The following is the latest health policy news from the federal government as of 2:45 p.m. on Thursday, April 21.  Some of the language used below is taken directly from government documents.

Proposed FY 2023 Medicare Inpatient Prospective Payment System Regulation

CMS has published its proposed FY 2023 Medicare inpatient prospective payment system regulation outlining how it envisions paying hospitals for the inpatient care they provide to Medicare patients in the coming fiscal year.  Highlights of the proposed regulation include:

  • A proposed 3.2 percent increase in inpatient rates and a 0.7 percent increase in LTCH rates.
  • A $654 million cut in the Medicare DSH uncompensated care pool.
  • A permanent limit of five percent in cuts in individual hospitals’ wage index in any one year.
  • Continued COVID-19-related suspension of some quality measures in the Hospital-Acquired Conditions Program, Hospital Readmissions Reduction Program, and Value-Based Purchasing Program.
  • Nearly a dozen requests for stakeholder comment on a variety of issues.

Learn more about the proposed rule in this CMS fact sheet and the proposed rule itself.  Another CMS news release addresses aspects of the proposed rule that seek to advance health equity and maternal health.  Stakeholder comments are due by June 17,

Department of Health and Human Services

Health Policy News

  • HHS has opened a portal through which payers and providers can report payment disputes and initiate steps to resolve those disagreements through a process of independent dispute resolution, a major aspect of implementation of the No Surprises Act, the surprise billing law passed in late 2020.  Find that portal here.
  • When payers and providers use that new portal they may find that the manner in which their disputes are addressed differs from what was described in regulations previously released by HHS.  HHS has revised its guidance for certified independent dispute resolution entities in response to a recent federal court ruling that vacated some aspects of those regulations.  Find the revised guidance here.
  • HHS and CMS are releasing data publicly, for the first time, on mergers, acquisitions, consolidations, and changes of ownership from 2016-2022 for hospitals and nursing homes enrolled in Medicare.  The agencies believe this data will provide a new tool for researchers, state and federal enforcement agencies, and the public to better understand the effect of consolidation on health care prices and quality of care.
  • HHS’s Office of the Assistant Secretary for Planning and Evaluation also is releasing a related report:  an analysis of the new CMS data examining trends in changes of ownership over the past six years.  Learn more about why HHS and CMS are releasing this data from this news release.
  • HHS has announced that it will award $226.5 million in grants to launch its Community Health Worker Training Program.  The Community Health Worker Training Program is a new, multi-year program focused on education and on-the-job training to build the pipeline of public health workers.  This program will seek to support training and apprenticeship programs to help more people enter the health workforce and serve as messengers to connect people to care and support, help ensure that patients follow-up on their providers’ recommendations, and focus on preventive and protective factors that can improve health and well-being.  Learn more about this grant funding opportunity from this HHS news release.  To learn more about applying for grants, see this grant opportunity notice.  Applications are due by June 14; there is no limit on the size of grants.
  • HHS and its Health Resources and Services Administration (HRSA) have announced the availability of nearly $90 million in grants to support new data-driven efforts for HRSA Health Center Program-supported health centers and look-alikes (HRSA-designated health centers) to identify and reduce health disparities.  The funding announced today can be used for various COVID-19 activities and for modifying, enhancing, and expanding health care services and infrastructure by improving health information technology, enhancing data collection, and supporting related staff training.  These efforts will advance broader COVID-19 response, mitigation, and recovery efforts.  In addition, they will help prepare for future public health emergencies.  To learn more about the funding opportunity, including how the money is to be used and what entities are eligible to apply for grants, see this HHS news release and this HRSA funding notice.  Applications are due by May 23.
  • HHS’s cybersecurity program has issued a warning for health care interests to be alert to attacks by the HIVE ransomware group.  HHS has posted a notice that explains its concerns, outlines how HIVE ransomware works and what signs organizations should look for to tell if their operations may be in jeopardy or under attack, and offers links to additional resources.
  • HHS and its Substance Abuse and Mental Health Services Administration (SAMHSA) have awarded nearly $105 million in grant funding to 54 states and territories in advance of the transition of the National Suicide Prevention Lifeline from the current 10-digit number to the 988 three-digit dialing code in July.  States and territories are expected to use the money to improve response rates, increase capacity to meet future demand, and ensure that calls initiated in their states or territories are first routed to local, regional, or state crisis call centers.  Learn more about the new funding, how it will be used, and the new approach to suicide prevention and find a link to a list of grant recipients (all of them state agencies) in this HHS news release.

COVID-19

Centers for Medicare & Medicaid Services

COVID-19

CMS has updated Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to require all laboratories to report COVID-19 test results in a standardized format and at a specified frequency.  Find the revised guidelines here.

