HHS Proposes New Safe Harbors Under the Anti-Kickback Statute and The Stark Law

HHS Proposes New Safe Harbors Under the Anti-Kickback Statute and The Stark Law

In a pair of proposed rules released by the Department of Health and Human Services (DHHS), Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS), the DHHS is looking to increase the utilization of value-based arrangements to drive health outcomes and ease the regulatory burdens associated with patient care coordination.  The proposed rules seek to change or add certain safe harbors or exceptions to the Anti-Kickback Statute (AKS), Physician Self-Referral prohibition (Stark Law), and the Civil Monetary Penalties (CMP) laws. 

Nixon Law Group, a leading health law firm, welcomes Faisal Khan, Esq.

Nixon Law Group, a leading health law firm, welcomes Faisal Khan, Esq.

Nixon Law Group, a leading health care law firm representing innovative healthcare providers and health technology companies, announced today that Faisal Khan, Esq. has joined the Firm as Senior Counsel. Mr. Khan will be based in Cleveland, Ohio, expanding Nixon Law Group's reach in the Midwest.

CMS’ New Coding Policy Will Speed up Reimbursement for New Drugs and Devices

CMS’ New Coding Policy Will Speed up Reimbursement for New Drugs and Devices

When developing new medical device and drug products, it is important to understand how the product will be adopted and paid for in the marketplace. The development of new drugs and devices involves countless hours researching, testing, modifying, iterating, and testing some more… In larger companies, whole teams of people also dedicate the same effort into developing a market access plan—meaning careful planning for manufacturing, distribution, and insurance contracting.  This strategic planning can be overlooked in start-up biotech companies operating on limited resources and which are squarely focused on innovating new technologies.

FDA: Abbreviated, Special and Traditional 510(k) Clearance Applications

FDA: Abbreviated, Special and Traditional 510(k) Clearance Applications

The FDA has just issued four final guidance documents related to the 510(k) clearance applications for medical devices.  The Guidance documents can be found here, and they describe the FDA’s current thinking on special 510(k) clearance programs such as the Abbreviated application and the newly established “Special 510(k)” program. 

Virginia Cannabis Industry Association (VCIA) to Host Legislative Update and 2020 Session Preview

Virginia Cannabis Industry Association (VCIA) to Host Legislative Update and 2020 Session Preview

The Virginia Cannabis Industry Association (VCIA) will host a series of regional legislative forums over the next several weeks.  Discussions will include an update about the Virginia cannabis industry and how outcomes of the November elections of all 140 seats of the Virginia General Assembly may affect the opportunities and challenges of this nascent industry. 

Out of the Box:  The FDA Wants to Understand How Prescribers Consider Serious Drug Safety Information.

Out of the Box: The FDA Wants to Understand How Prescribers Consider Serious Drug Safety Information.

We see the advertisements on the television, the music plays and people start barbequing, playing frisbee with their dogs, or walking through their neighborhood greeting neighbors with a smile.  A voiceover describes some medical condition, and then, they tell you that there’s a drug that may help.  After about thirty seconds of hearing about how the drug may help treat a specific condition, the voice starts to tell you all the things that may go wrong. 

Breakthrough Devices: CMS Removes Hurdles and Increases Payments for New Technology Add-On Payments Under the IPPS Final Rule

Breakthrough Devices: CMS Removes Hurdles and Increases Payments for New Technology Add-On Payments Under the IPPS Final Rule

Hospitals and medical device manufacturers will both benefit from the Centers for Medicare and Medicaid Services’ (CMS) finalization of the 2020 Inpatient Prospective Payment System (IPPS) Final Rule (“Final Rule”) scheduled to be published on August 16, 2019.  In an effort to increase Medicare beneficiaries’ access to innovative medical technologies, CMS has finalized certain changes to the “new technology add-on payment” “(NTAP) application and payment processes under the Final Rule. This change is likely to encourage hospital adoption of new technologies, which is intended to spur innovation and additional investment in these technologies.

New Maryland Telehealth Rules for Psychiatric Nurse Practitioners

New Maryland Telehealth Rules for Psychiatric Nurse Practitioners

Maryland’s Secretary of Health adopted new regulations that lay out standards for the nonclinical practice of teletherapy by certified registered nurse practitioners/psychiatric mental health (CRNP/PMHs) and psychiatric mental health/advanced practice registered nurses (PMH/APRNs).  

UPDATE: VDACS Food Safety Program Releases CBD Manufacturing Requirements for Virginia Industrial Hemp Processors

UPDATE: VDACS Food Safety Program Releases CBD Manufacturing Requirements for Virginia Industrial Hemp Processors

Following its July 15th letter to Virginia Industrial Hemp Processors (“Processors”) notifying them of Governor Ralph Northam’s recent directive regarding the manufacture of CBD in Virginia, the VDACS Food Safety Program (the “FSP”) sent a letter to Processors on Friday, July 26th setting forth guidelines for Processors to follow when manufacturing cannabidiol (“CBD”) products intended for human consumption (the “Food Safety Letter”).