Daily Rules, Proposed Rules, and Notices of the Federal Government
Under the Medicare program, eligible beneficiaries may receive covered services in a hospital provided certain requirements are met. Section 1861(e) of the Social Security Act (the Act) establishes distinct criteria for facilities seeking designation as a hospital. Regulations concerning provider agreements are at 42 CFR part 489 and those pertaining to activities relating to the survey and certification of facilities are at part 488. The regulations at part 482 specify the conditions that a hospital must meet to participate in the Medicare program, the scope of covered services and the conditions for Medicare payment for hospitals.
Generally, to enter into an agreement, a hospital must first be certified by a state survey agency as complying with the conditions or requirements set forth in part 482. Thereafter, the hospital is subject to regular surveys by a state survey agency to determine whether it continues to meet these requirements. However, there is an alternative to surveys by state agencies. Certification by a nationally recognized accreditation program can substitute for ongoing state review.
Section 1865(a)(1) of the Act provides that, if a provider entity demonstrates through accreditation by an approved national accrediting organization (AO) that all applicable Medicare conditions are met or exceeded, we will deem those provider entities as having met the requirements. Accreditation by an accrediting organization is voluntary and is not required for Medicare participation.
If an accrediting organization is recognized by the Secretary of the Department of Health and Human Services as having standards for accreditation that meet or exceed Medicare requirements, any provider entity accredited by the national accrediting body's approved program would be deemed to have met the Medicare conditions. A national accrediting organization applying for approval of its accreditation program under part 488, subpart A, must provide us with reasonable assurance that the accrediting organization requires the accredited provider entities to meet requirements that are at least as stringent as the Medicare conditions. Our regulations concerning the approval of accrediting organizations are set forth at § 488.4 and § 488.8(d)(3). The regulations at § 488.8(d)(3) require accrediting organizations to reapply for continued approval of its accreditation program every 6 years or sooner as determined by us.
Det Norske Veritas Healthcare's current term of approval for their hospital accreditation program expires September 26, 2012.
Section 1865(a)(3)(A) of the Act provides a statutory timetable to ensure that our review of applications for CMS-approval of an accreditation program is conducted in a timely manner. The statute provides CMS 210 days after the date of receipt of a complete application, with any documentation necessary to make the determination, to complete our survey activities and application process. Within 60 days after receiving a complete application, we must publish a notice in the
In the March 23, 2012
• An onsite administrative review of DNVHC's: (1) Corporate policies; (2) financial and human resources available to accomplish the proposed surveys; (3) procedures for training, monitoring, and evaluation of its surveyors; (4) ability to investigate and respond appropriately to complaints against accredited facilities; and (5) survey review and decision-making process for accreditation.
• The comparison of DNVHC's accreditation to our current Medicare hospital conditions of participation.
• A documentation review of DNVHC's survey process to determine the following:
+ Determine the composition of the survey team, surveyor qualifications, and DNVHC's ability to provide continuing surveyor training.
+ Compare DNVHC's processes to those of state survey agencies, including survey frequency, and the ability to investigate and respond appropriately to complaints against accredited facilities.
+ Evaluate DNVHC's procedures for monitoring hospitals out of compliance with DNVHC's program requirements. The monitoring procedures are used only when DNVHC identifies noncompliance. If noncompliance is identified through validation reviews, the state survey agency monitors corrections as specified at § 488.7(d).
+ Assess DNVHC's ability to report deficiencies to the surveyed facilities and respond to the facility's plan of correction in a timely manner.
+ Establish DNVHC's ability to provide us with electronic data and reports necessary for effective validation and assessment of the organization's survey process.
+ Determine the adequacy of staff and other resources.
+ Confirm DNVHC's ability to provide adequate funding for performing required surveys.
+ Confirm DNVHC's policies with respect to whether surveys are announced or unannounced.
+ Obtain DNVHC's agreement to provide us with a copy of the most current accreditation survey together with any other information related to the survey as we may require, including corrective action plans.
In accordance with section 1865(a)(3)(A) of the Act, the March 23, 2012 proposed notice also solicited public comments regarding whether DNVHC's requirements met or exceeded the Medicare conditions of participation for hospitals. We received two comments in response to our proposed notice. The commenters expressed continued support for DNVHC's hospital accreditation program. In addition, the commenters stated DNVHC's standards are closely aligned with the hospital conditions of participation, thus allowing hospitals to be in compliance with the Medicare requirements.
We compared DNVHC's hospital requirements and survey process with the Medicare conditions of participation and survey process as outlined in the State Operations Manual (SOM). Our review and evaluation of DNVHC's hospital application, which were conducted as described in section III. of this final notice, yielded the following:
• To meet the requirements at § 482.13(a), DNVHC revised its standards to include language to address the hospital's responsibility to protect and promote each patient's rights.
• To meet the requirements at § 482.13(a)(2), DNVHC revised its standards to require prompt resolution of patient grievances.
• To meet the requirements at § 482.13(b)(3), DNVHC revised its standards to include the requirements at § 489.100, § 489.102, § 489.104 regarding advanced directive.
• To meet the requirements at § 482.52(b), DNVHC revised its standards to ensure anesthesia services are consistent with the needs and resources of the hospital.
• To meet the requirements at § 489.13, DNVHC modified its policies related to the accreditation effective date.
• To meet the survey process requirements in Appendix A of the SOM, DNVHC revised its policy outlining the minimum number of inpatient records required for review during an accreditation survey.
• To meet the requirements at § 488.4, DNVHC revised its policies to require a copy of the surveyor's annual evaluation be included in the surveyor's file.
• DNVHC revised its complaint policies to ensure all complaint investigations are conducted in
• DNVHC revised its policies and procedures to clarify that they do not have authority to advise facilities regarding certification issues. Instead, DNVHC must contact the CMS Regional Office on facility specific certification issues for consultation and direction.
Based on our review and observations described in section III. of this final notice, we have determined that DNVHC's requirements for hospitals meet or exceed our requirements. Therefore, we approve DVNHC as a national accreditation organization for hospitals that request participation in the Medicare program, effective September 26, 2012, through September 26, 2018.
This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 35).
Section 1865 of the Social Security Act (42 U.S.C. 1395bb).