Weekly Health Care Policy Update – August 22, 2022

August 29, 2022

In this update: 

  • Administration Updates
    • Fauci to Step Down as Chief Medical Advisor and NIAID Director in December
  • Federal Agencies
    • HHS, Labor, and Treasury Finalize Second Surprise Billing Rule
    • CMS Publishes “Roadmap for End of the Covid-19 PHE” Documents
    • CMS Announces Nursing Home Staffing Study
    • CMS Releases Guidance on Children’s Physical Health and Mental Health in Medicaid
    • CMS Proposes Rule to Standardize Medicaid and CHIP Quality Reporting
    • FDA Finalizes Rule Enabling OTC Access to Hearing Aids
    • CDC and HHS Announce Release of Environmental Justice Index
    • HRSA Announces Bi-Valent Covid-19 Booster Pre-Order for Health Centers
  • Other Updates
    • FTC Publishes Paper Criticizing State Use of COPAs
    • Joint Commission Sets New Health Equity Accreditation Standards
  • New York State Updates
    • Governor Hochul Extends NYS Covid-19 Emergency Declaration
    • Governor Hochul Announces Partnership to Expand Credentialing Opportunities for DSPs
    • DOH Updates FAQs, Posts Webinar on Health Care Worker Bonus Program
    • DOH and OMH Release FAQ on Duals Billing
    • DFS Revises Proposed Regulation on Inaccurate Information in Provider Directories
    • CMS Grants Temporary 90-Day Extension of New York’s 1915(c) TBI Waiver
    • CMS Approves New York State SPA Providing Coverage of Qualifying Clinical Trial Costs
    • Governor Hochul Signs Health Care-Related Legislation
  • Funding Opportunities
    • HRSA Releases Emergency Medical Services for Children State Partnership NOFO
    • NYC ACS Releases Family Enrichment Center Round Three RFP
    • HRSA Issues NOFO for FY 2023 Teaching Health Center GME Program

Administration Update

Fauci to Step Down as Chief Medical Advisor and NIAID Director in December
Today (August 22nd), Dr. Anthony Fauci announced that he would be stepping down from his government roles as Chief Medical Advisor to the White House and Director of the National Institute of Allergy and Infectious Diseases (NIAID) in December. In a statement, President Biden thanked Dr. Fauci for his service but did not immediately name an interim successor.
 
The White House’s statement is available here.

Federal Agencies

HHS, Labor, and Treasury Finalize Second Surprise Billing Rule
On August 19th, the Departments of Health and Human Services (HHS), Labor, and the Treasury released the second part of the final rule on the independent dispute resolution (IDR) process enacted under the No Surprises Act. The finalized rule establishes disclosure requirements regarding the qualifying payment amount (QPA) that is used as part of the basis for resolving payment disputes under the IDR process. Plans must disclose what the QPA is for each item or service to nonparticipating providers who submit claims to them with each initial payment or denial notice when the QPA serves as the basis for cost-sharing, including if the claim was downcoded.
 
It also finalizes provisions that address adjustments required by two court decisions earlier this year, which vacated parts of the first part of the final rule on surprise billing that would have required IDRs to “select the offer closest to the QPA, unless the certified IDR entity determined that the credible information submitted by the parties clearly demonstrates that the QPA is materially different from the appropriate out-of-network rate.” The revised final rule will no longer require IDRs to default to an offer close to the QPA or to apply a presumption in favor of such an offer. Instead, IDRs are directed to “select the offer that best represents the value of the item or service under dispute after considering the QPA and all permissible information submitted by the parties.”
 
The Departments noted in a status update that utilization of the IDR process has been “substantially” above expectations, with more than 46,000 disputes raised in the first 4 months of operations. Over 21,000 of these disputes were challenged on grounds of eligibility, and at least 7,000 were already found to be ineligible. As such, the Departments seek to promote further guidance to ensure that fewer ineligible disputes are submitted.
 
A press release is available here. The Departments also released a Fact Sheet on the rule, which is available here, and a new Frequently Asked Questions (FAQ) document, available here. The text of the final rule is here.
 
CMS Publishes “Roadmap for End of the Covid-19 PHE” Documents
On August 18th, the Centers for Medicare & Medicaid Services (CMS) released a “Roadmap for the End of the Covid-19 Public Health Emergency” (PHE). The information in the Roadmap includes: 

  • An updated list of the blanket waivers for health care providers that CMS has issued during the PHE that currently remain effective.
  • A series of fact sheets directed towards provider types (physicians, hospitals, etc.) containing up-to-date information on PHE-related waivers and flexibilities, including information on what policies will and will not be continued after the end of the PHE.

