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.
General Data Protection Regulation (GDPR) preparedness should be a priority and we will review the steps you need to take to make sure you’re in compliance. Though the GDPR comes from the European Union, businesses everywhere should apply GDPR principles in practice.
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.
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.
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.
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.
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.
On January 9, the 2019 General Assembly Session will convene, and there are several bills that are set to be introduced that may have an impact on Virginia healthcare providers. We will update this post with additional legislation as session progresses.
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.