Health Service (IHS). Tso is currently the Director of the Navajo Area IHS, which delivers health care services to over 240,000 Native Americans. Overall, the Indian Health Service provides care to 2.6 million members of tribal communities. It includes 26 hospitals, 56 health centers, and 32 health stations, and has an annual budget of roughly $6 billion.

Federal Agencies

CMS Issues Guidance to States Regarding Medicaid Coverage Redeterminations
On March 3rd, the Centers for Medicare & Medicaid Services (CMS) issued guidance, via a State Health Official letter, providing states with additional time to complete Medicaid eligibility redeterminations following the end of the Covid-19 public health emergency (PHE). The PHE currently expires April 16th, but the Biden Administration has stated that it will provide at least 60 days’ notice before it decides to end the PHE.
 
The new CMS guidance extends the time frame by which states must complete Medicaid redeterminations and renewals to 14 months following the end of the PHE (up from 12 months). States must still initiate all renewals and other eligibility actions within 12 months. The additional two months is in response to state concerns that renewals cannot typically be initiated and completed in the same month.
 
The letter also clarifies that states must begin work to unwind continuous Medicaid enrollment no later than the first of the month following the end of the PHE. States can start the process up to two months before the end of the PHE, but if states terminate coverage prior to the end of the PHE, they will forfeit the additional 6.2% federal matching funds they are currently receiving.
 
States must submit to CMS a plan to distribute redetermination work throughout the 12-month period. CMS recommends that states initiate no more than one-ninth of all open renewals each month to avoid errors in processing and future peaks in routine renewal volume.
 
States may use various strategies to prioritize beneficiaries for eligibility redeterminations so long as such strategies aim to prevent churn, ease transitions in coverage, and achieve a sustainable renewal schedule. The guidance also describes how states can work to ensure smooth transitions from Medicaid or CHIP to Marketplace coverage, including requirements to exchange information with the Marketplace to help ensure prompt eligibility determinations and enrollment, where appropriate.
 
The State Health Official letter is available here. Also on March 3rd, CME released a communications toolkit (available here) to help individuals with Medicaid and CHIP understand steps they will need to take to renew their coverage and a slide deck (available here) explaining the role of managed care organizations in the redetermination process.
 
CMS Opens ACO REACH Applications
On March 7th, the Centers for Medicare and Medicaid Innovation (CMMI) began accepting applications for new participants in the Accountable Care Organization Realizing Equity, Access, and Community Health (ACO REACH) model. This is expected to be the only opportunity for organizations to establish a REACH ACO.
 
Applications are due April 22nd through the application portal, available here. SPG’s summary of the ACO REACH model is available here. Additional information is available on CMS’ ACO REACH model website, available here.
 
CMMI to Hold Roundtable on Safety Net Provider Participation on March 16th
On March 16th, CMS will hold a public roundtable discussion on how it can better support safety net providers to participate in CMMI models. The discussion will cover the following questions:

  • How should CMMI define safety net providers?
  • What financial incentives and structures would help recruit safety net providers into CMMI models?
  • What types of technical assistance, data, and workforce are needed to sustain safety net participation in CMMI models, and how can CMMI provide such support?

Registration is available here. Written comments may be submitted in advance to CMMIStrategy@cms.hhs.gov.
 
PTAC Requests Input on Population-Based Total Cost of Care Models
On March 8th, the Physician Focused Payment Model Technical Advisory Committee (PTAC) issued a request for public input to inform its review of population-based total cost of care models. PTAC conducted a first discussion of these models in its March 2022 public meeting and will hold several more through the course of 2022, including: 

  • A June 2022 discussion on assessing best practices in care delivery under such models; and
  • A September 2022 discussion on payment considerations and financial incentives in such models.

PTAC, which was created in 2015 by the Medicare Access and CHIP Reauthorization Act (MACRA), makes comments and recommendations to HHS on proposals for physician-focused payment models (PFPMs). PTAC is supported by the HHS Office of the Assistant Secretary for Planning and Evaluation (ASPE). It will submit a report to HHS based on the input it receives during these meetings.
 
The request is available here. Input should be submitted by April 15th.
 
CMS Updates Covid-19 Medicaid and CHIP Data, Showing Continuing Shortfalls in Mental Health Services
On March 4th, CMS released an updated Medicaid and Children’s Health Insurance Program (CHIP) data snapshot on the impact of Covid-19 on beneficiaries and service utilization through August 2021. From March 2020 through August 2021, over 117 million Americans were enrolled in the programs for at least one day, 40% of whom were children. This represents a 15% increase in enrollment over the study period, including a roughly 60% increase in beneficiaries in the pregnant eligibility group.  Overall, nearly 5 million beneficiaries were treated for Covid-19 during the period, 1.43 million of whom were under age 19, and 390,231 of whom required hospitalization. Only 14,753 beneficiaries under age 19 required hospitalization.
 