A press release announcing the “Roadmap” is available here and the comprehensive listing of blanket waivers is available here. The provider-specific fact sheets are housed here.
 
CMS Announces Nursing Home Staffing Study
Today (August 22nd), CMS announced that as part of its ongoing effort to develop new minimum staffing requirements for nursing homes, it will conduct a new staffing study. Currently, federal law only has a general requirement for nursing homes to have nursing services available 24/7, including the services of a registered nurse (RN) for at least 8 consecutive hours each day, with no particular requirement for staffing levels.
 
In its study, CMS will seek to use mixed qualitative and quantitative methods to identify a level of staff—including RNs, licensed practical or vocational nurses (LPNs/LVNs), and certified nurse aides (CNAs)—below which residents would be “at substantially increased risk” of inadequate care. CMS intends to use this and other information gathered to propose a new formal minimum staffing requirement in the spring of 2023.
 
CMS is conducting a stakeholder listening session on August 29th at 1pm to provide further information on the study and solicit other input on this topic. Registration is available here.
 
CMS’s press release is available here.
 
CMS Releases Guidance on Children’s Physical Health and Mental Health in Medicaid
On August 18th, CMS released two guidance documents for states concerning access to comprehensive health care, including behavioral and mental health care, for children enrolled in Medicaid or the Children’s Health Insurance Program (CHIP): 

  • The first guidance document reminds states of their obligation to cover necessary behavioral health care for children under the mandatory Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) benefit in Medicaid. Under EPSDT, all states must cover “necessary health care, diagnostic services, treatment, and other measures” to ameliorate conditions that include “physical and mental illness and conditions discovered by the screening services” regardless of the inclusion of such services in the Medicaid State Plan. The document further provides guidance and examples for Medicaid and CHIP programs on best practices for coverage of behavioral health services under EPSDT.
  • The second guidance document prompts states to work with schools to deliver on-site health care services to children enrolled in Medicaid, including immunizations, health screenings, oral health care, substance use disorder treatment, and mental health care.

The EPSDT guidance is available here. The guidance on school-based services is available here.
 
CMS Proposes Rule to Standardize Medicaid and CHIP Quality Reporting
On August 18th, CMS released a proposed rule to “promote consistent use of nationally standardized quality measures” in Medicaid and CHIP. The rule proposes to require all states to report three different quality measure sets annually: 

  • The Core Set of Children’s Health Care Quality Measures (in Medicaid and CHIP);
  • The behavioral health measures on the Core Set of Adult Health Care Quality Measures (in Medicaid); and
  • The two Core Sets of Health Home Quality Measures (in Medicaid, for the 20 states currently operating at least one Health Home).

Under this rule, reporting performance on these sets of quality measures would become mandatory for states starting in federal fiscal year 2024 (to report data that covers performance in calendar year 2023). These requirements will enable CMS to conduct evaluations of Medicaid and CHIP performance nationally and across states, and to monitor the impact of Health Homes for people with chronic conditions.  
 
The CMS press release is here and the full proposed rule is available here. Comments may be submitted through October 21st.
 
FDA Finalizes Rule Enabling OTC Access to Hearing Aids
On August 16th, the Food and Drug Administration (FDA) issued a final rule establishing a new category of over-the-counter (OTC) hearing aids, allowing consumers with “perceived mild to moderate hearing impairment” to purchase hearing aids directly from stores or online retailers without a medical exam, prescription, or a fitting adjustment by an audiologist. The new OTC category applies to certain air-conduction hearing aids intended for people 18 years and older. It does not include devices intended for severe hearing impairment. The final rule makes several important changes from the proposed rule issued in October 2021, including: 

  • Lowering the maximum sound output to reduce the risk to hearing from over-amplification of sound;
  • Revising the insertion depth limit in the ear canal;
  • Requiring that all OTC hearing aids have a user-adjustable volume control; and
  • Simplifying the phrasing throughout the required device labeling to ensure it is easily understood.

The final rule is available here.
 
CDC and HHS Announce Release of Environmental Justice Index
On August 10th, the Centers for Disease Control and Prevention (CDC), the Agency for Toxic Substances and Disease Registry (ATSDR), and the HHS Office of Environmental Justice announced the release of the Environmental Justice Index (EJI). The EJI is designed to measure total harm to human health that occurs from the combination of environmental burden such as pollution and poor environmental conditions, pre-existing health conditions, and social factors. The tool uses data from the U.S. Census Bureau, the U.S. Environmental Protection Agency, the U.S. Mine Safety and Health Administration, and the CDC to rank the cumulative impacts of environmental injustice on health for every census tract, providing a single score for local communities to help public health officials “identify and map areas most at risk for the health impacts of environmental burden.”
 
