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On November 1, 2023, the U.S. Department of Health and Human Services (HHS) published a proposed rule titled “21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking” (the Proposed Rule). The Proposed Rule, if finalized, would create disincentives for health care providers that the HHS Office of Inspector General (OIG) determines have committed “information blocking” (as defined at 45 C.F.R. § 171.103).Continue Reading HHS Proposes Disincentives for Providers that Commit Information Blocking

On November 1, 2022, the Centers for Medicare & Medicaid Services (CMS) issued final rules concerning the 2023 Hospital Outpatient Prospective Payment System (OPPS) payment rates and 2023 Medicare Physician Fee Schedule (PFS). These final rules implement various updates and policy changes for Medicare payments under the PFS and OPPS, and made significant updates to the Medicare Shared Savings Program (MSSP), which go into effect on or after January 1, 2023. We summarize the key changes below and will elaborate on these rules in future posts.Continue Reading CMS Issues Final Rules Concerning the 2023 Outpatient Prospective Payment System Rates and Physician Fee Schedule

On May 8, 2020, the Centers for Medicare & Medicaid Services (CMS) published an interim final rule with comment period (the “Interim Rule”) in the Federal Register, setting forth additional regulatory waivers and other changes to healthcare regulations and policies in response to the COVID-19 public health emergency (PHE). At a high level, the Interim Rule encompasses topics including expansion of telehealth, support for and expansion of COVID-19 testing, allowing certain licensed professionals to practice at the top of their licenses, Medicare payments for teaching hospitals, changes to the Medicare Shared Savings Program regarding financial methodologies, and application and risk assumption deadlines for accountable care organizations, among other changes. CMS has also updated provider-specific fact sheets on recent waivers and flexibilities, available here. Below are highlights from the Interim Rule.  Providers are encouraged to read all applicable sections of the Interim Rule in their entirety here. Comments may be submitted to CMS within 60 days of the date of publication in the Federal Register.
Continue Reading CMS Interim Rule Makes Sweeping Changes in Response to COVID-19 Public Health Emergency

On December 31, 2018, the Centers for Medicare and Medicaid Services (CMS) published a final rule (Final Rule) establishing the “Pathways to Success” program that overhauls the Medicare Shared Savings Program (MSSP). The Final Rule largely mirrors CMS’ proposed rule (see our summary here), but with several modifications in response to public comments. Accountable care organizations (ACOs) may participate in the Pathways to Success program beginning July 1, 2019, and those ACOs interested in beginning participation in July must submit to CMS a notice of intent to apply by January 18, 2019. CMS guidance on submission of the NOIA is available here. CMS expects to release application deadlines in the near future.

Significant features of the Pathways to Success program, which are described in detail below, include:

  • Replacement of Track 1, Track 2 and Track 3 with two participation options: the BASIC track (consisting of five levels) and ENHANCED track (similar to the current Track 3),
  • Creation of a “glide path” that requires ACOs to incrementally accept performance-based downside risk over the agreement period,
  • Requiring ACOs experienced with downside risk to assume downside risk, while allowing inexperienced ACOs an option to begin participation with no downside risk before advancing to riskier models,
  • Replacement of the previous three-year participation agreement period with a five-year period,
  • Creation of a six-month performance year from July 1, 2019 through December 31, 2019 to coincide with the one-time mid-year start date,
  • Revisions to the benchmarking methodology to incorporate regional trends from the beginning of an ACO’s participation in the MSSP,
  • Expansion of ACOs’ use of telehealth and availability of the SNF Three-Day Rule Waiver, and
  • Ability for ACOs to provide monetary incentives to encourage beneficiaries to receive certain primary care services.

Continue Reading CMS Finalizes Overhaul of the Medicare Shared Savings Program in “Pathways to Success” Final Rule

On November 1, 2018, the Centers for Medicare & Medicaid Services (CMS) released its 2019 Physician Fee Schedule Final Rule (PFS Rule), which contains a number of significant substantive changes to Medicare payment practices and policies. The PFS Rule will be officially published in the Federal Register on November 23, 2018. The PFS Rule also includes an interim final rule implementing amendments to federal telehealth regulations to maintain consistency with recent changes to the Social Security Act to address the opioid crisis enacted in October 2018 through the SUPPORT for Patients and Communities Act.
Continue Reading 2019 Physician Fee Schedule Rule Review: Option to Extend MSSP Agreements for Currently-Expiring ACOs Finalized

On August 17, 2018, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule (Proposed Rule) that proposes a comprehensive overhaul of the Medicare Shared Savings Program (MSSP).  Among other changes, CMS proposes to:

  • replace the current three-track program with two options (Basic and Enhanced),
  • establish a ‘glide path’ that propels accountable care organizations (ACOs) towards acceptance of performance-based down-side risk,
  • update the benchmarking methodology to incorporate regional trends from the start of an ACO’s participation in the MSSP,
  • expand the use of telehealth services by ACOs, and
  • permit ACOs to provide monetary rewards to beneficiaries for the receipt of certain primary care services.

Continue Reading CMS Identifies “Pathway to Success” for Accountable Care in Proposed Rule that Would Significantly Change Shared Savings Program

On December 20, 2016, CMS announced the formation of a new participation track under the Medicare Shared Savings Program (MSSP) – the Medicare ACO Track 1+ Model – which will start in 2018. Accountable care organizations (ACOs) participating in this model will agree to accept more limited downside risk than ACOs participating in Track 2…

On October 29, 2015, the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG), Health & Human Services issued a final rule (Final Rule) regarding waivers (ACO Waivers) of the physician self-referral law (Stark law), the federal Anti-Kickback Statute, and the Civil Monetary Penalties Law (CMP) provision relating to beneficiary inducements for Medicare accountable care organizations (ACOs) participating in the Medicare Shared Savings Program (MSSP). The ACO Waivers waive the application of these fraud and abuse laws to certain ACO activities that are reasonably related to the purposes of the MSSP. The Final Rule’s ACO Waivers are effective as of October 29, 2015.
Continue Reading Fraud And Abuse Waivers For ACOs