Total service use for beneficiaries under age 19 declined during the study period across primary, preventive, and mental health services, but rebounded for primary and preventive care by March 2021. Of all categories, mental health service levels remain the furthest below pre-pandemic levels. Childhood vaccinations were also down during this period, 4% lower than in the prior two-year period, as were childhood screenings, which were down 7%. Pediatric dental services also remain below pre-pandemic levels through August 2021.
 
Other notable observations from the snapshot include: 

  • Telehealth services spiked in April 2020 and then generally declined from May 2020 through August 2021.
  • Racial and ethnic minority groups experienced higher rates of depression, substance abuse, and self-reported suicidal thoughts during the pandemic.
  • Evidence indicates an increase in both adverse mental or behavioral health conditions and drug-related mortality during the pandemic.
  • Mental health services and substance use disorder services were lower across all ages during the pandemic, but behavioral health services delivered via telehealth increased dramatically.
  • Rates of live births during the pandemic are lower than compared to prior years.

The full report is available here.
 
OSHA Begins Three-Month Initiative of Focused Covid-19 Safety Inspections
On March 9th, the Occupational Safety and Health Administration (OSHA) began a three-month initiative to magnify the Agency’s presence in high-hazard health care facilities. The initiative is intended to encourage employers to “take the necessary steps to protect their workers against the hazards of Covid-19.” The partial-scope inspections will occur at facilities if they meet one of the following criteria: 

  1. Follow-up inspection of any prior inspection where a Covid-19-related citation or hazard alert letter was issued;
  2. Follow-up or monitoring inspections for randomly selected closed Covid-19 unprogrammed activity, to include Covid-19 complaints and Rapid Response Investigations; or
  3. Monitoring inspections for randomly selected, remote-only Covid-19 inspections where Covid-19-related citations were previously issued.

Inspections will be limited to the following assessments: 

  1. Determine whether previously cited COVID-19-related violations have been corrected or are still in the process of being corrected;
  2. Determine whether the employer has implemented a COVID-19 plan that includes preparedness, response, and control measures for the SARS-CoV-2 virus;
  3. Verify the existence and effectiveness of all control measures, including procedures for determining vaccination status by reviewing relevant records;
  4. Request and evaluate the establishment’s COVID-19 log and the Injury and Illness Logs for calendar years 2020, 2021, and 2022, if available, to identify work-related cases of COVID-19;
  5. Review the facility’s procedures for conducting hazard assessments and protocols for personal protective equipment (PPE) use;
  6. Conduct a limited records review of the employer’s respiratory protection program; and
  7. Perform a limited, focused walkaround of areas designated for COVID-19 patient treatment or handling, including performing employee interviews to determine compliance.

More information is available here.

Other Updates

MACPAC Holds March Meeting
On March 3rd and 4th, the Medicaid and CHIP Payment and Access Commission (MACPAC) held its monthly public meeting. During this meeting, Commissioners considered four issues to be included in MACPAC’s June 2022 Report to Congress. These are: 

  • Directed payments in managed care. Commissioners generally supported five recommendations made by staff: improving transparency, new provider-level data collection, clarifying directed payment goals and their relationship to network adequacy requirements, providing guidance for more meaningful, multi-year assessments of directed payments, and improving the coordination of reviews of directed payments and managed care rate setting. Commissioners will vote on these recommendations at the April 2022 meeting.
  • Improving the uptake of electronic health records by behavioral health providers. In April, the Commissioners will vote on recommendations to 1) create voluntary standards for behavioral health focused EHRs, and 2) identify Medicaid mechanisms to finance EHR adoption among behavioral health providers.
  • Requiring States to develop an integrated care strategy for dually eligible beneficiaries. Commissioners approved a recommendation to Congress that it should require states to develop such a strategy, structured to promote health equity and including an integration approach, eligibility and benefits covered, enrollment strategy, beneficiary protections, data analytics, and quality measurement.
  • Access to vaccines for adults enrolled in Medicaid. At the April meeting, Commissioners will vote on five recommendations to improve vaccine uptake by adults: 1) mandate vaccine coverage in Medicaid; 2) implement vaccine payment regulations; 3) encourage use of pharmacies and other providers; 4) improve vaccine education and outreach; and 5) improve immunization information systems.

