Summary of CY25 CMS Proposed Rules for RHCs

Eliminates Productivity Standards, Modifies Lab Requirements, and Seeks to Clarify “Primarily Engaged in Primary Care,” Among Other Key Provisions for RHCs

Sarah Hohman, NARHC Director of Government Affairs

On July 10th, the Centers for Medicare and Medicaid Services (CMS) issued the CY 2025 Medicare Physician Fee Schedule (MPFS) Proposed Rule. This year’s 2,248 page rule, contains several Rural Health Clinic (RHC) specific policy proposals, as well as other provisions with implications for the RHC community, including:

• Allowing RHCs to bill for administration of Part B preventive vaccines at time of service, not entirely in a lump sum settlement on cost report
• Elimination of RHC productivity standards
• Complete revision to RHC care management billing with the elimination of the G0511consolidated code
  • Establishment of new “Advanced Primary Care Management Services”
• Modification of specific lab services RHCs must have the ability to furnish within the facility
• Aims to clarify guidance versus regulatory discrepancies in how “primarily engaged in primary care” is defined and enforced
• Seeks to define “mental diseases” to support RHCs that offer behavioral health services within the confines of outdated statutory language
• Clarification of dental services able to be furnished in RHC setting
• Modified Intensive Outpatient Program (IOP) Services payment, a new billable service in the RHC beginning January 1, 2024
• Telehealth policy clarifications within CMS’ authority (the majority of Medicare telehealth policy extending past December 31, 2024 relies on Congressional action)

“In terms of the sheer number of substantial updates to the Rural Health Clinics program, this has been the biggest proposed rule in at least ten years,” said Nathan Baugh, Executive Director of NARHC. “While we always have more work to do when it comes to clarifying and updating regulations, and there are some things we asked CMS to address that were not included in this rule, many of these proposed changes are huge steps forward for the RHC program and we thank CMS for listening to Rural Health Clinic concerns over the years.”

If these policies are finalized by CMS this November, they would go into effect January 1, 2025, unless otherwise specified. While quite comprehensive, we encourage you to read the entirety of this article in order to understand the RHC-relevant provisions and NARHC’s perspectives on this year’s proposals!

Medicare Vaccine Reimbursement Changes
Background
RHC statute requires that flu, COVID-19, and pneumococcal vaccines and their administration to Medicare patients must be reimbursed at 100% of reasonable costs, instead of the 80% limit that applies to other services. The hepatitis B vaccine has been reimbursed as part of the RHC All-Inclusive Rate, however no insurance or deductible applies given that it is a preventive service.

While we don’t hear too many issues with MACs paying this lump sum amount for vaccines, RHCs have expressed cash flow challenges with the wait time between purchasing and administering vaccines and the cost report settlement.

What CMS Proposed
CMS heard these concerns and is proposing to allow RHCs to bill for the administration of pneumococcal, flu, COVID-19, and hepatitis B vaccines at time of service.

These claims would pay 95% of the Average Wholesale Price (AWP), and the administration would be reimbursed according to the Part B Vaccine Administration National Fee Schedule, adjusted for locality.

To comply with the statutory requirements of paying 100% of reasonable costs however, RHCs will still reconcile with CMS on an annual basis to receive their full vaccine and administrative costs.

Additionally, CMS is making RHC providers eligible to bill HCPCS code M0201 when one of these four vaccines is administered in a patient’s home. This is approximately a $38 additional reimbursement.

If these proposals are finalized, CMS will institute the changes beginning July 1, 2025.

NARHC Commentary
While pleased that CMS is acknowledging RHC concerns about the vaccine reimbursement process, we have since heard from cost report experts that billing at time of service combined with the settlement will not fix the underlying issue of the cost report mechanism used in the settlement. More specifically, the high-dose vaccines often needed for Medicare patients are more expensive, and not appropriately accounted for when averaged with other, non-Medicare lower-cost vaccines.

This may lead to RHCs being required to pay Medicare back at the time of settlement. NARHC will share these concerns with CMS in our comments and encourage them to consider other proposals.

Elimination of Productivity Standards
Currently, RHC productivity standards are established as 4,200 visits per full-time equivalent (FTE) physician and 2,100 visits per FTE nurse practitioner, PA, and certified nurse midwife. Other RHC practitioners are not subject to productivity standards.

Since all RHCs are now subject to some sort of upper payment limit (either the clinic specific cap for grandfathered RHCs or the national statutory cap for new and independent RHCs), the productivity standards have less impact as a guardrail.

Therefore, NARHC has urged CMS in recent years to reconsider and modernize the productivity standard. CMS agreed with the lack of necessity for these standards moving forward and has proposed eliminating productivity standards for RHCs. NARHC will comment in support of this proposal.

