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Theresa Thompson is an associate in the Corporate and Securities Practice Group in the firm's Washington, D.C. office.

On August 2, 2021, the Centers for Medicare and Medicaid Services (“CMS”) issued its hospital inpatient prospective payment system (“IPPS”) final rule (“Final Rule”) for fiscal year 2022. In addition to a number of other changes, the Final Rule repeals the price transparency requirement for hospitals, discussed in our September 2, 2020 blog post, obligating hospitals to report certain contract terms with Medicare Advantage (“MA”) plans for cost reporting periods ending on or after January 1, 2021.

Continue Reading CMS Backs Off Price Transparency for Providers and Plans

Introduction

CMS’ most recent Stark Law rulemaking includes important changes to the rules that allow physician practices to satisfy the definition of “Group Practice” while distributing designated health services (“DHS”) – based profit shares and productivity bonuses. 85 Fed. Reg. 77492 (Dec. 2, 2020) (the “Final Rule”).  As these changes go into effect January 1, 2022, and the ability to bill Medicare for DHS is often contingent on satisfying the definition of “Group Practice,” physician practices should take action now to assess their physician compensation arrangements and methodologies under the new rules.


Continue Reading Physician Group Practices Take Heed – January 1, 2022 Deadline Approaches for Compliance with CMS’ Recent Changes to Permissible “Group Practice” Compensation Methodologies

In its June 2021 physician supply and demand report, “The Complexities of Physician Supply and Demand: Projections From 2019 to 2034” (the “Report”), the Association of American Medical Colleges (“AAMC”) highlights the ongoing concern of physician shortages in the United States.  According to the Report, the U.S. faces a potential physician shortage of between 37,800 to 124,000 doctors by 2034. While an improvement from AAMC’s June 2020 report, the COVID-19 pandemic highlighted the consequences of failing to address this problem, as medical schools and teaching hospitals were forced to graduate medical students early, and hospitals scrambled to call up retired physicians and to pay steep travel and relocation rates, all to address the public health emergency.
Continue Reading Congressional Action in the Face of Mounting Concerns Regarding Current and Future Physician Shortages

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

On December 11, 2020, five hospital groups, including the American Hospital Association (“AHA”), and an organization of hospital pharmacists representing participants in the 340B drug pricing program (“340B Program”), filed a federal lawsuit (the “340B Program Litigation”) against the U.S. Department of Health and Human Services (“HHS”) over HHS’ alleged failure to enforce 340B Program requirements that obligate pharmaceutical manufacturers to provide 340B Program prescription drug discounts to pharmacies contracted by 340B Program-participating hospitals to dispense 340B Program drugs.[1]
Continue Reading Contract Pharmacies and the 340B Drug Discount Program: New Litigation and an Advisory Opinion Point to Ongoing Skirmishes on the 340B Battlefield

On December 28, 2020, the Consolidated Appropriations Act, 2021 (“Appropriations Act”) was passed into law. The Appropriations Act included the No Surprises Act (“Act”), which seeks to protect patients from surprise medical bills in situations where patients have little or no control over who provides their care, including nonemergency services provided by out-of-network providers at in-network facilities, emergency services provided by out-of-network providers and facilities, and air ambulance services. The Act, a rare piece of bipartisan, bicameral legislation, has been a long time in the making, and has undergone multiple iterations. Particularly during the public health emergency, the issue of surprise medical bills is especially pertinent, as the COVID-19 pandemic has increased the occurrence of surprise bills in a time where people are less likely to be able to shoulder the unexpected costs.
Continue Reading No Surprises Act Comes as a Surprise – Consolidated Appropriations Act Includes New Restrictions on Surprise Bills

In our November 25, 2000 Healthcare Law Blog article, “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,”  we discussed the advanced publication of two 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”) – both formally published on December 2, 2020 by the Centers for Medicare and Medicaid Services (“CMS”) and the Department of Health and Human Services, Office of Inspector General (“OIG”), respectively.
Continue Reading Analysis of OIG’s New and Revised Regulatory Safe Harbors to the Federal Health Care Program Anti-Kickback Statute and Beneficiary Inducement Prohibition

On December 2, 2020, the Centers for Medicare & Medicaid Services (“CMS”) finalized policies that “aim to increase choice, lower patients’ out-of-pocket costs, empower patients, and protect taxpayer dollars” with changes to the Medicare Hospital Outpatient Prospective Payment System (“OPPS”) and the Ambulatory Surgical Center (“ASC”) Payment System in the Medicare OPPS and ASC Final Rule (“Final Rule”). These changes include: elimination of the “Inpatient Only List” and additions and revisions to the “ASC Covered Procedures List” – two key areas of “site neutrality”. Site neutrality is a move to diminish or eliminate the reimbursement differences between different sites of service.
Continue Reading Forthcoming Medicare Rule Furthers Push for Site Neutrality

As mentioned in our November 25, 2000 Healthcare Law Blog article, “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 Centers for Medicare & Medicaid Services (CMS) published a final rule (“Final Rule”) on December 2, 2020 making significant changes to the regulatory framework implementing the federal physician self-referral prohibition (the “Stark Law”), 42 C.F.R. 411.351 et seq.
Continue Reading Critical Analysis and Practical Implications of CMS’ Changes to the Stark Law’s Implementing Regulations

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