Physicians

News & Analysis as of

HRSA Publishes 340B Drug Pricing Program Omnibus Guidance Notice: Significant Policy Ramifications Should Trigger Public Comment

On August 28, 2015, the Health Services Resources Administration (“HRSA”) published its 340B Drug Pricing Program Omnibus Guidance Notice in the Federal Register. Although many aspects of the Notice reiterate previous HRSA...more

CMS Proposes Exceptions, Revisions and Requests Comments to Ease Stark Law Compliance

The Centers for Medicare & Medicaid Services (CMS) recently proposed regulatory changes to the Stark Law that may ease certain compliance challenges. The Physician Self-Referral Law, located at 42 U.S.C. § 1395nn, and its...more

Third Circuit Rules Failure to Disclose Deadline to File Suit in Denial Letter Warrants Setting Aside Limitations of Suit...

The Third Circuit ruled on August 26, 2015, that if a claim administrator fails to disclose in its final denial letter any plan-imposed deadline to challenge the denial in court, then that deadline will be set aside in favor...more

Telehealth Commercial Coverage and Parity Laws: Trends, Challenges and Opportunities

There will always be differences among state laws on telehealth coverage, but what is remarkable is the rapidly increasing pace at which states have been adopting coverage statutes in the last few years, with currently 29...more

Omnibus 340B Guidance Raises New Issues for Covered Entities

The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new –...more

Ask But Don’t Tell: Kentucky Allows Defendant to Seek Ex Parte Interviews of Plaintiff’s Treating Physicians

We walked into the Drug and Device Law Rock Climber’s room last night to find her packing for her return to college while the ignored TV blared in the background. Onscreen was a popular cable reality franchise involving...more

Health Alert (Australia) - August 31, 2015

In This Issue: -Judgments; Legislation; and Reports -Excerpts from Judgments New South Wales (NSW) 28 August 2015 - Smith v Pennington [2015] NSWSC 1168 The Supreme Court gave judgement for the...more

Will the TELE-MED Act of 2015 Really Change Licensure Rules?

Congress is reviewing legislation designed to permit telemedicine providers to treat Medicare patients across state lines without the need for separate state licensure. The Telemedicine for Medicare Act of 2015 (S. 1778 and...more

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

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

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

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

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

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

Conscience Clauses for Health Care Providers

There has been a lot of news lately about a person’s right to decline to provide a service to another for reasons of conscience. For example, after the U.S. Supreme Court decision regarding marriage equality, the N.C....more

Proposed 2016 Medicare Physician Fee Schedule Includes Changes to Stark Regulations

The Centers for Medicare & Medicaid Services ("CMS") recently released the proposed 2016 Medicare Physician Fee Schedule (the "Proposed Rule"), which includes a number of proposed revisions to the regulations under the...more

The 60 Day Rule — Identification and Knowing Avoidance

On August 3, 2015, the United States District Court for the Southern District of New York issued an opinion and order in Kane v. Healthfirst, Inc., et al.[1] that provides the first judicial interpretation of the requirement...more

Corridors September 2015 - News for North Carolina Hospitals

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

The Health Law Guide to Hospital Operations

This operations guide provides a brief look at health law issues hospitals deal with on a daily basis. While a detailed coverage of the elements, drafting, implementation and continued governance of a hospital compliance...more

Washington Healthcare Update

This Week: FDA Begins Device User Fee Talks with Patients and Consumers Sept. 15... CMS Extends Partial Enforcement Delay of Two-Midnight Policy Through 2015... Alaska Legislature Sues Governor Over Medicaid Expansion....more

The Difficulty Of Challenging FCA Fine As Excessive

Last month, in U.S. ex rel. Drakeford v. Tuomey, No. 13-2219, (4th Cir. July 2, 2015), the Fourth Circuit affirmed a False Claims Act verdict against a nonprofit hospital in Sumter, South Carolina. In an area of the law where...more

Preemption (and Other Things) Defanging Depakote Claims

It wasn’t a complete win, but the summary judgment outcome in Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 4743056 (S.D. Ohio Aug. 10, 2015), has to put a spring in the step of the defendants as they...more

Central District of California "Discontinues" Much of Plaintiffs' Experts' Testimony in Cymbalta "Discontinuation Symptoms" Case

“I’m not a doctor, but I play one on TV” – shorthand for “I am pretending to know what I’m talking about, but I really don’t.” We have blogged frequently about experts inclined to such pretense and about courts’ varying...more

Free Patient Parking May Trigger False Claims Act Violation

Who knew? When you park for free at your doctor’s office, you may be a pawn in a scheme to violate the Anti-Kickback Statute, the Stark Law, and the False Claims Act. It’s enough to make you sick....more

Two-Midnight Rule Update

The Centers for Medicare and Medicaid Services (CMS) announced a further delay, through December 31, 2015, of the Recovery Auditors’ (RA) audits of the “Two-Midnight” Rule. Congress previously passed a law delaying...more

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