Month: July 2019

FDA Announces it is Expediting Review of CBD

Posted on July 15, 2019 by - Government Affairs

On July 12, 2019, Food and Drug Administration (FDA) Principal Deputy Commissioner Dr. Amy Abernathy announced via Twitter that the FDA is expediting its work to address the regulation of cannabidiol (CBD). She stated that FDA intends to report on its progress “around end of summer/early fall.”

Dr. Abernathy added that the FDA is enthusiastic about research into the therapeutic benefits of CBD products but reiterated the need to balance safety concerns. She also acknowledged the intense interest around this issue by saying that in addition to the over 100 speakers who presented at the May 31 FDA public hearing on cannabis products, there have been 3,417 comments submitted to the public docket (with four days remaining before the July 16 deadline).

Congress has also recently pressed the FDA for expedited action on CBD regulation. Senator Ron Wyden, D-Ore., sent the FDA a letter on June 25 urging the FDA to promptly issue guidance that ensures a regulatory pathway for the lawful use of hemp-derived CBD as a food additive and as an ingredient in dietary supplements. He called for FDA to issue an “enforcement discretion guidance” by August 1.

On the other side of the aisle, Senator Mitch McConnell, R-KY, met with Acting FDA Commissioner Dr. Ned Sharpless on June 28 and urged him to develop regulations to allow hemp-derived CBD to be lawfully marketed.

The House also recently passed an amendment to appropriations legislation directing FDA to “undertake a process to make lawful a safe level for conventional foods and dietary supplements containing [CBD] so long as the products are compliant with all other FDA rules and regulations.”

The emerging CBD industry creates opportunities for current participants in the drug supply chain, physicians, and other healthcare providers. However, anyone either currently involved in marketing or providing CBD products or those desiring to get into the CBD market should engage qualified guidance. Frier Levitt Government Affairs and Frier Levitt are committed to the healthcare industry and can provide sage advice to providers. Contact us today.

HHS Announces New Payment Models Impacting Nephrology Stakeholders

Posted on July 11, 2019 by - Government Affairs

Blog: HHS Announces New Payment Models Impacting Nephrology Stakeholders

President Trump has signed an Executive Order that directs the Department of Health and Human Services (HHS) to develop new nephrology policies to address reducing the number of patients developing kidney failure, increasing the number of kidneys available for transplant, and reducing the number of dialysis treatment at dialysis centers to encourage more in-home kidney dialysis. These policies will take shape in via five new CMS Center for Medicare and Medicaid Innovation payment models.

According to HHS, “the proposed required End-Stage Renal Disease (ESRD) Treatment Choices (ETC) Model would encourage greater use of home dialysis and kidney transplants for Medicare beneficiaries with ESRD in order to preserve or enhance their quality of care while reducing Medicare expenditures, and the Kidney Care First (KCF) and Comprehensive Kidney Care Contracting (CKCC) Models will test new Medicare payment options that aim to improve the quality of care for patients with kidney disease.”

Additionally, CMS announced four optional models:

  • The Kidney Care First (KCF) Model
  • The Comprehensive Kidney Care Contracting (CKCC) Graduated Model
  • CKCC Professional Model
  • The Global Model

These optional payment models are designed to help health care providers reduce the cost and improve the quality of care for patients with late-stage chronic kidney disease and ESRD. These models also aim to delay the need for dialysis and encourage kidney transplantation.

Healthcare and life sciences stakeholders can expect to continue to see policy changes for the foreseeable future so it is better to be prepared ahead of time before they happen. Frier Levitt Government Affairs (FLGA) monitors and forecasts issues of importance for healthcare and life sciences stakeholders, including state and federal legislation and regulation, all presented in a concise, easy to understand and time friendly format. FLGA’s monitoring and forecasting services allow stakeholders to stay educated and engaged on new developments before the trends become mainstream.

With laws and regulations changing all the time, it is imperative for healthcare and life sciences stakeholders and organizations to be proactive instead of reactive. Contact FLGA today to get “in the know” and finally be prepared for the changes ahead.