Health Policy News

  • CMS has presented an outline of its action plan to pursue high-quality, affordable health care for all people, regardless of their background, and to drive health equity across HHS.  Building on the agency’s commitment to make health equity the first “pillar” of its strategic vision, CMS Administrator Chiquita Brooks-LaSure invited health care industry leaders to make commitments to advance health equity and work with CMS to share best practices to address systemic inequities in the delivery of care.  The major actions of the plan’s health equity strategy are:
    • Close gaps in health care access, quality, and outcomes for underserved populations.
    • Promote culturally and linguistically appropriate services.
    • Build on outreach efforts to enroll eligible people across Medicare, Medicaid/CHIP, and the health insurance marketplace.
    • Expand and standardize the collection and use of data, including on race, ethnicity, preferred language, sexual orientation, gender identity, disability, income, geography, and other factors across CMS programs.
    • Evaluate policies to determine how CMS can support safety-net providers.
    • Ensure engagement with and accountability to the communities served by CMS in policy development and the implementation of CMS programs.
    • Incorporate screening for and promote broader access to health-related social needs.
    • Ensure that CMS programs serve as a model and catalyst to advance health equity.
    • Promote the highest quality outcomes and safest care for all people.

To ensure sustained progress through meaningful initiatives, CMS will convene industry stakeholders, including health care facilities, insurance companies, state officials and providers.  The first of these gatherings will take place this summer and focus on ways to improve maternal health outcomes experienced by pregnant and postpartum people.  CMS and experts will invite health care industry leaders to share best practices and commitments to strengthen maternal health.

Learn more from this CMS news release.

  • Last week the White House, HHS, and CMS announced their intention to establish a new designation of qualified providers as “maternity-friendly hospitals.”  This concept also was presented in the proposed FY 2023 inpatient prospective payment system rule CMS published earlier this week.  Now, CMS has posted a fact sheet that explains the concept, and its intentions, in greater detail.
  • CMS has shared with stakeholders an agency-wide strategy built around six “pillars” and a series of areas of endeavor through what it is referring to “cross-cutting initiatives.”  Its pillars are:
    • advance equity
    • expand access
    • engage partners
    • drive innovation
    • protect programs
    • foster excellence

The areas of endeavor CMS has identified as those in which it will be most active are:

  • elevating stakeholder voices through active engagement
  • behavioral health
  • drug price affordability
  • maternity care
  • benefit expansion
  • rural health
  • preparing the health care system for the post-pandemic world
  • coverage transition (following the end of the public health emergency)
  • national quality strategy
  • nursing homes and choice in long-term care
  • data to drive decision-making
  • integrating Medicare, Medicaid and CHIP, and the health insurance marketplace

In support of these efforts CMS has established a new web page that presents its strategy and cross-cutting initiatives.  To learn more about all of these endeavors and the agency’s plans, go here.

  • CMS has published a rule with comment period to finalize the two remaining proposals from the proposed rule titled “Medicare and Medicaid Programs; Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly,” which appeared in the Federal Register on February 18, 2020.  The two proposals being finalized from the February 2020 proposed rule include the maximum out-of-pocket limits for Medicare Parts A and B services and cost-sharing limits for Medicare Parts A and B services.   These regulations take effect on June 13, 2022.  Learn more from this Federal Register notice.
  • CMS has posted a new MLN Connects, its online newsletter addressing Medicare reimbursement issues.  The latest edition includes articles about a new Medicare provider compliance newsletter, an update on COVID-19 claims processing guidelines, and more.  Find it here.

Centers for Disease Control and Prevention

The CDC has announced the launch of a new Center for Forecasting and Outbreak Analysis.  The role of the new entity will be to seek to enhance the nation’s ability to use data, models, and analytics to enable timely, effective decision-making in response to public health threats for CDC and its public health partners.  The center’s goals are to improve outbreak response using infectious disease modeling and analytics and to provide support to leaders at the federal, state, and local levels.  It also will develop a program to provide insights about infectious disease events to the public to inform individual decision-making.  Learn more from this CDC news release and the Center for Forecasting and Outbreak Analysis’s new web page.

Food and Drug Administration

The FDA has issued emergency use authorization for the first COVID-19 diagnostic test that detects chemical compounds in breath samples. The tests will be performed in environments where the patient specimen is both collected and analyzed, such as doctors’ offices, hospitals, and mobile testing sites using an instrument about the size of a piece of carry-on luggage.  The test will be performed by qualified, trained operators under the supervision of health care providers licensed or authorized by state law to prescribe tests and can provide results in less than three minutes.  The device’s manufacturer expects to be able to produce approximately 100 instruments a week that can each be used to evaluate approximately 160 samples a day.  At this level of production, testing capacity using the device is expected to increase by approximately 64,000 samples a month.  Learn more from this FDA announcement and from the FDA’s emergency use authorization letter.

