Medicare and Medicaid Programs: Revisions to Deeming Authority Survey, Certification, and Enforcement Procedures
Final rule.
CFR Part: "42 CFR Parts 401, 488 and 489"
RIN Number: "RIN 0938-AQ33"
Citation: "80 FR 29796"
Document Number: "CMS-3255-F"
Page Number: "29796"
"Rules and Regulations"
SUMMARY: This final rule revises the survey, certification, and enforcement procedures related to CMS oversight of national accrediting organizations (AOs). The revisions implement certain provisions under the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). The revisions also clarify and strengthen our oversight of AOs that apply for, and are granted, recognition and approval of an accreditation program in accordance with the statute. The rule also extends some provisions, which are applicable to
EFFECTIVE DATE: This final rule is effective on
FOR FURTHER INFORMATION CONTACT:
Cindy Melanson, (410) 786-0310 or
SUPPLEMENTARY INFORMATION:
Acronyms
ADI Advanced Diagnostic Imaging Services
ASC Ambulatory Surgical Center
CfC Condition for coverage
CFR Code of Federal Regulations
CoP Condition of Participation
CORF Comprehensive Outpatient Rehabilitation Facility
EMTALA Emergency Medical Treatment and Labor Act
GAO
HHS [Department of]
LSC Life Safety Code
MIPPA Medicare Improvements for Patients and Providers Act of 2008
NF Nursing Facility
OPT Provider of outpatient physical therapy and speech language pathology services
SNF Skilled Nursing Facility
SOM State Operations Manual
The Act Social Security Act
TJC
I. Background
To participate in the
In accordance with section 1864 of the Act, state health departments or similar agencies, under an agreement with CMS, survey institutional health care providers and suppliers to ascertain compliance with the applicable CoPs, CfCs, conditions of certification, or requirements (as applicable), and certify their findings to us. Based on these state survey agency (SA) certifications, we determine whether the provider or supplier qualifies, or continues to qualify, for participation in the
Section 1865(a) of the Act allows "provider entities" which include all types of providers and suppliers subject to certification, with the exception of kidney transplant programs and end stage renal dialysis facilities, to demonstrate compliance with Medicare CoPs, requirements, CfCs, or conditions for certification through accreditation by a CMS-approved program of a national accrediting organization (AO). If an AO is recognized by the Secretary as having standards for accreditation that meet or exceed all applicable Medicare CoPs, requirements, CfCs, or conditions for certification, then any provider or supplier accredited by the AO's CMS-approved
We are responsible for the review, approval and subsequent oversight of national AOs'
In accordance with
In addition, section 1834(e) of the Act requires that, beginning
Section 125 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275, enacted on
Previously, in response to recommendations of the
FOOTNOTE 1 HCFA's Approval and Oversight of Private Accreditation Organizations (HEHS-99-197R),
CMS Needs Additional Authority to Adequately Oversee Patient Safety in Hospitals (GAO-04-850)
Hospital Oversight in
Moffett, M. & Bohara, A. Hospital Quality Oversight by the
Part 489 consists of regulations codifying
In the
II. Provisions of the Proposed Rule and Analysis of and Responses to Public Comments
A. Summary of the Proposed Rule
To conform our regulations to the MIPPA revisions to section 1865 of the Act, we proposed to eliminate the requirements at current
We also proposed numerous revisions to clarify and reorganize the existing regulations, to eliminate potentially confusing and unnecessary duplication, as well as to strengthen our ongoing oversight processes, consistent with the recommendations of the OIG, and the GAO. All 21 CMS-approved AO Medicare accreditation programs have received extensive reviews in accordance with the application and reapplication processes described at part 488 in recent years. The high volume of comprehensive AO application and reapplication reviews that we conducted has provided us with an abundance of opportunities to apply the existing AO oversight regulations in a variety of circumstances. This experience has helped us to identify areas of our regulations that need revision to more clearly articulate our intentions. Furthermore, we have become aware of the need to clarify, reorganize, and amend our regulations to support a more efficient and effective oversight process. In several situations, we had to require an AO to implement corrective action(s) to ensure comparability with the
To ensure that AOs are enforcing
Currently, when a "substantial allegation validation survey" of an accredited provider or supplier finds substantial non-compliance with one or more of
We also proposed to expand the scope of the AO oversight regulations at part 488, subpart A to include AOs with CMS-approved
We proposed to amend part 489 to use more appropriate terminology in the definition of "immediate jeopardy" and to extend certain of the provisions governing termination of provider agreements to certified suppliers.
B. Public Comments Received
We received 50 timely pieces of correspondence in response to the
1. General Comments
Many commenters presented brief comments expressing opposition to the proposed rule, but their comments were so vague that we are unable to provide specific responses to them.
Comment: Several commenters stated that the framework for oversight of hospital accreditation established with the creation of
Response: We disagree with the commenter. The statutory framework established in section 1865 of the Act, both before and after the MIPPA amendments, prescribes neither a "partnership" nor a "contractor" relationship between CMS and AOs. Instead, section 1865 of the Act establishes the criteria for our approval of a national AO's
Likewise, the commenter's concern that an AO cannot issue waivers to the LSC requirements adopted in various CoPs or CfCs reflects a misunderstanding of our policy. We are not delegating this authority to either the SAs or AOs. The commenter's references to the State Operations Manual (SOM) also appear to be inappropriate, since this manual provides interpretive guidance for the certification regulations at part 488, as well as for the provider-specific CoPs, CfCs, requirements or conditions for certification. If the commenter believes that any particular provider/supplier-specific regulations are in need of revision, there are appropriate avenues outside the AO oversight process for pursuing those changes. In fact, we have published three regulations since 2012 with the express purpose of reducing unnecessary burdens on certified providers and suppliers ("
We did not propose to change the current regulatory framework to create a "partnership" relationship such as the one that the commenters would prefer, nor are we amending our proposal to do so in this final rule, because we believe a "partnership" approach would be inconsistent with the statutory requirements, as well as with the recommendations of both GAO and OIG to strengthen our oversight of AOs.
Comment: Some commenters expressed general opposition to the regulation on the basis that it would subject AOs to standards and survey processes that can be out-of-date, ineffective or inappropriate to the delivery of high quality care. Commenters stated that the delivery of sophisticated, rapidly evolving, and technologically intensive services needs to be evaluated using state-of-the art knowledge and standards. Some of these commenters objected to AOs being held to requirements of the SOM, which is not subject to public notice or comment.
Response: We believe the commenters' concerns appear to be with the substantive regulations underlying the SOM, since the manual does not by itself create requirements for
Comment: One commenter stated support for the proposed rule, which he found reasonable. The commenter believes the proposed rule provided clarity and direction to AOs on a variety of issues.