The Commission also heard presentations and considered issues unrelated to the upcoming Report to Congress, including: 

  • Levering Medicaid policies to promote health equity;
  • Managed care rate setting and actuarial soundness (MACPAC published a new issue brief on this topic here);
  • Risk mitigation and rate setting; and
  • Considerations in redesigning the Home and Community-Based Services (HCBS) benefit.

The meeting agenda and presentation slides are available here.
 
Carin Alliance Launches “Digital Identity” Partnership with HHS and Other Stakeholders
On March 8th, the Carin Alliance announced the launch of its “Digital Identity” project, a multi-stakeholder collaboration, including teams from HHS, that seeks to create a proof of concept of a single sign-on credential system. The project’s aim is to allow patients to request data from multiple providers and health plans without multiple log-ins. Patients will use a credentialing service certified by an independent third party to authenticate themselves, which would allow them to access data from all participating providers and payers. The approach would: 

  • Allow a single, industry-led governance body to aggregate and manage federations between organizations;
  • Allow participants to buy products that support standards in identity and cryptography;
  • Support all identity use cases to include authentication, digital signatures, encryption and loT;
  • Require vendors to procure or issue their own reliable credentials when engaging in business; and
  • Consolidate liability, warranties, indemnification and other legal matters across all vendor identity credentials.

Carin’s initial partners include CVS Health, Cedars-Sinai Health System, Kaiser Permanente, and others. HHS’s External Management System team will assist with implementation, and CMS and the Office of the National Coordinator (ONC) will be “government observers.” Carin and its partners intend to establish the proof of concept project over the course of the year.
 
The slides from the Proof of Concept Kickoff Meeting are available here.

Legislative Hearings

Tuesday, March 15th:

  • At 10am, the Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a hearing on the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (S.3779 PREVENT Pandemics Act) which aims to strengthen public health and medical preparedness and response systems in the wake of the COVID-19 pandemic. More information is available here.
  • At 10am, the House Ways and Means Subcommittee on Worker and Family Support will hold a hearing entitled “Improving Family Outcomes through Home Visiting.” More information is available here.

Wednesday, March 16th:

  • At 10am, the Senate Finance Committee will hold a hearing entitled “Prescription Drug Price Inflation: An Urgent Need to Lower Drug Prices in Medicare.” More information is available here.
  • At 10am, the House Small Business Subcommittee on Oversight, Investigations, and Regulations will hold a hearing entitled “An Empirical Review of the Paycheck Protection Program.” More information is available here.

Thursday, March 17th:

  • At 10am, the Senate Finance Committee will hold a hearing entitled “Examining Charitable Giving and Trends in the Nonprofit Sector.” More information is available here.
  • At 10:15am, the Senate Homeland Security and Governmental Affairs Committee will hold a hearing entitled “Pandemic Response and Accountability: Reducing Fraud and Expanding Access to COVID-19 Relief through Effective Oversight.” More information is available here.
  • At 10:30am, the House Energy and Commerce Subcommittee on Health will hold a hearing entitled “The Future of Medicine: Legislation to Encourage Innovation and Improve Oversight,” which will examine bills including the Cures 2.0 Act (H.R.6000) and the Advanced Research Project Agency – Health (ARPA-H) Act (H.R. 5585). More information is available here.

New York State Updates

Governor Hochul Extends Statewide Disaster Emergency Due to Health Care Staffing Shortages
On March 1st, Governor Hochul issued Executive Order 4.6 (available here), which extends the statewide disaster emergency due to health care staffing shortages through March 31st. The Order continues the provisions in Executive Order 4 that reinstated many of the workforce and scope of practice flexibilities that applied during the New York State Covid-19 PHE. It also extends the following provisions in the amendments to Executive Order 4: 

  • Suspension of the staffing and minimum expense requirements for nursing homes passed in the State FY 2021-22 Budget; and
  • Waiving the requirement for surgical technologists working in health care facilities to meet the standards in Section 2824 of the Public Health Law, within two years of beginning their employment or contracts. The waived standard includes demonstrating the successful completion of a nationally accredited program for surgical technologists, or equivalent experience.