National Institutes of Health

The NIH’s National Cancer Institute has published a Notice of Special Interest to highlight its interest in receiving investigator-initiated applications for conducting research on the use of telehealth in cancer-related care.  Studies focused on populations that experience inequities in access to care and have worse cancer outcomes compared to the general population are strongly encouraged.  Applications are being accepted into 2024 but the next application deadline is June 9, 2022.  Learn more about what the National Cancer Institute seeks and the parameters of proposals in this funding notice.

Medicaid and CHIP Payment and Access Commission (MACPAC)

MACPAC has submitted comments to CMS in response to CMS’s request for information on access to coverage and care in Medicaid and the State Children’s Health Insurance Program (CHIP).  In its 19-page response MACPAC stresses three ideas:  that in CMS’s commitment to addressing health disparities and
inequities it maintain an equity focus in all aspects of its work to examine and improve access to care and be specific about the steps it intends to take to address disparities; that it focus on beneficiaries who are especially vulnerable to experiencing poor health outcomes because of barriers to care; and that it be transparent in its actions by releasing data and actively engaging stakeholders in policy-making processes.  Go here to see the MACPAC response to CMS’s request for information.

MACPAC has published a report on Medicaid reimbursement for the services of community health workers.  Its report begins with an overview of various types of community health workers and the services they provide; reviews selected studies documenting the effects of community health worker programs on health outcomes and costs; and describes state approaches to covering community health workers services through Medicaid, including the various authorities states use to provide Medicaid payment, the services they cover, the populations served, and training and certification requirements.  Learn more in the MACPAC issue brief “Medicaid Coverage of Community Health Worker Services.”

Government Accountability Office (GAO)

In a study to review scientific integrity policies and procedures and how allegations of political interference in scientific decision-making are addressed at the CDC, FDA, NIH, and HHS’s Office of the Assistant Secretary for Preparedness and Response, the GAO found that these agencies do not have procedures that defined political interference in scientific decision-making or describe how it should be reported and addressed.  GAO recommended that the agencies address this shortcoming.  Learn more in the GAO report “Scientific Integrity:  HHS Agencies Need to Develop Procedures on Reporting and Addressing Political Interference.”

Stakeholder Events

CMS – National Stakeholder Call – April 26

CMS administrator Chiquita Brooks-LaSure and her leadership team will hold a national stakeholder call on Tuesday, April 26 at 3:30 (eastern) to “…provide updates on the CMS Strategic Vision and key accomplishments during the first quarter of 2022.”  Learn more about the event here and go here to register to participate.

CMS – Medicare Cost Report E-Filing System: Interim Rate and Settlement Documentation Webinar – April 26

CMS will hold a webinar to provide information about new functionality in the Medicare Cost Report E-Filing system to Medicare Part A providers and organization that files cost reports on Tuesday, April 26 at 1:00 (eastern).  Go here to learn more about the webinar, including what it will cover and how to submit questions in advance, and go here to register to participate.

CMS Health Equity Symposium – April 28

CMS and its Office of Minority Health will hold a virtual health equity symposium on Thursday, April 28 at 1:00 (eastern).  During the event, agency officials will discuss how CMS is operationalizing health equity across all its programs and talk about HHS and CMS equity plan initiatives, including the importance of data collection, the connection to stakeholder and partner efforts to improve health equity, and additional health equity information and updates.  Go here to register to participate.

CDC – Clinician Outreach and Communication Activity – May 5

The CDC’s Clinical Outreach and Communication Activity organization will hold a virtual webinar on evaluating and supporting patients presenting with cognitive symptoms following COVID-19 on Thursday, May 5 at 2:00 (eastern).  Go here to learn more about the webinar, the presenters, and how to participate.

HHS/Health Resources and Services Administration – Telehealth – May 16-17

HRSA will hold a virtual national telehealth conference on Monday, May 16 and Tuesday, May 17.  Over the course of two days, experts and leaders in the field will examine the evolution of telehealth, discuss its place in an overall, integrated health care delivery model, and review the lessons learned during the COVID-19 pandemic to inform the future of telehealth.  To learn more about the conference, see its agenda, and register to participate, go here.

CMS – Clinical Laboratory Codes and Fees Public Meeting – June 23

CMS will hold a public meeting to receive comments and recommendations on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System codes being considered for Medicare payment under the Clinical Laboratory Fee Schedule for calendar year 2023.  The meeting is scheduled for Thursday, June 23 at 9:00 (eastern).  To learn more about the meeting, about submitting comments and presentations for the meeting, and about joining the meeting virtually, see this Federal Register notice.

CMS – Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests – July 18 and 19

CMS’s Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests will meet virtually on Monday, July 18 and Tuesday, July 19 beginning at 9:00 on both days.  The purpose of the panel is to advise HHS and CMS on issues related to clinical diagnostic laboratory tests.  Learn more about the panel and how to participate in the meeting from this Federal Register notice.