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What Has Fahlen Wrought?

The California Supreme Court's decision in Fahlen v. Sutter Central Valley Hospitals has confirmed (not created) a sea change in the relations between hospitals and their medical staffs on the one hand, and physicians on such...more

FDA, ONC and FCC Report Outlines Proposed Health Information Technology Regulatory Strategy and Recommendations

On April 3, 2014, the U.S. Food and Drug Administration, in conjunction with the Office of the National Coordinator for Health Information Technology and the Federal Communications Commission, issued a draft report that...more

D.C. Circuit Requires Greater Disclosure of Changes in Medicare Regulations

The rulemaking process often accommodates a variety of interests, including the preference of regulatory agencies to maintain some flexibility and the rights of interested parties to participate in the regulatory process. On...more

FDA, ONC, and FCC Issue Report on the Regulation and Oversight of Health IT Technologies

On April 3, 2014, the Food and Drug Administration (“FDA”) released its long-awaited report on a proposed framework for the regulation and oversight of health information technology (“health IT”). The report, developed in...more

OFCCP Withdraws Claim Regarding TRICARE Jurisdiction

Last week, the Office of Federal Contract Compliance Programs (OFCCP) dismissed OFCCP’s 2008 complaint against Florida Hospital of Orlando. In its Order of Dismissal, the Administrative Law Judge (ALJ) reported that OFCCP...more

One Step Away: European Parliament Approves New Clinical Trials Regulation

On April 2, 2014, the European Parliament approved the new clinical trials regulation (the “Regulation”) for the European Union (“EU”), with 594 votes in favor, 17 opposed and 13 abstentions. The European Parliament approved...more

D.C. Circuit Rules that the Medicare DSH Rule Requiring the Inclusion of Part C Days in the “Medicare Fraction” in the DSH Formula...

Last week, the United States Court of Appeals for the District of Columbia Circuit upheld the ruling of a federal district court vacating HHS’s 2004 Disproportionate Share Hospital (“DSH”) rule regarding Part C days. The...more

FDA Releases Draft Guidance on Section 503B Fees for Drug Compounding Outsourcing Facilities; Details Process for Paying and...

On April 1, 2014, the U.S. Food and Drug Administration (FDA) published notice of its Draft Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act...more

California Supreme Court Allows Whistleblowing Doctor To Sue Before Exhausting Judicial Remedies

Fahlen v. Sutter Central Valley Hospitals, S205568 (February 20, 2014): The California Supreme Court recently held that a physician, who claimed that a hospital terminated his staff privileges in retaliation for raising...more

FDA Draft Guidance Proposes Change to Combination Product Exclusivity Policy

New market exclusivity opportunities emerge for pharmaceutical companies. In draft guidance released by the Food and Drug Administration (FDA or the Agency) on February 24, 2014, the Agency proposed changes to its...more

Spring Fever - Cautious Optimism for More Critical Appellate Review of Agency Actions

The calendar tells us that it is now spring – the season of hope and optimism. While this may seem like a legal technicality given the weight of the objective physical evidence to the contrary, I, being a lawyer, have no...more

Counties Beware – Your Governmental Status Does Not Protect You from Liability for a HIPAA Breach

As a county government, you may think that you have the protection of sovereign immunity and protection from other governments penalizing you. Your status does not protect you. The Department of Health and Human Services...more

OFCCP Agrees to 5-Year Enforcement Moratorium for TRICARE Providers

In a letter to congressional leaders on March 11, 2014, Secretary of Labor Thomas E. Perez announced that the Office of Federal Contract Compliance Programs (OFCCP) will issue a directive establishing a five-year moratorium...more

FDA Issuing Referral Letters To State Boards Of Pharmacy Against Traditional Pharmacies

FDA has recently issued several "referral letters" (RLs) to state boards of pharmacy based on year-old pre-Compounding Quality Act Form 483 Inspectional Observations. FDA counts RLs as new instruments of oversight designed to...more

Unapproved New Uses: FDA Revisits Policies on Distributing Scientific Publications

In new Draft Guidance, FDA revises requirements for manufacturers’ distribution of publications about off-label uses for approved drugs or devices. On March 3, 2014, the Food and Drug Administration (FDA) released a...more

CMS Indicates Select Controversial Part D Proposals Will Not Be Finalized

Acknowledging concerns regarding some proposals in the January 2014 proposed rule for the Medicare Advantage and Part D Programs, the Centers for Medicare & Medicaid Services states it does “not plan to finalize” certain...more

CPSC is Now Publicly Posting “Letters of Advice” to its Website

In his keynote address at the annual conference of the International Consumer Product Health & Safety Organization (ICPHSO), Acting Chairman Adler announced that the agency had recently started posting what it calls “letters...more

Breaking News: FDA Testifies Before Senate HELP Committee, Questioned On Recent Compounding Quality Act Enforcement

Today Senator Lamar Alexander (R-TN), member of the Senate HELP Committee asked FDA Commissioner Margaret Hamburg what FDA's policy was with regard to asserting jurisdiction over 503A traditional compounding pharmacies. He...more

That Persnickety and Persistent NLRB

As has been reported in previous editions of the Health Law Update, National Labor Relations Board (NLRB)-watching now is a required activity for all employers—union and nonunion alike. On February 25, 2014, NLRB General...more

Congress To Hold Hearing On OFCCP Jurisdiction

On Thursday March 13, 2014 at 10:00 a.m., the Subcommittee on Workforce Protections will hold a hearing on the Protecting Health Care Providers from Increased Administrative Burdens Act (H.R. 3633). H.R. 3633 is a response by...more

Highlights from OMHA's Medicare Appellant Forum

The Office of Medicare Hearings and Appeals (OMHA) recently announced that for most hearing requests received after April 1, 2013, it will be deferring assigning to Administrative Law Judges (ALJs). OMHA will continue to...more

FDA Report to Congress: 1997 Guidance Provides Solid Foundation for 510(k) Modification Decisions

Interested stakeholders have until June 4, 2014, to comment on the FDA's long-anticipated report to Congress that includes its Proposed Policy on the Premarket Notification Requirements for Modified Medical Devices. The FDA...more

California Decision Allows Physician to Challenge Sham Peer Review as Whistleblower Retaliation

In Fahlen v. Sutter Central Valley Hospitals, the California Supreme Court found: A physician is not required to first exhaust his administrative remedies through the medical staff appeals process in order to...more

California Supreme Court Expands Protections To Whistle-Blowers And Weakens Hospital Peer Review Systems

The recent decision by the California Supreme Court in Fahlen v. Sutter Central Valley Hospitals, No. S205568 , 2014 WL 655995 (Cal. 2014) may significantly weaken the efficacy of hospital peer review proceedings in...more

FDA Updates Reprint Guidance, Reiterates Narrowness of Off-Label Safe-Harbor

FDA updates its recommendations for distribution of reprints, making requirements more specific and addressing additional types of materials typically distributed....more

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