The following is the latest health policy news from the federal government for August 9-15.  Some of the language used below is taken directly from government documents.

Department of Health and Human Services

• To advance its implementation of the 2009 Health Information Technology for Economic and Clinical Health Act (HITECH Act), HHS has published a proposed regulation that would amend and update its Health and Human Services Acquisition Regulation.  The proposed regulation would require health care organizations that contract with HHS to comply with standards for data exchange adopted by the Office of the National Coordinator for Health Information Technology (ONC).  The proposed rule seeks to align and coordinate health IT-related activities in support of HHS’s health IT and interoperability goals and to ensure the alignment of health IT activities to avoid the proliferation of what HHS describes as “ad hoc health IT and data silos” that threaten to undercut the effectiveness and efficiency of HHS’s policies and programs, are costly for federal and state agencies and private sector partners to create and maintain, lack synergies across programs, and, because of the lack of alignment across and within HHS agencies, impose significant burdens on health care providers, technology developers, and other health care stakeholders.  Learn more about the proposed rule from this HHS announcement and this Federal Register notice.  ONC also elaborates on the proposed regulation’s objectives in this entry on the ONC blog.  The deadline for submitting comments is October 8.
• HHS’s Office of the Assistant Secretary for Planning and Evaluation (ASPE) has published an issue brief on barriers and opportunities for improving interstate licensure portability for behavioral health practitioners.  Find that issue brief here.
• An audit performed by HHS’s Office of the Inspector General found that Medicare improperly paid hospitals $79 million for enrollees who had received mechanical ventilation because hospitals used incorrect procedure or diagnosis codes.  Learn more from this Office of the Inspector General report.

Centers for Medicare & Medicaid Services

• CMS will introduce a series of changes to the Accountable Care Organization Realizing Equity, Access, and Community Health (ACO REACH) Model starting in performance year 2025.  These changes are expected to improve the model test by adjusting the financial methodology to improve model sustainability based on the findings in the performance year 2022 evaluation report; by responding to feedback from interested parties on improvements to the accuracy of benchmarks; and by strengthening operational flexibility and risk management.  Go here for CMS’s summary of the changes.
• The Inflation Reduction Act of 2022 authorized Medicare to directly negotiate the prices of certain high-expenditure, single-source prescription drugs without generic or biosimilar competition with the manufacturers of those drugs.  CMS selected ten drugs covered under Medicare Part D for the first cycle of negotiations for initial price applicability year 2026 and has announced that the negotiated prices, if they are finalized, could save Medicare $6 billion and Medicare beneficiaries up to $1.5 billion during calendar year 2026 when the reductions take effect.  Learn more about the Inflation Reduction Act’s effect on the price of selected prescription drugs, the process of selecting the drug prices to be negotiated, the drugs that were selected to undergo this process and the savings CMS projects from the 10 individual drugs, and more from this CMS news release and an accompanying fact sheet.
• CMS has revised its bulletin on the July update of the hospital outpatient prospective payment system, updating the number of certain drugs, biologicals, and radiopharmaceuticals, adding new subsections, and updating the change request release data, transmittal number, and change request link.  Find the revised bulletin here.
• CMS has posted information about the October quarterly update of the Medicare physician fee schedule database, which includes new codes, procedure status changes, code short descriptor revisions, and payment policy indicator changes.  Find those updates in the October quarterly updates (ZIP).
• CMS has updated its resources to help skilled nursing facilities use place of service codes 21, 31, and 32.  Those updated resources are an updated skilled nursing facility three-day rule billing fact sheet; an updated Medicare skilled nursing facilities prospective payment system educational tool; and a skilled nursing facility billing reference educational tool.
• CMS has updated its April instructions to providers about including oral-only drugs in the ESRD prospective payment system bundled payment.  Find the updated instructions here.  The instructions take effect on January 1, 2025.
• CMS has posted a bulletin outlining updates of hospice payment rates, the hospice wage index, the hospice pricer, and the hospice cap for FY 2025.  Find that bulletin here.
• CMS has released a new poster for hospitals to display for patients to know their Emergency Medical Treatment & Labor Act (EMTALA) rights.  The poster includes information about how consumers can file a complaint if they believe their rights have been violated.  Find that poster here.
• CMS has updated the waivers and flexibilities it extended to health care providers in Florida, Georgia, South Carolina, and Texas in the wake of Hurricane Debby.  Find those waivers and flexibilities here.

