Weekly Health Care Policy Update – September 19, 2022

September 26, 2022

In this update: 

  • Administration Updates
    • White House to Appoint Dr. Renee Wegrzyn to Lead ARPA-H
  • Legislative Update
    • House Passes the Improving Seniors’ Timely Access to Care Act
    • Bipartisan House Group Requests Stakeholder Feedback on MACRA
    • 375 Stakeholder Organizations Urge Senate Leadership to Pass Medicare Telehealth Extension Bill
    • Ways and Means Committee Releases Report on Health Care and the Climate Crisis
  • Federal Agencies
    • HHS and Other Departments Issue RFI on Implementation of Advanced EOB, Good Faith Estimate Requirements
    • CMS Releases Medicare Telehealth Trend Report
    • CMS Releases Preliminary Readmissions Penalty Data for FY 2023
    • AHRQ Issues RFI on Person-Centered Care Planning for Multiple Chronic Conditions
    • HRSA Opens Comment Period for Policy Guidance on Telehealth in Health Centers’ Scope of Project
    • CMS Announces MEDCAC December Meeting and AHRQ Draft Report on Coverage with Evidence Development Criteria
    • CMS Releases Marketplace Enrollment Report for February 2022
    • HHS OIG Publishes Report on Limited Treatment of OUD in Medicare
    • HRSA to Host Maternal Health Webinar
    • CMMI Announces Webinar on Approach to Person-Centered Care
  • Other Updates
    • AHA Releases Report on the Financial Health of Hospitals
    • Joint Commission to Review its Quality Standards
  • New York State Updates
    • CMS Posts NYHER 1115 Waiver Amendment Proposal for Public Comment
    • DOH to Hold Webinar on Medicaid Pharmacy Carveout on September 20th
    • OMH to Hold Webinar on Updated Clinic Regulations on September 29th
    • OASAS Finalizes Modifications to Title 14 Requirements
  • Funding Opportunities
    • NYSHealth Opens RFP Process for the 2022 Special Projects Fund
    • OMH Issues RFP for Expansion of Trauma-Informed Network Resource Center

Administration Update

White House to Appoint Dr. Renee Wegrzyn to Lead ARPA-H
On September 12th, President Biden announced his intent to appoint Dr. Renee Wegrzyn as the first director of the Advanced Research Projects Agency for Health (ARPA-H). Dr. Wegrzyn is currently a vice president of business development at Ginkgo BioWorks and Head of Innovation at Concentric by Ginkgo. Her work focuses on applying synthetic biology to infectious diseases. She has previously held roles in the federal government as a program manager in the Biological Technologies Office of the Defense Advanced Research Projects Agency (DARPA) and at the Intelligence Advanced Research Projects Activity (IARPA). Dr. Wegrzyn has also served in the scientific advisory boards for the National Academies of Science Board on Army Research and Development, Revive & Restore, Air Force Research Labs, Nuclear Threat Initiative, and the Innovative Genomics Institute. ARPA-H was officially launched in March 2022.
 
The White House press release is available here.

Legislative Update

House Passes the Improving Seniors’ Timely Access to Care Act
On September 14th, the House of Representatives passed the Improving Seniors’ Timely Access to Care Act by a voice vote. The bill would establish new requirements for Medicare Advantage (MA) plans regarding their prior authorization processes. Specifically, it would require MA plans to:  

  • Enact electronic prior authorization programs that can provide real-time authorizations of “routinely approved” items and services;
  • Submit information to HHS on their prior authorization programs, such as the percentage of approved and denied requests and the average response time;
  • Provide information to providers and enrollees on their prior authorization criteria and policies; and
  • Meet other criteria for prior authorization programs as established by HHS to provide beneficiary protections.

The legislation responds to a report released in April (see SPG’s May 6th update here) by the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) which found that MA plans deny or delay access to a significant proportion of services that meet Medicare coverage standards. The bill was given floor time after it crossed the threshold of 290 sponsors in May (see SPG’s May 13th update here). It was strongly supported by the American Hospital Association.
 
