News & Analysis as of

Judicial Review Appeals Centers for Medicare & Medicaid Services (CMS)

Goodwin

Third Circuit Affirms Rejection of AstraZeneca’s Challenges to IRA Drug Price Negotiation Program

Goodwin on

On May 8, 2025, the Court of Appeals for the Third Circuit affirmed the district court’s dismissal of AstraZeneca’s challenges to the Inflation Reduction Act’s Drug Price Negotiation Program and CMS’s Guidance implementing...more

Mintz - Health Care Viewpoints

Appeals Court Rejects AstraZeneca’s Challenge to Medicare Drug Price Negotiation Program

A federal appellate court has handed down the first appellate-level decision addressing the merits of drug manufacturers’ challenges to the Inflation Reduction Act of 2022's (IRA) Medicare Drug Negotiation Program...more

Sheppard Mullin Richter & Hampton LLP

LDT Final Rule Series: Part 4 – Rule Overturned by Federal District Court

Last Monday, the U.S. District Court for the Eastern District of Texas (the “District Court”) issued a highly anticipated – and unsurprising – opinion invalidating the U.S. Food & Drug Administration’s (“FDA’s” or the...more

Hendershot Cowart P.C.

CMS, Qlarant Scrutinizing Medicare Claims for Skin Substitute Treatments

Hendershot Cowart P.C. on

Our firm is seeing an uptick in Medicare demand letters for the recovery of overpayment for skin substitutes, such as WoundFixTM, Biobrane, Dermagraft®, AmnioBand®, or AlloPatch®, used in the treatment of wounds. CMS auditors...more

Foley & Lardner LLP

Happy Holidays!! New Compliance Deadlines under the OSHA ETS to Employers with 100 or More Employees

Foley & Lardner LLP on

Developments immediately before the holiday break have many employers scrambling as the OSHA ETS has seemingly come back to life. The Sixth Circuit, in a 2-1 decision by a 3-member panel, dissolved the temporary stay...more

Baker Donelson

A SLIP on the LIP Adjustment: No Judicial Review Available for Hospitals' LIP Challenges

Baker Donelson on

In Northeast Hosp. Corp. v Sebelius, 657 F.3d 1 (D.C. Cir. 2011), the United States Court of Appeals for the District of Columbia Circuit upheld hospitals' challenge to CMS's disproportionate share hospital (DSH) calculation...more

Baker Donelson

Medicare 340B Drug Payment Policy Survives Legal Challenge; Hospitals Say, It's Not Over

Baker Donelson on

A federal court has handed CMS an initial legal victory enabling drastic cuts in Medicare Part B payment to take effect for separately payable drugs and biologicals purchased by hospitals under the 340B Drug Discount Program...more

King & Spalding

Federal District Court Rebukes CMS for Seeking to Remand Case in Which Providers Did Not Protest Unallowable Items on Their Cost...

King & Spalding on

Last week, the United States District Court for the District of Columbia denied CMS’s request to remand to the Provider Reimbursement Review Board (PRRB) the claims of several hospitals who sought expedited judicial review...more

Baker Donelson

D.C. Circuit Precludes Review of DSH Uncompensated Care Data

Baker Donelson on

On July 26, 2016, the United States Court of Appeals for the District of Columbia Circuit decided Fla. Health Sciences Ctr. v. Burwell. In that case, the Court analyzed a statutory bar against judicial review of estimates...more

Baker Donelson

D.C. District Court Strikes Down PRRB's Application of "Self-Disallowance" Jurisdictional

Baker Donelson on

In Banner Heart Hospital, et al. v. Burwell, the United States District Court for the District of Columbia (Court) held on August 19, 2016, that the Provider Reimbursement Review Board (PRRB) incorrectly declined to hear an...more

Baker Donelson

D.C. District Ct Applies Prohibition on Administrative and Judicial Review to IRF PPS Rates

Baker Donelson on

On July 25, 2016, Judge John D. Bates of the United States District Court for the District of Columbia issued a memorandum opinion broadly construing 42 U.S.C. § 1395ww(j) to prohibit administrative or judicial review of a...more

Baker Donelson

No Judicial Review of Contractor’s Finding of a High Payment Error Rate, a Condition for Extrapolation

Baker Donelson on

Before a Medicare contractor can use extrapolation to determine an overpayment amount, the Medicare statute requires that it must make a finding that there is a sustained or high level of payment error or that documented...more

12 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide