Important Updates from CMS: Stark and AKS Final Changes; Drug Prices; MIPS Hardship Application

From ACG Legislative and Public Policy Council Chair, James C. Hobley, MD, MSc, FACG

Stark Law and AKS Changes Released: The Department of Health and Human Services (HHS) on Friday released regulatory changes to the Stark Law and Anti-Kickback Statute (AKS). ACG is currently going through each rule and will provide more detailed guidance to membership. The Stark Law final rule creates permanent exceptions for value-based arrangements. The exceptions also apply to arrangements treating non-Medicare patients. The final rule provides additional guidance on key compliance requirements, such as how to determine whether compensation arrangements meet “fair market value” standards.  

Complimenting these Stark changes, the AKS final rule implements new and modifies existing safe harbors to foster and protect value-based arrangements. Value-based arrangements include: care coordination arrangements to improve quality, health outcomes, and efficiency; value-based arrangements with substantial downside financial risk; and value-based arrangements with full financial risk.

Click here for the Stark Law final rule and fact sheet.  Click here for AKS final rule and fact sheet.

Most Favored Nation Drug Pricing Model: The Trump Administration and the Centers for Medicare and Medicaid Services (CMS) also on Friday announced the much anticipated final rule on the Most Favored Nation (MFN) drug pricing model. Starting January 2021, the model will run for seven years. CMS will use the “MFN price” for top 50 Medicare Part B drugs and biologicals (highest spending). All Medicare-participating physicians, hospitals, and ambulatory surgical centers will be paid the MFN payment for these 50 drugs and biologicals, rather than the current average sales price (ASP) plus 6%. Of note to ACG members, this list includes infliximab (J1745) and ustekinumab (J3357). ACG is still reviewing the final rule’s impact to GI practices and will provide further guidance.

Click here for the final rule. Click here for the fact sheet.

MIPS Hardship Exemption Still Available. CMS also recently announced that the MIPS "Extreme and Uncontrollable Circumstances" Application remains open until December 31, 2020. The “Extreme and Uncontrollable Circumstances” policy allows MIPS eligible clinicians, groups, and virtual groups to submit an application requesting a reweighting of one or more MIPS performance categories to 0%. Submit an application now and be sure to cite COVID-19 as the reason for your application. If approved, you can still receive scores for the Quality, Improvement Activities, and Promoting Interoperability MIPS performance categories. Please note that if the Cost performance category is included in your approved application, you will not be scored on cost measures even if other data are submitted. Learn more in the 2020 Exceptions Applications Fact Sheet.

CMS Still Moving Forward with Medicare Cuts: We still need you advocacy help! Medicare physician payments are scheduled to be cut across most specialties in CY 2021 when increases to evaluation and management (E/M) services are implemented. GI procedures are scheduled to be cut roughly 10%.

Good news: A bill in Congress prevents these cuts for 2 years. The “Holding Providers Harmless from Medicare Cuts During COVID-19 Act of 2020” (H.R. 8702) was introduced by Reps. Ami Bera, MD (D-CA) and Larry Bucshon, MD (R-IN). The bill provides a temporary reprieve while ACG and stakeholders can work towards a permanent resolution.

DDNC Fall Forum: Focus on Step Therapy & Cost-Shifting in Patient Care

From ACG President-Elect Samir Shah, MD FACG; President of the Digestive Disease National Coalition

The Digestive Disease National Coalition (DDNC) on Monday held its virtual Fall Forum entitled “Patient Access to Care and Treatments in the Cost-Shifting Era." This event featured a presentation by Ralph McKibbin, MD, FACG outlining harmful cost-shifting tactics in patient care, including step therapy. ACG thanks the DDNC for gathering like-minded patient advocacy groups and medical societies together, and for championing these important policy issues. Step therapy and prior authorization reforms remain among the College’s top policy priorities. ACG is urging Congress as well as state legislatures to pass these necessary reforms to improve patient care.


ACG Practice Management Summit Registration is Still Open: Free On-Demand Session Below!

One benefit of the 2020 ACG Virtual Annual Meeting is that the registration is still open until December 31, 2020 and access to the platform is open until January 31, 2021!

There is still time to learn more about the hottest practice management and reimbursement issues impacting GI today and in the future. The Practice Management Summit offers new and innovative ways to improve patient care, improve operations, enhance productivity, and overall success in your careers. Register today and access the Practice Management Summit at ACG: Something for Everyone.

Free On-Demand Session! Check out this free on-demand session from this year's course. Former ACG Practice Management Committee Chair, Louis J. Wilson, MD, FACG discusses various ways to improve your GI practice’s bottom line without sacrificing quality.

Please note that CME and MOC for this lecture is only available through the ACG 2020 platform and you must
be registered for the Practice Management Summit to access the full set of lectures.

ACG Participating in National Colorectal Cancer Roundtable (NCCRT) Meeting

This week at the National Colorectal Cancer Roundtable (NCCRT) Annual Meeting, ACG President Dr. David A. Greenwald participated in a panel discussion on the importance of colorectal cancer screening despite COVID-19, and the need to emphasize safety with patients.

ACG thanks the NCCRT for their tireless work to improve colorectal cancer screening rates in the U.S.

What is the Practice Management Toolbox?

The Toolbox is a series of short articles, written by practicing gastroenterologists, that provide members with easily accessible information to improve their practices. Each article covers an issue important to private practice gastroenterologists and physician-lead clinical practices. They include a brief introduction, a topic overview, specific suggestions, helpful examples and a list of resources or references. Each month a new edition of the Toolbox will be released and will then remain available here along with all previous editions. The Practice Management Committee is confident this series will a provide valuable resource for members striving to optimize their practices.