Medicare Care Management Reforms and New Opportunities
Background
Since 2016, RHCs have been able to bill for Chronic Care Management (CCM) services through a consolidated care management code: G0511. This special payment rule pays approximately $72.90 in 2024, which is the average of the Physician Fee Schedule (PFS) rates for CCM, principal care management (PCM) services, Chronic Pain Management, General Behavioral Health Integration, as well as codes newly added in 2024: Remote Physiological Monitoring (RPM), Remote Therapeutic Monitoring (RTM), Community Health Integration (CHI), and Principal Illness Navigation (PIN) Services.

Beginning in 2024, the G0511 code was finally billable more than once per patient per month, so long as requirements are met and resource costs are not double counted, which NARHC has long advocated for. However, the single consolidated code currently represents 22 care management services, and this aggregation has presented a myriad of billing issues.

In last year’s comments, NARHC encouraged CMS to consider a revision to this complex bundled approach to RHC care management billing, either by allowing RHCs to bill care management services fee-for-service or creating more G-codes for the different buckets of care management services (i.e. RPM, RTM, CCM, etc.).

Further, there has been variation in how MACs have operationalized this policy and it was impossible for CMS to tell which specific care management services were being billed for in RHCs since everything was billed as G0511.

What CMS Proposed
CMS heard our concerns and recommendations and is proposing to allow RHCs to bill the individual codes that have historically been billed as the general care management code, G0511,instead of putting solely the consolidated code on a claim.

Therefore, if finalized, G0511 would no longer be payable. Instead, RHCs would bill, on the UB-04 claim form, the CPT codes in Table 24 (page 188 here). While some of the fee schedule reimbursements may be lower than the consolidated rate of $72.90, this change means RHCs will be eligible to bill for add-on time-based codes, too.

Separately, CMS proposed new codes for Advanced Primary Care Management (APCM) services, a set of three G-codes intended to bundle existing care management codes based on complexity of patient condition as per calendar month bundles. If an RHC billed for these codes, they would not bill for individual services explained above. This will be discussed in further detail at NARHC’s upcoming fee schedule webinar.

NARHC Commentary
We are very pleased with this proposed revision to RHC care management billing and appreciate CMS recognizing our concerns with the increasingly complex consolidated billing structure. In coming years, when CMS likely adds even more care management related opportunities, we believe that this billing structure will support RHCs being included in those new opportunities at the same time as their fee-for-service peers. Finally, we empathize with the challenges of your care management team becoming familiar with yet a new process, codes eligible to be billed, etc., and NARHC will continue to provide you with resources to ease the transition.

Conditions for Certification Changes – Lab Services
Background
RHC statute directs the HHS Secretary to ensure that RHCs provide routine diagnostic services. CMS has implemented this historically by requiring that RHCs have the equipment and supplies within the square footage of their RHCs to offer six specific lab services: chemical examinations of urine by stick or tablet method or both (including urine ketones); hemoglobin or hematocrit; blood glucose; examination of stool specimens for occult blood; pregnancy tests; and primary culturing for transmittal to a certified laboratory.

For several years, we have been hearing from RHCs that the hemoglobin/hematocrit requirement specifically is outdated given that providers rarely order these tests individually, and much more frequently they are ordered as part of a full panel. When this occurs, particularly for provider-based facilities who may be in close physical proximity to their parent hospital, many send patients to the full-service lab, making the equipment within the RHC duplicative, expensive, and wasteful.

NARHC has been advocating to Congress to remove the specific lab requirement to “directly provide” these services through a provision in the RHC Burden Reduction Act, in addition to encouraging CMS to use their authority to modify the specific list of required lab services.

What CMS Proposed
CMS is proposing to remove hemoglobin and hematocrit (H&H) from the listed lab services that RHCs must have the equipment and supplies to perform directly.

Additionally, they are proposing to update “primary culturing for transmittal to a certified laboratory” to “collection of patient specimens for transmittal to a certified laboratory for culturing” to reflect more current clinical laboratory standards.

NARHC Commentary
NARHC is very pleased to see CMS recognizing our advocacy on laboratory services and will be commenting in support of these proposals.

Note: if your RHC currently does utilize your H&H machine, and/or does primary culturing within your facility, this regulatory change does not prohibit you from continuing to do so, it simply offers additional flexibility in the situations where this isn’t being used or is no longer appropriate.

Conditions for Certification Changes – Provision of Primary Care versus Specialty Services
Background
RHC statute and associated regulations stipulates that RHCs must be primarily engaged in “providing outpatient services.” However, CMS State Operations Manual Appendix G explains that “RHCs may not be primarily engaged in specialized services.”

NARHC has pointed out this significant discrepancy for several years, however RHCs continue to be surveyed to the requirement that more than 50% of their hours must be the provision of primary care services.

This has become a greater issue as more RHCs offer a host of specialty services within their facility, services that clearly meet the outpatient requirement, but may tip total hours in the direction of specialty versus primary care services.

What CMS Proposed
CMS is acknowledging the discrepancy that exists between the various documents that regulate the RHC program and is proposing to ensure greater flexibility in the outpatient services that RHCs can provide. CMS would add the following clauses to the 491.9(2) regulation:

(i) The clinic or center must provide primary care services.
(ii) The clinic is not a rehabilitation agency or a facility primarily for the care and treatment of mental diseases.

CMS intent here is that RHCs would be required to provide primary care services, as they always have, but would no longer be surveyed to a requirement that they provide more than 50% of operating hours as primary care services.

NARHC Commentary
NARHC is pleased that CMS is proposing to clarify this discrepancy while still aligning with the intent of the RHC statute.

While CMS is technically adding something to the regulation, this is a decrease in the restrictive nature of the previously limiting threshold on specialty care to allow for greater flexibility foreach individual RHC. The proposed rule states that CMS expects RHCs to “offer a range of primary health care services to ensure that patients receive the necessary care at the earliest possible point of contact. Primary care services are critical in promoting health, preventing illness, and managing chronic conditions.”

Conditions for Certification Changes – Mental Health Services
Background
RHC statute reads that a Rural Health Clinic is “only a facility which... (iv) is not a rehabilitation facility or a facility which is primarily for the care and treatment of mental diseases.”

This has been interpreted to mean that RHCs can only provide up to 49% of their services as behavioral health services, without clear guidance as to how these services should be counted, and ultimately risking patient care access to these essential services.

NARHC has been advocating to Congress to remove this specific section of the statute through a provision in the RHC Burden Reduction Act, in addition to encouraging CMS to provide additional guidance on this outdated and arbitrary language.

What CMS Proposed
CMS acknowledges that “mental diseases” is outdated terminology and may have additional negative impacts on stigma and help-seeking behavior but recognizes that this language is in the law governing the RHC program and can only be removed by Congress.

However, they propose that by defining “mental diseases” they can then issue guidance to assess an RHC’s compliance with the requirement in a more uniform way.

They solicit comment on the following specific questions to help them define mental diseases:

• What types of behavioral health services are currently offered by RHCs (that is, therapy, counseling, medication management, substance use disorder treatment, etc.), and how often are these services provided?
• For those RHCs that are currently providing behavioral health services, who provides those services (that is, physician, psychologist, social worker, marriage and family therapist, or mental health counselor)? What is the clinic’s capacity to accept new behavioral health patients? What potential impacts do you anticipate for RHCs and the community if they were able to provide more behavioral health services? How would these impacts be addressed?
• Are there specific behavioral health conditions that your clinic is better equipped to treat than others, and if so, what are those behavioral health conditions?
• For those RHCs that are not currently providing behavioral health services, what barriers or challenges does the RHC face that limit the ability to furnish behavioral health services (that is, geographic location, transportation issues, service area size, staffing issues, stigma, regulatory or survey concerns)?
• What standards or criteria should surveyors use to evaluate whether a RHC is operating as a “facility which is primarily for the care and treatment of mental diseases”?

NARHC Commentary
First, NARHC encourages any RHCs that provide a significant amount of behavioral health services to share their expertise on the above questions.

However, we believe that CMS is risking additional unintended consequences by seeking to define such an outdated term. Instead, NARHC will encourage CMS to define a facility which is primarily for the care and treatment of mental diseases. Separately designated facilities such as Certified Community Behavioral Health Clinics (CCBHCs), Community Mental Health Centers (CMHCs), Opioid Treatment Programs (OTPs), and others could not be dually certified as an RHC. We agree that this is in alignment with the RHC statute. However, if it is not one of those facilities, we do not find it necessary for CMS to issue additional restrictions on the type or amount of behavioral health services done in the RHC.

Payment for Dental Services Furnished in RHCs
Medicare is precluded from paying for most dental services, including routine cleanings and treatment. However, exceptions are made for certain outpatient services if the dental service is “inextricably linked to, and substantially related and integral to the clinical success of, other covered services.”

This exception extends to RHCs, meaning that if the service meets the “inextricably linked” standard and is provided by a dentist in the RHC, it will qualify as an encounter and be paid the RHC’s All-Inclusive Rate. In these instances, the RHC should report the KX modifier to indicate that it meets these requirements, and that adequate documentation is in the medical record.

What CMS Proposed
In this year’s proposed rule, CMS is expanding the list of “inextricably linked” medical services to include dialysis services for beneficiaries with End-Stage Renal Disease (ESRD). The full list of qualifying inpatient and outpatient services is organ transplant, hematopoietic stem cell transplant, bone marrow transplant, cardiac valve replacement, valvuloplasty procedures, chemotherapy when used in the treatment of cancer, chimeric antigen receptor (CAR) T-cell therapy when used in the treatment of cancer, administration of high-dose bone-modifying agents (antiresorptive therapy) when used in the treatment of cancer, and dialysis services in the treatment of end stage renal disease.

