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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

GAO Report Finds Medicare Claim Review Programs Could Be Improved with Additional Prepayment Reviews and Better Data

On May 13, 2016, the U.S. Government Accountability Office (“GAO”) released a report on the review activities of the different Medicare claim review contractors that CMS uses to help reduce improper payments and protect the...more

CMS Announces Plans to Streamline the Stark Self-Referral Disclosure Protocol

On May 6, 2016, CMS published a notice (Notice), required under the Paperwork Reduction Act (PRA), seeking public comment on its plans to revise the information collected under the Medicare Self-referral Disclosure Protocol...more

OIG Updates Permissive Exclusion Criteria – Suggests Compliance Programs Are Expected

On April 18th, the Office of Inspector General (OIG) issued updated guidance describing the factors it will consider in determining whether to exercise its permissive authority to exclude individuals and entities from federal...more

Patient and Provider Groups Urge FDA to Institute Meaningful and Memorable Names for Biosimilars

A coalition of patient and provider groups sent an open letter to Leah Christl, FDA’s associate director for therapeutic biologics and biosimilars, urging FDA to use meaningful names for biosimilars instead of random ones. ...more

FDA issues guidance on the use of EHRs in clinical investigations

The U.S. Food and Drug Administration (FDA) just issued draft guidance on the Use of Electronic Health Record Data in Clinical Investigations for comment within the next 60 days. The guidance is intended to assist all...more

CMS Announces Risk-Based Adjusted Additional Documentation Request Limits for Institutional Providers

On May 3, 2016, CMS announced the availability of a revised method to calculate additional documentation request (ADR) limits for Institutional Providers in the Recovery Audit Contractor (RAC) Program. Under the new method,...more

Second Circuit Applies Stricter Rules for a Plan Administrator’s Noncompliance with Benefit Claims Regulations

In Depth - On April 12, 2016, the US Court of Appeals for the Second Circuit in Halo v. Yale Health Plan, 2016 WL 1426291 (2d Cir. Apr. 12, 2016), addressed various issues that could arise during a plan administrator’s...more

FDA Issues “Leapfrog” Draft Guidance for 3D Printing of Medical Devices

3D printing raises significant technical considerations for device manufacturers. In response to the increasing use of 3D printing in the medical device arena, on May 10, the US Food and Drug Administration (FDA or...more

California Court Rules Medicare Does Not Preempt Hospital Claims Against Payer

On April 27, 2016, a California state court judge in a Complex Litigation department for the County of Los Angeles, ruled in favor of 13 of our hospital clients on an important matter involving substantive and financial...more

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