CMS Proposes Changes to Overly Burdensome Rules

by King & Spalding

On February 4, 2013, CMS proposed certain reforms to Medicare regulations that would eliminate or change rules seen as unnecessary, obsolete, or excessively burdensome on hospitals and other health care providers.  The proposed rule is in line with President Obama’s call on federal agencies to reduce regulatory burdens on business.  All told, CMS projects its proposals would save $676 million annually, and $3.4 billion over five years.

Among the key changes proposed are the following:

Ambulatory Surgery Centers (ASCs): The proposed rule would reduce regulatory requirements that ASCs must meet in order to provide radiological services, and provide greater flexibility in the types of physicians who may supervise such services in an ASC.  Currently, ASCs must satisfy full hospital requirements for furnishing radiological services.  The proposed rule would only require compliance with the standard governing safety for patients and personnel and with certain personnel and records requirements.  If adopted, the proposed rules would also permit an MD/DO who is qualified by education and experience and ASC policy to supervise the provision of radiologic services.  Currently, a radiologist must supervise the provision of radiological services in an ASC.

Hospitals: The proposal includes several changes to the hospital conditions of participation (COPs).  The changes would impact the COPs addressing governance, medical staff, food and dietetic services, nuclear medicine services, outpatient services, and classification of swing bed services. For example, under the proposed rule,

  • The hospital no longer would need representatives of the medical staff to sit on the governing body.  The governing body would need to consult periodically with the individual responsible for the organized medical staff of the hospital.
  • The hospital would be required to have an organized and individual medical staff, distinct to the individual hospital, that operates under the bylaws of the governing body, and which is responsible for the quality of medical care provided to patients of the individual hospital.
  • The food and dietetic services COP would be changed to include that a therapeutic diet may be ordered by a qualified dietician, as authorized by the medical staff and in accordance with State law.
  • The COP for nuclear medicine services would be changed to allow for in-house preparation of radiopharmaceuticals by, or under the supervision of, an appropriately trained registered pharmacist or an MD or DO.  CMS, therefore, is proposing to remove the direct supervision requirement for the in-house preparation of radiopharmaceuticals.
  • CMS is proposing the addition of a new standard governing orders for outpatient services.  Orders for outpatient services may be made by any practitioner who is responsible for the care of the patient; licensed in the State where he or she provides care to the patient; acts within the scope of practice under state law; and is authorized in accordance with the policies adopted by the medical staff and approved by the governing body to order applicable outpatient services.  The standard would apply to all practitioners appointed to the hospital’s medical staff and who have been granted privileges to order outpatient services.  It also applies to practitioners not appointed to the medical staff, but who satisfy the criteria for authorization by a hospital for ordering outpatient services for their patients.
  • CMS has proposed moving the COPs for swing bed services from Subpart E (requirements for specialty hospitals) to Subpart D, which provides COPs for optional services.  The change would allow compliance with swing bed requirements to be evaluated during routine accrediting organization surveys.  Thus, CMS would no longer require a separate, additional survey specifically for swing bed approval.

Transplant Centers: CMS is proposing changes to the COPs governing transplant programs.  Specifically, the rule would eliminate redundant data submission requirements and provide greater flexibility in the re-approval cycle. 

Long-Term Care Hospitals: CMS is proposing providing a process for LTCH’s to apply for a deadline extension for the requirement to have an automatic sprinkler system installed in the building by August 13, 2013.

Rural Health Providers: CMS makes various proposals affecting the COPs for critical access hospitals (CAHs), rural health clinics (RHCs), and federally-qualified health centers (FQHCs).  For example, CMS would eliminate the need for a CAH to develop its patient care policies with at least one member who is not a member of the CAH’s staff.  It would revise RHC/FQHC rules to eliminate the requirement that a physician be onsite at least once every two weeks.  CMS also is soliciting comments on whether other possible changes might be appropriate to reduce barriers to service, such as in the area of telehealth services, hospice services, and home health services.

In addition to the above, CMS is proposing changes to the Clinical Laboratory Improvement Act (CLIA) regulations.  These changes would provide greater clarity to the treatment of proficiency testing samples, provide an exception to CMS’s long standing interpretation of what constitutes an “intentional” referral of proficiency testing samples, and provide new definitions for reflex testing, confirmatory testing, and repeat proficiency testing referral. 

Comments on the proposed rules are due no later than 5:00 pm on April 8, 2013.  The proposed rule was published on February 7, 2013 in the Federal Register. To view the proposed rule click here.

Reporter, Tracy Weir, Washington, D.C.,  +1 202 626 2923, .

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© King & Spalding | Attorney Advertising

Written by:

King & Spalding

King & Spalding on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.


JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at:

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.