The bill will now move to the Senate for action in that chamber, where it now has 43 co-sponsors (22 Republicans and 21 Democrats). The legislation can be found here.
 
Bipartisan House Group Requests Stakeholder Feedback on MACRA
On September 8th, a bipartisan group of Congressional representatives issued a Request for Information (RFI) seeking feedback on “actions Congress could take to stabilize the Medicare payment system, without dramatic increases in Medicare spending, while ensuring successful value-based care incentives are in place.” The letter notes that without further action, current policies may result in a reduction in value-based participation over the next few years, because: 

  • “Logistical challenges have plagued” the implementation of the Medicare Access and CHIP Reauthorization Act (MACRA);
  • The 5% incentive bonus for participants in Advanced Alternative Payment Models (APMs) will expire in 2022; and
  • Thresholds to qualify for APM incentives and future payment adjustments under the Merit-Based Incentive Payment System (MIPS) “are scheduled for steep increases” in coming years.

The RFI seeks input from “health care providers, advocacy organizations, health economists, health finance experts, and others” on: 

  • The effectiveness of MACRA policies;
  • Regulatory, statutory, and implementation barriers that need to be addressed for MACRA to fulfill its purpose of increasing value;
  • How to increase provider participation in value-based payment models; and
  • Recommendations to improve the MIPS and APM programs.

The full letter is available here. Its authors include Representatives Ami Bera (CA-7), Larry Bucshon (IN-8), Kim Schrier (WA-8), Michael Burgess (TX-26), Earl Blumenauer (OR-3), Brad Wenstrup (OH-2), Bradley Scott Schneider (IL-10), and Mariannette Miller-Meeks (IA-2). Six of the eight Representatives are doctors.
 
Feedback is due October 31st and may be submitted directly to macra.rfi@mail.house.gov.
 
375 Stakeholder Organizations Urge Senate Leadership to Pass Medicare Telehealth Extension Bill
On September 13th, a group of 375 provider, advocacy, and other organizations signed a letter to Senate Majority Leader Chuck Schumer (D-NY) and Minority Leader Mitch McConnell (R-KY) urging the Senate to ensure the certainty of telehealth services in Medicare beyond the Covid-19 Public Health Emergency. Specifically, the letter encourages the Senate to pass a two-year extension of the current telehealth flexibilities available under the Covid-19 public health emergency (PHE). The House of Representatives passed such an extension (H.R. 4040) by a bipartisan vote of 416-12 in July.
 
The letter also suggests that future legislation should permanently implement: 

  • The lifting of limitations on provider and patient locations (originating and distant sites);
  • The removal of the remaining in-person requirements for telemental health;
  • Policies to ensure continued access to clinically-appropriate controlled substances without in-person requirements; and
  • Actions to increase access to telehealth services in the commercial market.

The full letter is available here.
 
Ways and Means Committee Releases Report on Health Care and the Climate Crisis
On September 15th, the House Ways and Means Committee released a Majority Staff Report on “the role the U.S. health system plays in the climate crisis.” The report is based on responses to the RFI released by the Committee in March, which was sent to a range of health care stakeholders, including health systems, dialysis companies, nursing homes, and others, and discusses: 

  • How the climate crisis and the prevalence of extreme weather events impact health care organizations; and
  • How health care organizations are assessing their climate impact and working to reduce their carbon footprints.

The report notes that even though more than half of respondents said they had experienced five or more extreme weather events in the last five years, only about a third said they had implemented formal climate action or preparedness plans (CAPPs) to limit their climate-related risk. In terms of addressing their own carbon footprints, respondents had “a diversity of experiences,” with some having extensive data related to the impact of sustainability goals while others had no sustainability goals at all yet.
 
The full report is available here.

Federal Agencies

HHS and Other Departments Issue RFI on Implementation of Advanced EOB, Good Faith Estimate Requirements
On September 14th, HHS, the Deparment of Labor, and the Department of the Treasury released a request for information (RFI) to inform future rulemaking for the advanced explanation of benefits (AEOB) and good faith estimate (GFE) requirements of the No Surprises Act. While most provisions of the No Surprises Act took effect January 1st, the three Departments issued subregulatory guidance in August 2021 announcing a delay of these requirements to allow further time for providers to build capacity.
 
