Alert

Recommended Alerts

Sign Up For Alerts

Medicare Expands Coverage of “Breakthrough” Medical Devices and Codifies “Reasonable and Necessary” Standard

On January 14, 2021, the Centers for Medicare and Medicaid Services (“CMS”) published a final rule that significantly alters the Medicare reimbursement landscape for medical devices approved under the Food and Drug Administration’s (“FDA”) “Breakthrough Devices Program.” The rule, which represents the culmination of years of advocacy by the medical device industry and patient and provider interest groups, finalizes a September 1, 2020 proposed rule that aimed to address the substantial time lag between FDA authorization of medical devices and Medicare coverage of the same. Specifically, the rule establishes a Medicare Coverage of Innovative Technology (“MCIT”) pathway for Medicare coverage of Breakthrough Devices and related medical procedures during a four-year period that begins immediately upon FDA marketing authorization. The final rule also codifies the definition of the “reasonable and necessary” standard that is used to determine when other items and services (and MCIT devices after the four-year period) may be covered by the Medicare program. The new rule becomes effective March 15, 2021.

Read More

Physician Owned Distributorship Concerns Continue to Make News


Time to Read: 1 minutes Practices: Health Care

Printer-Friendly Version

On June 17, 2014, Southern California Public Radio affiliate KPCC broadcasted a report about physician-owned distributors of implantable medical devices (“PODs”) and the legal and ethical concerns that are raised when POD ownership gives referring physicians a financial interest in the implantable devices they order for their own patients. The report can be found here. The report highlights recent malpractice lawsuits against POD owners and the hospitals and ambulatory surgical centers (“ASCs”) in which those surgeons practice. It also notes government actions to rein in PODs, including the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) March 2013 Special Fraud Alert; the October 2013 OIG study on prevalence and use of POD devices; and the Sunshine Act reporting requirements, which will lead to public reporting on physician ownership in PODs and other physician-owned entities later this year.

Echoing the OIG’s 2013 findings, KPCC’s report questions the financial benefit of POD arrangements, and emphasizes the prospect of criminal prosecution for dealing with a POD. It also emphasizes that many hospitals are unaware that they purchase implantable devices from PODs, suggesting that additional due diligence by hospitals and other purchasers of implantable medical devices would be advisable. In this regard, a number of leading hospital systems have adopted policies that prohibit dealing with PODs owned by physicians who are on the hospitals’ medical staff. Examples of hospital policies can be found here. In sum, the report shows that, at a minimum, PODs continue to cast unwelcome media attention on the PODs themselves, their physician investors, and the hospitals and ASCs where the physicians perform their surgeries.

If you have any questions about the KPCC report, please do not hesitate to contact Tom Bulleit.

Printer-Friendly Version

Cookie Settings