Health Updates

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.
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HMOs May Not Terminate Physicians for Recommending Out-of-Network Providers

Under a new Texas law, effective September 1, 2015, health maintenance organizations (HMOs) can no longer terminate a physician from their networks solely because the physician informs his or her patients about the full range...more

D.C. Circuit Court of Appeals Upholds USDOL’s Revised Regulations on the “Companionship Exemption” Under the FLSA

On August 21, the United States Court of Appeals for the District of Columbia Circuit upheld the U.S. Department of Labor’s revisions to the “companionship exemption” under the Fair Labor Standards Act, and reversed two...more

Antitrust Enforcement Agencies Release Annual Report Summarizing 2014 Merger Enforcement Activity Under Hart-Scott-Rodino

The Hart-Scott-Rodino Antitrust Improvements Act (HSR) requires parties to a proposed acquisition of voting securities or assets meeting certain size threshold requirements to report the transaction to the Federal Trade...more

Comprehensive Care for Joint Replacement: CMS adopts mandatory approach to payment reform

On July 9, 2015, the Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule that seeks to implement a mandatory episode-based payment model for lower extremity joint replacement (and reattachment) care in...more

Lack of Proximate Cause for Failure to Warn Nets a Directed Verdict

A week ago, in a post-script to a post on Daubert decisions, we reported that the trial court in Hexum v. Eli Lilly & Co., No. 2:13-cv-02701-SVM-MAN, 2015 U.S. Dist. LEXIS 109737 (C.D. Cal. Aug. 18, 2015), had granted...more

Court Revives DOL's Expanded Overtime and Minimum Wage Rules for Home Health Care Workers

On August 21, 2015, the U.S. Court of Appeals for the District of Columbia in Home Care Association of America v. Weil reversed a lower court decision and upheld the U.S. Department of Labor's (DOL) 2013 regulatory change...more

Hong Kong Commissioner upgrades rules for processing biometric data

The Hong Kong Commissioner has published guidance (‘Guidance’) to assist data users in complying with Hong Kong’s privacy laws when processing biometric data, and takes a broader approach than previous guidance dealing with...more

Upping the Ante: Fines Increase for Failure to Comply with Affordable Care Act Reporting Requirements

The deadline for employers to comply with the Affordable Care Act (“ACA”) reporting requirements is finally here, with reporting first due in 2016. In keeping with the ACA’s historical pattern of ever-changing regulations and...more

Proposed Changes to Stark Rule Would Create New Hospital Exceptions and Lessen Burden of Self-Disclosures

In a development that is limited in scope but still welcomed by hospitals, the proposed 2016 Physician Fee Schedule proposes a number of new exceptions to the physician self-referral or Stark law and other refinements that...more

Biological/Biosimilar Nonproprietary Naming Guidance and Proposed Rule for Certain Proposed Nonproprietary Names for...

On August 27, 2015, FDA released a long-awaited draft guidance entitled “Nonproprietary Naming of Biological Products” (the “Draft Guidance”). The Draft Guidance sets forth a naming convention for all biological products –...more

Court Awards Employees of Home Health Care Companies Minimum Wage and Overtime Rights

Home health care providers could expect to pay their employees more after the Court of Appeals for the D.C. Circuit held an exemption of the Fair Labor Standards Act (FLSA) no longer applies to third-party employers of...more

Court Rejects Claim that a Doctor’s Loss of Privileges is an Antitrust Injury

A federal appeals court held that a doctor who lost his privileges at a local hospital failed to establish an antitrust injury sufficient to confer standing under the Sherman Act. The United States Court of Appeals for the...more

AmerisourceBergen Guest Post: Solutions to Overcome Reimbursement Challenges in Personalized Medicine

The continued development and refinement of personalized medicine (PM) has offered an opportunity to revolutionize medical practice and improve outcomes by providing treatments for patients with the notion that “this drug is...more

The ERISA Litigation Newsletter - August 2015

Editor's Overview - As the summer draws to a close, this month's Newsletter previews three cases that the U.S. Supreme Court already has agreed to hear that ought to be of particular interest to ERISA plan sponsors and...more

When the Government Comes Knocking

This article will provide an outline of some of the most significant points for hospitals to use when confronted with a formal government investigation under the Criminal or Civil False Claims Act. As noted below, you should...more

Breaking News: Proposed 340B Omnibus Guidance Released

The Health Resources and Services Administration (“HRSA”) released an advanced copy of its long-awaited proposed 340B Omnibus Guidance (“Guidance”) today. The document can be found here. Polsinelli is currently reviewing the...more

OIG Reviews Overlap Between Physician-Owned Hospitals and Physician-Owned Distributors (PODs) of Spinal Devices

The Office of Inspector General (OIG) of the Department of Health and Human Services has issued a report on “Overlap Between Physician-Owned Hospitals and Physician-Owned Distributors.” The OIG reviewed 12 hospitals that...more

CMS Publishes Corrections to Comprehensive Care for Joint Replacement Model Proposed Rule

On August 25, 2015, the Centers for Medicare & Medicaid Services (CMS) published technical and typographical corrections to its July 14, 2015 proposed rule to establish a Comprehensive Care for Joint Replacement Model. As...more

Back to School – HIPAA 101

After a summer that saw major data breaches at the Office of Personnel Management and UCLA Health System, this fall is a great time to take your organization back to school on HIPAA compliance and data security. Here are...more

CMS Updates Inpatient Hospital “Two Midnight” Review Education/Enforcement Strategy

CMS recently provided an update on its education and enforcement strategies related to its “Two Midnight” policy, which addresses when surgical procedures, diagnostic tests and other treatments are generally considered...more

CMS Seeks Feedback on Home Health Face-to-Face Encounter Clinical Templates

CMS is inviting comments on voluntary home health electronic and paper “progress note” templates intended to assist physicians with documenting a face-to-face examination for purposes of the Medicare home health benefit....more

Responding to Subpoenas and Other Requests for Personal Health Information: Take Them at Face Value

Healthcare providers and other HIPAA covered entities receive requests for protected health information (“PHI”) from a variety of sources on a daily basis. Such requests can range from informal requests made during the course...more

Another Successful First Amendment Challenge to the Prohibition of Off-Label Promotion for FDA-Approved Drugs

The Free Speech Clause of the First Amendment prevailed in the latest challenge to the FDA's prohibition against marketing FDA-approved drugs for off-label (or non-FDA-approved) uses. Applying the Second Circuit’s...more

Providers + Retailers - The New Front Door to Health

During last week’s webinar on providers and retail health, the second in a series sponsored by Foley and Oliver Wyman, top executives representing different industry sectors shared their points of view on the challenges and...more

OIG Approves Limited, Free Drug Program

On August 12, 2015, the Department of Health and Human Services, Office of Inspector General (OIG) issued Advisory Opinion 15-11, approving two pharmaceutical manufacturers’ free starter drug program. Citing the limited scope...more

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