FDA: Reviewing Novel Coronavirus's Impact to U.S. Drug Supply
From ACG FDA Related Matters Committee Chair Stephen Hanauer, MD, FACG
On Tuesday, February 25, the U.S. Food and Drug Administration (FDA) announced an effort to track how the U.S. drug supply chain could potentially be impacted by the coronavirus outbreak. According to reports, the FDA has identified about 20 drug products which are either solely manufactured in China or contain an active pharmaceutical ingredient solely made in China. The "FDA is keenly aware that the outbreak will likely effect the medical product supply chain, including critical supplies needed in the U.S.," Commissioner Stephen Hahn said at a press briefing.
Of note, the FDA has received no reports of potential shortages to date. The agency is also contacting more than 180 manufacturers of U.S.-approved drug products that are made in China to remind them of their requirement to notify the FDA of anticipated supply disruptions.
Drug companies are required to notify the FDA 6 months in advance before a product discontinuation or manufacturing interruption. If that is not possible, notification must come as soon as practicable, and no less than five business days before a product is discontinued or manufacturing is interrupted.
According to Politico, China provides the raw material used in 13% of U.S. drugs, and together with India accounts for 40% of factories manufacturing drug ingredients and finished medicines for U.S. patients.
The National Institutes of Health (NIH) has also commenced a randomized controlled trial for the treatment of COVID-19 patients. According the FDA, sponsors are expected to allow 30 days between submission and initiation of an initial IND protocol to allow for safety review. However, the FDA has been using both pre-IND discussions and a “highly expedited initial review” to allow such trials to begin as soon as possible.
New Program This Year: ACG's Meet Your Governor Initiative
From ACG Governors James Hobley, MD, MSc, FACG, and Alison Schneider, MD, FACG
We want to remind ACG members of two exciting upcoming ACG regional courses:
Meet Your ACG Governor!
We appreciate the opportunity to meet you and learn more about important issues in our states and regions. Dr. Hobley will be at the welcome reception for registered attendees on Friday, March 6th (ACG/LGS Course). Dr. Schneider will be at the registration desk each morning on March 13-15 (ACG/FGS Course).
We hope to see you there!
ACG on Capitol Hill: Meeting with Congress and Key Healthcare Policy Staff
From ACG Legislative and Public Policy Council Chair, Whitfield L. Knapple, MD, FACG
This week ACG was on Capitol Hill meeting with Congress, including chief policy staff from the U.S. House Committee on Ways & Means to discuss important legislative priorities. A quick summary:
Removing Barriers to Colorectal Cancer Screening Act (HR 1570): ACG conveyed the hope that the Ways & Means Committee includes this bill in any “surprise billing” or drug pricing legislative packages coming out the of the House. Ways & Means Committee Chairman, Richard Neal (D-MA) has been a long-time champion of ACG priorities and was the chief sponsor of the SCREEN Act in previous Congresses, a bill that pre-dated but addressed the same issues as the Removing Barriers bill (as well as seeking to protect Medicare reimbursement of colonoscopy). ACG urged the committee staff and Chairman Neal to work together with the current champions of H.R. 1570, Rep. Donald Payne, Jr. (D-NJ) and others. March is “colorectal cancer awareness month” and right around the corner. ACG will be joining patient advocates and the Digestive Disease National Coalition (DDNC) on Capitol Hill next week to advocate for H.R. 1570 and other important priorities. ACG Vice President, Samir Shah, MD, FACG is also President of the DDNC.
The House passed a drug pricing bill last year that included the language from H.R. 1570, so there is momentum!
Improving Seniors' Timely Access to Care Act (H.R. 3107): ACG also urged the committee to consider H.R. 3107. The bill improves the Medicare Advantage prior authorization process, including real-time decision-making via electronic means for routinely-approved items and services. ACG Governors have conveyed members’ frustration with prior authorization, coverage denials, as well as the laborious and painstaking process of simply getting to talk to the insurance plan’s medical director. Thus, the ACG Public Policy Council is actively working with Congress on this issue on your behalf.
According to the Medicare Payment Advisory Committee (MedPAC), Medicare Advantage enrollment reached 21.9 million beneficiaries in 2019.This represents 34% of all Medicare beneficiaries. Medicare Advantage enrollment has grown steadily since 2003, increasing almost fivefold. However, a September 2018 U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) review of Medicare Advantage denials from 2014-2016 reinforces the point that prior authorization requirements prevent patients from receiving medically necessary care. According to the report, Medicare Advantage organizations overturned 75% of their own denials during 2014-16, or approximately 216,000 denials each year. During the same period, independent reviewers at higher levels of the appeals process overturned even more denials in favor of beneficiaries and providers. ACG also highlighted to committee staff another important finding related to the prior authorization process in the OIG report: “This is especially concerning because beneficiaries and providers rarely used the appeals process designed to ensure access to care and payment, appealing only 1 percent of denials during 2014- 2016.”
Remember to contact your ACG Governor on important state and local issues impacting you and your practice.
The ACG Board of Governors is one of the most unique aspects of the American College of Gastroenterology. Governors are ACG Fellows that are elected from the membership of a particular state or region. There are currently 77 Governors across seven different regions in the U.S. and abroad. The Board of Governors acts as a two-way conduit between College leadership and the membership at-large. This helps the College make certain it is meeting the ever-evolving needs of the membership.
New ACG Practice Management Toolbox Article: Fat(ty Liver) is our Future: Setting Up a Disease Management Program in Your Practice
New this week to the ACG Practice Management Toolbox is an article brought to you by committee members Richard Nemec MD, FACG and Bennie Upchurch, MD, FACG that discusses high quality disease management programs and how to effectively integrate them into your practice and distinguish your practice. Click the link below to read the article.
Professional Service Agreements: Perfect Solutions to Affiliations? By Ann Bittinger, Esq.
ACG recently commissioned Ann Bittinger, Esq. to draft a white paper on Professional Services Agreements (PSA) as a resource for our members. In addition to guidance and perspective, Ms. Bittinger also provides template legal contract language that will be helpful to ACG members negotiating a PSA with a health system. Download this language for your use!