HHS Newsletters

• CMS – MLN Connects – August 15
• AHRQ News Now – August 6
• HRSA eNews – August 1 (includes funding opportunities)
• HRSA – July in brief

HHS Videos

• CMS – “Day Of vs. Date From and Timing Comparisons.”  As part of CMS’s “Teach Me CQL” series, this video presents an overview of timing precision in date comparisons in CQL (clinical quality language), reviews the use of “day of” and “date from” in CQL, and provide examples of timing precision and “day of” and “date from” in current program eCQMs.
• CMS – “Analyzing Network Data to Improve Access to Providers to Meeting the Health Equity Needs.”
• CMS – “Ensuring Access for Patients with Disabilities in an Evolving Telehealth Landscape.”

Medicaid and CHIP Payment and Access Commission (MACPAC)

MACPAC examines access to care for two groups that use Medicaid-funded long-term services and supports – Medicaid beneficiaries who are age 65 and older (including individuals with physical disabilities) and Medicaid beneficiaries who are age 18 to 64 with physical disabilities – in its new report “Access in Brief:  Seniors and Adults with Physical Disabilities.”

Government Accountability Office (GAO)

In 2023 Medicare introduced a benefit that helps certain kidney transplant patients pay for the immunosuppressive drugs they need to prevent their bodies from rejecting their new kidney.  Patients are eligible for this benefit if they had Medicare coverage for their kidney transplant, that coverage has ended, and they are not enrolled in certain types of health coverage.  This benefit is limited to immunosuppressive drugs and does not cover other Medicare services.  In the new report “Kidney Transplants:  Medicare Coverage of Immunosuppressive Drugs” the GAO examines Medicare’s implementation of this program.

Centers for Disease Control and Prevention

The CDC has issued a health alert notifying providers, public health authorities, and the public about current increases in human parvovirus B19 activity in the U.S.  Parvovirus B19 is a seasonal respiratory virus that is transmitted through respiratory droplets by people with symptomatic or asymptomatic infection.  Learn more from this CDC alert.

Food and Drug Administration

The FDA has approved the first epinephrine product for the treatment of anaphylaxis that is not administered by injection; it is administered through a nasal spray.  Learn more from this FDA news release.

National Institutes of Health

An NIH-supported study has found that routine lab tests may not be useful in diagnosing long COVID for people who have symptoms of the condition.  Learn more from this NIH news release.

Department of Homeland Security

The Department of Homeland Security’s Cybersecurity and Instructure Security Agency (CISA), in partnership with the FBI, has released an update to joint Cybersecurity Advisory #StopRansomware: Royal Ransomware, #StopRansomware: BlackSuit (Royal) Ransomware.  The updated advisory provides network defenders with recent and historically observed tactics, techniques, and procedures (TTPs) and indicators of compromise (IOCs) associated with BlackSuit and legacy Royal activity.  FBI investigations identified these TTPs and IOCs as recently as July 2024.  BlackSuit ransomware attacks have spread across numerous critical infrastructure sectors including, but not limited to, commercial facilities, health care and public health, government facilities, and critical manufacturing.  Learn more from this CISA alert, which includes links to more information and advice about addressing BlackSuit and legacy Royal activity.

Stakeholder Events

CMS – Maternal Health Webinar – August 20

CMS will hold a maternal health webinar on Medicaid and CHIP program collaborations with hospitals on AIM (Alliance for Innovation on Maternal Health) bundles on Tuesday, August 20 at 2:00 (eastern).  Go here to register to participate.

CMS – 2024 “Rural Health Hackathon” – August 22 and 29

CMS and its Center for Medicare and Medicaid Innovation are holding a series of collaborative sessions, to be held in person, designed to generate and develop creative and actionable ideas to address rural health challenges.  The event seeks to build on CMS’s outreach to rural communities through site visits and listening sessions to better understand rural health care issues.  At these sessions CMS will bring together rural health community care providers, community organizations, industry and tech entrepreneurs, funders, policy experts, and beneficiaries to attempt to take advantage of the collective experience and expertise of participants to generate new ideas to address some of the top challenges affecting health care in rural health settings and drive action to improve clinical outcomes, increase access, and foster a better care experience for patients and providers in rural communities.  The two remaining Hackathon events will be held in person on August 22 in Dallas and on August 29 in Wilson, North Carolina.  Learn more about the event, including how to participate in person or submit ideas virtually, from this CMS announcement.

