Industry News, April 2024

​First Coast Service Options Issues Guidance for Avoiding Code G2211 Denials

According to First Coast Service Options, Inc., the Medicare Administrative Contractor (MAC) for Florida, Puerto Rico, and the U.S. Virgin Islands, has been receiving a flood of appeals requests for denials of HCPCS code G2211 when billed with an office and outpatient (O/O) E/M service (CPT® codes 99202-99205 and 99211-99215) appended with modifier 25 because National Correct Coding Initiative (NCCI) edits do not apply in this scenario.

Guidance for Avoiding Code G2211 Denials

The Centers for Medicare and Medicaid Services (CMS) have implemented edits, which instruct the MACs to deny these types of claims. These denials are not related to NCCI edits.

HCPCS code G2211 is a new E/M O/O add-on code used to report visit complexity when reported with CPT® codes 99202-99205 and 99211-99215. The O/O E/M visit complexity add-on code G2211 is not payable when reported with the O/O E/M visit appended with payment modifier 25 (Significant, Separately Identifiable Evaluation and Management Service by the Same Physician or Other Qualified Health Care Professional on the Same Day of the Procedure or Other Service). Separately identifiable visits performed on the same day as minor procedures (such as 0- or 10-day global procedures) have “resources sufficiently distinct from costs associated with furnishing standalone O/O E/M visits to justify different payment.”
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The MAC recommends the following to avoid code G2211 denials:

• Do not report code G2211 when modifier 25 is reported on an associated E/M visit (CPT® codes 99202- 99205 and 99211-99215);
• Do not use modifier 25 with HCPCS code G2211;
• Do not use modifier 25 with CPT® code 99211;
• Do not use modifier 25 by a physician other than the physician performing the procedure; and
• Do not use modifier 25 when documentation does not support a significant, separately identifiable E/M service. 

RESOURCES

• MLN Matters MM13272
• MLN Matters MM13473
• FAQ on G2211
• Modifier 25 Fact Sheet​

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ACR Revises Statement on Contrast Supervision Requirements

On February 26, 2024, the American College of Radiology (ACR) Committee on Drugs and Contrast Media released a revised statement, clarifying ACRs stance on direct supervision requirements for contrast studies. ACR states that direct supervision requires one of the following to be onsite; a radiologist, other physician (including radiology residents and fellows), or qualified person. In addition to acting under the general supervision of a physician, the radiologist, other physician, or qualified person must:

• Be trained in and meet institutional periodic competency guidelines for evaluating patients, differentiating different types of adverse reactions to contrast materials, and diagnosing adverse reactions.
• Have the ability to recognize a hypersensitivity immediate reaction or adverse event is occurring, due to the administration of contrast administration, and know when medical intervention is needed.
• Have training on, and be legally permitted to administer, prescription medications and any other appropriate interventions independently, or under a standing orders/algorithmic approach under state law or regulations, and under local institutional, site, and facility policies, guidelines, and rules. Indicated interventions for urgent response to an adverse event due to the administration of contrast materials can be found in the ACR Manual of Contrast Media.
• Be able to consult with the supervising physician within an appropriate timeframe.
• Hold a BLS certification (minimum requirement).
• Understand when a call for assistance is necessary, and how to activate the emergency response system.

​The ACR also reminds readers that remote supervision “should comply with all federal/state law or regulations and local, institutional, site and facility policies, guidelines, or rules related to telemedicine.” Whenever contrast is administered, remote general supervision should be available and “include the standard post administration monitoring as dictated by all federal/state law or regulations and under local, institutional, site, and facility policies, guidelines, or rules.” The timeliness and availability of emergency response systems should also be considered.

While the revised statement from the ACR is intended to provide more flexibility to imaging facilities, readers should also refer to authoritative guidance in the Medicare Benefit Policy Manual, Chapter 6, Section 20.4.4 regarding direct supervision in the hospital outpatient setting.
The Medicare Benefit Policy Manual acknowledges that “trained ancillary staff and technicians are the primary operators of some specialized diagnostic testing equipment, and while in such cases CMS does not expect the supervisory physician to operate this equipment instead of a technician”.  CMS does include the following criteria to be met.