More information on the EJI is available here.
 
HRSA Announces Bi-Valent Covid-19 Booster Pre-Order for Health Centers
On August 17th, the Health Resources and Services Administration (HRSA) announced that health centers may now order the Pfizer-BioNTech Covid-19 bi-valent booster for patients 12 and older and the Moderna Covid-19 bi-valent booster for patients ages 12 and older. Both products are pending FDA authorization and recommendation by the CDC’s Advisory Committee on Immunization Practices (ACIP), but HRSA encourages health centers to pre-order as it will ensure availability of either/both vaccines immediately if such approvals/guidance are issued.
 
More information on the CDC’s Fall Vaccination Operational Planning Guide, which includes information on upcoming bi-valent booster doses, is available here.

Other Updates

FTC Publishes Paper Criticizing State Use of COPAs
On August 15th, the Federal Trade Commission (FTC) published a paper and a fact sheet that criticizes states’ usage of Certificates of Public Advantage (COPAs), which has increased in recent years. States often issue COPAs to immunize hospital mergers from antitrust laws in favor of state oversight. The FTC concludes, however, that COPAs are “often detrimental for patient costs, patient care, and healthcare worker wages.” The paper highlights the fact that most COPAs have resulted in a single hospital monopoly, and warns that such “substantial market power” can lead to higher prices, reduced quality of care, and even employer decisions to limit or eliminate insurance coverage. The paper also points to one study showing that mergers that significantly increase hospital concentration in local labor markets resulted in nominal wages that were 6.8% lower for nurses and pharmacy workers and 4.0% lower for non-medical skilled workers. Overall, FTC urges states to avoid using COPAs and invites state lawmakers to “work collaboratively with competition policy experts to minimize the harmful effects of further hospital consolidation on local patients, employers, and hospital employees.”
 
The Commission voted 5-0 to issue the policy paper. Links to the press release, policy paper, and fact sheet can be found here.
 
Joint Commission Sets New Health Equity Accreditation Standards
On August 11th, the Joint Commission announced that it would add health equity standards to accreditation programs for ambulatory health care organizations, behavioral health and human service organizations, critical access facilities, and hospitals beginning January 1, 2023. The new accreditation requirements will include: 

  • Designating a leader(s) to direct activities to reduce health care disparities;
  • Assessing patients’ health-related social needs and providing information on support resources;
  • Stratifying quality and safety data using socio-demographic characteristics;
  • Writing an action plan to address at least one of the identified disparities; and
  • Taking action when goals are not achieved or sustained.

More information is available here.

New York State Updates

Governor Hochul Extends NYS Covid-19 Emergency Declaration
On August 13th, Governor Hochul issued Executive Order 11.9, which extends New York’s second Covid-19 State Disaster Emergency declaration through September 12th. 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.   
 
Executive Order 11.9 is available here.
 
Governor Hochul Announces Partnership to Expand Credentialing Opportunities for DSPs
On August 15th, Governor Hochul announced that the New York State Office for People with Developmental Disabilities (OPWDD) has begun a three-year, $10 million partnership with the National Alliance for Direct Support Professionals to expand opportunities for professional credentialing. The partnership, which is supported by federal funding through the American Rescue Plan Act, will provide access to three levels of direct support professional (DSP) credentialing and frontline supervisor certification through participation in the National Alliance “E-Badge Academy.”
 
In next few weeks, the National Alliance will release a Request for Proposals (RFP) for eligible home and community-based service (HCBS) provider organizations to participate in the E-Badge Academy. The three-year project will provide credentialing or certification for about 2,442 DSPs and frontline supervisors. The project will also provide bonuses for participating DSPs and will reimburse employers for training hours undertaken by their staff.
 
The Governor’s press release is available here.
 
DOH Updates FAQs, Posts Webinar on Health Care Worker Bonus Program
On August 19th, DOH held a webinar to discuss the Health Care Worker Bonus (HWB) program, which offers certain “frontline” health care workers bonuses of up to $3,000. Qualified employers are required to participate by submitting requests for funding to DOH and paying the bonuses to their employees. On the webinar, DOH clarified that only providers who are included in the list of provider and facility types in statute are eligible for the HWB program. For example, private physician practices are not included.
 
