By: J. Parker Zopp
New Year’s Resolutions are often quickly abandoned as the warm glow and hopeful aura of the holidays are snuffed out by winter’s more frigid days. At least one recent survey claims that people give up on those optimistic goals around 3.74 months into the new year.[1] While Jack Frost may sweep away certain resolutions, those in the health care industry should hold fast to at least one goal throughout the entirety of the year: maintaining compliance with 42 U.S.C. 1395nn, also referred to as the Physician Self-Referral Law or the “Stark Law.”
While the Stark Law is a nuanced regulatory framework, the framework’s main premise is that it prohibits physicians from referring patients to receive designated health services (DHS) payable by federal health care programs from entities with which the physician or an immediate family member has a financial relationship, unless there is an applicable exception.[2] It also prohibits persons and entities from filing claims for any improperly referred DHS.[3]
To comply with the Stark Law, those in the health care industry thus need to know which services federal regulations classify as DHS. The Center for Medicare and Medicaid Services (CMS) aids the industry here in part by annually publishing the “Code List.” This is the list of Current Procedural Terminology (CPT) and Healthcare Common Procedure Coding System (HCPCS) codes that identifies items and services that classify as DHS for four DHS categories, as well as those items that may qualify for exceptions to DHS classification. As of January 1, 2024, CMS began operating from an updated Code List, which includes several noteworthy changes.
Decoding the Code List
Prior to 2022, CMS published updates to the Code List through addendum to an annual rule on Federal Register. However, now CMS publishes the Code List and its updates on its website, listed here.
Federal regulations detail that there are ten DHS categories. However, the Code List only lists the applicable codes for services that would fall under four of those ten DHS categories.[4] Those four DHS categories found on the Code List include the following:
- Clinical laboratory services;
- Physical therapy, occupational therapy, and outpatient speech-language pathology services;
- Radiology and certain other imaging services; and
- Radiation therapy services and supplies.
With respect to these four categories only, this means that if the Code List does not include a code with a corresponding service, then that service is not a DHS under the Stark Law. However, if the service could fall under to one of the other six DHS categories, verification of whether the service is a DHS may only be accomplished by reviewing the regulatory framework that defines those categories.
In addition to designating certain services as DHS, the Code List also identifies those items and services that may qualify for either of the following two exceptions to the Stark Law prohibitions:
2024 Updates to the Code List
Beginning this year, CMS defines definitive drug testing laboratory services as DHS on the Code List. Definitive drug testing differs from presumptive drug testing in the sense that the goal is not to identify the use or non-use of a drug or class of drugs. Instead, definitive drug testing seeks to identify specific drugs, specific drug concentrations, and associated metabolites. This addition could affect providers in several different areas the pain management and behavioral health care spaces.
The Code List also details certain codes for services that provide training for patient caregivers under the category of physical therapy, occupational therapy, and outpatient speech-language pathology services. For radiation services, it adds codes pertaining to therapeutic radiology simulation-aided field setting and stereotactic body radiation therapy. To the category of radiology and certain other imaging services, the update adds, among other services, codes pertaining to cardiac ultrasounds and cerebral MRI quantification software that can assist clinicians to diagnose brain disorders such as Alzheimer’s Disease and Dementia.
The most notable deletions form the Code List in the 2024 update are certain COVID-19 specimen collection and testing codes. These type of removals will likely become more prevalent as public health programs related to COVID-19 continue to expire.
Looking Ahead to 2025
CMS will publish the next annual update to the Codes List on or before December 2, 2024, and there will be a 30-day public comment period for stakeholders to voice their opinions on the proposals.
Jackson Kelly attorneys are ready to assist you with Stark Law compliance and other health care compliance matters.
[1] Forbes, New Year’s Resolutions 2024 (Dec. 18, 2023, 4:37 am), https://www.forbes.com/health/mind/new-years-resolutions-statistics/.
[2] See 42 U.S.C. § 1395nn(a)(1)(A).
[3] See id. at §1395nn(a)(1)(B).
[4] See 42 C.F.R. § 411.351. The remaining DHS categories are as follows: durable medical equipment and supplies; parenteral and enteral nutrients, equipment and supplies; prosthetics, orthotics, and prosthetic devices and supplies; home health services; outpatient prescription drugs; and inpatient and outpatient hospital services. See id.
[5] See 42 C.F.R. § 411.355(g).
[6] See id. at § 411.355(h).