Health Administrative Agency

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

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

FDA Issued Draft Guidance on Interchangeability

Today, the FDA announced the availability of a draft guidance on biosimilar interchangeability, entitled “Considerations in Demonstrating Interchangeability With a Reference Product,” which is currently available on FDA’s...more

Birmingham Medical News: End in Sight for Medicare ALJ Backlog?

As providers who are currently undergoing a Medicare claims appeal know, there is a lengthy delay to having an appeal actually heard by an Administrative Law Judge (“ALJ”). Some estimates indicate that it will currently take...more

HHS Ordered To Eliminate Medicare Appeals Backlog By 2021

On January 4, 2017, the U.S. District Court for the District of Columbia rejected a request by the Secretary of HHS asking the court to reconsider its decision that requires HHS to eliminate the backlog of Medicare claims...more

Mississippi CON Report

Certificates of Need Approved and Staff Recommendations – December 2016 - 1. CON – Final Orders - a. CON Review Number: HG-A-0715-015 – Singing River Health System d/b/a Singing River Hospital – Amendment and Cost...more

U.S. Access Board Issues Standards for Medical Diagnostic Equipment

Seyfarth Synopsis: Many years in the making, today the Access Board issued design criteria and other standards for medical diagnostic equipment. Today, the U.S. Access Board issued new accessibility standards for medical...more

On the Heels of 21st Century Cures Enactment, FDA Finalizes Medical Device Accessories Guidance

On December 30, 2016, the Food and Drug Administration (FDA or the Agency) issued a final guidance document entitled Medical Device Accessories – Describing Accessories and Classification Pathways for New Accessory Types....more

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

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

FDA Guidance on Cybersecurity in Medical Devices

On December 28, 2016, the Food and Drug Administration (FDA) issued guidance on Postmarket Management of Cybersecurity in Medical Devices. The guidance clarified aspects of the reporting requirements under Part 806 (21 CFR...more

OIG Finalizes New and Amended Anti-Kickback and CMP Safe Harbors

On December 7, 2016, the Department of Health and Human Services Office of the Inspector General (OIG) issued a final rule to establish new safe harbors under the anti-kickback statute and civil monetary penalty (CMP) rules,...more

FDA: The Powdered Gloves Come Off

In a rare move, the Food and Drug Administration (FDA) announced on Friday that it is banning the following devices after determining that they present an unreasonable and substantial risk of illness or injury that cannot be...more

More Digital Health Device Makers Expected to Seek FDA Clearance

Investors are increasingly interested in companies with technologies that will be subject to U.S. Food and Drug Administration (FDA) regulation. Until recently, some investors shied away from companies targeting the...more

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

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

Landmark Mental Health Bill Creates Unique Opportunity for Connecticut Providers

Something refreshing actually came out of the U.S. Congress last week. In a rare display of bipartisanship, the Senate voted 94 to 5 to pass the 21st Century Cures Act, which is being called the most comprehensive mental...more

21st Century Cures: Health Information Technology and Digital Health Tool Provisions in Title IV

The 21st Century Cures Act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide variety of other health-related measures, including...more

21st Century Cures: Congress Enacts Medicare Advantage and Small Business Insurance Market Reforms

The 21st Century Cures Act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide variety of other health-related measures, including...more

Senate Passes 21st Century Cures Act, but Can It Cure an Ailing FDA?

On Wednesday, the U.S. Senate overwhelmingly passed the 21st Century Cures Act (the “Act”) by a vote of 94 to 5. Spearheaded by Michigan Representative Frank Upton, the bill now heads to President Obama who has promised to...more

Court Orders HHS to Fix the Medicare Appeals Backlog by the End of 2020

Medicare providers with pending cases at the administrative law judge (“ALJ”) level received positive news last week as a federal judge for the United States District Court for the District of Columbia (the “Court”) granted...more

Health Canada releases revised guidance on the submission requirements for biosimilar biologic drugs

On December 2, 2016, Health Canada released the revised Guidance Document Information and Submission Requirements for Biosimilar Biologic Drugs. The Guidance is intended to assist biosimilar companies to navigate the...more

[Webinar] The “Risky Business” of the Federal False Claims Act: Strategic Thinking for 2017 - December 8th, 12:00pm ET

Calling in-house counsel and top executives at government and defense contractors, health care and long term care providers, and manufacturing companies. On December 8 at 11:30 am ET, join Williams Mullen attorneys at this...more

Manatt on Health Reform: Weekly Highlights - November 2016 #4

CMS releases a wave of new regulations and guidance for Medicaid and CHIP; Michigan receives CMS approval for a lead abatement initiative; and Utah continues to push for its limited expansion of Medicaid coverage....more

Promise to Repeal the ACA Poses Threat to MACRA Implementation

Most of the post-election discussion of the ACA has focused on how promises to repeal the law could impact the newly insured. But one priority area of the ACA that has received very little discussion is the federal...more

Basics of the BPCIA

The FDA broadly defines biologics as medical products derived from living sources (human, animal, plant, or microorganism) intended to treat or prevent diseases. Biologics thus include such varied vehicles of medical...more

Briefing Points for the Board: The Election and the 2017 Health Policy Agenda

It is vitally important for the health system board, as well as certain of its key committees, to receive an introductory briefing as soon as possible on the health policy implications of last week’s Presidential and...more

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

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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