OMH Publishes Revised Crisis Stabilization Center Regulations
On March 9th, OMH published a notice in the State Register (available here) revising proposed regulations to Crisis Stabilization Centers. Among other changes, the revised regulations: 

  • Amend definitions, including revisions to clarify the voluntary status of centers;
  • Remove requirements that providers seeking licensure for Crisis Stabilization Centers must be currently licensed under Article 28, 31 or 32 and allowing any providers “licensed, certified, or otherwise authorized by OMH, OASAS, and DOH” to apply for licensure.
  • Update language to use more appropriate and inclusive terminology for populations served based on public comment;
  • Provide staffing clarifications, including qualifications for Medical Directors;
  • Require centers to have an overdose prevention kit onsite with appropriately trained staff; and
  • Provide clarification that centers may have Memorandums of Understanding (MOUs) with any available crisis residential services or comparable services to ensure that options are maximized for recipients who require care longer than 24 hours.

The updated regulations are available here. Public comment on the revised regulations may be submitted to regs@omh.ny.gov through April 23rd. OMH has extended the deadline for applications to become a Crisis Stabilization Center to June 9th and will host a bidder’s conference on March 23rd at 1:30pm. Details on the application and conference are available here.
 
NYS OMH Releases Memo on Mask Requirements in School-Based Settings and Updates Infection Control Guidance
On March 3rd, the New York State Office of Mental Health (OMH) released a memo (available here) to providers operating children’s day treatment programs, school-based mental health clinics, and other OMH programs operating on school campuses regarding mask requirements. In alignment with New York’s current stance on school masking, if a county and school district has lifted mask requirements, OMH will also not require masks in any provider-operated outpatient educational settings in that area. This update does not apply to OMH inpatient settings.
 
OMH has also updated its Infection Control Manual for Public Mental Health System Programs (available here) in accordance with this memo. The manual also includes the following changes: 

  • Provides greater discretion to agencies that run ambulatory programs to consider particular local conditions in designing their infection control protocols for Covid-19 (e.g. vaccination rate among staff and clients, comorbid medical conditions among staff and clients, physical space, access to high-quality, well-fitting masks, transportation issues, etc.);  
  • Prevents agencies from developing across-the-board policies that forbid in-person visits for non-vaccinated clients and updates the list of factors to consider when making individualized decisions about which clients can be seen virtually vs. in-person;
  • Provides recommendations for securely-fitting, high-quality masks throughout guidance;
  • Clarifies that discontinuation of isolation for congregate settings remains at least 10 days; and
  • Updates the vaccination recommendation table.

DOH Submits Interim Evaluation Reports on HARP and SDC to CMS
On February 9th, the New York State Department of Health (DOH) submitted an Interim Evaluation Report on the Health and Recovery Plan (HARP) program (available here) to the Centers for Medicare and Medicaid Services (CMS). The Report evaluated the HARP program’s goals to improve health and behavioral health outcomes for mainstream and HARP managed care enrollees and to provide HARP enrollees with a behavioral health (BH) HCBS package, expected to offset its costs. Some of the Report’s notable findings include:

  • A “striking” low level of assessment of BH HCBS eligibility, and minimal utilization of these services. The report noted that “the system was ill prepared to support these services.”
  • No clear effect of the HARP program on acute care utilization, a contributing factor to which may have been the low level of BH HCBS utilization.
  • A “concerning” finding of modest utilization of specialty BH clinic programs, whether OMH or OASAS-licensed, by Supplemental Security Income (SSI) beneficiaries.

On March 9th, DOH submitted an Interim Evaluation Report on the Self-Directed Care (SDC) pilot program (available here) to CMS. The Report evaluated the SDC program’s goal of implementing a viable program for HARP enrollees eligible for BH HCBS to self-direct services. It found that the program was successfully implemented largely as intended and was well received by both participants and program staff. The Report also includes recommendations for program improvement should the State choose to scale the program in the future. Due to data limitations, the evaluation was unable to examine the impacts of the program on its other goals, to improve recovery-oriented outcomes and maintain cost neutrality.
 
DOH Outlines Implementation Timeline for PCS/CDPAS Regulatory Changes
On March 4th, DOH sent a letter to Medicaid Managed Care Organizations, Local Departments of Social Services, Plan/Provider Associations, and other interested parties regarding the implementation timeline for additional regulatory changes to personal care and consumer directed personal assistance services (PCS/CDPAS).
 
As indicated in the letter, the Independent Assessor will launch on May 1st for the initial assessment process only. The transition of reassessments, routine and non-routine, will not be effective until later (likely after the end of the federal Covid-19 PHE). Other policy changes are also being delayed, including the requirement that beneficiaries must demonstrate a need for help with at least three activities of daily living (ADL), or two ADLs for beneficiaries who have dementia or Alzheimer’s disease.
 
The letter is available here. Questions may be submitted to independent.assessor@health.ny.gov.