On August 14, 2023, the Centers for Medicare & Medicaid Services (CMS) released guidance on changes to the Accountable Care Organization Realizing Equity, Access, and Community Health (ACO REACH) Model starting in performance year 2024 (PY2024). The changes came about in response to stakeholder and participant feedback. All ACO REACH participants should familiarize themselves with the upcoming changes.Continue Reading CMS Announces Changes to ACO REACH Model

On July 13, 2023, the Centers for Medicare & Medicaid Services (“CMS”) issued its proposed rule (the “Proposed Rule”) for the 2024 Medicare Physician Fee Schedule (“PFS”). The Proposed Rule, which was issued in the Federal Register on August 7, 2023,  includes updated payment rates, changes to reimbursement for services related to health equity and social determinants of health, increases to payment for cancer care support, and changes to enrollment for mental health providers. CMS projects that the Proposed Rule will lead to growth in the Medicare Shared Savings Program (“MSSP”).Continue Reading CMS Announces Proposed Rule for 2024 Medicare Physician Fee Schedule

On April 12, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released a final rule updating key regulations pertaining to Programs of All-Inclusive Care for the Elderly (“PACE”) (the “Final Rule”). Overall, these changes, summarized below, will offer significant administrative and operational flexibilities. Except as otherwise noted, the requirements of the Final Rule are effective January 1, 2024.Continue Reading CMS Releases CY2024 Final Rule for PACE Organizations

On December 5, 2022, the Department of Health and Human Services (“HHS”), Office of Inspector General (“OIG”), released their Semiannual Report to Congress for the period beginning on April 1, 2022, and ending on September 30, 2022 (the “Semiannual Report”).[1]Continue Reading OIG Shines a Spotlight on Nursing Homes, Opioid Misuse, and Health Equity in the FY2022 Semiannual Report

Effective January 1, 2024, the recently enacted California Assembly Bill 1278,[1] requires a physician and surgeon (defined as a physician and surgeon licensed pursuant to the Medical Practice Act or an osteopathic physician and surgeon licensed by the Osteopathic Medical Board of California under the Osteopathic Act, but not a physician or surgeon working in a hospital emergency room) to provide a written or electronic notice of the Open Payments database to a patient at the initial office visit. The written or electronic notice shall contain the following text:Continue Reading California Passes First State Law Requiring Physicians to Disclose Open Payments Database to Patients

On December 2, 2021, the Centers for Medicare & Medicaid Services (“CMS”) issued a memorandum (the “CMS Memo”) addressing survey and enforcement of the COVID-19 vaccine requirement applicable to Medicare and Medicaid participating healthcare providers and suppliers and their staff. The CMS Memo was issued in response to preliminary injunctions against the implementation and enforcement of the Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule  published on November 4, 2021, which requires staff working in Medicare or Medicaid certified providers and suppliers (including nursing facilities, hospitals, dialysis facilities and all other provider types covered by the rule) to have the shots necessary to be fully vaccinated against COVID-19 by January 4, 2022, and receive their first shot prior to December 6, 2021 (the “Rule”).
Continue Reading CMS Suspends Vaccine Mandate Enforcement for Healthcare Workers

On October 20, 2021, the Centers for Medicare and Medicaid (“CMS”) Innovation Center (“Innovation Center”) published a white paper detailing its vision for the next ten years: a health system that achieves equitable outcomes through high quality, affordable, person-centered care.  The white paper first recounts the last ten years of testing and learning that laid the foundation for the Innovation Center’s future strategy.  The future strategy is organized around five strategic objectives that will guide the Innovation’s Center’s models and priorities for the next ten years.  The five strategic objectives for advancing this systemwide transformation include (1) Drive Accountable Care, (2) Advance Health Equity, (3) Support Innovation, (4) Address Affordability, and (5) Partner to Achieve System Transformation.  These strategic objectives aim to guide the Innovation Center’s models which will seek to reduce program costs and improve quality and outcomes for Medicare and Medicaid beneficiaries.  Finally, the white paper emphasizes its approach to measuring the progress of each of these objectives and assessing the impact the objectives have on beneficiaries, providers, and the market as a whole.
Continue Reading Centers for Medicare and Medicaid Innovation Center: Equity and Vision

On October 4, 2021, California Governor Gavin Newsom signed California bill SB-664 “Hospice licensure: moratorium on new licenses” (the “Bill”) into law.  The Bill, which passed the California Assembly on September 8, 2021 and the California Senate on September 9, 2021, imposes a moratorium on the California Department of Public Health (the “Department”) issuing new hospice licenses on or after January 1, 2022.  Under the California Hospice Licensure Act of 1990, a person, political subdivision of the state, or other governmental agency must obtain a license from the Department to provide hospice services to an individual who is experiencing the last phase of life due to a terminal disease.  The moratorium will end either three hundred and sixty five (365) days from the date the California State Auditor publishes a report on hospice licensure or when the provisions of the Bill are repealed on January 1, 2027, whichever is sooner.  The Department may grant an exception to the moratorium upon making a written finding that an applicant for a new license, or with a license application pending on January 1, 2022, has shown a ‘demonstrable need’ for hospice services in the area.  However, the Bill does not affect the Department’s ability to renew existing licenses.
Continue Reading New California Law Imposes Moratorium on New Hospice Licenses

Where does my prescription come from? Has it been altered or diluted? Can I trust the label? With millions of prescriptions filled each year, quality control and security across the pharmaceutical supply chain seems like a herculean task. In an attempt to slay this proverbial hydra, the Food and Drug Administration (FDA) developed a new pilot program – the DSCSA Blockchain Interoperability Pilot (the “Blockchain Pilot”) – which aims to use blockchain to create a secure electronic, interoperable system that tracks and traces certain prescription drugs as they are distributed in the United States.
Continue Reading What’s in the Bottle? FDA Announces New Blockchain Pilot Program for Tracking Drug Distribution

Skilled nursing facilities (SNFs) operate in a changing and challenging environment. The upcoming implementation by the Centers for Medicare & Medicaid Services (CMS) of a Patient Driven Payment Model will shift the reimbursement paradigm for SNFs from a focus on the volume of services provided to a focus on specific, clinically-relevant patient characteristics. Combining this significant change in reimbursement criteria with the challenges of low to non-existent profit margins, high employee churn, federal and state regulatory scrutiny and an active plaintiffs’ class action bar, means that in order to survive in today’s marketplace, SNFs must evolve their practices to maximize their operational efficiency and improve their bottom line.
Continue Reading SPOTLIGHT ON INNOVATION: Improving best practices for infection control at skilled nursing facilities

Where does my prescription come from? Has it been altered or diluted? Can I trust the label? With millions of prescriptions filled each year, quality control and security across the pharmaceutical supply chain seems like a herculean task. In an attempt to slay this proverbial hydra, the Food and Drug Administration (FDA) developed a new pilot program – the DSCSA Blockchain Interoperability Pilot (the “Blockchain Pilot”) – which aims to use blockchain to create a secure electronic, interoperable system that tracks and traces certain prescription drugs as they are distributed in the United States.
Continue Reading What’s in the Bottle? FDA Announces New Blockchain Pilot Program for Tracking Drug Distribution