Viewing entries in
Healthcare Reform

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.

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 CMS Innovation Models: Primary Care First and Direct Contracting

New CMS Innovation Models: Primary Care First and Direct Contracting

In April, the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) announced a new set of payment models meant to allow primary care providers deliver better care at a lower cost to their patients by removing unneccessary administrative and adjust payouts from procedures to outcomes.

Practice Agreement Requirements for Virginia Nurse Practitioners

Practice Agreement Requirements for Virginia Nurse Practitioners

In Virginia (and in many other states), NPs who do not have an autonomous practice must practice under the direct supervision of a physician as part of a patient care team, pursuant to what is called a “Practice Agreement,” or, “Collaborative Practice Agreement.” A Practice Agreement is an agreement between an NP and the NP’s supervising physician that describes the relationship between the parties, including the procedures to be followed and acts to be performed by the NP in the course of providing care to patients.