On November 29, 2023, the Centers for Medicare & Medicaid Services (CMS) published the 2024 annual update to the designated health services (DHS) Code List. This annual update includes important changes for Medicare providers...more
When the COVID-19 Public Health Emergency (“PHE”) ended on May 11, 2023, many physician groups furnishing certain medical equipment, devices, and/or supplies to their Medicare patients became in violation of the federal...more
In this session, McDermott Will & Emery Partners Denise Burke, Tony Maida and Monica Wallace discussed top issues and enforcement trends that physician practice management companies (PPMs) and ambulatory surgery centers...more
On March 29, 2023, the Department of Justice’s (DOJ) Office for the Eastern District of Michigan announced a notable set of three settlements (collectively, the Settlement) in excess of $69 million dollars total with a...more
Effective March 1st, certain providers choosing to self-disclose Stark Law violations must use forms updated by the Centers for Medicare & Medicaid Services (“CMS”)....more
On January 23, the Centers for Medicare & Medicaid Services (CMS) released revisions to its Voluntary Self-Referral Disclosure Protocol (SRDP), an important mechanism through which providers may disclose actual or potential...more
As part of its recent rulemaking process, the Centers for Medicare and Medicaid Services (CMS) finalized a new exception to the Physician Self-Referral Law (the Stark Law) to protect arrangements where limited remuneration is...more
With the benefit of more than three decades of rulemaking and hundreds of submissions under the Self-Referral Disclosure Protocol, CMS has seized the opportunity in the final Sprint Regulations to adopt a number of...more
On March 30, 2020, the Secretary of the U.S. Department of Health and Human Services issued a "blanket waiver" impacting the physician self-referral law known as the Stark Law. The blanket waiver—which is retroactively...more
In this week’s episode, Mary Beth Johnston, Carolyn Merritt and Leah Richardson discuss the ways in which the Centers for Medicare and Medicaid Services’ (CMS) response to the ongoing COVID-19 outbreak is easing certain...more
On March 30, 2020, the Secretary of the United States Department of Health and Human Services (“HHS”) exercised his authority to waive certain Medicare requirements during an emergency and issued blanket waivers of sanctions...more
The United Stated Department of Health and Human Services (“HHS”) published a notice of proposed rulemaking (NPRM) containing proposed changes to the Physician Self-Referral Law (“Stark Law,” or “Stark”) on October 17, 2019....more
As part of a larger “Regulatory Sprint to Coordinated Care” the Centers for Medicare & Medicaid Services (CMS) of the U.S. Department of Health & Human Services (HHS) recently issued a proposed rule aimed at modernizing and...more
A physician-owned hospital with operating rooms at a second campus that have been inactive since before March 23, 2010 received approval from CMS to include such spaces within the hospital's aggregate capacity limits,...more
Last summer The Centers for Medicare and Medicaid Services (CMS) solicited input on potential amendments to the federal Physician Self-Referral Law (the Stark Law)....more
As discussed in a previous blog, beginning on June 1, 2017, health care providers of services and suppliers wanting to voluntarily disclose actual or potential violations of the Stark Law must follow a new process finalized...more
The Centers for Medicare and Medicaid Services (CMS) has finalized Form CMS-10328 (the SRDP Form), a new OMB-approved information collection instrument that must be used by providers and suppliers utilizing the Stark Law...more
Parties disclosing actual or potential violations of the Stark law will use a new series of forms under CMS's Voluntary Self-Referral Disclosure Protocol (SRDP) process as of June 1, 2017. According to CMS, the new forms...more
On May 6, 2016, CMS published a notice (Notice), required under the Paperwork Reduction Act (PRA), seeking public comment on its plans to revise the information collected under the Medicare Self-referral Disclosure Protocol...more
On November 16, 2015, the Centers for Medicare and Medicaid Services (CMS) published the 2016 Medicare Physician Fee Schedule final rule with comment period in the Federal Register at 80 Fed. Reg. 70,886, which includes a...more
Nearly four years after publishing their joint interim final rule with comment period, effective November 2, 2011 (IFC), the OIG and CMS (Agencies) have finalized the waivers of various fraud and abuse laws in the context of...more
After the federal government’s victory against Tuomey Hospital, we have seen an increasing number of large False Claims Act (FCA) settlements with hospitals involving Stark Law allegations. Relators are even citing, as...more
On July 15, 2015, the Centers for Medicare and Medicaid Services (“CMS”) published proposed regulations governing policies and payments made under the Physician Fee Schedule for calendar year 2016 (the “Proposed Rule”). In...more
The proposed Physician Fee Schedule for CY 2016 includes multiple technical revisions to the regulations implementing the Stark law. These revisions appear to be designed to provide greater clarity and flexibility with...more
On July 2, 2015, the United States Court of Appeals for the Fourth Circuit affirmed a $237 million judgment against Tuomey Healthcare System, Inc. (“Tuomey”), in a federal False Claims Act (“FCA”) case arising out of...more