CMS Proposes Changes Affecting Rural Health Care Providers

This article is Part III in a series discussing the proposed rule to revise certain Conditions of Participation, Conditions for Coverage and regulations under the Clinical Laboratory Improvement Amendments of 1998 published on February 7, 2013. This final installment provides an overview of the changes applicable to rural health care providers, including critical access hospitals, rural health clinics and federally qualified health centers. Part I addressed changes applicable to CLIA certified laboratories and several other changes applicable to other types of health care providers and is available here. Part II addressed changes applicable to hospitals and is available here.

Executive Summary

On February 7, 2013, the Centers for Medicare and Medicaid Services (“CMS”) released a proposed rule (“Proposed Rule”) that would revise the Conditions of Participation (“CoPs”) and Conditions for Coverage (“CfCs”) for a variety of health care providers and suppliers, as well as certain regulations under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”). The Proposed Rule is the latest in a series of rulemaking initiatives implementing the President’s Executive Order 13563 (“EO 13563”) calling for the removal or revision of obsolete, duplicative or unnecessary regulatory provisions in order to reduce burdens for these providers. Two other final rules implementing EO 13563 were published on May 16, 2012 and made effective on July 16, 2012. These are summarized here and here. A copy of the Proposed Rule can be found here.

CMS invites comments on the Proposed Rule, which must be received by CMS no later than 5 P.M. on April 8, 2013. Commenters should refer to file code CMS-3267-P and should submit comments in accordance with the instructions described in the Proposed Rule.

Proposed Revisions Applicable to Critical Access Hospitals (“CAHs”), Rural Health Clinics (“RHCs”) and Federally Qualified Health Centers (“FQHCs”)

CAH CoPs: Provision of Services (42 C.F.R. §485.635)

The current CAH CoPs require that a CAH develop its patient care policies and procedures with the advice of a group of professionals that includes at least one individual who is not a member of the CAH staff. CMS proposes eliminating the requirement that at least one non-CAH staff member participate in this group. In support of this change, CMS notes that CAHs face considerable challenges in securing outside individuals to participate in the policy development process and that these challenges are compounded by a high rate of turnover. In addition, CMS notes that the original reasons for this requirement, such as lack of local resources and internal expertise, have largely been addressed through statutory changes requiring the development of rural health networks that have occurred since these regulations were introduced.

CAH and RHC/FQHC Physician Responsibilities (42 C.F.R. §§ 485.63(b)(2); 491.8(b)(2); and 491.2)

Current regulations require that, in most circumstances, a physician be present in the CAH, RHC or FQHC for sufficient periods of time, meaning at least once every two weeks, to provide medical direction, medical care services, consultation and supervision of clinical staff. CMS acknowledges that providers in the areas served by CAHs, RHCs and FQHCs often find it burdensome to comply with this biweekly visit requirement. This, combined with the substantial recent improvements in telemedicine-related technology, has lead CMS to believe that it is not always necessary for physicians to meet the biweekly visit requirement. Accordingly, CMS now believes that providers should have the flexibility to determine how and how often to provide the necessary oversight in light of the population served and the range of services offered. This may include more frequent visits for a CAH with a busy emergency department and less frequent visits for a remote RHC that provides primarily preventive care.

CMS therefore proposes revising the CAH regulations at 42 C.F.R. §485.631(b)(2) and the RHC/FQHC regulations at 42 C.F.R. §491.8(b)(2) to eliminate the requirement that a physician be onsite at least once in every two-week period. Instead, for CAHs, CMS would require that a physician be present for “sufficient periods of time” to provide medical direction, consultation and supervision of CAH services and be available through radio or telephone communication for consultation, assistance with emergencies or patient referral. For RHCs and FQHCs, a physician would be required to “periodically” review the clinic’s or center’s patient records, provide medical orders and provide medical care services to the clinic’s or center’s patients. CMS does not indicate what “periodically” might mean.

Finally, CMS proposes a clarifying change to the definition of “physician” in 42 C.F.R. §491.2 to be consistent with Medicare payment regulations. Specifically, “physician” would mean, in addition to MDs and DOs, a dentist, optometrist, podiatrist or chiropractor providing permitted RHC and FQHC services.

Other Issues Considered – RHCs

In addition to the proposed revisions summarized above, CMS also seeks stakeholder comments on several other potential changes related to RHC-related services, as noted below:

Telehealth Services. Currently, RHCs are not eligible to function as distant site telehealth services providers. While RHC practitioners can furnish and bill for telehealth distant site services when they are not otherwise providing RHC services, they cannot do so when they are providing RHC services. This is the case since RHC practitioner services are paid for in the RHC all-inclusive rate per visit. As such, they cannot bill Medicare Part B as distant site providers while working for an RHC as this would result in duplicate payments. Recognizing that RHCs may be in a unique position to provide these services, CMS is interested in exploring ways to allow RHC practitioners to furnish distant site telehealth services (particularly in the area of mental health) that will not result in duplicate payments.

CMS is requesting comments on changes that could be made to Medicare Provider Reimbursement Manual provisions, RHC cost report instructions and other policies that would allow RHCs to furnish telehealth services. Specifically, CMS is interested in comments that address the above concerns without adding undue cost reporting and compliance burdens and that address whether changes should apply to all services or only specific services (such as mental health).

Hospice Services. Though RHCs are often the only health care providers in rural areas, RHCs are not authorized hospice providers. Further, RHCs may only treat hospice beneficiaries for medical conditions unrelated to a certified terminal illness. In addition, similar to the billing limitations for telehealth services, RHC practitioners are not permitted to furnish and bill for hospice services while working for an RHC as this would result in duplicate payments. Again, CMS is soliciting comments that address ways to change Medicare provider reimbursement principles, cost report instructions and other policies that would legally allow RHC practitioners to furnish hospice services without resulting in duplicate payment and without adding additional administrative burdens on providers.

Home Health Services. While RHCs are permitted to provide home health services, CMS acknowledges that few actually do so, perhaps due to the substantive burdens associated with qualifying to provide these services at an RHC. CMS seeks data and comments on the need for home health services in communities served by RHCs, barriers to providing these services, shortages of home health agencies or other difficulties beneficiaries face in accessing these services and strategies to reduce or eliminate those barriers.

Other Services. CMS also seeks comments on other services that RHCs cannot, but should be able to, provide, along with an explanation of the basis for any unmet needs, the barriers and possible solutions.

Practical Takeaways

In addition to carefully considering the details of CMS’s proposals in light of their specific operations, each affected provider also should evaluate current practices given the anticipated direction of the Proposed Rule. For example, we recommend that:

CAHs consider how the Proposed Rule might impact their policy development teams and overall policy development strategies;
RHCs consider responding to CMS’s request for innovative payment solutions and ideas to promote access to telehealth, hospice, home health and other services in their communities;
CAHs, RHCs and FQHCs evaluate their policies and procedures regarding physician supervision and consider what modifications might be possible in the event the Proposed Rule is finalized;
RHCs consider sharing with CMS the regulatory and administrative challenges associated with the provision of home health and hospice services in their communities; and
CAHs, RHCs and FQHCs consider whether they would benefit from submission of other comments on this Proposed Rule.

If you have any questions, would like additional information about this topic or need help preparing and submitting comments, please contact: