Administrative Agency Health

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Bankruptcy Courts Lack Subject Matter Jurisdiction Over Medicare Issues, Eleventh Circuit Rules

In a detailed opinion that likely constitutes the last word on the matter, the Eleventh Circuit recently held in Fla. Agency for Health Care Administration v. Bayou Shores SNF, LLC that bankruptcy courts lack jurisdiction...more

Client Alert - The Government Makes a Business Associate Pay: What HIPAA Covered Entities and Business Associates Can Learn from...

The government has entered into its first settlement with a HIPAA business associate, including a $650,000.00 monetary penalty, ushering in a new period of enforcement for third parties who use Protected Health Information...more

HHS Proposes Rules to Streamline the Medicare Appeals Process to Address Backlog

The Department of Health and Human Services (HHS) has issued a proposed rule intended to address the significant backlog resulting from “an unprecedented and sustained increase” in Medicare appeals. According to HHS, its...more

FDA Reorganization Takes on Cancer Moonshot and Other Initiatives

On July 11, 1969, the United States accomplished the almost unthinkable –two men walking on the moon. Conjuring images of that moon landing, President Obama moved forward the “Cancer Moonshot” program at his January 2016...more

Teaming Up to Cure Cancer "Patents 4 Patients" – Fast Track Review

The United States Patent and Trademark Office “USPTO” is launching the “Patents 4 Patients” initiative, which will provide an accelerated review for methods of cancer treatments. Effective on June 29, 2016 the new “Cancer...more

Medicare Appeals Backlog: HHS' Response to the Decade-Long Delay in Reviewing Appeals

The Department of Health and Human Services (HHS) published its proposed rule [PDF] revamping the Medicare appeals process at the Administrative Law Judge (ALJ) level on July 5, 2016. The proposed rule extensively revises...more

Injunction Enjoining Enforcement of HHS Attestation Rule Affirmed

The Court of Appeals for the District of Columbia affirmed the District Court’s decision in Central United Life v. Burwell on July 1, 2016. This decision is very significant for those assessing the future strength of, and...more

HHS Proposes Significant Changes to ALJ Hearing Procedures

HHS announced a Proposed Rule on July 5, 2016 aimed at reducing the backlog of appeals at the Office of Medicare Hearings and Appeals (OMHA) and Departmental Appeals Board (DAB) for Medicare payment and coverage...more

Texas Medical Board Seeks State Action Immunity Protection in Fifth Circuit Brief

On June 17, the Texas Medical Board (“Board”) filed a brief with the Fifth Circuit Court of Appeals reiterating that the Board’s rulemaking processes are protected under the state action immunity doctrine, noting that the...more

Also In The News - Health Headlines - June 2016 #3

OMB Reviewing Proposal on Handling of 340B Disputes -- On June 15, 2016, the Office of Management and Budget (OMB) started its review of a proposed rule under the 340B discount program, according to the OMB’s website. Under...more

AMA Demands Appeals Process for Physician Payment Rates

On June 14, 2016, during its annual meeting in Chicago, the American Medical Association’s (AMA) House of Delegates approved a resolution recommending the overhaul of CMS’s physician payment rate determination methodologies,...more

Airline Industry Alert: FAA Does Not Recommend Routine Psychological Testing for Pilots

On June 9, 2016, the FAA announced specific actions that it will take, in conjunction with airlines and pilots' unions, concerning pilots' mental health in response to the Malaysia Flight 370 and Germanwings Flight 9525...more

NIH Signals “Paradigm Shift” with Policy on Multi-Site Studies

Federally-funded clinical trials conducted at multiple sites will move to a single Institutional Review Board (IRB) review scheme under a new National Institutes of Health (NIH) Policy. The NIH has finalized its policy to...more

GAO Highlights Significant Backlog in Medicare Appeals, Routine ALJ Failure to Meet Statutory Deadlines

The Medicare appeals process has not been able to keep up with an explosion in the number of volume, particularly at the administrative law judge (ALJ) level (Level 3), resulting in significant backlogs and widespread failure...more

Alabama CON Report

I. SHPDA Administrative Report - A. Contested Cases - For the following projects no vote was required because the recommended order of the Administrative Law Judge becomes the final order of the Agency when no...more

FTC Delays Ruling in LabMD Appeal

The Federal Trade Commission has decided to put off until late July a decision about whether to overturn a ruling by the agency’s chief administrative law judge in the closely watched data security action against LabMD, the...more

GAO Issues Recommendations To Improve Medicare Appeals Backlog

On June 9, 2016, the Government Accountability Office (GAO) publicly released a report published May 10, 2016, regarding the continuing challenges surrounding the backlog of the administrative appeals process for Medicare...more

Tennessee Health Services And Facilities Report: June 2016 Newsletter

The Tennessee Health Services and Development Agency ("HSDA") is responsible for regulating the health care industry in Tennessee through the Certificate of Need Program. A Certificate of Need ("CON") is a permit for the...more

Still Waiting—FDA Delays Rulemaking

The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduction of a spending bill that would have blocked funding for the...more

The Aftermath: Developments From The 2016 Session of The Connecticut General Assembly Affecting The Workplace

The 2016 session of the Connecticut General Assembly has just concluded, along with subsequent “special sessions.” Most prominently from an employment law standpoint, the General Assembly passed (and the Governor signed)...more

CMS Announces "Pause" in QIO Review of Inpatient Admissions

Last week CMS announced a temporary "pause" in the review of inpatient admissions by the Beneficiary and Family Centered Care Quality Improvement Organizations (QIOs). CMS posted this announcement on its Inpatient Hospital...more

Tenth Circuit Rebukes CMS for Applying Wrong Regulations in Overpayment Action

The United States Court of Appeals for the Tenth Circuit shot down CMS’s overpayment recoupment related to physical therapy and skilled nursing services, citing multiple errors in CMS’s appeal briefing and concluding that “an...more

CMS Limits MAC and QIC Scope of Review

Medicare Administrative Contractors (MACs) and Qualified Independent Contractors (QICs) should not expand redeterminations and reconsiderations of claims denied on the basis of complex pre–or post–pay payments or automated...more

FDA Issues Guidance on Expanded Access Use of Investigational Drugs

The U.S. Food and Drug Administration (FDA) issued three final guidance documents on June 2, 2016, that address FDA's rules and regulations governing "expanded access" to investigational drugs. The expanded access process –...more

Is Sponsor-Submitted Clinical Data Safe?

The U.S. Food and Drug Administration has a tricky task at hand when it comes to reviewing, evaluating, investigating and eventually approving prescription medications. Yes, the agency has a mission to ensure patient safety,...more

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