The current list of eligible providers is: 

  • Article 28 hospitals and diagnostic and treatment centers;
  • Article 30 emergency medical services providers;
  • Article 36 (Public Health Law) home care providers;
  • Article 40 hospices;
  • Article 16 developmental disabilities providers;
  • Article 31 mental health providers;
  • Article 32 substance abuse providers;
  • Article 36 (Mental Hygiene Law) crisis stabilization centers;
  • Residential care programs licensed under Article 7 of Social Services Law;
  • School-based health centers;
  • Pharmacies registered under Section 6808 of the Education Law;
  • Programs funded by the Office of Mental Health (OMH), Office of Addiction Services and Supports (OASAS), or OPWDD; and
  • Other providers as determined by the Commissioner (no such determinations have yet been made).

DOH also clarified that employers will be reimbursed for the relevant payroll and FICA taxes that apply to these payments. Although they are exempt from state and local taxes, employers will still need to consider federal tax withholdings.
 
The webinar also included some clarifying guidance on specific employee titles that are eligible and ineligible for the HWB program. These include: 

  • Eligible employees: 
    • Infusion nurses in LHCSAs;
    • Pharmacists and pharmacy technicians in LHCSAs or Certified Home Health Agencies (CHHAs);
    • Patient Access Representatives or Coordinators.
  • Ineligible employees: 
    • Medical records employees;
    • Call center employees;
    • Billing coordinators;
    • Staff who work exclusively at non-patient facilities.

The updated FAQs are available here. The slides from the webinar are available here. Further webinars will be held on August 26th and September 2nd, and DOH expects to make further updates to the FAQs each Friday.

DOH and OMH Release FAQ on Duals Billing
On August 16th, DOH and the New York State Office of Mental Health (OMH) released an FAQ document related to billing for beneficiaries who are dually enrolled in Medicaid and Medicare. In general, for Medicare-covered services provided to duals, providers may bill Medicare and then “balance bill” the remainder to Medicaid if the Medicaid rate is higher. If covered services are provided by non-Medicare professionals, the provider should follow the “zero-fill” process to bill Medicaid directly. This document examines these and other example billing scenarios and describes under what conditions providers are eligible to receive the full Medicaid/APG rate for dual eligibles, and when the zero-fill process is appropriate. Note that the guidance in the FAQ does not apply to partial dual eligibles (Medicare enrollees who are partially eligible for Medicaid through the Medicare Savings Program).
 
The FAQ is available here. Questions may be submitted to OMH-Managed-Care@omh.ny.gov.
 
DFS Revises Proposed Regulation on Inaccurate Information in Provider Directories
On August 17th, the New York State Department of Financial Services (DFS) issued revisions to a proposed regulation that aims to protect consumers against health care provider directory misinformation, consistent with the federal No Surprises Act requirements. The revised regulation amends the previous regulation to clarify that the disclosure requirements apply to stand-alone dental and vision insurance.
 
The revised regulation also implements the requirement, as passed in New York’s Enacted Budget for Fiscal Year (FY) 2023, that if an issuer provides inaccurate network status information to an insured individual, the issuer must: 

  • Employ no greater cost-sharing requirements than would have applied if the provider were in-network; and
  • Reimburse the provider for the out-of-network services they provided to that insured individual, regardless of whether the policy covers out-of-network services.

The notice of revised rulemaking is available in the State Register here. The revised proposed regulation is available here. Comments will be accepted through October 1st.
 
CMS Grants Temporary 90-Day Extension of New York’s 1915(c) TBI Waiver
On August 17th, CMS granted a 90-day temporary extension of New York’s 1915(c) Traumatic Brain Injury (TBI) waiver. The TBI waiver, which was otherwise set to expire on August 31st, provides HCBS to individuals who have experienced the onset of a TBI between the ages of 18 and 64 and who meet a nursing facility level of care. The temporary extension will allow the State to “appropriately address CMS feedback regarding the significant programmatic, fiscal, and quality changes identified in the waiver renewal application.”
 
The renewal application: 

  • Allows for flexibility in the intake process by including telephonic and virtual methods for the collection of applicant information;
  • Adds guidance on Service Coordination visits and flexibilities related to Level of Care assessments, including requiring Service Coordination contact at least monthly with a quarterly in-home face-to-face visit (or more frequently as needed);
  • Updates minimum wage language and cost reporting language to reflect the enacted New York State Budget and current practices;
  • Adds language to provide consistency between Licensed Home Care Services (LHCSA) regulations and waiver service definitions, including modifying the provider qualification requirements for Nursing Supervision; and
  • Clarifies the State’s timeline for federally mandated 372 reporting.

The CMS approval letter is available here. The draft renewal application is available here.
 