Response: We appreciate the commenter's support.
Comment: One commenter stated that a historical anomaly gave a single hospital accreditor statutory recognition and allowed it to avoid many of the requirements imposed on other hospital accreditors that were subject to CMS oversight. As a result, the commenter, a different AO, stated, this made its own hospital accreditation program more rigorous, but also gave it a more burdensome, less flexible appearance. The commenter stated that health care systems with hospitals accredited under both AOs found it difficult to harmonize their processes due to these differences. The commenter stated it had expected that when the statute was changed in 2008 and all AOs came under CMS oversight that this problem would be corrected. However, the commenter stated that this was not the case, and that so-called legacy issues remain 5 years later. For this reason the commenter indicated its reluctance to unconditionally endorse the more demanding oversight requirements embodied in the proposed regulation until CMS demonstrates its willingness and ability to apply its requirements across the board to all AOs.
Response: We are committed to treating all AOs subject to our oversight in the same manner. The commenter is correct that a number of legacy issues came to light that we had not identified during the initial application review process for the AO program affected by the MIPPA amendments, given the complexity of that hospital accreditation program. As legacy issues have been identified we have and will continue to work diligently to assure that all AOs are treated equitably and fairly.
Comment: One commenter called the proposed rule a reflection of CMS's commitment to continuously improve its regulations so that they effective promote accountability, protect public health and safety, and improve operational efficiency. The commenter indicated their understanding of the need for tighter controls and strict application of standards and their appreciation of how this will effectuate the safe and consistent delivery of quality care to patients. The commenter also stated that the challenge is to understand how to preserve the innovative aspects of quality by balancing the necessarily prescriptive characteristics of accreditation with the ability to promote quality using multiple techniques, and expressed his hope that the proposed rule would leave room for some degree of flexibility as AOs continue to navigate this inherent and dynamic tension.
Response: We appreciate the commenter's statements about the regulation. It is our intention to provide AOs the flexibility to innovate within the framework of assuring that the statutory requirements to meet or exceed the
Comment: A group of commenters expressed concern that the proposed rule left open the possibility that CMS could potentially approve an AO's application for a
Response: We thank the commenters for their support of our effort to clarify and strengthen our oversight of AOs. The commenters' remarks about the inherent problems they see in permitting a role for private AOs in the
The statute distinguishes AO programs for skilled nursing facilities (SNFs) from other accreditation programs for which AOs seek CMS approval in two respects: (1) The statutory timeframe for completing our review of an AO's application for our approval does not apply to accreditation programs for SNFs (section 1865(a)(3)(B) of the Act); and (2) even if we find that an AO's SNF accreditation program meets or exceeds all applicable requirements, we nevertheless have the discretion to not approve that accreditation program. Unlike the situation with kidney transplant and end stage renal dialysis programs, which, in accordance with the provisions at section 1865(a)(1) of the Act, we may not consider for deemed status, the statute does not permit us to refuse to accept for review an AO's application for approval of a Medicare SNF accreditation program. Accordingly, we proposed revisions to the regulations to recognize the technical possibility that at some future date an AO may choose to submit an application for our approval of a Medicare SNF accreditation program.
However, we emphasize that it was not the intent of our proposed revisions to signal any interest on our part in receiving AO applications for approval of a
"A fundamental question is the appropriateness of allowing a private entity to perform an important public function. In some sense,
There has been no evidence since we issued that report that convinces us that we should reconsider our position. To the contrary, in our recent annual reports to
Further, the commenters raise important issues about the apparent contradictions between section 1865 of the Act's prohibition on disclosure of most accreditation surveys and other statutory provisions that require disclosure of all long term care facility surveys. Should we ever receive an application from an AO seeking our approval of a Medicare SNF accreditation program, these and other similar issues would weigh very heavily in any decision on our part whether to exercise our discretion to disapprove a Medicare SNF accreditation program, regardless of whether the AO's application suggested that its requirements met or exceeded the Medicare SNF requirements.
Upon closer review we also acknowledge that the wording of one proposed provision did not adequately reflect the special statutory status of SNFs at section 1865(a)(3)(B) of the Act. Proposed
2. Accreditation of Advanced Diagnostic Imaging Suppliers
Comment: One commenter indicated concern for our proposal to include oversight of the accreditors of the technical component of ADI services under part 488. The commenter noted that ADI AOs are currently subject to oversight regulations at
Response: We do not agree that individual elements of increased AO oversight are inappropriate or overly burdensome for suppliers of the technical component of ADI services. We discussed in the proposed rule our initiative to broaden our quality oversight of both the CMS-approved AOs, as well as suppliers of ADI services, indicating we anticipated future rulemaking to develop and implement
In response to comments, we also note that our proposed definition did not clearly exclude physician practices, and it was never our intent to imply that they might be subject to the provisions of parts 488 and 489. Also, the proposed definition incorrectly referred to transplant centers as a type of supplier when in fact they are neither a discrete provider or supplier type, but rather a part of a certified hospital that is subject to additional conditions. The proposed definition also excluded from the definition end stage renal dialysis facilities, which are subject to many of the provisions of part 488, even though they are not eligible by statute to participate in
We have also had questions about what categories of supplier are subject to accreditation requirements. We believe that to ensure an accurate definition of the suppliers to which part 488 applies, it would be better to enumerate the covered supplier types. Accordingly, in this final rule we are withdrawing our proposed revision to the definition of "supplier" at
We are also removing the reference to "1843(e) [sic]--Requirements for Advanced Diagnostic Imaging (ADI) Services" at
3. Definitions (
Section 488.1 sets forth definitions for terms used in part 488. We proposed revisions at
* We proposed deleting the definition of "accredited provider or supplier." Use of this language has caused confusion both internally and externally. National AOs offer a variety of accreditation programs. However, not all programs are CMS-approved accreditation programs for the purpose of
* We proposed deleting the language, "AOA stands for the
* We proposed expanding the definition of "certification" to include the rural health clinic (RHC) conditions for certification; clarifying that each provider or supplier must meet its respective conditions or requirements to be certified; and deleting the language "for SNFs and NFs" to eliminate redundancy. We received no comments on this proposed revision.
* We proposed adding a definition of "conditions for certification" to include the terminology for standards that RHCs must meet to participate in the
* We proposed adding a definition of "deemed status" to increase clarity and reduce ambiguity when referring to the status of providers and suppliers accredited under a CMS-approved accreditation program and who are participating in
Comment: One commenter found the following statement within the definition of "deemed status" confusing. The proposed definition reads: "Deemed status is an alternative to regular surveys by the SA to determine whether or not it continues to meet the
Response: We agree with the commenter that the definition could be clearer and are revising it in this final rule to indicate that it means that we have certified a provider or supplier for
* We proposed revising the definition of "full review" to clarify that the regulations at part 488 apply to all providers and suppliers, not just hospitals. We received no comments on this proposed revision.