• The supervisory physician must have, within his or her State scope of practice and hospital-granted privileges, the knowledge, skills, ability, and privileges to perform the service or procedure
• The physician that supervises the provision of the diagnostic service must be knowledgeable about the test and clinically able to furnish the test.
• The supervisory responsibility is more than the capacity to respond to an emergency and includes the ability to take over performance of a procedure or provide additional orders.

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New Guidance from the HHS Regarding Hospital Interpretive Guidelines for Informed Consent

The Department of Health and Human Services (HHS) issued new guidance to the nation’s teaching hospitals and medical schools regarding Hospital Interpretive Guidelines for Informed Consent. 

Specifically, requiring written informed patient consent for breast, pelvic, prostate, and rectal exams – especially if the patient is anesthetized – for educational and training purposes performed by medical students, nurse practitioners and/or physician assistants. Informed patient consent includes the patient’s right to “refuse consent for sensitive examinations conducted for teaching purposes and the right to refuse to consent to any previously unagreed examinations to treatment while under anesthesia.” 

Requirements related to informed consent for hospitals are found throughout the Hospital Conditions of Participation (CoPs). According to HHS, this new guidance was released to reinforce hospitals’ compliance to obtain written informed patient consent relating to medical professionals performing sensitive examinations, especially those under anesthesia. Federal regulations previously identified obtaining consent for exams related to surgeries but did not provide the level of detail pertaining to medical students.
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CMS surveyors are required to make sure each hospital’s patient informed consent policy, processes, and forms contain information to allow patients or their representatives to make fully informed decisions about their patient care. If hospitals do not obtain written informed patient consent, they may be ineligible for Medicare and Medicaid program participation. In addition, they may be subject to investigations and fines if they violate patient privacy laws under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule.

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Six topics added to ACR Influential Imaging Appropriateness Criteria®

According to the American College of Radiology (ACR) website,

 ACR Appropriateness Criteria® (AC) are evidence-based guidelines to assist referring physicians and other providers in making the most appropriate imaging or treatment decision for a specific clinical condition. Employing these guidelines helps providers enhance their quality of care and contribute to the most efficacious use of radiology. The AC is not intended to be used as coding guidance for radiologic procedures.”

Expert panels made up of leaders in radiology and other specialties develop and review these guidelines annually. The ACR AC currently makes up the most comprehensive evidence-based guidelines for the selection of diagnostic imaging, protocols for radiotherapy, and image guided interventional procedures.

The ACR released six new topics and revised six topics in an update to its ACR AC on April 9, 2024. The ACR AC guidelines are meant to assist physicians in ordering correct services and limit healthcare waste. There are now 239 diagnostic and interventional topics and 3,900 clinical scenarios covered in the guidelines. A narrative, evidence table, and literature search summary are included in each topic.
The six new topics include:

• Acute elbow and forearm pain
• Endometriosis
• Imaging of suspected intracranial hypotension
• Penetrating torso trauma
• Thoracic back pain
• Tracheobronchial disease

The six revised topics include:

• Acute onset of scrotal pain-without trauma, without antecedent mass
• Altered mental status, coma, delirium, psychosis
• Multiple gestations
• Nonvariceal upper gastrointestinal bleeding
• Pretreatment staging of urothelial cancer
• Stress (fatigue/insufficiency) fracture, including sacrum, excluding other vertebrae

The ACR AC website has an interactive AC portal that can be used to access the AC topics, variants, clinical scenarios, and recommendations. The site also allows for feedback and comments on any topic. Users can comment on existing AC content here and suggest new AC content here. Additionally, the Journal of the American College of Radiology (JACR), together with the ACR AC Patient Engagement Subcommittee published patient summaries intended to improve patient comprehension of appropriate tests for their encounter. These summaries are written by patients, for patients, in a language that is easy for the layperson to understand. Patient-friendly summaries can be found here.

