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Medicare 340B Drug Payment Policy Survives Legal Challenge; Hospitals Say, It's Not Over

by Baker Ober Health Law on

A federal court has handed CMS an initial legal victory enabling drastic cuts in Medicare Part B payment to take effect for separately payable drugs and biologicals purchased by hospitals under the 340B Drug Discount Program...more

Court Upholds Procedural Validity of HHS's Outlier Reconciliation Instructions

by Baker Ober Health Law on

On December 26, 2017, the United States Court of Appeals for the District of Columbia Circuit upheld the procedural validity of 2010 manual instructions setting out the criteria by which Medicare outlier payments might be...more

Rx IP Update - December 2017

by Smart & Biggar on

PMPRB News - PMPRB releases scoping paper relating to proposed amended Regulations - As previously reported, on December 2, 2017, Canada’s Governor-in-Council published proposed Regulations Amending the Patented...more

Superior Court Upholds Retirement Board's Provision of Due Process Through Administrative Hearing Process

by Nossaman LLP on

Due process-based claims have taken center stage in several claims against some California public retirement systems of late. A recent ruling by the Superior Court for the County of Marin, however, held that the Board of...more

Health Alert (Australia) 20 November 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: New South Wales (NSW) 15 November 2017 - Clarke v Nursing and Midwifery Council [2017] NSWCATOD 163 - Nursing – appeal against...more

Rx IP Update - October 2017

by Smart & Biggar on

Pfizer obtains orders of prohibition on polymorphic form patent - On September 22, the Federal Court, in a pair of decisions, granted Orders of prohibition under the Patented Medicines (Notice of Compliance) Regulations...more

Florida Administrative Law Judge Invalidates Governor’s Executive Order Mandating Generators for Senior Housing Facilities

Last week, an Administrative Law Judge ruled against the governor and state agencies regulating senior housing communities, finding that the controversial emergency order did not address a true emergency and as written was...more

Perspectives for the Professions Newsletter - September 2017: Importance of Clear Guidelines and Policies

by Field Law on

Silwin v College of Physicians and Surgeons, 2017 ONSC 1947, upholding a Discipline Committee’s decision to reject a defence of officially induced error on the basis that the professional unreasonably misinterpreted the...more

Court of Appeals Reverses D.D.C. Order Requiring HHS to Eliminate Medicare Appeals Backlog by December 31, 2020

by Baker Ober Health Law on

Hopes were dashed for sooner relief from the backlog of Administrative Law Judge (ALJ) appeals. With the backlog of Medicare reimbursement appeals steadily growing, a reversal by the U.S. Court of Appeals for the District of...more

FDA Marketing Exclusivity Periods Limited To Same Active Moiety

by Foley & Lardner LLP on

In Otsuka Pharm. Co., Ltd. v. Price, No. 16-5229 (D.C. Cir. Aug. 29, 2017), the U.S. Court of Appeals for the District of Columbia Circuit affirmed the district court decision upholding FDA’s “same moiety” test for defining...more

Hospitals Plagued by HHS's 2012 Medicare DSH Calculation Obtain Relief from the D.C. Circuit

by Baker Ober Health Law on

Hospitals affected by HHS's 2014 decision to include Medicare Part C enrollees as part of the Medicare fraction of the disproportionate share calculation obtained relief late last month when that position was voided by the...more

Minnesota Patent Litigation Wrap-Up – July 2017

by Fish & Richardson on

This post continues our monthly summary of patent litigation in the District of Minnesota, including short summaries of substantive orders issued in pending cases. In July 2017, there were three notable decisions for...more

D.C. Circuit Decides Part C DSH Issue in Favor of Providers

by King & Spalding on

On July 25, 2017, the United States Court of Appeals for the District of Columbia Circuit held that HHS violated the terms of the Medicare statute by failing to undertake notice-and-comment rulemaking in implementing its...more

Dietary Supplement & Cosmetics Legal Bulletin | July 2017

JAMA Study and Editorial Call for Improvements in Cosmetic Regulation and Surveillance - In response to a study analyzing adverse events for cosmetics and personal care products, the Journal of the American Medical...more

ACA Retaliation Claim Survives Despite No Complaint About ACA Provisions

On April 28, 2017, the United States Department of Labor Administrative Review Board (“ARB”) allowed a whistleblower retaliation claim under the Patient Protection and Affordable Care Act (“ACA”) to proceed even though the...more

D.C. District Court Upholds CMS’s Predicate Fact Three-Year Reopening Limitation

by King & Spalding on

On March 10, 2017, Judge John Bates of the U.S. District Court for the District of Columbia upheld CMS’s three-year cost report reopening limitation, as applied to “predicate fact” determinations. The regulation at issue is...more

Proof by Proxy in FCA Suits? District Court Says It Depends

by Morgan Lewis on

Admissibility of statistical sampling to prove liability in FCA suit is fact dependent. In a February 14, 2017 decision, the Fourth Circuit declined to rule on the question of whether statistical sampling can be used to...more

Fourth Circuit Takes a Pass on Statistical Sampling, Finds DOJ's Settlement Veto Authority Unreviewable

by Bass, Berry & Sims PLC on

After granting the relators’ petition for an interlocutory review of the district court’s rejection of the use of statistical sampling to establish FCA liability, the Fourth Circuit ultimately declined to reach that issue in...more

ERISA: Winning Tactic on Summary Judgment to Prove Claimant Received the Policy: Get Key Evidence into the Administrative Record

You know that to apply an exclusion in a policy, the claims administrator must show that the claimant received the policy. But what happens when the claimant submits a declaration disputing your proof that she received...more

Perspectives for the Professions: Case Summary: Third Party Accreditation

by Field Law on

B.C. College of Optics Inc. v. The College of Opticians of British Columbia, 2016 BCCA 85, allowing an appeal of the lower Court’s finding that the regulator could not require a third-party assessment of a training program as...more

FDA Takes Action in the Last Days of the Obama Administration to Clarify Some of Its Views on Off-Label Communications

by King & Spalding on

In the last few days of the Obama Administration, the Food and Drug Administration (FDA or the Agency) issued a number of documents with implications for manufacturer communications with health care practitioners and payors. ...more

Perspectives for the Professions - January 2017: Case Summary: Test for Interim Conditions

by Field Law on

Scott v. College of Massage Therapists of BC, 2016 BCCA 180, allowing an appeal of the lower Court’s decision to quash an interim condition on practice. A massage therapist was the subject of a complaint that he had...more

U.S. District Court for District of Columbia Requires HHS to Eliminate Medicare Appeals Backlog by December 31, 2020

by Baker Ober Health Law on

On December 5, 2016, a U.S. District Court for the District of Columbia granted summary judgment in American Hospital Association, et al., v. Burwell, in favor of the American Hospital Association (AHA) in its quest to reduce...more

It Ain't Over 'Till It's Over – First Circuit Rejects Settlement Agreements Between Providers and Intermediary and Upholds Cost...

by Baker Ober Health Law on

On October 27, 2016, a three-judge panel for the United States Court of Appeals for the First Circuit issued an opinion concluding that a Medicare fiscal intermediary (Intermediary) does not have the authority to enter into a...more

D.C. District Court Bucks the Trend and Rules for Hospital in Provider Tax Case

by Baker Ober Health Law on

Many states assess taxes against hospitals and other providers as a means of funding their Medicaid and other healthcare-related programs. The revenue generated by the taxes is used, with CMS’s approval, to fund Medicaid...more

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