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Commentary |

Improving the Rules for Hospital Participation in Medicare and Medicaid

Patrick H. Conway, MD, MSc; Donald M. Berwick, MD, MPP
[+] Author Affiliations

Author Affiliations: Centers for Medicare & Medicaid Services, Baltimore, Maryland (Drs Conway and Berwick); and Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio (Dr Conway).


JAMA. 2011;306(20):2256-2257. doi:10.1001/jama.2011.1611
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The hospital “conditions of participation” establish the quality and safety standards that all US hospitals must follow to participate in the Medicare and Medicaid programs. The conditions of participation are the basis for onsite surveys that determine if a hospital meets the standards for accreditation. Such accreditation surveys are conducted by the Centers for Medicare & Medicaid Services (CMS), the Joint Commission, state survey agencies, and others.1 The CMS can terminate hospital provider agreements that have been found to be out of compliance with the conditions of participation, thus making hospitals ineligible for payment by the Medicare and Medicaid programs. Since updated in 1986, the last major change to the conditions of participation was attempted in 1997, but failed due to more than 60 000 public comments and dissenting opinions.

Since then, the CMS has made one-by-one updates. However, review and revision of the entire hospital conditions of participation is needed to achieve current, higher quality and safety standards and remove unnecessary burdensome regulations that are costly to the health care system. The CMS gathered input from multiple stakeholders for more than 1 year and on October 18, 2011, proposed a major revision of the hospital conditions of participation.2 This new proposal should increase patient-centered care in hospitals and enhance care coordination. Despite adding new standards, the proposed rule is projected to save more than $900 million annually due to removing unnecessary regulations. The aim of this Commentary is to explain what revisions are being proposed and why, and engage with the medical community in a discussion to finalize revised hospital conditions of participation.

A primary objective of revising the conditions of participation is to promote higher quality and safer health care. Specifically, the CMS wants to address 3 major areas that cause morbidity and mortality and increase health care costs: care transitions from the hospital, patient-centered care, and hospital quality improvement programs. The CMS proposal is influenced by a constant focus on what is best for patients.

The revised requirements will focus hospitals and clinicians on improving hand-offs and coordination of care between settings. For patients discharged to another facility, it will require hospitals to send necessary medical information to a receiving facility to support a safe and effective transition of care and communication of the patient's postdischarge goals. The CMS considered requiring specific information to be included in the discharge plan and instructions given to patients at discharge, such as written information on warning signs and symptoms that may indicate the need to seek immediate medical attention, follow-up contact information and appointments, planned diagnostic tests, and reconciliation of all medications. The CMS also considered requiring hospitals to establish a process to obtain feedback from a sample of patients and local health care professionals to improve the discharge process over time.

The proposed rule sustains the requirement that all hospitals maintain an effective internal system for assessing quality, studying adverse events, and improving both the safety and quality of care (quality assessment and performance improvement program). The CMS considered additional requirements to strengthen the quality program such as accountability of the hospital governing body for the program, quality measurement based on data obtained in the delivery of care, and use of nationally recognized evidence-based guidelines to improve the quality of care and promote quality measurement and continuous improvement. Surveyors will assess this quality program in hospitals.

The proposed rule also encourages a stronger patient-centered culture and engagement in the hospital. For example, it encourages hospitals to take a patient-centered approach and permit self-administration of home medications by patients or administration by their support persons. Hospitals have the flexibility to establish this as a standing policy for all hospitalized patients or to tailor the policy (eg, for certain medications or with physician approval).

In addition, the CMS considered new requirements such as specific standards for infection control and prevention. However, rather than proposing specific new requirements in this area, the CMS looks forward to engaging the medical community on what additional quality and safety standards may be needed in the future and how best to include those in the conditions of participation.

Revisions for hospital conditions of participation are needed that simplify governance and support care coordination. For example, under the proposed rule, one governing body may oversee multiple hospitals in a single system. This supports coordination across a system. Another example is hospitals are allowed to have a single, integrated care plan that involves multiple disciplines. This removes the requirement for a stand-alone nursing care plan separate from other care plans, and supports patient care coordination. In addition, the proposed rule requires medical, nursing, and pharmacy staff to approve preprinted and electronic standing orders, order sets, and protocols based on nationally recognized guidelines, thereby supporting standardization of evidence-based care by multidisciplinary teams.

Stakeholders had expressed to the CMS the need to remove many unnecessary burdensome regulations that add cost to the system and do not improve patient care. A few examples follow. First, the proposed rule broadens the concept of medical staff to all practitioners granted hospital privileges to practice in the hospital in accordance with state law. This allows hospitals to grant practice privileges to individuals such as advanced practice registered nurses to the full extent of state law. Second, the proposed rule eliminates the requirement for authentication of verbal orders within 48 hours. It makes permanent the current temporary requirement that all orders be dated, timed, and authenticated by the ordering practitioner or another practitioner responsible for the patient's care. Third, it removes the duplicative requirement for a single director of outpatient services who oversees all outpatient departments in a hospital. Fourth, in an effort to support critical access hospitals (CAHs) and their provision of services through arrangements such as contracting or telemedicine, it eliminates the requirement that CAHs must provide diagnostic and therapeutic services, laboratory services, and radiology services directly by CAH staff. This allows CAHs to improve patient access to these services by providing them to patients through contractual arrangements.

The proposed rule is available online2 and will be open for a 60-day public comment period via http://www.regulations.gov. There should be considerable interest from many external stakeholders who indicated that revisions are needed now. We call on the medical community and stakeholders to improve the final rule and support updating the hospital conditions of participation to improve patient care and lower health care costs.

Corresponding Author: Patrick H. Conway, MD, MSc, Centers for Medicare & Medicaid Services, Mailstop S3-02-01, 7500 Security Blvd, Baltimore, MD 21244 (Patrick.Conway@cms.hhs.gov).

Published Online: October 18, 2011. doi:10.1001/jama.2011.1611

Conflict of Interest Disclosures: Both authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.

Disclaimer: The views expressed represent those of the authors and do not necessarily represent the views of the Department of Health and Human Services or the Centers for Medicare & Medicaid Services.

Additional Contributions: We acknowledge Danielle Andrews, MHA, CMDR, Scott Cooper, MMSc, PA-C, Marilyn Dahl, MA, Walt Francis, MA, MPP, MPA, Thomas Hamilton, BA, Jeannie Miller, RN, MPH, John J. Thomas, BS, and Jackie White, MPA, for review and comments on this manuscript and other staff from the Centers for Medicare & Medicaid Services that worked diligently on the proposed rule for the hospital conditions of participation. The persons listed in this section received compensation for their contributions to the proposed rule as employees of the Centers for Medicare & Medicaid Services.

Additional Information: The Centers for Medicare & Medicaid Services (CMS) will accept public comments on the proposed rule through December 17, 2011 (60 days). To submit a comment to the CMS, please visit http://www.regulations.gov and enter “CMS-3244-P” as your keyword/ID. Click the “Submit a Comment” link next to the regulation title to send in a typed comment or to upload a file that contains your comment. You may also mail your comment to CMS using the address listed at the beginning of our Federal Register notice.

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US Centers for Medicare & Medicaid Services.  Accreditation standards. http://www.cms.gov/SurveyCertificationGenInfo/07_Accreditation.asp. Accessibility verified September 12, 2011
US Centers for Medicare & Medicaid Services.  Proposed rule. http://www.cms.gov/CFCsAndCoPs/06_Hospitals.asp
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