* We proposed adding a definition of "immediate jeopardy" at
* We proposed deleting the language, "JCAHO stands for the
* We proposed adding a definition of "national accreditation organization" to specify that CMS requires a program for which an AO is seeking initial approval to already be fully implemented and operational nationally.
Comment: We received several comments on this proposal. One commenter proposed that we modify that part of the definition that describes the providers and suppliers accredited by national AOs by replacing the phrase "healthcare facility" with "healthcare organization". The commenter stated this modification better describes organizations that are "entities" which may not be traditional bricks & mortar establishments with a physical building at which services are provided. Several commenters proposed modifying the definition to include a minimum quantitative threshold for accredited facilities to be considered "national." Another commenter stated that CMS should not exceed the existing criteria that an accreditation program includes at least one facility in each of at least five states to be considered national.
Response: We agree that the term "health care facility" could be misconstrued to refer only to providers or certified suppliers who provide their services in traditional bricks and mortar settings, rather than to those which provide services in the patient's home, such as home health agencies or hospices. To address this ambiguity, we believe it would be more precise to use the term "provider entity," which is used in section 1865 of the Act, rather than the commenter's suggested term, "healthcare organization." Section 1865(a)(4) of the Act defines a "provider entity" as "a provider of services, supplier, facility, clinic, agency, or laboratory." Therefore, we are, in this final rule, revising the definition to replace the term "health care facility" with "provider entity."
We note that once an AO has a CMS-approved
We do not require an AO seeking initial CMS approval of a new
* We proposed expanding the definition of "provider of services or provider" to include a clinic, rehabilitation agency or public health agency that furnishes outpatient physical therapy or speech language pathology services. This proposed change is consistent with the language at section 1861(p)(4) of the Act. We received no comments on this proposal.
* We proposed revising the definition of "reasonable assurance" by deleting the language "taken as a whole." This proposed change would clarify the requirement that an AO's CMS-approved accreditation program has standards that meet or exceed all applicable
Comment: A number of commenters expressed concern with removing the language, "taken as a whole," from the definition of "reasonable assurance." The commenters interpreted the intent of the proposed definition to be a requirement for an exact, one-one correlation of the AO's standards and survey processes with those utilized by SAs in the SOM. Another commenter suggested that we add to the definition the following wording to indicate that requirements which are not identical may achieve the same patient safety goals: ". . .although AO standards and
Response: We believe that the language, "taken as a whole," is not consistent with section 1865(a)(1) of the Act, which requires that a national AO demonstrate that its
Further, when determining if all requirements are met or exceeded in an AO's program, we are required under section 1865(a)(2) of the Act to consider the AO's requirements for accreditation, its survey procedures, its ability to provide adequate resources for conducting required surveys and supplying information for use in enforcement activities, its monitoring procedures for provider entities found out of compliance and its ability to provide us with necessary information for validation. Our primary purpose for proposing to revise part 488 was to align our regulatory requirements with the revised statutory requirements.
We also note that the language, "taken as a whole," in the current definition of "reasonable assurance" also contradicts the current
* We proposed updating the definition of "SA" for added clarity and precision. We received no comments on this proposal.
* We proposed revising the definition of "substantial allegation of non-compliance" to correct a previous error.
Comment: One commenter suggested, for the definition of "substantial allegation of noncompliance", that complaints only be submitted in writing and that they not be permitted to be anonymous, to allow an AO to gather and verify all necessary data and avoid spending resources on an unfounded allegation. Another commenter suggested revising the definition to include the following language: "could or may materially affect the health and safety of patients . . ." This commenter stated that the language in the current definition is so broad and vague that SAs conduct about 4000 complaint surveys annually in accredited hospitals, but over the past decade only 5 or 6 percent of these surveys have resulted in condition-level deficiency citations.
Response: Part 488 establishes definitions and requirements that are applicable, depending on the context, to actions taken by an SA, AOs or CMS. The term "substantial allegation of noncompliance" is used in the current regulations at
It is our longstanding policy, reflected in the current definition of this term, that we and SAs accept complaints from a variety of sources, including anonymous sources, communicated in any of a wide variety of methods, not just in writing. It has been our experience that complaints can be a very effective means to focus survey activity to identify serious noncompliance by a provider or supplier. The definition for a substantial allegation of noncompliance is used to establish a threshold for us to authorize an SA investigation of a complaint concerning a deemed status provider entity. Thus, we believe the commenter who suggested that all complaints be in writing and that anonymous complaints not be accepted is misunderstanding the context in which this definition is used, given that the commenter's rationale for the suggested changes is that they would make it easier for AOs to gather and validate data related to complaints the AO investigates.
For the suggestion that the word "materially" be added to the definition, we do not believe that this would add any more specificity or clarity. We believe that the language about the complaint raising doubts as to a provider's or supplier's compliance with any Medicare CoP, CfC, condition for certification, or other requirement is sufficiently clear. In recent years, we have provided additional guidance and training on the appropriate triage categories for complaints to both our regional offices, and to SAs, which receive most of the complaints. The fact that only 7.4 percent of complaint surveys (based on FY 2012 and FY 2013 data) resulted in citations of condition-level noncompliance does not necessarily mean that the other complaints were not credible allegations that warranted further investigation.
In the course of reviewing the comments on this definition we reviewed not only the current definition found at
* We proposed modifying the definition of "supplier" to make it consistent with the definition of supplier as amended by section 901 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173) and to add a clarification that for the purposes of part 488 the term "supplier" does not include suppliers of durable medical equipment and supplies, kidney transplant centers, or end stage renal dialysis facilities. As indicated in our earlier response to comments about the inclusion of suppliers of the technical component of ADI services, we are in this final rule withdrawing our proposal to revise the definition of "supplier" and reverting to the current definition, which enumerates the types of certified suppliers covered by part 488. There were no comments on this.
* We proposed deleting the definition of "validation review period." The concept of a fixed review period would not be used in the proposed revisions at
Comment: One commenter objected to our proposal to delete the definition of the term "validation review period," stating that it will be difficult to validate the AO survey if significant time has passed, since the provider may have undergone significant changes in practice, policies, procedures and processes.
Response: We believe the commenter misunderstood the way in which the term "validation review period" is used in the current regulations, and thus the effect of our proposal to delete this term. The term "validation review period" under the current regulation refers to the 1 year period during which CMS conducts a review of the validation surveys and evaluates the results of the most recent surveys performed by an accrediting organization. After a "validation review period," as set out in the current regulation at
However, we believe the commenter is referring, instead, to a maximum length for the time interval between an AO's survey of a provider or supplier and the SA's conduct of a representative sample validation survey of that provider or supplier. We are retaining our current policy, which permits us to use, when calculating the validation survey disparity rate for our annual report required under section 1875 of the Act, only those validation surveys conducted by SAs no more than 60 days after the conclusion of the AO's survey. We note that section 3242 of the SOM articulates the requirement for SAs to adhere to the 60-day timeframe for conducting a representative sample validation survey. After due consideration of these comments, we are, in this final rule, not incorporating a definition of a "validation review period."
4. Conditions of Participation; Conditions for Coverage; Conditions for Certification; and Long-Term Care Requirements (
Section 488.3 sets forth the conditions or requirements that a prospective provider or supplier must meet to be approved for participation in or coverage under the
Comment: Many commenters expressed concerns that the proposed revisions to
Response: Section 1863 of the Act requires us to consult with appropriate SAs and national accrediting bodies when determining CoPs for hospitals, psychiatric hospitals, SNFs, HHAs, CORFs, hospices and ASCs. By contrast, the current language at
5. CMS-Approved National Accreditation Programs for Providers and Suppliers (
We proposed to revise
* We proposed at
* We stated in the preamble that we were proposing at
Comment: Several commenters indicated the provision described at
Response: The commenters are correct that we proposed to reserve
Comment: Several commenters objected to our statement in the preamble that we were making explicit in proposed
Response: Section 1865(a)(1) of the Act refers to "accreditation of a provider entity" and authorizes us to accept such accreditation as demonstrating the provider's or supplier's compliance with
We also note that it is a voluntary decision on the part of an AO whether it includes standards that exceed the
It would be contrary to the statute if CMS accepted deemed status based on satisfaction of only some of the accreditation requirements in its CMS-approved
In our view, this does not create a double standard with deemed status providers and suppliers having to satisfy higher standards to participate in
In view of the changes we made to the definition of "supplier," as discussed above, we are making conforming changes in this final rule to
6. Application and Reapplication Procedures for National Accreditation Organizations (
We proposed to revise
Specifically, we proposed the following revisions:
* We proposed at
* We proposed at
* We proposed at
* We proposed at
* We proposed at
* We proposed at
* We proposed at
Comment: A commenter proposed expanding the definition of "survey" to include a "desk review" for suppliers of advanced diagnostic imaging.
Response: Since we are rescinding our proposal to apply the provisions of part 488 to accreditors of suppliers of the technical component of advanced diagnostic imaging services, it is not necessary to address in this final rule issues that are specific to such accreditation. For deemed status providers and suppliers, as defined in this final rule, a reaccreditation survey assessing compliance with all accreditation program standards must be conducted via an on-site survey.
Comment: One commenter indicated that the current AO performance measure used by CMS to assess if triennial surveys are timely requires that, for ASCs surveyed for first-time participation in an AO's
Response: We proposed a maximum interval of 36 months from the "previous accreditation survey," which could encompass more than the last date the AO was on-site as part of its reaccreditation survey. The commenter may be confusing the special requirements that apply to accreditation surveys of initial applicants for
Comment: One commenter proposed that we require that a minimum percentage of surveys commence during off-business hours, to further reduce the predictability of surveys.
Response: We do not impose such an obligation on SAs, except in the case of long term care facilities, and we see no compelling reasons why we should do so for AOs for non-long term care provider or supplier types. While it might be possible to conduct a survey outside typical "business hours" in health care facilities that provide care on a 24 hours per day/7 days per week basis, such surveys in ambulatory care settings would generally eliminate the possibility of surveyors being able to observe how care is actually provided by the facility. Even in the case of other types of acute care facilities operating on a 24/7 basis, there would be fewer opportunities to observe the wide range of health care services furnished than during daytime hours. If an AO has received a credible allegation of serious deficiencies that occur only during specific time periods, then it would be logical to conduct a survey during such periods, but we are not aware of such complaints specific to off-hours operations. We are making no changes in response to this comment.
* We proposed at
Comment: One commenter representing health care services consumers indicated its support for requiring comparability of the survey process, to ensure surveys meet
Response: The SOM is a complex document that provides guidance for a number of different
We also have noted that it is not uncommon for objections to be raised about "the SOM" which are really objections to the underlying regulatory requirements found in the various conditions or requirements. We take such concerns seriously and have made a number of regulatory changes to various providers and suppliers in recent years, to revise outdated regulations and remove unduly burdensome requirements that do not contribute to increased patient or resident quality and safety. However, we emphasize that an AO does not have the authority to modify in its
For the commenters' objections to survey process issues, such as survey team composition, survey frequency and duration, how complaints are handled, etc., we note that Section 1865(a)(1) of the Act requires us to make a finding that the AO's accreditation program meets or exceeds all applicable
Comment: One commenter expressed concern this provision would conflict with recent legislation in its State recognizing national AO accreditation in place of a State hospital licensure survey, recognizing that an AO can be more nimble in updating its accreditation standards than the State can in updating its licensure standards. The commenter stated the provisions of this rule would be a step back by forcing AOs to rely on outdated provisions that are part of the SOM.
Response: We do not establish state licensure requirements. We believe this comment also is referring primarily to provider/supplier-specific conditions or requirements rather than to survey process requirements. However, for both accreditation standards and survey processes, we are compelled by section 1865 of the Act to determine whether an AO's requirements meet or exceed all applicable
* We proposed at
* We proposed at
* We proposed at
* We proposed at
* We proposed at
Comment: One commenter expressed support for this provision, saying it would allow CMS to better monitor an AO and its actions.
Response: We thank the commenter for their support. We are adopting this provision without change in this final rule.
* We proposed at
Comment: One commenter requested clarification whether the proposed requirement would change the current process for providing survey information to CMS. Several commenters responded to this provision expressing concerns about disclosing survey and survey-related information to CMS. One commenter indicated that the proposed provision would provide CMS with broad authority to collect information related to a survey, including patient safety work product (PSWP) protected under the Federal Patient Safety and Quality Improvement Act (PSQIA). The commenter suggested CMS add clarifying language acknowledging that it may not be feasible for the AO to provide some information obtained from an accredited entity during a survey. The commenter also requested that we add the language "when specifically requested by CMS" since it does not believe routine submission of information to CMS is needed. Another commenter expressed concern that certain information protected from disclosure by federal standards would lose its protected status if shared, and requested we add clarification that information required would only be related to the deemed status accreditation survey. By contrast, other commenters stated that CMS cannot monitor the work of AOs without seeing their most recent surveys for a provider and indicated the proposed provision would improve CMS's ability to obtain this information. The commenters suggested that failure of an AO to furnish us with copy of an accreditation survey be grounds for withdrawing deeming authority for that organization.
Response: Consistent with the existing requirement at
For an AO not being permitted to disclose to CMS patient safety work product protected under the Patient Safety and Quality Improvement Act (PSQIA) (Public Law 109-41), we do not believe that the PSQIA was intended to inhibit our legitimate AO approval, validation and other oversight activities under part 488. Additionally, providers/suppliers cannot unilaterally declare the factual information used in developing a "patient safety work product" (PSWP) to be itself non-disclosable. Indeed, the Department's final rule implementing PSQIA, "Patient Safety and Quality Improvement; Final Rule" states explicitly that "nothing in the final rule or the statute relieves a provider from his or her obligation to disclose information from such original records or other information that is not patient safety work product to comply with state reporting or other laws." (73 FR 70732, 70786,
For the commenter's suggestion that we add language, "when specifically requested by CMS," we believe that our proposal could more effectively differentiate between the routine electronic submission we require of information extracted from each survey report from copies of the survey report, as well as other information related to the survey report which we request routinely in the case of surveys of initial applicants for
* We proposed at
Comment: One commenter noted a contradiction between our proposed requirement and the requirement for AOs accrediting suppliers of the technical component of advanced diagnostic imaging services at
Response: We agree that there was a conflict between our proposal and
Comment: Several commenters found the proposed shortening of the timeframe from 10 days to 1 business day problematic. One commenter suggested 2 days as an alternative. Another commenter said a one-day notification is feasible, but may result in omission of important information or details pertaining to the case, which could lead CMS to make uninformed decisions or conclusions. This commenter also suggested that CMS Regional Offices be held to the same requirement and should notify the pertinent AO when the SA or Regional Office declares an immediate jeopardy situation. Another commenter also suggested that its experience with follow-up requests from us for more detailed information calls into question the utility of requiring faster, but less detailed notification. On the other hand, another commenter applauded us for reducing the notification time, but believed that 1 business day was too long, given the possibility of greater harm to patients occurring. This group suggested we revise our proposal to require immediate notification.
Response: We believe that once an immediate jeopardy has been determined by an AO to be present, regardless of whether or not the AO survey team also finds that the immediate jeopardy was removed while the team was on site, there is sufficient information within one business day for AOs to provide notification to CMS. As previously indicated, we generally exercise our enforcement discretion to require an SA survey before taking official enforcement action against a provider or supplier, and to arrange a timely state survey to determine whether there continues to be either an immediate jeopardy or even lower-level but substantial noncompliance requiring our enforcement action, we need prompt notice from an AO. We also note that since the original provision was adopted, email has generally replaced hard-copy mail as the primary means of communication between AOs and ourselves, and thus an extended 10-day time frame is no longer necessary. We do recognize that we frequently ask an AO to provide us with more detail about an immediate jeopardy after its initial notice to us before we authorize a state survey, and thus we believe it would be appropriate to extend the notification timeframe to 2 business days. For the comment calling for us to shorten the timeframe to immediate notification, we believe that this affords the AO too little time to complete its internal notification and decision-making processes. Since we expect that the AO will be taking appropriate action to require prompt correction of any immediate jeopardy situation, we believe that a small delay does not increase the risk of harm. Accordingly, we are revising the proposed provision in this final rule to require notice to us about an immediate jeopardy situation within two business days. This policy is consistent with the policy we have adopted for the technical component of advanced diagnostic imaging services.
* We proposed at
* We also proposed at
Comment: Several commenters objected to both of these proposed provisions, expressing concerns they would prescribe the size and composition of survey teams, thereby increasing the costs to facilities, which could cause more facilities to seek
Response: Section 1865(a)(2) of the Act requires us, when determining whether an AO meets or exceeds all applicable
For the comment about focusing on AO performance rather than dictating internal AO processes, we note that it was through our ongoing evaluation of AO performance that we identified problems with several AOs, such as failure to identify serious noncompliance with the LSC requirements, or inability to perform timely reaccreditation surveys, which may be related to the survey resources the AO makes available to accomplish its required survey work. Therefore, we believe it is incumbent upon us to obtain more information from AO applicants for new or renewed approval about the way in which they assure adequate survey resources. We are making no changes in this final rule in response to these comments and are adopting
* We proposed at
Comment: We received one comment asking for clarification of the difference between "surveyors" and "AO staff" and also recommending that surveyors for ADI have experience in diagnostic imaging.
Response: We consider "surveyors" to include all individuals who conduct on-site surveys, or inspections, of providers and suppliers seeking new or continued deemed status. Surveyors typically also have additional off-site responsibilities established by the AO. We believe the commenter's question relates to some of the unique circumstances pertaining to accreditation of suppliers of the technical component of ADI services. Given our decision to remove all reference to ADI services and their accreditation from part 488 in this final rule, we believe that it is not necessary to address the commenter's recommendation for ADI surveyor qualifications. We are not making any changes in response to this comment and are adopting this provision in this final rule as proposed.
* We proposed at
* We proposed at
Comment: One commenter expressed its opposition to the proposal since it believes it implies that the AO's surveyor evaluation system would require prior approval, which would restrict the AO's flexibility in adjusting evaluation processes to emerging trends and impair the evaluation of quality assurance processes.
Response: This requirement is unchanged from the existing requirement at
* We proposed
Comment: Some commenters proposed adding a minimum timeframe of 2 years after termination of a surveyor's affiliation with a provider or supplier during which the surveyor would be precluded from participating in a survey or accreditation decision for that provider or supplier. The commenters also proposed we require an AO to have different personnel on a survey team from that which previously surveyed the provider or supplier.
Response: The commenters are focusing on prior affiliations and seems to presume that an AO's surveyors are full-time staff. Our proposal was focused on avoiding conflicts of interest where AO staff has current affiliations with providers or suppliers, since it is our understanding that few AOs employ full-time surveyors, but instead rely upon contracted surveyors who often have ongoing relationships with some providers and suppliers. However, we agree that it could also create the appearance of a conflict of interest for an individual to participate in a survey of a provider or supplier with which he or she was previously affiliated and that such appearance should also be avoided as much as possible. Nevertheless, we do not specifically mandate in regulation or policy that SAs preclude newly-hired staff from engaging in surveys or decisions affecting a prior employer for a specified period of time. In section 4008 of the SOM we establish a policy for conflicts of interest of SA employees engaged in federal survey and certification work, indicating that such conflicts may arise when public employees utilize their position for private gain or to secure unfair advantages for outside associates. We specifically state that it is not possible to list all situations that could be construed as potential conflicts of interest, but do provide some examples of potential conflicts, including having various relationships with a health care facility in the employing state. We also indicate in section 4008B of the SOM that state codes provide judicial or administrative remedies for abuses of influence and that employee actions would be handled in accordance with the applicable State procedures. Thus we do not prescribe uniform limitations or prohibitions that all states must incorporate. AOs might not be as likely as states to have conflict of interest policies absent our requirement that they do so, but this does not necessarily mean that we should specify in regulation the detailed content of such policies. We also believe that a 2-year ban on a surveyor's participation is excessive and might unduly limit an AO's (or state's) ability to use its staff resources effectively. Within CMS, for example, a newly-hired employee is precluded from participating in matters concerning a prior employer for one year. In summary, while we believe it is prudent for both AOs and states to avoid conflicts of interest involving previous as well as current affiliations, we believe we should not in this regulation specify in detail how to avoid such conflicts.
We also do not require SAs to use different personnel for successive surveys of a provider or supplier; in fact, we believe it is more likely that SAs would have the same personnel conducting successive surveys than would AOs, given the national scope of an AO's operations. We also see no particular value to such a requirement; one might argue that familiarity of a surveyor with a facility might enhance their ability to identify deficient practices. In fact, some AOs have suggested that SAs tend to be more successful in identifying LSC deficiencies in providers or suppliers precisely because they have long-standing familiarity with the physical plants of facilities in their states.
Comment: Commenters stated that the "business-client relationship" that exists between AOs and the facilities they survey creates an inherent conflict of interest and expressed concern that this provision does not address this more generic type of conflict of interest.
Response: Section 1865 of the Act specifically allows for us to certify providers or suppliers as meeting the applicable conditions or requirements on the basis of accreditation of providers or suppliers by private AOs. Thus, under the law the business-client relationship is not prohibited in those cases where we have reviewed the AO's
Comment: Several commenters proposed that we also preclude surveyors from participating in a survey or accreditation decision when they have a financial or professional affiliation with a competitor of the provider or supplier being surveyed.
Response: We believe there is merit to the commenters' concerns, particularly given that few AOs employ full-time surveyors but instead rely upon contracted surveyors who often have ongoing relationships with some providers and suppliers. We expect AOs to be careful to avoid the appearance of conflicts of interest that could compromise confidence in the objectivity of their survey findings or accreditation decisions. At the same time, we are reluctant to attempt to specify in regulation a definition or methodology for determining which providers or suppliers are "competitors" of a provider or supplier being surveyed, since there are many varying factors that could influence whether there is a competitive relationship among providers and suppliers and to what extent that would deleteriously impact surveyors' objectivity.
In light of the various commenters' concerns about potential conflicts of interest scenarios that go beyond the situation of a surveyor being involved in a survey or accreditation decision of a facility with which he or she has a current professional or financial affiliation, as well as our intent to not micro-manage the way in which either states or AOs avoid conflicts of interest, we are in this final rule revising this provision to state more generically that an AO must provide us its policies and procedures for avoiding conflicts of interest, including the appearance of conflicts of interest.
* We proposed at
* We also proposed at
Comment: One commenter indicated its support for these provisions, while another indicated it appreciated that this provision would require AOs to devote more resources to articulating their plans for data use.
Response: We thank the commenters for their support.
Comment: One commenter proposed we add language indicating CMS will be judicious and prudent with its requests for data, acknowledging that each demand for data is resource intensive and can be costly.
Response: We agree that we should not require AOs to submit data that are not necessary for us to support our evaluation of an AO's performance, and that we should be mindful of the need to avoid undue burdens on AOs. However, we do not agree that the regulations need further revisions to reflect this principle, since it already clearly links the data to be submitted to our evaluation of an AO's performance. Upon adoption we are, however, making non-substantive stylistic edits and changing the order of the last two sentences of this provision.
* We proposed at
Comment: One commenter proposed we mandate that AO procedures for investigating complaints, include timeframes for resolution and a process to communicate the results to the complainant. The commenter also proposed that complaint resolution timeframes be consistent with those utilized by SAs and the complaint procedures be made publicly available upon request.
Response: We require in this provision that AOs seeking CMS-approval of their accreditation program provide us information on their processes for responding to, and investigating complaints, including grievances, against accredited facilities. We compare their policies and procedures to those we require for SAs during the application process and determine whether all applicable
Comment: One commenter asked us to identify ombudsmen programs for advanced diagnostic imaging.
Response: We are not aware of ADI ombudsmen programs, and since we have rescinded our proposal to apply part 488 to accreditors of suppliers of the technical component of ADI services, the question is largely moot. However, we are taking this opportunity to note that we believe the language of the regulation makes it clear that we expect AOs to coordinate with licensing bodies and ombudsman programs in their investigation of complaints when it is appropriate to do so. For example, if in the course of an investigation an AO identifies a matter that appears to warrant separate investigation and action by the state authority responsible for licensing health care professionals, we would expect the AO to make an appropriate referral. Likewise, if there is an ombudsman program for the type of provider or supplier the AO accredits, we would also expect it to make appropriate referrals to such ombudsman programs. To make our intent clearer we are revising this provision in this final rule to require referrals, when applicable, to appropriate licensing bodies and ombudsman programs.
* We proposed at
The current provision at
We also proposed to include within
Comment: We received no comments on proposed
Response: By "withdrawal" we mean a voluntary decision on the part of the accredited provider or supplier to end its participation in the accreditation program. This is in contrast to an AO's revocation of accreditation, which we view as including both an action taken when an AO concludes that a provider or supplier is substantially noncompliant with accreditation standards and has not corrected its deficient practices within the timeframe specified by the AO, as well as an action taken by an AO to revoke a provider's or supplier's accreditation due to the provider's or supplier's nonpayment of accreditation fees. By "revised" we mean a change in a provider's or supplier's accreditation status, based on the formal accreditation status categories the AO employs. We intended this latter term to include both adverse changes that fall short of revocation, as well as positive changes reflecting a provider's or supplier's improved compliance. Reflecting upon the commenters' comments, we believe that our additional language "any remedial or adverse action taken against it" is vague and potentially duplicative, and thus should be removed. Our intent was for AOs to notify us when they have taken a final action concerning a change in the accreditation status of a deemed status provider or supplier. If an action is not final until after an appeals process, then notice would not be required until three business days after that process has concluded and a final AO determination has been made. If a voluntary withdrawal from accreditation is not effected until an AO completes a number of steps to try to reverse the provider's or supplier's decision, and the AO continues to accredit the provider/supplier during this process, then notice would not be required until 3 business days after the effective date that the AO ultimately processes the provider's or supplier's voluntary withdrawal. In this latter case we would expect that the AO's timeframe for pursuing a revised decision from its customer would not be unreasonably long, so as to call into question whether the provider/supplier continued to meet the AO's accreditation standards. For example, we anticipate that a provider/supplier might notify an AO of its intent to withdraw shortly before its next payment is due, which might also be shortly before its current 3-year accreditation expires. We believe it is important to have these providers/suppliers recertified via another survey, either by another AO the provider or supplier has concurrently chosen or, in the alternative, by an SA in a timely manner. In the case of an HHA, we must ensure that the statutorily-mandated maximum survey interval of no more than 36 months is maintained, and that SAs are afforded as much advance notice of their need to conduct a survey as possible.
We do not believe that it would be reasonable to shorten this timeframe further, to 1 day. We note that the separate requirement at
For ADI AOs, this comment was one of the many that made us conclude that this type of accreditation could not reasonably be accommodated within the framework of part 488 and that we needed to remove ADI accreditation from this final rule. We have already established a weekly data submission schedule for ADI AOs to identify all suppliers of the technical components of ADI services that they accredit as of that week, to ensure that their
In light of these clarifications, we are revising the provision to clarify that notice is required for any decision to revoke, withdraw, or revise the accreditation status of a specific deemed status provider or supplier within 3 business days' of the effective date the AO takes action.
* We proposed at
* We proposed at
Comment: One commenter suggested that if an AO is truly national in scope, then it should be accrediting significantly more than 50 facilities. This commenter also suggested the final rule should make clear the time interval for reaching the threshold. By contrast, all of the other commenters on this provision opposed this proposal. One commenter found the number to be both too large and arbitrary. Several commenters suggested that we consider all of an AO's approved programs when assessing its infrastructure and sustainability, rather than each individual
Response: We do not agree that our proposal would have created a significant barrier to entry for AO's seeking our initial approval. Our proposal would have established a minimum of 50 accredited facilities for each
On the other hand, we recognize the merit of those commenters who pointed out that the market for a particular program might be more limited, as is the case with psychiatric hospitals or for programs focused on rural areas. We also agree that smaller AOs seeking to compete with larger AOs have a legitimate interest in providing "one-stop shopping" for health care systems seeking deemed status for all the various types of providers and suppliers in their system. Finally, we acknowledge that the overall surveyor and administrative infrastructure of an AO that has several CMS-approved
* We proposed at
Comment: We received one comment suggesting that we include the phrase "deemed status" in front of "accreditation" in the phrase "all accreditation surveys."
Response: For an accreditation program for which an AO is seeking our initial approval, addition of the suggested phrase would not be appropriate, since none of the facilities accredited by the AO under that not-yet-approved program would have deemed status based on that accreditation program. Even for a renewal application, an AO might include a survey scheduled for a provider or supplier that does not have deemed status, either because it is seeking initial enrollment and certification in the
* We proposed at
* We proposed at
Comment: One commenter indicated that an AO should be required to provide written notice to all patients or assure that the providers they accredit provide patients written notice, saying that patients have a right to know of any change in oversight of the provider.
Response: We believe that it is both unnecessary and unduly burdensome to require written notification of each patient when there is a change in their provider's oversight, whether from one AO to another, or from an AO to SA supervision, or from SA supervision to an AO, regardless of whether the change is due to decisions in individual cases on the part of the provider/supplier or AO, or if it is due to a voluntary or involuntary termination of an AO accreditation program's approval for
Comment: One commenter noted a contradiction between this provision and the one we proposed at
Response: We agree that the interaction between proposed
* We proposed at
Comment: Numerous commenters expressed concerns with or opposition to our proposed changes. Some of the commenters made objections similar to those they raised about our proposal at
One commenter referenced our preamble statement, with regard to proposed
Several commenters indicated that not allowing an AO to adopt revised standards prior to our approval would slow down implementation of changes needed to meet an ever-changing health care environment and advances in the oversight of quality and safety.
One commenter indicated that 60 days was a reasonable amount of time for an AO to prepare and CMS to review proposed changes, but expressed concern about the uncertainty created for the AO if it was prohibited from implementing its proposed changes until we gave our approval. This commenter indicated there could be potentially damaging and costly implementation effects if CMS did not give its approval in a timely fashion and noted that there was nothing in the proposed rule to hold us accountable for rendering timely decisions. The commenter suggested that we revise the proposal to state that unless we affirmatively rejected an AO's proposed changes within 60 days, the changes would be deemed approved and would take effect. The commenter also proposed as an alternative that we eliminate the 60 day advance notice requirement and replace it with a requirement that an AO submit proposed changes prior to implementation and not implement the changes until 30 days after receiving approval from CMS. The commenter stated that this would give CMS an open-ended review period, prevent implementation prior to approval, and not interfere with AOs' plans to roll-out a change. Another commenter requested that we establish a timeframe by which CMS would have to give its response to a proposed change.
Response: We find many of the comments surprising, since we do not believe our proposal differs substantively, beyond the change from 30 to 60 days, from the requirements under the current regulations, which are found at
The commenter who noted our preamble statement in reference to our proposal at
We find merit in those comments that expressed concern about undue delays if our reviews are not timely. We believe that we should be accountable to AOs just as we expect them to be accountable to us. We also agree that the language of both the current and proposed regulations, by specifying a notice requirement tied to the effective date of an AO's proposed changes, can be a source of confusion. Accordingly, in this final rule we are revising this provision to: change the number to
* We proposed at
Comment: One commenter requested clarification on how CMS will communicate these changes, asking if they would be published in the
Response: Our reference to changes to the "applicable
Comment: Several commenters requested that the provision be modified to include a mechanism for AOs to request additional time in implementing changes to their programs in response to CMS-initiated changes. These commenters also proposed that we include a timeframe to complete our review of the AO's changes, with one commenter suggesting 30 days.
Response: We agree and are modifying our proposal in this final rule to indicate we will give due consideration to an AO's request for extension submitted prior to the deadline. We also are revising the final rule to indicate that the AO agrees not to implement its proposed changes without our prior written notice of continued program approval, except as provided for at
Comment: One commenter opposed our requiring AOs to obtain CMS approval prior to implementing any changes to a CMS-approved program, indicating this would cause delays in implementation and limit flexibility.
Response: Section 1865 of the Act requires us to determine whether an AO's
In this final, rule we are adopting this provision revised to reflect the numbering change referenced above, to make clearer that the purpose of our review is to determine whether the proposed revised accreditation program meets the standards for our continued approval, to make explicit that we will give due consideration to timely requests for an extension of the deadline for submitting proposed revisions to us; and to cross-reference
* We proposed at
Comment: Two commenters expressed concerns with our proposal to change the current requirement for an AO to "permit" its surveyors to act as witnesses to a requirement for its surveyors to serve as witnesses. One indicated a surveyor should be able to refuse to be a witness. The other indicated that this provision would force an employer to condition an employee's hire on compelled speech, which could impact an individual's First Amendment rights. This commenter suggested the current provision could be strengthened without impacting an individual's rights, and proposed we used language such as "make surveyors available" or have CMS serve an AO with an administrative subpoena if a surveyor is reluctant to serve as a witness.
