Weekly Health Care Policy Update – January 22, 2022

In this update: 

• Covid-19 Updates
  • CMS Delays Vaccine Mandate Deadline in 24 States
  • Biden Administration Announces Free N95 Distribution, Begins Free Rapid Test Distribution
  • NYS DOH Extends Covid-19 HERO Act Designation Through February 15^th
  • NYS OMH Releases Updated Guidance on Federal Covid-19 Vaccination Mandates
  • Updated NYS DOH Covid-19 Guidance Documents
• Agency Updates
  • ONC Seeks Comment on Electronic Prior Authorization Standards for HIT Certification Program
  • FTC/DOJ Seek Public Input as Part of Merger Guideline Review
  • Fowler Says CMMI Will Consider Changing Risk Adjustment Methodology
  • HRSA Announces Awards to Improve Health Care Worker Retention
• Other
  • MedPAC Considers New APM Parameters, Approves Recommendations for March Report to Congress
  • MACPAC Holds Monthly Public Meeting
  • Study Examines Which Health Systems Overutilize Low-Value Services
  • HHS OCR Reports 2021 Was Record Year for Data Breaches
• Congressional Hearings
• New York State Updates
  • DOH Updates New York State Roadmap for Medicaid Payment Reform
  • Dr. Mary T. Bassett Confirmed as New York State Health Commissioner
  • DOH Updates Adult BH HCBS Guidance and Workflow
  • DOH and DFS Announce Extension of NY State of Health Open Enrollment Period
  • DOH Clarifies HCBS Rate Enhancement Timelines
• Funding Opportunities
  • AHRQ Conference Grant Program Funding Opportunity
  • HRSA Issues RFP for Behavioral Health in Rural Areas

COVID-19 Updates

CMS Delays Vaccine Mandate Deadline in 24 States
On January 14^th, the Centers for Medicare and Medicaid Services (CMS) issued new guidance on its Covid-19 vaccine mandate for employees at Medicare and Medicaid-certified facilities. The guidance followed the Supreme Court’s decision that the mandate was constitutional. The new CMS guidance applies to the 24 states where the mandate was previously stayed: Alabama, Alaska, Arizona, Arkansas, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Utah, West Virginia, and Wyoming. Texas was excluded as it had a separate lawsuit; however, it withdrew that lawsuit on January 19^th.
 
Health care workers in those 24 states must now receive a first shot by February 14^th and receive all necessary doses to complete a vaccine series (or have been granted a qualifying exemption) by March 15^th. Facilities must achieve a 100% vaccination rate within 90 days of the memorandum or be subject to enforcement action.
 
The guidance does not affect compliance for providers in states where the mandate was already in effect, where the compliance dates were January 27^th for a first dose and February 28^th for a complete series, or in Texas, for which CMS has yet to issue guidance on a compliance timeline.
 
The guidance is available here.
 
Biden Administration Announces Free N95 Distribution, Begins Free Rapid Test Distribution
On January 19^th, the Biden Administration announced that it would distribute 400 million non-surgical N95 masks from the Strategic National Stockpile. The masks will be available for free at pharmacies and health centers by early February. The supply will not include child-sized masks, but the government is working to procure those as well. The Stockpile is administered by the Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR). The distribution represents a little more than half of the Stockpile’s inventory, which includes more than 750 million N95 masks.

The Administration also began the distribution of free at-home Covid-19 rapid tests. Upon request, any household will receive 4 at-home Covid-19 tests through the Postal Service. The Administration began accepting requests at COVIDtests.gov on January 18^th. 

NYS DOH Extends Covid-19 HERO Act Designation Through February 15^th
On January 15^th, the New York State Department of Health (DOH) extended its designation of Covid-19 as an airborne infectious disease that presents serious risk of harm to the public health in New York State. This designation, initially implemented on September 6^th, triggers the HERO Act, which requires all employers to implement workforce safety plans to protect employees against exposure and disease. The designation will now continue through February 15^th.
 
The Commissioner’s designation is available here and additional details on the HERO Act are available here.
 
NYS OMH Releases Updated Guidance on Federal Covid-19 Vaccination Mandates
On January 11^th, the New York State Office of Mental Health (OMH) released updated guidance regarding the CMS Covid-19 vaccination mandate and its applicability to the OMH system. The guidance specifies that the vaccine mandate applies only to the following programs: 

• OMH-operated or-licensed hospitals;
• Comprehensive Psychiatric Emergency Programs (CPEPs); and
• OMH licensed residential treatment facilities (RTFs) for youth.

The mandate does not apply to freestanding clinics or other programs. Additionally, fully remote workers and ad hoc, non-health care workers are not required to comply.
 
The updated guidance is available here.
 
Updated NYS DOH Covid-19 Guidance Documents
Over the past week, DOH has released the following updated guidance documents related to the Covid-19 pandemic: 

• Updated Isolation and Quarantine Guidance (here)
• Isolation and Quarantine Tables (here)
• Frequently Asked Questions for Employers (here)
• Frequently Asked Questions for Schools (here)
• Health Advisory: Nursing Home Staff and Visitation Requirements (here)
• Pediatric Covid-19 Update (here)

Agency Updates

ONC Seeks Comment on Electronic Prior Authorization Standards for HIT Certification Program
Today, January 21^st, the HHS Office of the National Coordinator for Health Information Technology (ONC) published a Request for Information (RFI), which seeks comment on electronic prior authorization standards that ONC might implement within its Health IT Certification Program. Under the Certification Program, HIT developers submit their products to third-party testing laboratories for an assessment of their conformity with ONC’s standards. Ongoing surveillance is performed by ONC-authorized certification bodies. The program is voluntary, although most HIT developers participate.
 
In the RFI, ONC notes that CMS, under the Trump Administration, proposed a rule on Interoperability and Prior Authorization in December 2020, which would require payers to implement two application programming interfaces (APIs) to allow providers to look up services that require prior authorization and to facilitate transmission of prior authorization requests. Although CMS continues to consider whether to finalize and/or modify that rule, ONC believes that in the interim, there is “strong support across healthcare industry stakeholders” for additional action.
 
ONC specifically requests comments on: 

• The functional capabilities required to support electronic prior authorization in HIT;
• Implementation specifications to support electronic prior authorization, and specifically, whether the three HL7 FHIR Da Vinci implementation guides proposed previously by ONC are ready for adoption or if alternatives should be pursued;
• Standards for healthcare attachments; and
• Potential impacts on patients, providers, and developers.

The RFI notice can be found here. Comments must be submitted by March 25^th.
 
FTC/DOJ Seek Public Input as Part of Merger Guideline Review
On January 18^th, Federal Trade Commission (FTC) Chair Lina Khan announced that the FTC and the Department of Justice (DOJ) would jointly launch a review of merger guidelines. As part of the review, the agency is issuing an RFI with dozens of questions regarding appropriate standards and factors that should be considered. In her public comments, Khan noted the agencies were seeking input on key questions and topics including:

• Are the guidelines adequately attentive to the range of business strategies and incentives that might drive acquisitions?
• How should the guidelines analyze whether a merger may “tend to create a monopoly” or whether there is a “trend toward concentration” in the industry?
• Do the guidelines adequately assess whether mergers may lessen competition in labor markets, thereby harming workers?
• Are there factors beyond wages, salaries, and financial compensation that the guideline should consider when determining anticompetitive effects?
• When a merger is expected to generate cost savings through layoffs or reduction of capacity, should the guidelines treat this elimination of jobs or capacity as cognizable efficiencies?
• Are the guidelines unduly limited in their focus on particular types of evidence?
• Are there certain markets where the guidelines should provide a framework to assess direct evidence of market power?
• What types of indicators of market power should the guidelines consider?
• What types of evidence should the guidelines consider in evaluating non-price effects?

The FTC press release can be found here. The RFI is available here. 
 
