CMS Proposes Additional Changes to Promote Flexibility and Reduce Burdens on Hospitals

This article is Part II 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 second installment provides an overview of the changes applicable to hospitals. 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 III will address changes impacting rural health care providers, including critical access hospitals, rural health clinics and federally qualified health centers.

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.

The deadline for submitting comments to the Proposed Rule is 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.

The Proposed Revisions – Hospitals

Food and Dietetic Services Requirements (42 C.F.R. §482.28)

The current regulations at 42 C.F.R. §482.28(b) require that a therapeutic diet be prescribed only by the practitioner or practitioners responsible for the patient’s care (i.e., MD/DO, APRN, PA). The Interpretive Guidelines for this requirement clarify that, while a dietician may assess the patient’s nutritional needs and provide recommendations or consultations, the patient’s diet must be prescribed/ordered by the practitioner responsible for the patient’s care. In response to feedback that CMS received as part of a prior rulemaking process, CMS proposes revising 42 C.F.R. §§482.28(b)(1) and (2). The revision would allow patient nutritional needs to be met in accordance with recognized dietary practices and would permit patient diets, including therapeutic diets, to be ordered by a “qualified” dietician, as authorized by the medical staff and in accordance with state law, as well as by a practitioner responsible for the care of the patient as is currently required. In order to meet this regulation, a hospital would be permitted to appoint dieticians to the medical staff and grant dieticians specific nutrition-ordering privileges or authorize dieticians to have ordering privileges without medical staff appointment. This change is supported by scientific studies demonstrating the beneficial clinical effects of nutrition-order writing by registered dieticians and is intended to provide hospitals with considerable flexibility and cost savings in the area of nutritional care.

Nuclear Medicine Services Requirements (42 C.F.R. §482.53)

The regulations at 42 C.F.R. §482.53(b)(1) currently require that in-house preparation of radiopharmaceuticals be performed by, or under the direct supervision of, an appropriately trained pharmacist, MD or DO. In this context, direct supervision means the supervising professional must be physically present in the hospital and immediately available during radiopharmaceutical preparation. CMS proposes eliminating the word “direct,” which would allow appropriately trained hospital staff to prepare radiopharmaceuticals without the physical presence of a pharmacist or physician. This change is intended to reduce the burden and cost associated with emergency and after-hours radiopharmaceutical preparation. If finalized, the proposed revision would permit hospitals to establish their own policies on supervision of nuclear medicine personnel and preparation of radiopharmaceuticals.

Outpatient Services Requirements (42 C.F.R. §482.54)

CMS proposes a new section, 42 C.F.R. §482.54(c), addressing orders for outpatient services to codify recent changes to certain related interpretive guidelines. Specifically, this new standard would allow outpatient services to be ordered by a practitioner – even a non-medical staff member practitioner – who meets the following conditions: (1) is responsible for the care of the patient; (2) is licensed in the state where he or she provides care to the patient; (3) is acting within his or her state scope of practice; and (4) is authorized to order the applicable outpatient service in accordance with policies adopted by the medical staff and approved by the governing body. These requirements would apply to medical staff members and non-medical staff members, as well as all hospital services offered on an outpatient basis (even if there is current regulatory language that would appear to impose more stringent limits in the absence of the clarifying language proposed, e.g., nuclear medicine services). Hospitals would have the option to determine what types of outpatient services appropriately may be ordered by a practitioner without medical staff privileges.

Special Requirements for Hospital Providers of “Swing Beds” (42 C.F.R. §482.66)

Currently, the location of the swing bed requirements within the federal regulations prohibits a survey on these requirements by an Accreditation Organization (“AO”) as part of its CMS-approved Medicare hospital accreditation program. CMS proposes relocating these requirements from 42 C.F.R. §482.66 subpart E to 42 C.F.R. §482.58 subpart D to allow AOs to survey compliance with swing bed requirements during routine accreditation surveys. For deemed hospitals, this change is intended to relieve the burden of a separate state survey to assess compliance with swing bed requirements.

Transplant-Related Requirements

CMS currently requires transplant centers to report significant changes related to its transplant program, as well as any changes that could affect its compliance with the CoPs. For example, a transplant center must report to CMS information that may impact its compliance with the clinical experience (a decrease in the number of required transplants below a certain minimum) and outcome requirements (a decrease in survival rates below a target threshold) located in the CoPs. Because CMS already receives some of this information from other sources, and the reporting requirements related to non-compliance with certain average measures are confusing for hospitals to apply in practice, CMS proposes eliminating these reporting requirements in 42 C.F.R. §482.74(a)(2).

Also, related to transplant outcome review, the regulations at 42 C.F.R. §482.80(c) and 42 C.F.R. §482.82(c) currently direct CMS to review adult and pediatric outcomes separately when approval to perform both adult and pediatric transplants is requested, except in the case of lung transplants. As of June 2010, the age categories for lung transplant patients are now the same as for all other transplants reported to the Scientific Registry of Transplant Recipients (“SRTR”). Therefore, since this language is no longer necessary, CMS proposes eliminating the language excepting lung transplants.

Finally, CMS is proposing several changes to promote efficiency and the appropriate use of resources with respect to transplant centers. For example, 42 C.F.R. §482.80(c)(2) and 42 C.F.R. §482.82(c)(2) state that the required number of transplants must have been performed during the time frame reported in the most recent SRTR center-specific report. However, CMS proposes removing these sections as there is no requirement for a certain number of transplants during a period that could be covered in such a single report. Further, current process and regulatory criteria may require automatic onsite review of all CoPs under a three-year pre-approval cycle. CMS believes that many of these onsite surveys are unnecessary and also fail to target survey resources to the appropriate locations. Therefore, CMS proposes removing the automatic three-year pre-approval process and clarifying that the review of mitigating factors, including a new list of examples that CMS would consider, may occur at any time if there is non-compliance with the CoPs.

Medical Staff and Governing Body Requirements (42 C.F.R. §§482.12 and 482.22)

The Proposed Rule includes changes that would impact the relationship between the medical staff(s) and the governing body of the hospital or of the multi-hospital system and clarify the scope of the medical staff generally. An in-depth summary of these Proposed Rule changes is available here.

Practical Takeaways

The Proposed Rule has the potential to impact hospitals in a variety of areas. Hospitals should carefully consider the details of CMS’s proposals in light of their specific operations and evaluate current practices given the direction of the Proposed Rule. For example, we recommend that hospitals:

Consider whether expanding the role of qualified dieticians with respect to nutrition-ordering privileges would benefit the hospital’s patients and promote clinical efficiency;
Consider the scope of outpatient services orders the hospital may desire to accept from non-medical staff members;
Review nuclear medicine procedure and radiopharmaceutical preparation schedules in anticipation of a relaxation of the supervision requirements;
Review their corporate bylaws as well as medical staff bylaws, rules and regulations and related policies to determine how the changes in the Proposed Rule might impact the relationship between the medical staff and the governing body. Hospitals may also wish to consider how best and how frequently to facilitate collaboration and consultation between the governing body and the medical staff; and
Consider whether they would benefit from submission of 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: