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CMS Announces Plans to Streamline the Stark Self-Referral Disclosure Protocol

On May 6, 2016, CMS published a notice (Notice), required under the Paperwork Reduction Act (PRA), seeking public comment on its plans to revise the information collected under the Medicare Self-referral Disclosure Protocol...more

OIG Updates Permissive Exclusion Criteria – Suggests Compliance Programs Are Expected

On April 18th, the Office of Inspector General (OIG) issued updated guidance describing the factors it will consider in determining whether to exercise its permissive authority to exclude individuals and entities from federal...more

Patient and Provider Groups Urge FDA to Institute Meaningful and Memorable Names for Biosimilars

A coalition of patient and provider groups sent an open letter to Leah Christl, FDA’s associate director for therapeutic biologics and biosimilars, urging FDA to use meaningful names for biosimilars instead of random ones. ...more

FDA issues guidance on the use of EHRs in clinical investigations

The U.S. Food and Drug Administration (FDA) just issued draft guidance on the Use of Electronic Health Record Data in Clinical Investigations for comment within the next 60 days. The guidance is intended to assist all...more

CMS Announces Risk-Based Adjusted Additional Documentation Request Limits for Institutional Providers

On May 3, 2016, CMS announced the availability of a revised method to calculate additional documentation request (ADR) limits for Institutional Providers in the Recovery Audit Contractor (RAC) Program. Under the new method,...more

Second Circuit Applies Stricter Rules for a Plan Administrator’s Noncompliance with Benefit Claims Regulations

In Depth - On April 12, 2016, the US Court of Appeals for the Second Circuit in Halo v. Yale Health Plan, 2016 WL 1426291 (2d Cir. Apr. 12, 2016), addressed various issues that could arise during a plan administrator’s...more

FDA Issues “Leapfrog” Draft Guidance for 3D Printing of Medical Devices

3D printing raises significant technical considerations for device manufacturers. In response to the increasing use of 3D printing in the medical device arena, on May 10, the US Food and Drug Administration (FDA or...more

California Court Rules Medicare Does Not Preempt Hospital Claims Against Payer

On April 27, 2016, a California state court judge in a Complex Litigation department for the County of Los Angeles, ruled in favor of 13 of our hospital clients on an important matter involving substantive and financial...more

Federal Judge Refuses FTC Request to Block Hershey/Pinnacle Deal; FTC to Appeal

Hospitals and other providers who have been tracking Federal Trade Commission (FTC) and Department of Justice Antitrust Division hospital merger challenges over the last several years will want to take note of the federal...more

D.C. District Court Resolves Challenge to Medicare's Outlier Payment Rules for Banner Health v. Burwell

On March 31, 2016, Judge Colleen Kollar-Kotelly of the United States District Court for the District of Columbia (the “D.C. District Court”) issued a highly anticipated memorandum opinion settling what will probably be the...more

OIG Issues New Criteria for Implementing its Section 1128(b)(7) Exclusion Authority

The Office of Inspector General (OIG) of the Department of Health and Human Services has issued new, non-binding “Criteria for Implementing Section 1128(b)(7) Exclusion Authority” updating the factors OIG will consider in...more

Prohibition on Pharmacy Inducements Beyond College of Pharmacists’ Authority

In Sobeys West Inc v. Alberta College of Pharmacists, 2016 ABQB 232, the Alberta Court of Queen’s Bench held that amendments to the College of Pharmacists’ Codes of Ethics and Standards of Practice prohibiting inducements to...more

Another Day, Another Violation: Board Targets Hospital’s Work Rules Prohibiting Offensive Conduct

Seyfarth Synopsis: Board panel finds hospital’s work rule prohibiting employees from engaging in offensive conduct to be unlawful. In Valley Health System, LLC d/b/a Spring Valley Hosp. Med. Ctr., 363 NLRB No. 178 (May...more

OIG Issues Revised Policy Statement Regarding Permissive Exclusion

On April 18, 2016, the Office of Inspector General of the United States Department of Health and Human Services (“OIG”) issued a revised policy statement containing the new criteria that OIG intends to use in implementing its...more

OIG Issues New Exclusion and CIA Guidance

On April 18, 2016, Inspector General Daniel R. Levinson announced the publication of updated guidance on how the Office of Inspector General (OIG) makes decisions about using its permissive exclusion authority and requiring...more

FDA Proposes Ban on Electrical Stimulation Devices for Aggressive or Self-Injurious Behavior

On April 25, the U.S. Food and Drug Administration published a proposed rule banning electrical stimulation devices (ESDs) used to treat aggressive or self-injurious behavior....more

CMS Proposes to Reverse 0.2 Percent IPPS Rate Reduction After Two-Midnight Rule Litigation Loss

In the FY 2017 IPPS Proposed Rule, CMS announced that it would reverse the 0.2 percent IPPS rate cut that was imposed in FY 2014 (and re-adopted in subsequent years) related to the Two Midnight Rule and increase the...more

Capturing Flagg: Fifth Circuit, En Banc, Holds that Failure to Complete Pre-suit Medical Board Review Renders Med Mal Defendants...

We previously wrote about the Fifth Circuit’s panel decision and the defendants’ petition for rehearing en banc in this case. As we reported earlier, the issue is whether a non-diverse defendant is improperly joined by...more

"New HHS OIG Criteria to Guide Resolution of Health Care Investigations"

The Office of Inspector General of the Department of Health and Human Services (OIG) has issued updated guidance on the use of its so-called permissive exclusion authority under Section 1128(b)(7) of the Social Security Act...more

FTC, ONC, OCR and FDA release online tool for mobile health app developers

While attending the International Association of Privacy Professionals annual global event, and listening to Chairwoman Edith Ramirez discuss the Federal Trade Commission’s (FTC) concerns about consumer privacy, the FTC, the...more

Employee Benefits & Executive Compensation Advisory: The ACA: New Concerns for Employer Plan Sponsors Under the Fair Labor...

The Affordable Care Act (ACA) anti-retaliation provisions have been in effect for several years, but have so far largely gone unnoticed. Now that employees can get financial assistance through the Health Insurance...more

Medicare Appeals 10-Year Backlog: D.C. Circuit Signals Enough is Enough

Issued within a month of one another, two cases regarding the Medicare appeals backlog reached opposite conclusions, providing a circuit-split. The first case from the D.C. Circuit, signaling a major shift toward judicial...more

Howard Young on Coming Changes To The Healthcare Space [Video]

Howard Young, co-head of the healthcare practice at Morgan Lewis, talks about some of the major forces driving change and consolidation within the healthcare industry. According to Young, innovations in technology and changes...more

Office of Medicare Hearings and Appeals Launches Settlement Conference Facilitation Pilot for Medicare Part A Claims

The HHS Office of Medicare Hearings and Appeals (“OMHA”) recently launched Phase III of the Settlement Conference Facilitation (“SCF”) Pilot to help resolve outstanding Medicare Part A appeals. The SCF program is one of...more

China FDA Announces Good Clinical Practices for Medical Devices

On March 23, 2016, the China Food and Drug Administration (“CFDA”) and the National Health and Family Planning Commission jointly promulgated the final revision to the 2004 Medical Device Clinical Studies Rules (“MDCSR”), the...more

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