Fowler Says CMMI Will Consider Changing Risk Adjustment Methodology
On January 19^th, Center for Medicare and Medicaid Innovation (CMMI) Director Liz Fowler said that CMMI is “looking at opportunities to replace or improve” its current risk adjustment methodologies, to address concerns about “coding and upcoding gains” that allow entities to receive increased payments without improving care. As an example of approaches CMMI might take, Fowler cited the program-wide constraint on risk score growth which is being implemented in the Global and Professional Direct Contracting (GPDC) program model. She suggested that such lessons might, if successful, be applied to the Medicare Shared Savings Program (MSSP) or Medicare Advantage.
 
Fowler was speaking at a webinar held by the United States of Care, a health policy research nonprofit, which has posted a video and transcript of the event here.
 
HRSA Announces Awards to Improve Health Care Worker Retention
On January 20^th, the Health Resources and Services Administration (HRSA) announced 45 awards totaling $103 million to “improve the retention of health care workers and help respond to the nation’s critical staffing needs by reducing burnout and promoting mental health and wellness among the health care workforce.” Awards will fund evidence-informed programs, practices, and training with a specific focus on providers in underserved and rural communities. The funding was made available through the American Rescue Plan. HRSA is making the awards through three programs: 

• $28.6 million to 10 grantees through the Promoting Resilience and Mental Health Among Health Professional Workforce;
• $68.2 million to 34 grantees through the Health and Public Safety Workforce Resiliency Training Program; and
• $6 million to George Washington University through the Health and Public Safety Workforce Resiliency Technical Assistance Center.

The press release is available here. A full list of award recipients, including the Research Foundation of the State University of New York, the Icahn School of Medicine at Mount Sinai, and La Casa De Salud, can be found here.

Other Updates

MedPAC Considers New APM Parameters, Approves Recommendations for March Report to Congress
On January 13^th and 14^th, the Medicare Payment Advisory Commission (MedPAC) convened for its monthly public meeting. Commissioners discussed a new population-based alternative payment model proposal, which would utilize administratively-set savings benchmarks and multiple tracks for different provider types. This would be a departure from the Medicare Shared Savings Program’s current ongoing rebasing of ACO benchmarks. Staff presented a potential model that would include three tracks: 

1. Independent physician practices, small safety net providers, or rural providers, with no financial risk and 50% shared savings;
2. Mid-sized organizations, such as multi-specialty physician practices or small community hospitals, with 75% shared savings/losses; and
3. Large health systems, with 100% shared savings/losses.

The Commission intends to include a chapter on its APM proposal in its June 2022 report to Congress.
 
Additionally, Commissioners approved a number of recommendations to Congress, which are not binding, regarding 2023 payment updates for Medicare providers, including: 

• For acute care hospitals, the current law update (presently 2.5% for inpatient services and 2% for outpatient services);
• For physicians and other providers paid under the Physician Fee Schedule, the current law update (presently 0%);
• For skilled nursing facilities, home health agencies, and inpatient rehabilitation facilities, a 5% payment reduction;
• For ambulatory surgery centers, no update to the 2022 conversion factor;
• For the end-stage renal disease prospective payment system, the update amount determined under current law;
• For hospice payments, eliminate the current law update to the base payment rate and wage adjust and reduce the hospice aggregate cap by 20%; and
• For long-term care hospitals, a 2% payment update.

The meeting agenda and slides are available here.
 
MACPAC Holds Monthly Public Meeting
The Medicaid and CHIP Payment and Access Commission (MACPAC) held its monthly public meeting on January 20^th and 21^st. The agenda included items such as: 

• The Commission’s approach to its access monitoring recommendations, to be included in the June report;
• Improving vaccine access;
• Restarting Medicaid eligibility redeterminations;
• State development of a formal care integration strategy for dual-eligible beneficiaries;
• The proposed rule affecting dual-eligible Special Needs Plans; and
• Review of a required report on the Money Follows the Person qualified residence criteria.

The agenda and slides may be found here.
 