The “inextricably linked” dental services are a “dental or oral examination performed as part of a comprehensive workup prior to, and medically necessary diagnostic and treatment services to eliminate an oral or dental infection prior to, or contemporaneously with” if related to the above conditions.

Additionally, CMS is seeking comment on whether a medical encounter and a covered dental visit should be eligible for an exception to the same day visit limitations in the RHC and be paid as a separate billable encounter.

NARHC Commentary
NARHC plans to comment in support of these proposals and asks the RHC community for any information regarding provision of dental services in RHCs that may be useful data or anecdotal evidence to include.

Intensive Outpatient Program (IOP) Services Furnished in RHCs
Background
Beginning in 2024, RHCs can furnish Intensive Outpatient Program (IOP) services, behavioral health services intended to serve patients who need care at a level equivalent to 9-19 hours of care per week.

This reimburses outside of the All-Inclusive Rate via a special payment rule that corresponds to approximately three services per patient per day, $259.13.

Others eligible to bill for IOP services can receive either the 3-services-per-day payment rate, or the 4-services-per-day payment rate, depending on the number of services provided, but RHCs and FQHCs are limited to the lower payment rate, regardless of the number of services provided.

What CMS Proposed
CMS acknowledged NARHC’s comments from last year regarding this discrepancy and are now proposing to allow for RHCs to bill for the three or four services per day IOP, depending on the number of services provided.

NARHC Commentary
NARHC plans to comment in support of this proposal.

RHC Telehealth Policy
Background
Current Medicare medical telehealth flexibilities will expire on December 31, 2024 without Congressional action. NARHC has been consistently advocating on Capitol Hill for an extension of these policies that includes a fix to reimbursement to ensure that RHCs are paid at parity for in-person and telehealth visits, like fee-for-service providers have received since 2020.

What CMS Proposed
CMS elected to use their authority in this year’s proposed rule to ensure that medical telehealth flexibilities do not lapse in the event Congress doesn’t pass telehealth legislation by December 31. They are proposing to extend current telehealth policy (the G2025 methodology) through December 31, 2025, if Congress does not act in time. Additionally, they are proposing to waive the occasional in-person requirement currently on the books for mental health telehealth through December 31, 2025, as well.

NARHC Commentary
Given how bipartisan and popular telehealth is, it is almost entirely guaranteed that Congress will pass telehealth legislation before it lapses later this year. However, NARHC is appreciative of CMS doing their part to ensure that disruptions in care are not experienced by safety-net providers in the event legislation is not passed.

Instead of simply extending the current G2025 policy however, NARHC believes that CMS should instead use their authority to change the RHC medical definition of a visit to include visits done via telecommunications technology. This would result in normal RHC billing for telehealth visits that would generate an All-Inclusive Rate payment. In this year’s proposed rule, CMS acknowledges this as an alternate proposal to extending G2025 policy, and NARHC will comment strongly in this alternative direction.

What Was NOT Proposed

While covering what is included in the proposed rules is important, and this certainly was a significant year for RHC regulatory policy change, it is also important to identify items that we have proposed to CMS that were not addressed in this year’s rule.

For instance, NARHC was hopeful that CMS would utilize this rulemaking opportunity to further expand upon preventive care eligible for adequate reimbursement in the RHC setting by amending the definition of an RHC medical visit to allow for Annual Wellness Visits (other than IPPEs) to be eligible for same day billing, as well as allowing those AWVs to be completed by RNs, as they are in non-RHC settings. Additionally, CMS did not propose to make RHCs eligible for separate reimbursement associated with the complex E/M add-on code (G2211) or the Social Determinants of Health (SDOH) Risk Assessment, nor did they explicitly change their guidance to allow for RHCs offering telehealth services outside of traditional RHC hours of operation.

Final Comments

NARHC appreciates the significant RHC provisions included in this year’s proposed rule and we look forward to engaging with CMS to ensure that they are finalized in such ways to achieve the greatest positive impact for our safety-net providers.

The National Association of Rural Health Clinics (NARHC) will be submitting comments on all RHC-provisions, which will be reviewed by the NARHC Policy Committee, to CMS by September 9, 2024.

Additionally, we encourage you to join our Washington, D.C. team for a webinar on August 15, 2024, where we will discuss the proposed rule and hear your feedback about implementation of these various policy proposals. Please register for the webinar and submit any questions you would like addressed during the webinar here.

Please contact Sarah Hohman, NARHC Director of Government Affairs at Sarah.Hohman@narhc.org with any questions or other feedback.