CMS Approves New York State SPA Providing Coverage of Qualifying Clinical Trial Costs
On August 17th, CMS approved New York’s State Plan Amendment (SPA) that sought to include in the Medicaid benefit routine patient costs for items and services furnished in connection with participation in qualifying clinical trials. Routine patient costs do not include any investigational item or service that is the subject of the qualifying clinical trial and is not otherwise covered outside of the clinical trial under the state plan, waiver, or demonstration project. The approval is effective retroactive to April 1, 2022.
 
The SPA is available here and the CMS approval letter is available here.
 
Governor Hochul Signs Health Care-Related Legislation
This past week, Governor Hochul signed the following health care-related legislation: 

  • S8219A/A9730 requires an annual report for the independent substance use disorder and mental health ombudsman program by October 31st each year.
  • S8057A/A9344 requires the Office of Addiction Services and Supports (OASAS), in consultation with OMH, to provide annual outreach services to make certain stakeholders aware of the independent substance use disorder and mental health ombudsman program. 
  • S9185/A9764 renames the Office of Minority Health to the Office of Health Equity (OHE) and the Minority Health Council to the Health Equity Council and redefines OHE’s duties.
  • S7548A/A8540 requires school districts to develop a procedure to provide same-day notification to parents of students with disabilities if a physical or mechanical restraint is applied on the student or if the student is placed in a time-out room.
  • S8746/A6727 updates the practice of physical therapist assistant from a credentialed to licensed profession.
  • S67A/A3298 requires certain health care practitioners treating patients diagnosed with epilepsy to provide such patients with current and evidence-based information about sudden unexpected death in epilepsy risk factors and contact information for nonprofit organizations that provide information and support services for epilepsy conditions.
  • S995/A159 provides additional remedies for patients’ private right of actions in residential health care facilities, allowing class actions by a patient, patient’s legal representative, or such patient’s estate.

Funding Opportunities

HRSA Releases Emergency Medical Services for Children State Partnership NOFO
On August 9th, HRSA released a notice of funding opportunity (NOFO) for the Fiscal Year 2023 Emergency Medical Services for Children (EMSC) State Partnership. This opportunity supports demonstration projects for the expansion and improvement of emergency medical services for children who require treatment for trauma or critical care, particularly among children living in racial/ethnic minority, tribal, and rural communities. To achieve this goal, the program aims to: 

  • Expand the uptake of Pediatric Readiness Guidelines in Emergency Departments;
  • Develop Pediatric Readiness in Emergency Medical Services (EMS) Systems;
  • Increase pediatric disaster readiness by supporting the integration of pediatrics in hospital and prehospital disaster plans; and
  • Prioritize family partnership and leadership to improve EMSC systems of care.

Through this opportunity, HRSA will award over $12 million in annual funding to 59 grantees (up to $205,000 annually per award). Grants will last for four years, starting on April 1, 2023. Eligible applicants are state governments and accredited schools of medicine. One award will be made per state/jurisdiction.
 
Additional details are available here. Applications are due on November 7th. Questions may be sent to Jocelyn Hulbert at JHulbert@hrsa.gov.
 
ACS Releases Family Enrichment Center Round Three RFP
On August 8th, the New York City Administration for Children’s Services (ACS) released an RFP for a third round of funding to expand the Family Enrichment Center (FEC) model. The FEC model is a family-centered, place-based primary prevention approach available to all members in the community that aims to strengthen family protective factors, increase child and family wellbeing, and promote stability. FEC activities and events are available to everyone, regardless of current or past child welfare involvement.
 
ACS will award a total of $15.75 million over three years to nine organizations located in priority districts across the five boroughs as outlined in the RFP. Contracts will start on July 1, 2023, with the option to renew for two additional three-year contracts. Eligible applicants should have at least five years of relevant experience in the community district where they are applying to establish and manage an FEC.
 
The RFP is available in the PASSPort portal here by searching “Family Enrichment Centers 3.” Applications are due on September 30th. Questions may be sent to FEC-RFP@acs.nyc.gov through September 23rd.
 
HRSA Issues NOFO for FY 2023 Teaching Health Center GME Program
On August 19th, HRSA issued a NOFO for the FY 2023 Teaching Health Center Graduate Medical Education (THCGME) program. This program provides funding for the training of residents in primary care residency programs in community-based centers. TCHGME makes funds available for: 

  • Expansion awards to support an increased number of full-time equivalent (FTE) positions at existing TCHGME programs; and
  • New awards to support FTE positions at new Teaching Health Centers that have never received a payment through this program before.

HRSA expects to make 28 awards totaling $18.4 million in FY 2023. Applicants must operate an accredited primary care residency program in a federally-qualified health center (FQHC) or similar setting, or have formed a GME consortium that operates such a program.
 
The NOFO is available here. Applications are due October 18th.