The RFI requests information about topics including: 

  • How cost estimates and benefit explanations should be transferred within the health care system and to patients and whether providers should have to inform insurers when patients waive balance billing and cost-sharing protections;
  • Whether to encourage Fast Healthcare Interoperability Resources-based interfaces and how to address related privacy concerns;
  • The inclusion of diagnosis codes on AEOBs;
  • How the No Surprises Act and state surprise billing laws should be reflected in AEOBs; and
  • Potential economic impacts of the pending regulations.

The RFI was published in the September 16th Federal Register and may be found here. Comments are due November 15th. The August 2021 subregulatory guidance may be found here.
 
CMS Releases Medicare Telehealth Trend Report
On September 15th, the Centers for Medicare and Medicaid Services (CMS) released a new Medicare Telehealth Trends dataset with information about beneficiaries’ use of telehealth services in ambulatory settings between January 1, 2020 and March 31, 2022. The data encompasses preliminary Medicare Part B fee-for-service claims during this period. Highlights include: 

  • Overall, the percentage of Medicare users who received a telehealth service peaked in Q2 of 2020, at 47%. That number steadily decreased through Q4 of 2021 to a low of 16%, but increased slightly to 19% in Q1 of 2022.
  • Dual eligible beneficiaries were more likely to be telehealth users. Over 55% of such beneficiaries accessing telehealth services in Q2 of 2020, compared to under 45% of Medicare-only beneficiaries. This trend remained consistent through Q1 of 2022.
  • Younger Medicare beneficiaries, ages 0 to 64, were also much more likely to use telehealth services with a roughly 15 percentage point gap between that group and older beneficiary groups.
  • Urban Medicare beneficiaries were roughly 5 to 8 percentage points more likely to use telehealth services throughout this study than their rural counterparts.
  • Overall, White Medicare beneficiaries were the lowest users of telehealth by percentage, while Hispanic beneficiaries and Asian/Pacific Islander beneficiaries were most likely to use telehealth services.

This data is in accord with the OIG study on telehealth usage during a shorter timeframe (March 2020 through February 2021) released on September 7th (summarized in SPG’s September 13th update). The full data set can be found here.
 
CMS Releases Preliminary Readmissions Penalty Data for FY 2023
On September 15th, CMS released preliminary data for the Hospital Readmission Reduction Program (HRRP) penalties that will be assessed in fiscal year (FY) 2023. This is the first year that CMS has incorporated data collected during the Covid-19 pandemic, although CMS excluded claims from the first half of 2020. As such, the data covers the period from July 2018 through December 2019 and July 2020 through June 2021. CMS also suppressed the pneumonia readmissions measure.
 
As a result, the HRRP penalties are the lowest in nearly ten years. In FY 2023, more than 25% of hospitals will not face readmissions penalties, up from under 18% in FY 2022. In addition, there will be a 57% decrease in hospitals paying penalties that exceed 1%.
 
AHRQ Issues RFI on Person-Centered Care Planning for Multiple Chronic Conditions
On September 16th, the Agency for Healthcare Research and Quality (AHRQ) released an RFI seeking comment on “the current state of comprehensive, longitudinal, person-centered care planning” for people who have or at risk for developing multiple chronic conditions (MCC). AHRQ is looking for information on innovative models of care and other approaches to help clinicians engage in effective care planning that will improve the care they offer to people with MCC. AHRQ asks a wide variety of specific questions across areas that include but are not limited to: 

  • The structure of effective care planning models (including team roles and responsibilities, appropriate credentials, etc.);
  • Payment models that might sustain such models; and
  • The impact of electronic care planning and supporting interoperability in care planning.

The RFI is available here. Comments may be submitted through November 15th.
 
