Health Updates

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New Year, New Possibilities: OIG Final Rule Amends Beneficiary Inducement Rules

The Office of Inspector General (“OIG”) of the Department of Health and Human Services has issued a final rule (“Final Rule”) adding new safe harbors to the federal anti-kickback statute, amending existing safe harbors, and...more

Federal Court Enjoins Part of ACA Final Non-Discrimination Rule

On December 31, 2016, the U.S. District Court for the Northern District of Texas issued a nationwide injunction in Franciscan Alliance, Inc. v. Burwell, N.D. Tex., No. 16-cv-108, holding that portions of the final rule issued...more

Blog: FDA Issues Discussion Paper on Laboratory Developed Tests

The U.S. Food and Drug Administration (FDA) issued today a Discussion Paper on Laboratory Tests (LDTs). The Discussion Paper follows draft guidance issued by the FDA in 2014 (2014 Draft Guidance) and a stakeholder workshop...more

Patient Records Requests: What You Need to Know [Video]

Our guest on Healthcare Matters is Richard J. Rymond, an attorney at Reminger Co., LPA, who specializes in in medical, dental and other forms of professional, commercial and general liability. He is the Dental Liability...more

Time Waits for No One: OCR Announces First HIPAA Settlement for Lack of Timely Breach Notification

On Jan. 9, 2017, the Department of Health and Human Services Office for Civil Rights (“OCR”) announced the first HIPAA enforcement action for failure to timely report a breach. Often investigating and making formal...more

New Hampshire Psychiatric Hospital Patient Records Posted Online by Former Patient

The New Hampshire Department of Health and Human Services has notified up to 15,000 patients of its psychiatric hospital (New Hampshire Hospital) that their names, addresses, Social Security numbers, Medicaid ID numbers and...more

Affordable Care Act Repeal

Recently the Wall Street Journal stated the New England Journal of Medicine published an op-ed by President Obama in which he critiqued the Republicans’ strategy to repeal the Affordable Care Act, and then replace it at a...more

The Old and the New – Day 3 Notes from the JPMorgan Healthcare Conference

Day 3 of the JPMorgan healthcare conference was one of striking contrasts between the old and the new. (And, by the way, the rain finally stopped for a day, but it will be back tomorrow to finish off the last day of the...more

News from Abroad: Summary Report on the Final Guidance from the English Court of Appeal on Second Medical Use Patents

The final decision of the Court of Appeal in the Lyrica® litigation was handed down on 13 October 2016. This litigation, relating to the painkiller pregabalin marketed by Warner-Lambert for the treatment of pain under the...more

SC Public Policy Update - January 2017

What's New - Members of the South Carolina General Assembly returned to Columbia on Tuesday, January 10th, to begin the first year of the 122nd Legislative Session. The top priorities facing lawmakers entering the new...more

Eighth Circuit Rules That ERISA Expressly Preempts Iowa Pharmacy Benefit Law

The United States Court of Appeals for the Eighth Circuit recently held that ERISA expressly preempts an Iowa law that imposes onerous regulatory requirements on pharmaceutical benefit managers operating in Iowa. The reversal...more

Failure to Timely Notify Results in Enforcement Action and Significant Settlement

For the first time, on January 9, 2017, the Department of Health and Human Services, Office for Civil Rights (HHS/OCR) settled a HIPAA enforcement action based on the untimely reporting of a breach of unsecured protected...more

Grassley Continues To Press CMS on Medicaid Drug Rebate Classifications: What Will Be the Fallout?

Back in early October, we were all transfixed by the announced Mylan settlement with the U.S. Department of Justice (DOJ) over Mylan’s alleged underpayments of Medicaid Drug Rebates for the EpiPen. Although Mylan indicated...more

Judge Denies HHS’s Request to Rescind Timeline to Eliminate the Medicare Appeals Backlog

On January 4, 2017, the court in the American Hospital Association (AHA) v. Burwell litigation denied HHS’s motion to reconsider, which means that HHS must comply with the court’s timeline to eliminate the Medicare appeals...more

CMS Finalizes Testing of New Episode Payment Models and MSSP Track 1+ ACO

On January 3, 2017, CMS published a final rule addressing three care coordination models: - Cardiac care: CMS added two new cardiac care episode payment models (“EPMs”) for items and services furnished to patients...more

FDA Releases Biosimilar Naming Guidance

FDA just released a final Guidance for Industry, “Nonproprietary Naming of Biological Products.” The guidance provides that naming for originator biological products, related biological products, and biosimilars should...more

OIG Issues Favorable Advisory Opinion for Cost-Sharing Waiver and Stipend Arrangements in a Government-Funded Clinical Research...

The Office of Inspector General (OIG) recently issued a favorable advisory opinion (Advisory Opinion) to a university health system (Requestor) regarding two arrangements: (1) a proposal to waive cost-sharing obligations of...more

Urban hospitals that established GME caps after 1996: Be careful with this compliance issue

If a teaching hospital meets certain regulatory requirements, the hospital is generally permitted to loan its cap slots to other hospitals through a Medicare GME affiliated group agreement. (See Sharing FTE Caps: Threshold...more

HHS OIG Finalizes New Exclusion Rules as Administration Exits

With just a week left before a new administration takes office, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized changes to the regulations authorizing OIG to exclude...more

Fitness Enthusiasm Wanes Early: ACA-Related Congressional Actions January 5 – 12

On January 5, the House passed the “Regulations from the Executive in Need of Scrutiny Act of 2017” (H.R. 26), streamlining the process for Congressional review and rejection of administrative agency rules, including a...more

Breach of Privacy Prompts Breach of Etiquette: DHHS Sets New Precedent in Privacy Breach Enforcement

On January 9, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) took action against a health system for non-timely reporting of a breach of protected health information. It was the first...more

CMS Finalizes Mandatory Cardiac and Joint Bundles … But Their Future is Uncertain

When Tom Price assumes the top post at the U.S. Department of Health and Human Services (HHS) later this month (subject to Senate confirmation), the ink will barely be dry on a final rule issued by the Centers for Medicare &...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

Food for Thought (and Health): Day 2 Notes from the JP Morgan Healthcare Conference

Addressing the Social Determinants of Health: Is the healthcare industry pushing a rock up a hill? We collectively are trying to provide healthcare with improved quality and reduced cost, but the structure of the nation’s...more

"OFAC Eases Restrictions on the Export of Medical Devices to Iran"

On December 22, 2016, the U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) announced amendments to the general license (GL) that authorizes the export or re-export of certain medical devices to Iran....more

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