On June 24, 2024, the Department of Health and Human Services (“HHS”) released a final rule (“Disincentives Final Rule”) establishing disincentives for certain healthcare providers that have committed information blocking. The information blocking disincentives directly impact Medicare-enrolled healthcare providers or suppliers including hospitals, critical access hospitals, MIPS-eligible clinicians, and ACOs. The Disincentives Final Rule has been submitted to the Office of the Federal Register for publication and will become effective 30 days after Federal Register publication.Continue Reading Healthcare Providers Who Engage in Information Blocking Will Face Disincentives Described in an HHS Final Rule    

Last week, the Centers for Medicare & Medicaid Services (CMS) released data—for the first time—reporting on mergers, acquisitions, consolidations, and changes of ownership of Medicare enrolled hospitals and nursing homes over the past six years. This data, expected to be updated on a quarterly basis moving forward, has been lauded as an important step in improving transparency around nursing facility ownership and enhancing nursing home safety and quality of care. In conjunction with the release of CMS’ data, HHS’s Office of the Assistant Secretary for Planning and Evaluation (ASPE) released a related report analyzing the data and examining trends in changes of ownership over the past six years. In its report, ASPE also offers preliminary insights into how the data on ownership changes can support implementing policies bolstering competition in health care as well as ensuring program integrity in Medicare and Medicaid.Continue Reading Changing Hands, Not Washing Them: CMS’ First Report on Nursing Home M&A Data

The final rule implementing “Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs” is now available for review, and set for publication in the May 9, 2022 Federal Register.   The final rule adopts the proposed change that requires initial and service area expansion applicants to submit their

On April 4, 2022, in Pharmaceutical Care Management Association (PCMA) v. Mulready, Case No. CIV-19-977-J (W.D. Okla. 2022), the U.S. District Court for the Western District of Oklahoma ruled on PCMA’s claim that Oklahoma’s Patient’s Right to Pharmacy Choice Act (Act), Okla. Stat. tit. 36, § 6958, et seq., was preempted under ERISA and Medicare Part D.
Continue Reading State PBM Regulation: The Struggle Continues – Oklahoma District Court Latest to Rule on ERISA, Part D Preemption

CMS Administrator Chiquita Brooks-LaSure and CMS Innovation Center Director Elizabeth Fowler continue to forge ahead with the Biden-Harris Administration’s plans to evaluate and streamline the alternative payment models being tested at the Innovation Center. The most recent example, announced late last month, includes the redesign and renaming of the controversial Global and Professional Direct Contracting (GPDC) model that aims to introduce value-based payment arrangements in traditional Medicare. The newly announced model, renamed the Accountable Care Organization Realizing Equity, Access, and Community Health (ACO REACH) Model, aligns with CMS’s restated goals for the Innovation Center—as outlined in its October 2021 “strategic refresh” white paper—to drive accountable care, advance health equity, support care innovations, improve access by addressing affordability, and partner to achieve system transformation.
Continue Reading CMS Innovation Center Redesigns Direct Contracting Entity Model, Launches ACO REACH

Today, CMS released its strategy for the CMS Innovation Center (the “Strategy”) in a White Paper, Innovation Center Strategy Refresh. This Strategy and the connection to broader CMS priorities was outlined by CMS Administrator Brooks-LaSure and CMS Innovation Center Director, Liz Fowler, in a webinar and is intended as a blueprint for the next 10 years.  While the Innovation Center’s overarching goal continues to be expansion of successful models that reduce program costs and improve quality and outcomes for Medicare and Medicaid beneficiaries, CMS highlights five strategic objectives: Drive Accountable Care, Advance Health Equity, Support Innovation, Address Affordability, and Partner to Achieve System Transformation and created a new vision: “A health system that achieves equitable outcomes through high-quality, affordable, and person-centered care.”
Continue Reading CMS Innovation Center Announces New Strategic Direction Under the Biden Administration

On October 29, 2020, CMS issued the Home Health Prospective Payment System final rule [CMS-1730-F, CMS-1744-IFC, and CMS-5531-IFC], which permanently authorizes use of telecommunications technology as part of patient care under the Medicare home health benefit.[1]

The final rule is another regulatory step toward CMS recognizing the critical role of virtual care in the home health and other care settings, beyond the COVID-19 pandemic.[2]

Use of Telecommunications Technology in Home Health Services

In April 2020, CMS had initiated regulatory changes proposing to expand the use of telecommunication in the provision of home health services covered by Medicare.  CMS stated that its goal in expanding this permitted use of telecommunications technology in furnishing home health care is to “improve efficiencies, expand the reach of healthcare providers, allow more specialized care in the home, and allow home health agencies to see more patients or to communicate with patients more often.”

In the final rule, effective January 1, 2021, home health agencies (HHAs) will be able to use telecommunications – and receive reimbursement for home health services – under the following conditions:Continue Reading HHS Approves Telecommunications for Providing Medicare Home Health Services, on a Permanent Basis, Effective January 1, 2021

On August 20, 2020 the Department of Health and Human Services (HHS) published a notice of proposed rulemaking (85 Fed. Reg. 51397) on good practices for the release and maintenance of agency guidance documents. Comments must be posted by 11:59 pm on September 16, 2020.

As instructed in the October 9, 2019 Executive Order 13891 (EO), titled ‘‘Promoting the Rule of Law Through Improved Agency Guidance Documents (84 FR 55235 (Oct. 15, 2019)), HHS proposes to issue regulations to ensure (i) there is proper notice of any new guidance, and (ii) that the guidance does not impose obligations on regulated parties that are not already reflected in duly enacted statutes or regulations.

This proposed rule appears to follow the Office of Management and Budget, “Final Bulletin for Agency Good Guidance Practices,” issued on January 25, 2007 (72 Fed. Reg. 3432) with respect to the significant guidance document that may, for example “adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities” or “materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof” and generally requires a 30 day notice and comment period.

BackgroundContinue Reading HHS Proposes a New Rule to Govern Release and Maintenance of Agency’s Guidance Documents

On July 17th, the California Office of Administrative Law (“OAL”) approved an emergency regulation (effective until January 14, 2021) from the California Department of Managed Health Care (“DMHC”) that specifies COVID-19 diagnostic testing coverage requirements for California health care service plans. Medi-Cal managed care plans, Medicare Advantage plans, and specialized health plans are not subject to the regulation. The DMHC provided additional context to the emergency regulation in an all plan letter issued on July 23rd.

The regulation deems COVID-19 testing to be an urgent health care service during the California state of emergency. It also states that COVID-19 diagnostic testing is a medically necessary basic health care service for enrollees who are essential workers, regardless of whether the enrollee has symptoms of COVID-19 or a known or suspected exposure to a person with COVID-19. Essential workers are defined in the regulation to include a broad range of individuals working in the health care, emergency services, public transportation, congregate care, correctional, food service, and education sectors. Additionally, they include individuals who work in retail, manufacturing, agriculture, and food manufacturing that either have frequent interactions with the public or cannot regularly maintain at least six feet of space from other workers.

Between the regulation, all plan letter, and other applicable federal law, California health plans will need to comply with the following requirements for enrollees seeking COVID-19 testing:Continue Reading Required Coverage of COVID-19 Testing for Essential Workers in California

On April 30, 2020, the Centers for Medicare and Medicaid Services (CMS) announced a second round of regulatory waivers and rule changes in an interim final rule with comment (IFC) that added significant flexibilities for the coverage of telehealth services furnished by a broader set of eligible clinicians and in nontraditional health settings during the