Study Examines Which Health Systems Overutilize Low-Value Services
On January 14^th, researchers at Johns Hopkins University published a study in JAMA which examined 676 U.S. health systems to determine which systems were most likely to provide excessive amounts of low-value services. The study found that the systems most prone to overuse were: 

• Having fewer primary care physicians;
• Having higher bed counts; and
• Being investor-owned.

On the other hand, factors associated with less overuse included: 

• Being an academic medical center or having a teaching hospital;
• Providing a disproportionate amount of uncompensated care; and
• Being an integrated delivery system (e.g., Kaiser Permanente).

Factors that were not associated with either more or less overuse included: 

• Participation in CMS programs such as Accountable Care Organizations (ACOs) or bundled payment programs; and
• Ownership of a Medicare Advantage plan.

The study analyzed Medicare claims data from 2016 through 2018 at 676 health systems. Six New York hospitals were placed in the highest category, indicating the most overuse (Category 5). Conversely, the lowest two overuse scores in New York belonged to the specialty provider ArchCare and to New York City Health + Hospitals.
 
The JAMA article is available here, and all health system scores are available in Table 4 here.

HHS OCR Reports 2021 Was Record Year for Data Breaches
According to data from the HHS Office for Civil Rights (OCR), there were more health care data breaches in 2021 than any year since OCR launched its breach-tracking portal in 2010. Covered entities reported 712 breaches in 2021 affecting more than 45 million patients. Hacking and IT incidents accounted for about 74% of all reported breaches. Each of the 10 largest breaches involved cybercriminals infiltrating servers or email systems. Because covered entities have 60 days to report a breach, the 2021 tally is likely to increase.
 
A list of breaches currently under investigation by OCR is available here.

Congressional Hearings

No major health care-related hearings are scheduled next week. No health care-related hearings are currently scheduled next week. In particular, further information on the Senate Finance Committee hearing on youth mental health that was planned for January 26^th has not yet been publicly posted.

New York State Updates

DOH Updates New York State Roadmap for Medicaid Payment Reform
On January 19^th, DOH released for public comment an updated draft of the State’s Value Based Payment (VBP) Roadmap. The Roadmap, which outlines the State’s expectations for managed care organizations (MCOs) and providers related to the implementation of VBP, has not been renewed or updated since the expiration of the Delivery System Reform Incentive Payment (DSRIP) program in March 2020.
 
The update does not contain material changes to the requirements of the program, but it does reaffirm DOH’s commitment to VBP and reinforces DOH’s continued expectations for MCOs and contractors regarding VBP arrangements. The update also includes the following changes, among others: 

• Makes technical clarifications and removes outdated references;
• Streamlines and updates the structure of the Roadmap;
• Removes references to Integrated Primary Care (IPC) arrangements and associated requirements; and
• Changes Managed Long Term Care (MLTC) Partially Capitated arrangement requirements to guidelines.

The updates do not require changes to existing VBP contracts but should be incorporated as new contracts are executed or existing contracts are renegotiated.
 
Additionally, DOH is seeking feedback for a forthcoming, more substantial update to the Roadmap that would be associated with DOH application for a new 1115 Waiver. Interested parties may provide feedback by participating in DOH’s educational webinar on January 25^th at 1pm (registration here) or via the public comment form (available here). Questions and comments (using the provided form) may be submitted to vbp@health.ny.gov through February 18^th.
 
The updated VBP Roadmap draft is available here and the State’s Executive Summary is available here.

Dr. Mary T. Bassett Confirmed as New York State Health Commissioner
On January 20^th, the New York State Senate confirmed Dr. Mary T. Bassett as the 17^th New York State Health Commissioner. Dr. Bassett has served as Acting Health Commissioner since December 1^st. Prior to this, Bassett most recently served as the director of the François-Xavier Bagnoud Center for Health and Human Rights at Harvard University and as a professor in the department of Social and Behavioral Sciences at the Harvard T.H. Chan School of Public Health. Dr. Bassett served as Commissioner of the New York City Department of Health and Mental Hygiene from 2014 to 2018.
 
A statement from Commissioner Bassett is available here.

DOH Updates Adult BH HCBS Guidance and Workflow
On January 14^th, DOH updated the Adult Behavioral Health Home and Community Based Services (BH HCBS) Guidance (available here) for Health and Recovery Plan (HARP) and HIV Special Needs Plan (SNP) members enrolled in a Health Home. Effective January 1, 2022, MCOs, Health Homes, and Care Management Agencies will follow the updated workflow in the guidance, which includes the following key changes: 

• Only members who are interested in BH HCBS will need to receive the NYS Eligibility Assessment to access services;
• The 90-day timeframe to complete the NYS Eligibility Assessment is removed; and
• The face-to-face requirement for administering the NYS Eligibility Assessment can be met via telehealth.

Questions may be submitted to SpecialtyMH_HHCM@omh.ny.gov or to the Health Home email portal.

DOH and DFS Announce Extension of NY State of Health Open Enrollment Period
On January 14^th, the New York State Department of Financial Services (DFS) and DOH announced that the Open Enrollment period for NY State of Health, the State’s health plan marketplace, will continue to remain available, consistent with the extension of the federal Public Health Emergency. New Yorkers who enroll by January 15^th will receive coverage beginning February 1^st.
 
The DFS press release is available here.
 
DOH Clarifies HCBS Rate Enhancement Timelines
On January 19^th, DOH posted a Public Notice in the State Register (available here) clarifying the details regarding several proposed rate enhancements, which are included in the State’s spending plan for the enhanced Federal Medical Assistance Percentage (FMAP) for HCBS contained in the American Rescue Plan (ARP). The notice states that:

• Enhanced rates for the Children and Family Treatment and Support Services (CFTSS) package (14%) and for preventive and rehabilitative residential treatment services (25%) began effective October 1, 2021 and will extend through September 30, 2022.
• Enhanced rates for Personalized Recovery Oriented Services (PROS) programs (10.3%) began effective October 14, 2021. An additional 12% increase (for a total of 22.3%) will apply only during the period from October 14, 2021 through March 31, 2022.
• Enhanced rates for residential and state-plan approved addiction services (10%) began effective November 1, 2021 and will last through June 30, 2022.

Funding Opportunities

AHRQ Conference Grant Program Funding Opportunity
On January 19^th, the Agency for Healthcare Research and Quality (AHRQ) at HHS announced its continued interest in supporting conferences through its Conference Grant Program. AHRQ may provide up to $50,000 in direct support for conferences, regardless of project direction. Eligible applicants include public or private not-for-profit organizations.
 
AHRQ will support conferences that further its mission to promote evidence-based health care. Types of conferences eligible for support may include: 

• Research development;
• Research design and methodology;
• Dissemination and implementation; and
• Research training, infrastructure, and career development.

AHRQ is especially interested in supporting conferences that: 

• Include plans for disseminating complementary conference materials beyond the participants attending the event; or
• Address issues related to priority populations, including low income groups, racial and ethnic minority groups, women, children, the elderly, individuals with special health care needs (e.g., with disabilities and those who need chronic care and end-of-life health care), and individuals living in inner-city, rural, and frontier areas.

This funding opportunity expires November 3, 2022. More information on this opportunity is available here.
 
HRSA Issues RFP for Behavioral Health in Rural Areas
On January 18^th, HRSA announced that it would accept applications for the Rural Communities Opioid Response Program’s Behavioral Health Care Support (RCORP-BHS) initiative. Under this initiative, HRSA will award up to $500,000 per year to 26 applicants for four years to fund activities to improve the availability, quality, and capacity of behavioral health services in HRSA-designated rural counties and census tracts.  
 
Applicants may be any public or private, for-profit or not-for-profit entity. However, the applicant must be part of a consortium of at least four separately owned entities, of which at least 50% must be physically located in designated rural areas.
 
An HHS press release is available here, and the Notice of Funding Opportunity is available here.