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

Massachusetts Health Care Update: Senate Bill, Medication Switching, and Opioids

by Mintz Levin - ML Strategies on

Massachusetts policymakers continue to debate health care reform proposals with important implications for industry stakeholders. This month the Senate passed sweeping health care reform legislation, a special commission held...more

Lawsuit Seeks to Shut Down Pennsylvania’s Medical Marijuana Program Before It Even Sets Up Shop

by Cozen O'Connor on

A lawsuit accusing Pennsylvania’s fledgling medical marijuana program of running a faulty permitting process could stonewall patients looking for relief. Keystone ReLeaf (Keystone), a Bethlehem-based medical marijuana...more

Canada releases proposed amendments to Regulations governing patented medicines pricing

by Smart & Biggar on

On December 2, 2017 Canada’s Governor-in-Council published proposed Regulations Amending the Patented Medicines Regulations (“the proposed Regulations”). The 75-day consultation period ends February 15, 2018. The proposed...more

CMS Announces New Nationwide ‘Targeted Probe and Educate’ Medical Review Strategy

by Morgan Lewis on

The Centers for Medicare & Medicaid Services recently expanded its national audit strategy, titled “Targeted Probe and Educate,” for Medicare billing review after pilot programs with four Medicare Administrative Contractors...more

FDA Releases Stem Cell Guidance Documents

by Foley & Lardner LLP on

Therapies that use autologous or allogeneic stem cells are examples of early personalized therapies. Removing cells from a patient and reintroducing them to the same or a matched patient, for example, as done in bone marrow...more

Manatt on Health: Medicaid Edition: CMS Administrator Highlights Medicaid Policy Goals and New Guidance

Since assuming office last January, the Trump administration has signaled a shift in Medicaid policy. In early November, Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma made the administration’s...more

Superior Court Upholds Retirement Board's Provision of Due Process Through Administrative Hearing Process

by Nossaman LLP on

Due process-based claims have taken center stage in several claims against some California public retirement systems of late. A recent ruling by the Superior Court for the County of Marin, however, held that the Board of...more

Health Alert (Australia) 20 November 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: New South Wales (NSW) 15 November 2017 - Clarke v Nursing and Midwifery Council [2017] NSWCATOD 163 - Nursing – appeal against...more

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

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