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

Do You Know Where Your Tax-Exempt Bond Records Are?


Time to Read: 1 minutes Practices: Health Care

Printer-Friendly Version

On August 21, the IRS issued its long-awaited tax-exempt bond financings “compliance check questionnaire,” which has reportedly been mailed to hundreds of tax-exempt borrowers across the country, including universities, hospitals, and cultural organizations.

As anticipated, the questionnaire seeks detailed information about a borrower’s record-keeping and compliance assurance practices. For a copy of our previous Client Alert about this matter, which encouraged the adoption of an appropriate record-keeping policy, click here. If you have not yet adopted such a policy, you may wish to consider doing so at this time.

Why does this matter? Tax-exempt bonds are subject to post-closing operational requirements until the bonds are redeemed, such as limitations on “private use” of bond-financed property. The IRS has the authority to revoke retroactively the tax-exempt status of bonds issued on behalf of any borrower that fails to comply with these requirements. Any threatened or actual revocation of the tax-exempt status of a non-profit organization’s bonds may have a material, adverse effect on that organization’s access to and cost of capital, in addition to the expense of defending against such action and potential penalties.

How to find out more: On September 7, 2007, Ropes & Gray will review the questionnaire and suggest compliance strategies in an educational teleconference.

Contact Information
For further information, please contact your usual Ropes & Gray lawyer.

Printer-Friendly Version

Cookie Settings