HRSA Opens Comment Period for Policy Guidance on Telehealth in Health Centers’ Scope of Project
On September 14th, the Health Resources and Services Administration (HRSA) announced that it would open public comment on a Draft Scope of Project and Telehealth Policy Information Notice (PIN). The purpose of the PIN is to “establish policy guidance for health centers that provide services via telehealth within the HRSA-approved scope of project.” The document clarifies that telehealth is not a “service or service delivery method requiring specific HRSA approval.” The guidance covers: 

  • Considerations for delivering services via telehealth within the HRSA-approved scope of project, such as: 
    • Health centers must ensure that telehealth patients have access to the full scope of HRSA-approved services.
    • Health centers should delineate staff responsibilities pertaining to telehealth, such as who will obtain informed consent for telehealth services.
    • Health centers must ensure that appropriate sliding fee scale discounts are available to patients served by telehealth.
  • Criteria for delivering services via telehealth within the HRSA-approved scope of project, including: 
    • The health center must document an appropriate intake process.
    • The health service provided must be in the health center’s scope of project.
    • The individual receiving services must be “physically located within the health center’s service area.”
    • The provider may be located at a health center site or elsewhere.
  • Telehealth and eligibility for other federal programs. 
    • Services delivered by telehealth may be eligible for federal liability coverage and for 340B discounts, if other program requirements are met.

The full document, as well as a link to submit comments, can be found here. Comments may be submitted through November 14th.
 
CMS Announces MEDCAC December Meeting and AHRQ Draft Report on Coverage with Evidence Development Criteria
On September 12th, CMS announced that it will convene a panel of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) on December 7th. The meeting will examine the minimum Coverage with Evidence Development (CED) criteria for clinical studies submitted for CMS approval. CED enables the Medicare program to cover items and services on the condition that they are furnished in the context of approved clinical studies or with the collection of additional clinical data. The CED process was designed in 2005 and was recently applied to Aduhelm, the controversial treatment for Alzheimer’s disease approved by the Food and Drug Administration in June 2021.
 
With the MEDCAC announcement, CMS also announced the release of a new report by AHRQ on CED. The report makes recommendations to CMS for an update to the CED study design requirements and will be central to the discussion in the MEDCAC meeting.
 
The AHRQ report is available here and is open for comment through September 28th.
 
CMS Releases Marketplace Enrollment Report for February 2022
On September 16th, CMS released data on enrollment in individual Marketplace coverage in February 2022. CMS notes that total effectuated enrollment has increased to 13.8 million in February 2022, up significantly from the average monthly enrollment of 10.3 million in 2020. Year-over-year, the average total premium paid by consumers after tax credits fell by more than $30 per month, to an average of $127.03, largely as a result of the American Rescue Plan’s enhanced premium tax credits.
 
The full report is available here.
 
HHS OIG Publishes Report on Limited Treatment of OUD in Medicare
On September 13th, the HHS OIG published a report entitled “Opioid Overdoses and the Limited Treatment of Opioid Use Disorder Continue to be Concerns for Medicare Beneficiaries.” The report found that 50,400 Part D beneficiaries experienced an opioid overdose during 2021, and notes that the number is likely an undercount given that it only includes those beneficiaries who received medical care that was billed to Medicare. Even though the number of Medicare Part D beneficiaries receiving opioids in 2021 decreased, a trend that continued from prior years, over one million Medicare beneficiaries had a diagnosis of opioid use disorder in 2021. Fewer than 20% of these beneficiaries received medication to treat the disorder, while the number of Part D beneficiaries receiving naloxone increased.
 
OIG recommends that CMS take steps to improve access to medications for the treatment of opioid use disorder and other support services, which echoes OIG’s conclusion in a December 2021 report.
 
The full report is available here.
 
HRSA to Host Maternal Health Webinar
On September 20th at 12pm, HRSA will host a webinar entitled “Utilizing Telehealth to Address Maternal Health Challenges.” Topics will include: 

  • Funding and resources to support maternal and child health initiatives;
  • Recognizing the need and impact of tele-behavioral health resources for the perinatal population;
  • Identifying local and national resources;
  • The educational and physical benefits of remote blood pressure monitoring; and
  • The evidence base for patient-reported data and the benefits of patient-engaged care.

Registration is available here.
 
