Health Care Counsel Blog

Legislation included as part of the massive congressional budget deal reached earlier this month will pave the way for expanded use of telehealth technologies that improve access to care and reduce cost of health care.

Personalized medicine patent claims have been under assault since the Supreme Court’s Mayo v. Prometheus decision.

The Bipartisan Budget Act of 2018 was signed into law on February 9, 2018 in order to avert another shut-down of the federal government.

On December 28, 2017, the Centers for Medicare and Medicaid Services (CMS) issued Survey and Certification Memorandum Number 18-10-ALL to the State Survey Agencies clarifying its position regarding texting health care information by providers.

Three Department of Justice memoranda recently emerged that shed light on DOJ enforcement policies.

As was widely reported, Congress approved legislation late Monday, January 22, 2018 to provide continuing appropriations for federal agencies through February 8, 2018, ending the government shutdown that began Saturday.

A new administrative rule promulgated and adopted by the Attorney General for the state of New Jersey (the AG) will “regulate the receipt and acceptance by prescribers of anything of value from pharmaceutical manufacturers.”

This year brought us very significant changes in patent jurisprudence from the Supreme Court and Federal Circuit affecting Chemical & Life Sciences patent practice.

The Department of Health and Human Services Office of Inspector General (OIG) recently released a proposed rule soliciting recommendations for new Anti-Kickback Statute (AKS) safe harbors, modifications to existing safe harbors, and new OIG Special Fraud Alerts.

In late December 2017, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) released the findings of a report titled “Potential Misclassifications Reported by Drug Manufacturers May Have Led to $1 Billion in Lost Medicaid Rebates.”

The Department of Justice recently published its annual False Claims Act (FCA) recoveries statistics for Fiscal Year 2017, reporting $3.7 billion in FCA settlements and judgments in FY 2017.

On December 8, 2017, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed a lawsuit in the US District Court for the Eastern District of California seeking to block California’s new drug transparency law.

The world of health care reimbursement can involve many different players on the payer side. Group health plans and health insurers are well-known players, but networks, administrators, repricers, consultants, and others may enter the scene as well.

California agencies posted their proposed emergency regulations for commercial medicinal and adult-use cannabis.

The advance copy of the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs (HOPPS) final rule for calendar year 2018 (the Final Rule) was released on November 1, 2017.

California Governor Jerry Brown signed two major pieces of legislation affecting the application and hiring process for nearly all employees. AB 168 prohibits employers from seeking salary history information about an applicant for employment, among its related provisions.

Following in the steps of Maryland and Nevada, California just adopted a comprehensive drug pricing transparency law that will have a significant impact on the pharmaceutical industry, particularly on drug manufacturers. n

The issue of where a medical provider with an assignment of benefits may sue an ERISA-governed healthcare plan for unreimbursed medical care is important.

On August 21, 2017, the Health Resources and Services Administration published a proposed rule that would entertain even further delays of the implementation of a January 5, 2017 Final Rule regarding calculation of 340B ceiling prices.

Over the past month, California has been a veritable hotbed of activity regarding the regulation of cannabis for both medical and adult use.

On July 18, 2017, FDA held a public meeting to address efforts to ensure a balance between innovation in drug development and accelerating the access of the public to lower-cost alternatives to innovator drug therapies is maintained under the Drug Price Competition and Patent Term Restoration Act.

The Centers for Medicare & Medicaid Services has released its annual proposed update to the hospital outpatient prospective payment system for calendar year 2018.

AnMed Health, a hospital located in South Carolina, recently agreed to pay almost $1.3 million dollars and enter into a settlement agreement with the HHS Office of Inspector General to resolve allegations that it violated the Emergency Medical Treatment and Labor Act.

Earlier this year, Abid Hospital in Pakistan began accepting PakCoin (a cryptocurrency similar to Bitcoin) as payment for healthcare services, paving the way for innovative medical payment solutions in Asia.

Last week, the FDA released a draft guidance titled Product Identifier Requirements Under the Drug Supply Chain Security Act—Compliance Policy, with a 60-day comment period ending around September 3, 2017.