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Health Alert (Australia) - October 20, 2014

In This Issue: Judgements, Legislation, and Reports. Excerpt from Judgments: Commonwealth - 15 October 2014 - Gray v Richards [2014] HCA 40 - In 2003, a 10-year-old girl...more

New Challenge to 340B Rule Regarding Orphan Drugs

On October 9, 2014, Pharmaceutical Research and Manufacturers of America (PhRMA) filed a complaint (the October 9 Complaint) against the U.S. Department of Health and Human Services (HHS), the Health Resources and Services...more

CMS Makes Limited Time Offer to Settle RAC Claims Pending Appeal

The Centers for Medicare and Medicaid Services (CMS) made an offer to settle currently pending RAC appeals for partial payment of 68 percent of the net claim amount if a hospital agrees to withdraw all of its RAC appeals. The...more

Health Headlines: Also in the News - September 2014 #4

CMS To Hold National Provider Call On Medicare Appeals Settlement Process – CMS has scheduled a “national provider call” on October 9, 2014, from 1:30 p.m. to 3:00 p.m. ET, to update providers on the global settlement...more

Audits and Appeals: A Routine Cost of Doing Business with Medicare

The Centers for Medicare and Medicaid Services has unleashed an alphabet of auditors to identify overpayments. These auditors are armed with the authority to conduct pre-payment reviews, and post-payment audits, as well as...more

Health Law Wire: OMIG Outlines Exclusions/Reinstatement Procedures (9/14)

On September 29th, the Office of the Medicaid Inspector General (OMIG) conducted a webinar entitled, “The OMIG Exclusion and Reinstatement Process.” The webinar provided valuable information on what practices could result in...more

Federal District Court Vacates Decision of Medicare Appeals Council on Inpatient Rehabilitation Coverage

In its recent decision in Teche Specialty Hospital v. Sebelius, the District Court for the Western District of Louisiana vacated two inpatient rehabilitation (IRF) coverage denials by the Medicare Appeals Council (MAC). The...more

Court Finds FDA Explanation of Knee Implant Reversal Lame

The FDA had approved the mesh—called the Collagen Scaffold—in December 2008. But after the change in administrations the following month, the agency decided that the approval process had been flawed and had been the focus of...more

Judge Dismisses FDA Spying Case But Not Because It’s Innocent

Earlier this week a federal judge dismissed a lawsuit by six former and current FDA scientists who allege that the FDA retaliated and spied on them for blowing the whistle on FDA approval of medical devices that put cancer...more

Scripts Newsletter - October 2014

In this issue: - Health Care Decisions — Who Decides? - Medical Software Licensing — Tips from the Trenches - An Ounce of Prevention — The Importance of Periodic Corporate Audits - ACA -...more

Court Dismisses AHA’s Challenge to CMS Billing Policy

On September 17, 2014, the U.S. District Court for the District of Columbia dismissed a lawsuit brought by the American Hospital Association (AHA), three individual hospitals, and two health care systems that challenged CMS’s...more

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

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