CMMI Announces Webinar on Approach to Person-Centered Care
On September 20th at 3:30pm, the CMS Innovation Center (CMMI) will host a webinar on the Center’s approach to “testing models and innovations that support person-centered care.” The session will cover: 

  • How CMMI’s “Strategy Refresh” is building a more person-centered health system;
  • How CMMI model tests will incorporate patient perspectives across the life cycle of models to ensure patient needs are met; and
  • How patient-reported outcome measures will be leveraged in models to better measure patient experience and outcomes.

Attendees may submit written comments or questions in advance through the registration page, or during the session. Registration is available here.

Other Updates

AHA Releases Report on the Financial Health of Hospitals
On September 15th, the American Hospital Association (AHA) released a new analysis of the financial health of the country’s hospitals. The report, prepared by Kaufman, Hall & Associates, finds that 2022 was the most financially difficult year for hospitals since the beginning of the pandemic, with more than half of hospitals currently experiencing operating losses. The report projects that this could rise to two-thirds by the end of the year. Margins are expected to be down 37% relative to pre-pandemic levels, while expenses are projected to be up nearly $135 billion over 2021, including an $86 billion increase in labor expenses.
 
As a result, AHA recommends that Congress should consider the following actions: 

  • Preventing imposition of the PAYGO 4% cut to Medicare reimbursement and reinstituting the suspension of the 2% Medicare sequester;
  • Making Covid-19 emergency waivers permanent, including flexibilities for telehealth and hospital-at-home programs;
  • Extending programs for rural communities, such as the low-volume adjustment and the Medicare-dependent hospital programs, which are set to expire on September 30th;
  • Evaluating payment adjustments under the Medicare payment system;
  • Advancing ideas to stabilize safety net hospitals;
  • Seeking an equitable remedy for those hospitals affected by unlawful 340B payment cuts in previous years, based on the Supreme Court’s decision; and
  • Increasing oversight and administrative simplification initiatives for commercial health plans.

AHA’s press release on the analysis is here. The full report is available here.
 
Joint Commission to Review its Quality Standards
On September 13th, Joint Commission President and CEO Jonathan Perlin announced that the organization would begin a review of all requirements that go “above-and-beyond” CMS Conditions of Participation (CoPs), and are not on crosswalks to the CoPs, in order to focus on those that are “most meaningful in driving safety, quality, equity, and value.” The Joint Commission will specifically investigate about 500 quality measures, considering whether requirements address important quality and safety issues, whether they are redundant with other requirements, and whether the time and resources needed to comply are commensurate with the benefit. The Joint Commission will identify an initial set of standards to be retired in January and will release updates every six months thereafter, in collaboration with experts in the field.
 
The press release is available here.

New York State Updates

CMS Posts NYHER 1115 Waiver Amendment Proposal for Public Comment
On September 19th, CMS publicly posted the New York’s application for a new amendment to its 1115 waiver, called New York Health Equity Reform (NYHER), following its review of the application’s completeness (available here). This initiates a 30-day federal comment period.
 
Through the application, New York is seeking $13.52 billion over five years to fund programs to address health disparities and systemic health care delivery issues that have been intensified by the Covid-19 pandemic. The amendment seeks to achieve the integration of social, physical health, and behavioral health into the fabric of the New York State Medicaid program. 
 
SPG’s summary of the NYHER proposal is available here, and its full text is available here. Comments may be submitted here through October 19th.
 
DOH to Hold Webinar on Medicaid Pharmacy Carveout on September 20th
On September 20th at 1pm, the Department of Health (DOH) will host an informational webinar about the transition of the pharmacy benefit from Medicaid Managed Care to NYRx, the Medicaid fee-for-service pharmacy program. The webinar is part of a recurring monthly series for stakeholders on the carveout, which is set to take place beginning April 1, 2023.
 
There will be a designated question and answer period at the end of the webinar. Required registration for the webinar is available here. Following the webinar, the presentation will be posted to the DOH website here.
 