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HHS Issues Final Rule for 340B Administrative Dispute Resolution Process

On April 19, 2024, the Department of Health and Human Services (HHS) issued its final rule to establish a 340B Administrative Dispute Resolution (ADR) process under the 340B Drug Pricing Program (340B Program) as required by the Affordable Care Act. The purpose of the 340B Program ADR process is to assist hospitals and other covered entities, and manufacturers in resolving disputes involving overcharging, duplication of discounts, or drug diversion (examples include dispensing 340B drugs at ineligible sites; to ineligible patients; by ineligible providers; and/or failure to monitor and correct inventory). This final rule is effective June 18, 2024.

Historically, HHS has encouraged covered entities and pharmaceutical companies to work together to resolve 340B Program disputes in good faith. HHS recognizes that most disputes are resolved in a timely manner without third party intervention. The 340B ADR process is not meant to replace good faith efforts, but rather provide assistance when those good faith efforts have failed to resolve disputes in a timely, consistent, and fair manner.

HHS issued this final rule to revise the current ADR process by modifying the regulations under the 2020 final rule. Specifically:

• Establish a more practical, less trial-like, less resource intensive, and accessible administrative process, whereby all covered entities have equal access to the ADR process.
• Re-structure the 340B ADR Panel members to consist of 340B program subject matter experts from the Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs, to ensure Panel members have specific knowledge of the 340B Program and the ability to commit some of their time to the Panel activities.

• Outline specific types of claims that can be addressed through the ADR process to align with statutory provisions: claims for overcharge, diversion or duplicate discounts.
• Require both parties (the covered entity and the manufacturer) to undertake good faith efforts to resolve disputes before initiating the ADR process. This includes documentation to support each party’s claims, communication documentation between the parties and maintenance of that documentation by both parties until the date of the final agency decision.
• Include a process for either party to have the 340B Panel’s decision reconsidered, or appealed, by the HRSA. This includes a 30-day window in which parties can request a reconsideration; and a decision within 180 calendar days from the start of the appeals process which will be binding to both parties, unless altered by the Secretary or invalidated a Federal Court order.

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​In addition, HHS finalized the provision for the automatic transfer of any pending claims to the new process. This means the petitioner will not have to resubmit claims under the new process and will ensure the continuity of the 340B ADR process for those parties involved in claims disputes under the 2020 final rule. These claims will be first in the queue to be reviewed after the effective date. 

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Radiology Group must pay $3.1M to Settle False Claims Act Violations

The Radiology Group, LLC, an Atlanta-based teleradiology firm, has agreed to pay $3.1 million to settle a False Claims Act lawsuit for fraudulent billing practices. This firm, which provides nationwide services to hospitals, urgent care centers, and primary care providers, improperly billed government healthcare programs for work done by contractors in India. In a press release, the U.S. Attorney’s Office asserted that:

• A U.S.-based radiologist in the firm was merely “rubber-stamping” radiology exam interpretation reports without ensuring appropriate review and accuracy of those reports before sending findings to healthcare providers.
• The contractors in India preparing the reports were not allowed to practice medicine in the U.S. or bill federal healthcare programs; but the firm misrepresented the actual provider of radiology services when billing for those services to federal healthcare programs by improperly seeking payment for radiology services furnished entirely by persons located outside the U.S.

​As part of the settlement, The Radiology Group has admitted to and accepted responsibility for the violations.

Defendants potentially jeopardized patients’ health by taking shortcuts when it came to ensuring that important radiological tests were done and reviewed properly,” Naomi Gruchacz, Health and Human Services, Office of Inspector General, special agent in charge, said. “Individuals and entities that participate in the federal healthcare system are required to obey the laws meant to preserve the integrity of program funds and the provision of appropriate, quality services to patients.”

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