CMS – Transition of PrEP from Medicare Part D to Medicare Part B Webinar – August 22

CMS is encouraging pharmacies and other affected parties to prepare now for the expected transition of coverage from Medicare Part D to Medicare Part B for Preexposure Prophylaxis (PrEP) using antiretroviral drugs to prevent HIV.  It expects to release a final National Coverage Determination (NCD) in late September 2024, with coverage under Part B to begin once it issues this final NCD.  CMS will answer questions about the transition during pharmacy enrollment office hours on Thursday, August 22 from 3:30-4:30 (eastern).  Go here to learn more and register to participate.

FDA – Implementation of New In Vitro Diagnostic Products Regulation – August 22

Earlier this year the FDA issued a final rule amending its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory.  At the time, the FDA outlined a policy to phase out its general enforcement discretion approach to laboratory-developed tests.  On Thursday, August 22 at 1:00 (eastern) the FDA will host a webinar for laboratory manufacturers and other interested stakeholders to discuss how to comply with medical device reporting requirements, correction and removal reporting requirements, and quality system requirements regarding complaint files beginning May 6, 2025.  Go here for more information about the webinar and how to participate.

CMS – Advisory Panel on Hospital Outpatient Payment Meeting – August 26-27

CMS’s Advisory Panel on Hospital Outpatient Payment will meet virtually on Monday, August 26 and Tuesday, August 27. The purpose of the panel is to advise the Secretary on the clinical integrity of the Ambulatory Payment Classification groups and their associated weights, which are major elements of the Medicare hospital outpatient prospective payment system, the ambulatory surgical center payment system, and the supervision of hospital outpatient therapeutic services.  The panel invites presentations and comment letters.  Learn more about the panel, submitting materials, and how to participate in the meeting from this CMS notice.

CMS – Rural Health Open Door Forum – August 29

CMS will hold an open-door forum for rural health providers on Thursday, August 29 at 2:00 (eastern).  Go here to register to participate.

CMS – Skilled Nursing Facilities/Long-Term-Care Providers Open Door Forum – September 5

CMS will hold an open-door forum for skilled nursing facilities/long-term care providers on Thursday, September 5 at 2:00 (eastern).  Go here to register to participate.

MedPAC – Commissioners Meeting – September 5-6

MedPAC commissioners will hold their next public meeting on Thursday, September 5 and Friday, September 6.  The meeting agenda and information about participating in the meetings in person or remotely are not yet available but when they are they will be posted here.

CMS – Hospital Open Door Forum – September 10

CMS will hold an open-door forum for hospital officials on Tuesday, September 10 at 2:00 (eastern).  Go here to register to participate.

CMS – Maternal Health Webinar – September 17

CMS will hold a maternal health informational webinar offering an overview of maternal health affinity groups and the expression-of-interest process on Tuesday, September 17 at 2:00 (eastern).  Go here to register to participate.

CMS – Home Health, Hospice, and DME Open Door Forum – September 18

CMS will hold an open-door forum for home health, hospice, and DME providers on Wednesday, September 18 at 2:00 (eastern).  Go here to register to participate.

CDC – Outreach Webinar on Lyme Disease – September 19

As part of its clinician outreach and communication efforts, the CDC will hold a webinar on new clinical tools and resources to support patients with prolonged symptoms and concerns about Lyme disease.  Presenters will offer a brief overview of Lyme disease, provide a diagnostic and management framework for patients with prolonged symptoms and concerns about Lyme disease, and review new clinical tools and resources to help support these patients.  Continuing education credits are available.  Learn more about the webinar and how to participate from this CDC notice.

MACPAC – Commissioners Meeting – September 19-20

MACPAC commissioners will hold their next public meeting on Thursday, September 19 and Friday, September 20.  The meeting agenda and information about participating in the meetings in person or remotely are not yet available but when they are they will be posted here.