Administrative Agency Health Civil Procedure

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CMS Clarifies Terms of Global Settlement Offer

As previously reported, on August 29, 2014, CMS issued a global settlement offer (GSO) to acute care hospitals with pending appeals of denials for inpatient claims. Specifically, CMS is offering to settle all qualifying...more

HHS Asserts the Everybody-Does-It Defense

If that sounds familiar, your child may have a future as a lawyer for Health & Human Services. Because that’s one of the primary arguments asserted by HHS last Friday in its motion to dismiss the lawsuit by the American...more

Drug-Device Apple Cart Upset Again

On September 9, 2014, in Prevor v. Food and Drug Administration, the D.C. District Court held against FDA's interpretation of the definition of a medical device included in the Federal Food, Drug and Cosmetic Act (the act)....more

Attention Hospitals! Act Now To Get 68 Cents For Your Medicare Dollar!

It’s no secret that CMS is drowning in appeals from denials of Medicare claims for inpatient care. The number of pending appeals was estimated at half a million back in February, and it’s only grown since then. One reason...more

Medicare Beneficiaries Sue HHS Over 489-Day Backlog in ALJ Appeals

The Center for Medicare Advocacy (CMA) filed a complaint last week on behalf of five Medicare beneficiaries in federal district Court in Connecticut requesting a court order requiring the Secretary of HHS to clear a massive...more

Special (Limited) CMS Offer to Settle Claims on Appeal

With little fanfare just before the Labor Day weekend, CMS announced a program in which it would enter into administrative agreements with eligible providers in exchange for the providers’ withdrawal of pending appeals...more

CMS Makes Global Offer to Settle All Acute Care Inpatient Claims on Appeal

On August 29, 2014, CMS issued settlement terms to acute care hospitals with pending appeals of denials for inpatient claims. CMS is offering to settle all qualifying claims at 68 percent of the “net paid amount” of such...more

RAC Program to Resume Limited Reviews

On August 4, 2014, the Centers for Medicare and Medicaid Services (CMS) announced that it would allow the Recovery Audit Contractor Program (RAC) to resume a limited number of reviews in August. The program has been dormant...more

OMHA Announces Two New Programs to Process Administrative Law Judge (ALJ) Hearings More Efficiently

Earlier this year, the Office of Medicare Hearings and Appeals (OMHA) announced that for most hearing requests received after April 1, 2013, it will be deferring assignment of ALJs. OMHA’s announcement is available on its...more

Court Slams Medicare Agency, Notes Reputation As “Unfeeling Bureaucracy”

The Department of Health & Human Services’ Provider Reimbursement Review Board (Board) came in for some withering criticism last Friday from the federal court hearing the appeal of University of Chicago Hospital from the...more

Hospitals File Lawsuit Over Medicare ALJ Hearings Delays

Over 460,000 appeals requesting hearings before an administrative law judge (ALJ) were pending in the Office of Medicare Hearings and Appeals (OMHA) at the end of 2013, with 15,000 new appeals being submitted each week. At...more

HHS Relabels Invalidated 340b Regulation As “Interpretative Rule”

Earlier this week HHS came out swinging in the latest round of its battle with the Pharmaceutical Research & Manufacturers of America (PhRMA) over the Affordable Care Act’s provisions on 340B and orphan drugs. HHS reasserted...more

HHS Says It Has Authority to Issue Interpretive Guidance on Contested 340B Orphan Drug Rule Despite Court Order Vacating Final...

According to a recent court filing by HHS, the agency should not be precluded from issuing interpretative guidance regarding a provision of the 340B Drug Pricing Program even though a federal district court previously vacated...more

A Tale of Two Circuits: D.C. Circuit, Fourth Circuit Split on ACA Subsidies

It was the best of times for ACA subsidies, it was the worst of times for ACA subsidies. On Tuesday, the Court of Appeals for the D.C. Circuit (“D.C. Circuit”) and the Court of Appeals for the Fourth Circuit (“Fourth...more

The Orphan Drug Wars: HHS Interpretive Rule Clarifies Orphan Drug Exclusion

On July 21, 2014, the U.S. Department of Health and Human Services (HHS) released an “Interpretive Rule” in response to a recent U.S. District Court decision that vacated the July 23, 2013, orphan drug rule on the grounds...more

Buckle Up—Unwinding Phoebe Putney’s Acquisition of Palmyra Down in Georgia May End Up Being Back on the Table

Almost one year ago, Federal Trade Commission (FTC) agreed to settle its antitrust challenge of Phoebe Putney Health System’s (Phoebe Putney) acquisition of Palmyra Medical Center (Palmyra) without requiring divesture or any...more

D.C. Circuit Says CMS Doesn’t Know What’s New

On Tuesday of last week the D.C. Circuit Court ruled that the Provider Review Reimbursement Board doesn’t know what’s new. It reversed the PRRB’s decision, along with the District Court’s decision that upheld it. In doing...more

D.C. Circuit Overturns PRRB’s Decision that Only Newly Built Hospitals Can Qualify for Favorable Capital Reimbursement Rates

In Select Specialty Hospital – Bloomington, Inc. v. Burwell, No. 15-5355 (D.C. Cir., Jul. 8, 2014), a group of long-term care hospitals (LTCHs) successfully challenged the Secretary’s determination that they were not “new...more

Recent Court Decision May Impact 340B Drug Pricing Program "Mega-Reg"

A federal district court invalidated the first regulation published by the U.S. Department of Health and Human Services (HHS) addressing the 340B Drug Pricing Program (340B Program), on May 23, 2014, ruling that HHS had not...more

Illinois Supreme Court Debates Effect of Improper Venue in Administrative Review Cases

Our reports on the civil arguments during last month’s term of the Illinois Supreme Court begin with Slepicka v. State of Illinois, a decision from the Fourth District which poses two important and closely related issues for...more

NLRB ALJ Rules That An Interim Grievance Procedure Does Not Require An Arbitration Option

In a decision issued last week, an Administrative Law Judge (“ALJ”) for the National Labor Relations Board (“NLRB”) ruled that an interim grievance procedure between an employer and a newly-certified union did not have to...more

Status of 340B “Mega-Rule” in Question as HHS Decides How to Proceed with Vacatur of Orphan Drug Rule

For over a year, participants in the 340B Drug Pricing Program (340B Program) and others have been waiting for the release of the so-called proposed “Mega-Rule” by the Department of Health and Human Services (HHS). The...more

HHS Poised For Round Two Of Orphan Drug Fight

HHS isn’t ready to throw in the towel in the fight over expansion of the 340B program under the Affordable Care Act (ACA). On Thursday HHS said in a court filing that it will appeal last month’s federal court ruling that...more

The Orphan Drug Wars: HHS’s Recent Loss to PhRMA

On May 27, 2014, almost a year following the promulgation of its final rule, the U.S. Department of Health and Human Services (HHS) had its rule vacated by the U.S. District Court for the District of Columbia under an...more

Recent Court Decision Limits HRSA's Authority Under the 340B Drug Discount Program - Will It Change the Impact of the Anticipated...

In the rapidly evolving landscape of the 340B Drug Discount Program, a recent court decision is the first to limit the rulemaking authority of the Health Resource and Services Administration (HRSA). This decision may...more

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