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On July 13, 2021, the Centers for Medicare & Medicaid Services (“CMS”) unveiled a proposal to temporarily extend Medicare coverage for particular telehealth services granted during the COVID-19 public health emergency (the “Pandemic”), in order to evaluate which services should be covered permanently. Through the 2022 Physician Fee Schedule (“PFS”), CMS is allowing certain services to remain on the telehealth list until the end of December 31, 2023.
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Continue Reading CMS’ Proposal to Expand Telehealth Coverage

On July 13, 2021, the Centers for Medicare and Medicaid Services (“CMS”) released a Proposed Rule that proposes to amend certain regulations implementing the Physician Self-Referral Law, otherwise known as the “Stark Law”. The Proposed Rule proposes to revise once again the definition of “indirect compensation arrangement” (ICA), effectively to revert the meaning of the definition back – for the vast majority of indirect financial relationships between DHS entities and referring physicians – to the definition of that term as it was in place prior to the latest Stark Law rulemaking, “Modernizing and Clarifying the Physician Self-Referral Regulations” (the “MCR Final Rule”), published on December 2, 2020.[1]  The Proposed Rule also proposes to define the term “unit” and the phrase “services that are personally performed”, both for purposes of the ICA definition.
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Continue Reading CMS Proposes to Revise, Again, the Stark Law’s Definition of “Indirect Compensation Arrangement”: What Was Old is New Again

In July 2020, we discussed a ruling by the D.C. Court of Appeals upholding the Department of Health and Human Services’ (HHS) site-neutral payment rules. On Monday, June 28, 2021, the Supreme Court declined, without comment, to hear an appeal from the American Hospital Association (AHA) and other provider groups asking it to reverse this ruling.
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Continue Reading Site-Neutral Payments Stand: SCOTUS Declines to Hear AHA Appeal, Preserving Lower Payments to Off-Campus Provider-Based Departments

On May 21, 2021, the Centers for Medicare and Medicaid Services (“CMS”) announced that the Next Generation Accountable Care Organization (“ACO”) Model (“NGACO Model” or “Model”), set to end December 31, 2021, will not be extended after receiving a one-year extension due to COVID-19.  The decision comes as a surprise to NGACO participants and other industry groups who have been calling on CMS to revisit its decision and closely consider the Model’s merits and potential as a permanent program option.  Industry stakeholders, such as the National Association of ACOs (“NAACOS”), expressed initial disappointment with CMS’ decision to end the program, but were later able to find some reprieve with CMS’ decision to “allow Next Gen ACOs a limited opportunity to apply for Direct Contracting . . . . starting next year.”
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Continue Reading CMS’ Next Generation Accountable Care Organization (NGACO) Model Set To End in December 2021

Over the last year, we have seen volatility in the healthcare industry overall, and Medicare Advantage (“MA”) and Medicare Part D plans (together, “Plans”) have not been immune. Particularly because of their risk adjustment payment models, and metrics by which they are measured, it was unclear how the Centers for Medicare and Medicaid Services (“CMS”) would respond.…
Continue Reading CMS to the Rescue for MA and Part D Plans – Rate Announcement Includes Significant Increase in Plan Payments for 2022

In our December 7, 2020 Blog Post, “Permanent Expansion of Medicare Telehealth Services,” we discussed the 2021 Medicare Physician Fee Schedule Final Rule (the “Final Rule”) and the regulatory changes made therein by the Centers for Medicare and Medicaid Services (“CMS”) to expand Medicare telehealth coverage within the confines of existing Medicare statutory law.  The Final Rule was first posted on December 2, 2020 and was formally published in the Federal Register on December 28, 2020.…
Continue Reading The Permanency for Audio-Only Telehealth Act: A Matter of Healthcare Equity?

On September 13, 2020, President Trump issued an Executive Order (the “Executive Order”) directing the Department of Health and Human Services (“HHS”) to issue regulations instituting two most-favored-nations (“MFN”) payment…
Continue Reading Medicare Part B Most Favored Nation Drug Pricing Model: New Rules, New Lawsuits, New Tweets

On December 3, 2020, Centers for Medicare & Medicaid Services (“CMS”) announced key details concerning a new value-based reimbursement and patient care model – the Geographic Direct Contracting Model (the “Model” or “Geo”). Geo is a geographic-based approach to value-based Medicare reimbursement and patient care that focuses on improving health outcomes and decreasing the cost of care across an entire geographic region. Direct contracting entities (“DCEs”) participating in the Model will be taking responsibility for the total cost of care of Medicare fee-for-service beneficiaries in their region.  Accountable care organizations (ACOs), health systems, health care provider groups, health plans, and other potential applicants will be permitted to participate in the Model as DCEs.  The Model intends to encourage care coordination across a physical, geographic area and to deliver care that considers a region’s particular local needs.[1]…
Continue Reading CMS Announces New Geographic Direct Contracting Model: Letters of Interest Due by December 21, 2020

On December 1, 2020, the Centers for Medicare and Medicaid Services (“CMS”) released the annual Physician Fee Schedule final rule (“Final Rule”) which, among other things, aimed to further President Trump’s October 3, 2019 Executive Order #13890 on “Protecting and Improving Medicare for Our Nation’s Seniors” (the “EO”) by expanding the use of proven alternatives like telehealth services to Medicare beneficiaries even after the conclusion of the COVID-19 Public Health Emergency (the “Pandemic”).…
Continue Reading Permanent Expansion of Medicare Telehealth Services

On November 20, 2020, the Centers for Medicare and Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) promulgated much-anticipated and significant final rules intended to “modernize” and “clarify” regulations regarding the Physician Self-Referral Law (“Stark Law Final Rule”) and the Anti-Kickback Statute (“AKS Final Rule”).  In the immediate future, Sheppard Mullin will post on this Healthcare Law Blog a comprehensive critical analysis of both the Stark Law Final Rule and the AKS Final Rule and their practical impacts.…
Continue Reading Big Changes for Health Care Fraud and Abuse: HHS Gifts Providers Updates to the Stark Law and the AKS, Just in Time for the Holidays

The Physician Payment Sunshine Act (the “Sunshine Act”) – a federal law first adopted as Section 6002 of the Patient Protection and Affordable Care Act of 2010 (“PPACA”) – requires the Centers for Medicare and Medicaid Services (“CMS”) to collect and display information reported by applicable manufacturers and group purchasing organizations about the payments and other transfers of value these organizations have made to physicians and teaching hospitals. Currently, CMS fulfills its Sunshine Act obligations to collect and report data to the public through the “Open Payments” program.…
Continue Reading On Your Mark, Get Set, Go: Life Science Companies Face A Challenging Year For Compliance With New Open Payment Program Data Collection And Reporting Requirements