Overview
Ropes & Gray’s health care litigation team is leading precedent setting cases against regulatory agencies, like the Centers for Medicare & Medicaid Services (CMS), that are changing the federal agency rulemaking process, with significant consequences across the health care industry. With a deep understanding of health care reimbursement and a proven track-record of success for our clients, our team helps our clients navigate some of the most critical cases to their revenue streams.
Experience
- Prevailed in significant D.C. Circuit and Supreme Court appeal affirming the invalidation of a Medicare policy standard involving Medicare Disproportionate Share payments adopted without proper notice and comment. We continue to litigate the landmark Azar v. Allina Health Services (Allina) on behalf of the nation’s top hospitals. Despite the favorable U.S. Supreme Court ruling, in June 2023 CMS issued a retroactive rule to enact the same policy struck by the Supreme Court. We are challenging this new rule in Allina Health System, et al. v. Becerra.
- Obtained a favorable decision for Sentara Healthcare, ordering CMS to reimburse Sentara for the Medicare’s share of indigent patients’ unpaid “bad debt” for fiscal years 2010-2013. This ruling validated hospitals’ use of third-party information in determining whether patients are indigent for purposes of Medicare bad debt reimbursement and could strengthen providers’ defence of the use of third-party data for a broader range of purposes.
- Representing Indiana University Health’s Clarian Health Westin in precedent-setting litigation challenging the CMS’s recalculation and recoupment of Medicare outlier payments (special Medicare payments to hospitals for extraordinarily costly inpatient cases). Many hospitals across the nation have faced these improper, retroactive recoupments, and await the outcome of this litigation.
- Filed novel mandamus action, Alameda County v. Becerra, for 46 of mostly California hospitals to force the issuance of unlawfully withheld Medicare cost report settlements. The case is being copied by lawyers for hundreds of hospitals across the country.
- Represented Baylor Scott & White Health Plan (“Scott & White”) in a matter concerning the lawful calculation of the Medicare program’s share of the health plan’s costs of physician and supplier services furnished to Medicare enrollees. The Court issued a quick decision, without oral argument, finding in favor of Scott & White. The agency filed a notice of appeal to the D.C. Circuit, but later withdrew the appeal.
- Representing Alcresta Therapeutics, a small pharmaceutical manufacturer whose sole product is RELiZORB, an enzyme cartridge that is used in enteral feeding by patients who suffer from serious diseases such as cystic fibrosis, an action pending in federal district court challenging a claim underpayment and the agency’s ongoing attempts to evade the D.C. Circuit’s injunction. RELiZORB helps many patients who are unable to maintain sufficient body weight and would otherwise face severe health consequences without the product. When CMS refused to issue an appropriate billing code to allow Medicare beneficiaries access to RELiZORB, our team obtained an emergency injunction from the D.C. Circuit, which ordered the Secretary of HHS to issue a code for RELiZORB. Alcresta Therapeutics, Inc. v. Azar, 755 Fed. Appx. 1 (2018). Despite this, CMS continues to underpay on claims for RELiZORB, threatening both beneficiary access to the product and the viability of Alcresta as a company.
- Advising Chiesi as it deals with interpreting a final regulation creating new definitions of the Medicaid statutory terms “line extension” and “new formulation.” CMS made an about-face, years after the effective date of the relevant statute, that broadened Medicaid drug rebate program liability significantly.
Pharma and Health Care Practice of the Year
Ropes & Gray’s life sciences and healthcare teams delivered exceptional results for clients, steering transformative deals and facilitating over 110 complex licensing and collaboration transactions with an aggregate value of $55 billion.
