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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

Food and Beverage News and Trends - Food and Beverage Alert (US): September 2014

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. - Poll indicates strong support by parents for school lunch standards. On...more

PGR Report -- The Attack of 35 U.S.C. § 112

Last week, on September 2, 2014, Accord Healthcare, Inc. ("Accord") filed what appears to be the second-ever Post-Grant Review ("PGR") (see Petition). This PGR was for U.S. Patent No. 8,598,219 ("the '219 Patent"), which is...more

A (Second) Lawsuit Seeks to Compel Statutory Timeframe for Administrative Law Judge Review of Medicare Claims Appeals

On August 26th, the Center for Medicare Advocacy filed a nationwide class action lawsuit against the Secretary of Health and Human Services. The complaint alleges that, as implemented, the Medicare administrative review...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

Is Interstate Physician Licensing on the Horizon?

Physician licensing is, and always has been, a matter for the states. But ease of travel from one state to another has long placed a strain on that approach, as physicians and patients alike move easily from one state to...more

CMS Offers Deal to Hospitals to Drop RAC Appeals

On August 29, 2014, the Centers for Medicare & Medicaid Services (CMS) issued a deal to hospitals willing to drop pending inpatient-status claims appeals. These appeals have grown exponentially in recent years due to the...more

Health Care Reform Implementation Update

As summer rolls to a close, the agencies continue to make announcements and roll out additional regulations. The Department of Health and Human Services (HHS) introduced the new CEO of Healthcare.gov, awarded grants to 147...more

North Carolina Dental Board Urges Reversal of FTC’s “Radical” Stance on State Action Immunity

North Carolina’s State Board of Dental Examiners has urged the U.S. Supreme Court to reject the Federal Trade Commission’s (FTC’s) “radical departure” from decades of established precedent that offers state actors immunity...more

MoFo New York Tax Insights - Volume 5, Issue 9 - September 2014

In This Issue: - ALJ Upholds Denial of Sales Tax Refund Because Vendor Failed to First Make Refunds to Customers - HMO Held Exempt from New York City General Corporation Tax - State Tax Department Issues...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

FDA Posts Largest-Ever Medical Device Recall

On August 29, 2014, the FDA issued 233 Class I medical device recalls for products manufactured by Customed. According to its website, Puerto Rico-based Customed is a medical supplies leader and distributes a wide range of...more

Considering Sex-Specific Variation for Personalized Medicine

Personalized medicine may use devices and assays that identify sex-related differences. For example, a device or an assay may determine if a cancer patient harboring a particular genetic variance will or will not respond to a...more

FDA’s Substantial Equivalence Guidance Describes FDA’s Process for Evaluating Substantial Equivalence and Updates to the 510(k)...

The U.S. Food and Drug Administration (FDA) has issued a final guidance document titled The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] (July 28, 2014) (“SE Guidance”). The SE...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

DEA Issues Final Rule Up-Scheduling Hydrocodone Combination Products from Schedule III to Schedule II

On August 22, 2014, the Drug Enforcement Administration (DEA) published a final rule upscheduling hydrocodone combination products (HCPs) under the Controlled Substances Act (CSA) from Schedule III to Schedule II. The...more

AHA Renews Complaints about OIG Hospital Compliance Reviews

The American Hospital Association (AHA) has renewed its complaints about OIG “hospital compliance reviews.” Last Thursday AHA Executive Vice President Rick Pollack sent a letter to Health & Human Services Secretary Burwell...more

Medical Device Update: FDA Issues Draft Guidance on Streamlined De Novo Classification Process

On August 14, the Food and Drug Administration (FDA) issued a draft guidance titled “De Novo Classification Process (Evaluation of Automatic Class III Designation).” The draft provides guidance on a streamlined process for...more

FDA Notifies Congress of Framework for Long-Awaited Guidance on Laboratory Developed Tests and Issues Final Guidance on Companion...

Laboratory Developed Tests - After many years of promising that it would be providing guidance on the regulation of laboratory developed tests (LDTs), the Food and Drug Administration (FDA) provided notice to Congress...more

Physicians Write Letter to FDA Regarding Biosimilar Naming Concerns

On Thursday, August 14, 2014, several physicians wrote a letter to Commissioner Hamburg of the U.S. Food and Drug Administration (FDA) expressing their concerns regarding the naming of biosimilar products in light of the...more

FDA Approves Cancer Screening Test as First Device Under Parallel Review Pilot

On August 11, 2014, the Food and Drug Administration (FDA) issued a premarket approval (PMA) for Exact Sciences’ Cologuard, a colorectal cancer screening test, and the Centers for Medicare & Medicaid Services (CMS) issued a...more

Tennessee Attorney General States that Physical Therapists Cannot Perform Trigger-Point Dry Needling

In an opinion released on June 19, 2014, the Office of the Tennessee Attorney General stated that Physical Therapists cannot lawfully perform Intramuscular Manual Therapy or Trigger-Point Dry Needling. Dry Needling therapy...more

FDA to Strengthen Oversight of Certain In Vitro Diagnostic Devices

In the wake of a new Medicare reimbursement framework, FDA plans stricter regulation of some in vitro diagnostic devices. On July 31, 2014, the U.S. Food and Drug Administration (FDA; Agency) announced its intent to...more

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