OMH to Hold Webinar on Updated Clinic Regulations on September 29th
On September 29th at 3pm, the Office of Mental Health (OMH) will hold a webinar that provides an overview of the regulatory updates to Part 599 of Title 14 of the New York Codes, Rules, and Regulations for Mental Health Outpatient Treatment and Rehabilitative Services (MHOTRS), formerly the Article 31 clinic treatment programs. In November 2021, CMS approved moving the Article 31 clinic services into the Medicaid Rehabilitative Services (“rehab option”) in the State Plan Amendment, requiring several amendments to Part 599. The regulatory amendments add flexibility for billing and waiver processes, allow for the provision of peer/family support services, and allow offsite services for all populations served within MHOTRS.
 
The text of the proposed Part 599 regulations are available here. Registration for the webinar is available here.
 
OASAS Finalizes Modifications to Title 14 Requirements
On September 14th, the Office of Addiction Services and Supports (OASAS) published final rules in the State Register amending the following parts of Title 14 of the New York Codes Rules, and Regulations, following a public comment period: 

  • Part 800: General Provisions Applicable to All Programs Certified, Funded or Otherwise Authorized by OASAS
  • Part 815: Patient Rights in OASAS Programs
  • Part 816: Withdrawal and Stabilization Services
  • Part 817: Residential Rehabilitation Services for Youth
  • Part 818: Inpatient Rehabilitation Services
  • Part 819: Residential Services
  • Part 820: Residential Services
  • Part 822: Outpatient Programs
  • Part 830: Designated Services and License Endorsements
  • Part 836: Incident Reporting Requirements at All Certified, Licensed, Funded, or Operated Services

The amendments include technical changes and updates of terminology and program standards. No significant changes were made from the last published proposed rules. The Notice of Adoption for the amended rules is available here.

Funding Opportunities

NYSHealth Opens RFP Process for the 2022 Special Projects Fund
On September 15th, the New York Health Foundation (NYHealth) began accepting online inquiries for the first cycle of the 2023 Special Projects Fund.
 
The Fund provides a total of about $2.5 million per cycle for projects that support NYHealth’s mission to improve the health of all New Yorkers, especially the most vulnerable populations. In order to extend its mission across different focus areas, projects selected for funding are not permitted to address any of the following NYHealth priorities: 

  • Healthy Food, Healthy Lives;
  • Veterans’ Health; and
  • Primary Care (new this year, replacing Empowering Health Care Consumers).

NYHealth will provide a one-time, nonrenewable grant between $50,000 and $300,000 to successful applicants. Special Projects Fund grants are typically in the $250,000 range, with about five to fifteen awards made annually. Applicants must be not-for-profit 501(c)(3) organizations or for-profit organizations that can demonstrate their ability to significantly impact the health of New Yorkers in alignment with NYHealth’s mission. Previously awarded projects are available here.
 
The full RFP is available here and an FAQ is available here. Online inquiries are due on October 12th by 1pm. Full proposals, for invited applicants only, will be due on January 12, 2023.  
 
OMH Issues RFP for Expansion of Trauma-Informed Network and Resource Center
On September 14th, OMH announced the availability of $9.5 million over five years for one entity to operate the New York State Trauma-Informed Network, which was first established in 2018, and further expand the initiative by establishing a Resource Center. The project will now be known as the NYS Trauma-Informed Network and Resource Center (TINRC). The resource center will advance the understanding of trauma, the use of trauma-informed principles, and the availability of trauma-informed care throughout NYS.
 
The selected entity is expected to: 

  • Promote the NYS TINRC throughout NYS;
  • Provide ongoing support to agencies and organizations already implementing trauma-informed practices; and
  • Expand training and support to new agencies and organizations, especially those serving ethnoracially diverse populations.

Eligible applicants include 501(c)(3) not-for-profit agencies with demonstrated experience providing information and training around trauma and trauma-informed practices and providing support for the implementation of trauma-informed practices in organizations and/or communities.
 
The RFP is available here. Questions may be submitted by email to OMHLocalProcurement@omh.ny.gov by September 28th; answers will be posted by October 13th.
 
Interested applicants must submit a letter of intent (LOI) to bid by October 20th to OMHLocalProcurement@omh.ny.gov with the subject line “LOI for NYS Trauma Informed Network and Resource Center”. Proposals are due on October 26th by 1pm.