CCM Compliance Frequently Asked Questions

Like all Medicare programs, Chronic Care Management (CCM) comes with legal and compliance questions. Donna Wilkinson, executive VP and legal counsel, answers the compliance questions ChartSpan, a CCM organization, receives most often.

Q: In your opinion, what compliance requirement of Medicare’s Chronic Care Management program gets overlooked the most?

A: In my opinion, the compliance issue which gets overlooked the most is the Initiating Visit required by CMS. CMS requires an initiating visit for either (1) new patients or (2) patients who the billing practitioner has not seen within one (1) year. If a patient does not fall in either of those two categories, meaning they have seen the practitioner within the last twelve (12) months, an initiating visit is not needed. If an initiating visit is needed because a patient falls in the one of the two categories mentioned, such a visit can occur during an E/M visit, Annual Wellness Visit or Initial Preventive Physical Exam, and the practitioner needs to discuss CCM during such a visit.

Q: Medicare is a federal program, but when considering how to staff a CCM program with clinicians, state licensure rules come into effect. Please explain.

A: CCM services do not require a physician’s physical presence but are performed under the “general supervision” of the billing practitioner by “clinical staff.” CMS does not define the term “clinical staff” but instead refers to the CPT codes, which uses the following definition, “a person who works under the supervision of a physician or other qualified health care professional and who is allowed by law, regulation and facility policy to perform or assist in the performance of a specific professional service, but who does not individually report that professional service.” Due to this definition, state and local laws must be analyzed to ensure clinical staff may perform CCM services in a particular jurisdiction. Lastly, CMS requires that providers be in compliance with all applicable state law in order for CCM services to be validly billed to Medicare. Whether the activities undertaken by clinical staff in performance of CCM services may be reasonably categorized as the practice of medicine, nursing, or neither is a question of state law. This means in some states CCM clinical services may need to be provided by a LPN, RN, or LVN, but in other states, this may not be a requirement.

Q: In last year’s Physician Fee Schedule, CMS cleared up years of confusion regarding enrolling patients in a CCM program under General Supervision. Explain the confusion and the clear new rule CMS has put in effect regarding enrolling patients in a CCM program.

A: CMS has implemented many changes to the CCM program since its implementation in January 2015. The issue of what level of supervision a CCM program can be implemented using has changed several times as well. In December 2019, CMS issued its first clarification on the supervision issue and stated CCM enrollment must be done under Direct Supervision effective January 2020. In April 2020, after the Public Health Emergency due to Covid-19 was declared, CMS temporarily suspended the Direct Supervision requirement and states enrollment in CCM could occur under General Supervision. In July 2021, a preliminary physician fee schedule introduced a permanent change to the policy whereby General Supervision would be the CCM program standard; however later in November 2021 when the final physician fee schedule for 2022 was released, CMS indicated they had not yet reached a decision and would look to address the supervision issue in a future rule but wanted to make the permanent rule General Supervision. In February 2023, with the Public Health Emergency ending, and no permanent rule in place, CCM providers were struggling to understand what the supervision requirement would be, knowing by December 31, 2023 all Public Health Emergency waivers were ending. Fortunately, in November 2023, with the issuance of the final physician fee schedule, CMS memorialized that consent and enrollment for CCM could be done under general supervision on a go forward basis.

Q: In order to ensure a compliant patient enrollment in a CCM program, what program elements or information must be provided and explained to a patient?

A: CMS requires that a CCM provider obtains a patient’s verbal or written consent for CCM services before billing them and records such consent. With the CCM MLN there are four elements which must be explained to a patient before they can provide informed consent to opt into the program:

Availability of CCM services (outlining the services included: creation of care goals and care plans, help with refills, assistance with SDOH, a 24/7 nurse line, monthly calls with clinical staff)
Cost sharing responsibilities (there may be a copay and deductibles do apply)
Only one practitioner can furnish and bill CCM during each calendar month (a patient can only be enrolled under one provider)
Patient’s right to stop CCM services at any time (a patient may unenroll at any time)

Q: Has Medicare ever established a compliance requirement that a patient must engage via telephone, in order for a practice to submit a claim for reimbursement?

A: CMS has not established any compliance requirement that a patient must engage via telephone in order for a provider to submit for reimbursement. We have received various guidance documents and FAQs from CMS that do give us insight into activities which may count toward care each month, and those activities may not necessarily include direct telephone engagement. For instance, CMS understands there may be circumstances where clinical staff perform a single activity that will benefit multiple beneficiaries, such time spent on such activity may be split amongst the beneficiaries. In these same guidance documents issued directly by CMS, we know that CMS agrees that activities which are not direct telephone engagement may count toward billable time, such as patient education, review of medical records and test results, and coordination and exchange of health information with other practitioners.

Q: Can a service provider like ChartSpan have the fees we charge for delivering care to patients tied to the reimbursement a provider earns from Medicare in a CCM program?

A: Due to the Anti-Kickback Statute and the Civil Monetary Penalties Law, ChartSpan, or any third-party working under General Supervision, “incident to”, cannot have the fees it charges for its services determined based on the amount of reimbursement received by a practitioner from Medicare. A third party working under general supervision of a practitioner is not allowed to receive payment from said practitioner which takes into account the value of revenue generation where that revenue is being made in whole or in part by a federal health care program. In determining if a contract for payment poses a high risk of fraud and abuse, OIG will look to ensure the fee received by the partner (here, ChartSpan) is not related to the value or volume of reimbursable services.

Further Compliance Questions

These questions are intended to guide you as you explore CCM’s possibilities. If you have further questions about compliance requirements for CCM, visit the Centers for Medicare & Medicaid Services website or contact ChartSpan at https://www.chartspan.com/talk-to-an-expert/.

*This FAQ is not intended to be legal advice and is presented for educational purposes only. This FAQ should not be used as a substitute for legal advice.