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Read need-to-know updates, commentary, and analysis on Administrative Agency issues written by leading professionals.

Home Health Payment Rule Published

by Baker Ober Health Law on

On November 1, 2017, CMS released the Final Rule for the 2018 home health prospective payment system rate update, including the CY 2019 case mix adjustment methodology refinements. CMS also made changes to the Value Based...more

Ready to Release a New Pharmaceutical? What to Think About When Selecting Your Drug Name

by Foley & Lardner LLP on

Pharmaceutical name clearance in the United States can be complicated. This post aims to provide insight into the regulatory safety review process and the trademark registration process for candidate drug names. This...more

FDA Issues Warning Letters To Cannabidiol Product Manufacturers Over Health Claims

by Farrell Fritz, P.C. on

On November 1, 2017, the Food and Drug Administration (FDA) published a release concerning its issuance of warning letters to four companies concerning the marketing of products containing cannabidiol (CBD)....more

340B Hospitals File Suit in Wake of Hospital Outpatient Cuts

by Foley Hoag LLP on

On November 13, 2017, a group of hospital trade associations (the American Hospital Association, the Association of American Medical Colleges, and America’s Essential Hospitals), along with two health system providers, filed...more

Data Privacy + Cybersecurity Insider - November 2017 #2

by Robinson & Cole LLP on

Michigan Governor Rick Snyder has signed into law the Cyber Civilian Corps Act, which established the Michigan Cyber Civilian Corps, dubbed MiC3. The corps has been in existence for three years but not statutorily deployed. ...more

Hazardous Waste Enforcement: U.S. Environmental Protection Agency and San Antonio, Texas Medical Facility Operator...

The United States Environmental Protection Agency (“EPA”) and Gastroenterology Consultants of San Antonio, P.A. (“GCS”) entered into a Consent Agreement and Final Order (“CA”) addressing alleged Resource Conservation and...more

Update: HHS Announces Two Additional Medicare Appeals Settlement Initiatives

by Polsinelli on

On Nov. 3, Health & Human Services (HHS) announced two additional initiatives to address the mounting Medicare appeals backlog at the Administrative Law Judge (ALJ) level: (i) expand the Settlement Conference Facilitation...more

Recent Developments in Antitrust Scrutiny of Healthcare-Provider Transactions

by Holland & Knight LLP on

As the trend of acquisitions of physician practices and mergers of hospitals continues, so does antitrust scrutiny of these deals. There was activity this week in three different proposed transactions that caught the...more

CMS Updates the Medicare Program Integrity Manual Provisions Addressing ALJ Hearings

by King & Spalding on

On October 13, 2017, HHS issued a transmittal change request to update Section 3.9 of the Medicare Program Integrity Manual (MPIM), stating that only one entity (CMS or a CMS contractor) may attend an ALJ hearing as a party,...more

The Impact of the New Connecticut Budget on the Health Care Industry

The bipartisan state budget became law yesterday (the “Budget Act”). While Governor Malloy vetoed a provision requiring supplemental payments to hospitals, the Budget Act includes numerous other provisions affecting the...more

Biotech Patent Applications May be Eligible to Receive Benefits From Ongoing USPTO Initiatives

by Knobbe Martens on

A pair of ongoing USPTO initiatives, Patents for Humanity and Patents 4 Patients, offer incentives that certain biotechnology patent applications may be eligible for. Patents for Humanity is open to patents and applications...more

Positive Ruling On Generator Rules May Not Protect Owners In The Short Term

Notwithstanding what we consider a well-reasoned and proper ruling by an Administrative Law Judge against Governor Scott’s emergency rule on generators and fuel, cautious senior living facility owners may still want to submit...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's Emergency Generator Rules Invalidated

by Baker Ober Health Law on

On Friday, Judge Garnett W. Chisenhall, a duly-designated administrative law judge of the Florida Division of Administrative Hearings, issued a ruling invalidating emergency rules requiring all Florida nursing homes and...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

Professional Regulatory Alert: No Loyalty Program for Drugs: Court Confirms Prohibition on Pharmacy Inducements

by Field Law on

The Alberta Court of Appeal recently confirmed that professional regulators have significant discretion to implement rules and policies intended to protect the public interest. Specifically, rules and policies may include the...more

WPI Insider Briefing: Will the New Composition of Federal Agencies Effect Change?

by Littler on

Nine months into President Trump’s term, the pace of nominations and appointments to fill critical position within his administration is accelerating. Action on the nominations to the National Labor Relations Board (NLRB),...more

PTAB Declines Request to Review Method of Treating Lymphoma Claim

A Patent Trial and Appeal Board (PTAB) panel declined to institute an inter partes review (IPR) of a claim directed to a method for treating low grade B-cell non-Hodgkin’s lymphoma. The challenged method required patients to...more

Policy Management Lessons From the VHA

by NAVEX Global on

Corporate compliance officers can learn a lot from their counterparts in government agencies. Today we’re going to review lessons about successful policy management, or the lack thereof, from the Veterans Health...more

FDA Simplifies and Clarifies Expanded Access Program

by Hogan Lovells on

Last week, FDA announced via a blog post simplifications and clarifications to its expanded access program. Under FDA’s expanded access program, physicians may request that patients with a serious condition receive treatment...more

USPTO Finds SureGene Personalized Medicine Treatment Unpatentable Under Mayo

by Foley & Lardner LLP on

In Ex Parte Timothy, the USPTO Patent Trial and Appeal Board (PTAB) affirmed the Examiner’s rejection of personalized medicine treatment claims. This decision highlights the PTAB’s willingness to invalidate claims that it...more

A Conversation on CMS’ Emergency Preparedness Compliance for Healthcare Providers

by Carlton Fields on

Hurricane Irma recently wreaked havoc on the Caribbean and much of the state of Florida. In the storm's aftermath, ten residents of a South Florida nursing facility died because the facility lost power, and did not have...more

Value-Based Contracting for Prescription Drugs and Medical Devices: An Innovative Solution Impaired by Outdated Regulations

by Pepper Hamilton LLP on

Often lost in the cacophony of headlines surrounding rising health care costs is the promise that value-based contracting offers as a possible solution. In contrast to the traditional fee-for-service model, value-based...more

FDA Launches New Tool For Accessing Drug Adverse Event Information

by Hogan Lovells on

FDA recently launched a public dashboard within the FDA’s Adverse Event Reporting System (FAERS) to improve access to data on adverse events related to drug and biological products. FDA Commissioner Scott Gottlieb, M.D....more

Working Together: FDA Releases Final Guidance on Interoperability

by Hogan Lovells on

On September 6, 2017, the Food and Drug Administration (FDA or the Agency) released its final guidance document, Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices (Final...more

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