Response: Although section 1865(b) of the Act clearly authorizes us to take enforcement action on the basis of a survey conducted by an AO with an approved
* We proposed at
We proposed at
* We proposed at
Comment: We received no comments on our proposed
Response: We agree with the commenter that an AO's ability to request a reconsideration of a denial should not be conditioned upon precluding that AO's submission of an initial application for a different program. As we indicated in the preamble to the proposed rule, it was not our intent to change the current regulatory requirement, but we agree that the language in the proposed
* We proposed at
Comment: Two commenters responded to this provision by indicating the public cannot evaluate and comment on an applicant if it does not have the information in the application. One commenter requested that we publish in the final rule information on how to obtain a copy of an AO's application, while the other requested that the application be posted on the internet during the public comment period.
Response: The information about an AO's application which the Secretary is required to disclose to the public in accordance with section 1865(a)(3)(A) of the Act is the identity of the AO making the request, and the nature of the request. We appreciate the commenters' interest in having more information to enable them to make comments to us. However, AOs regard the detailed information about their programs to be proprietary information which is exempted from disclosure under the Freedom of Information Act (5 U.S.C. 552(b)(4)) and HHS regulations (see, for example, 45 CFR 5.65), and thus we do not provide copies of the applications when requested to do so, nor would we be able to post these applications on our Web site.
As discussed in our response to comments about the application of section 1865 of the Act to long term care facilities, we are making a technical correction to reflect the fact that the 210 day timeframe does not apply in the case of an application for a Medicare SNF accreditation program. We are also making a technical correction to
7. Providers or Suppliers That Participate in the Medicaid Program Under a CMS-Approved Accreditation Program (
* We proposed to broaden and revise the standard's title. We stated that the proposed regulations at
8. Release and Use of Accreditation Surveys (
* We proposed revising this standard's title to be more reflective of the standard's content. We proposed at
We proposed other changes as part of our effort to reorganize and clarify the regulations, as follows:
* We proposed at
* We proposed at
We also stated that we were taking the opportunity to clarify in the preamble that we recognize that, in accordance with the Patient Safety Act and Quality Improvement Act (PSQIA) (Pub. L. 109-41) and implementing regulations at 42 CFR 3.206(b)(8)(i) and (ii), an AO may not further disclose patient safety work product it receives when such work product complies with the requirements for patient safety work product protected under the PSQIA.
Comment: A number of commenters indicated their opposition to the disclosure of accreditation surveys and related information. One commenter proposed that CMS provide any corrective action plan when releasing information about enforcement action.
Response: Section 1865(b) of the Act prohibits our disclosure of any accreditation surveys conducted by AOs, with the exception of surveys conducted of HHAs. In the case of HHAs, routine disclosure is expressly permitted under the Act. However, for accreditation surveys of any type of provider or supplier, section 1865(b) of the Act also provides that we may disclose an accreditation survey and related information to the extent that such survey and information relate to an enforcement action we have taken. In such cases our policy is to disclose the information upon receipt of a written request. If we have received related corrective action plans developed by the provider/supplier, we would include those in the disclosure.
Comment: One comment from a group of organizations indicated that, given the large amount of public funding nursing homes receive, consumers have a right to know about quality of care in a nursing home. They also questioned how Nursing Home Compare could be maintained without AO survey results, stating that deemed status would undermine Nursing Home Compare. This group also recommended that we change the language of the regulation to say we "must," upon written request, disclose surveys and information related to an enforcement action.
Response: Section 1865(b) of the Act says that we "may" disclose an accreditation survey and other information related to an enforcement action we take, but does not require us to do so. The policy we proposed at
With regard to public disclosure requirements related to surveys of nursing homes and the potential impact on Nursing Home Compare of not disclosing accreditation surveys, we believe these are among the many issues we would need to consider should we ever receive an application from an AO seeking our approval of a
Comment: A number of commenters, mostly representing hospitals, expressed concern with the provision indicating that we may determine on the basis of our own investigation of the accreditation survey that a provider or supplier does not meet the applicable
Response: This provision is a long-standing regulatory component of part 488. Section 1865(c) of the Act provides that if we find a provider entity has significant deficiencies, that entity shall not be deemed to meet the conditions or requirements. Neither approval of an AO's accreditation program nor a section 1864 agreement with an SA are delegations of authority to either AOs or SAs to make
As we stated in our response to comments concerning proposed
To illuminate what we mean by an "investigation," we provide the following examples of situations when, after our review, we have rejected an AO's deemed status recommendation and have denied a prospective provider's or supplier's application for certification and
We have also had instances where an AO's survey report for a prospective provider or supplier indicated that deficiencies were identified that the AO did not find rose to substantial noncompliance with a
Occasionally we obtain information that raises compliance issues not addressed by the AO's survey. For example, for hospitals or CAHs enrolling in
9. On-Going Review of Accreditation Organizations (
We proposed modifying the title of this standard with language that is more specific and clarifies that our oversight of accreditation programs is continuous. We also proposed further revisions at
* We proposed at
Comment: One commenter expressed opposition to our proposal to change the heading of this requirement from "validation" review to "ongoing" review, suggesting that the change would allow hospitals to be surveyed at any time for validation purposes, instead of as part of a random sample within 60 days of an AO's survey. The commenter stated that this would put deemed status and non-accredited hospitals on an unequal playing field, since hospitals choosing to be accredited by a private AO could be subject to a full validation survey beyond a 60-day period while hospitals surveyed by the state under contract to CMS are not governed by the same set of rules. The commenter further stated that the contracts between the states and CMS are confidentially negotiated and not transparent, and questioned why a hospital would have any incentive to work with an AO when it would be subject to a different set of standards. A number of other commenters also objected to our removing the "fixed period" during which a validation survey could be conducted.
Response: The commenters misunderstand both our current requirements and our proposal. Although proposed
Comment: One commenter proposed modifying the language of this provision to state that ongoing review of AOs is applied to CMS-approved accreditation programs only. The commenter also stated that "onsite observations should be as minimally disruptive as possible and be limited in scope".
Response: We believe it is clear that the provisions of part 488 apply only to those accreditation programs for which AOs are seeking or have already received our approval. We make every attempt to minimize disruption to the AO's operations when we make onsite observations, and we limit the scope of our observations to matters pertaining to the program under review.
Comment: One commenter requested that CMS identify how it would conduct validation surveys of suppliers of the technical component of advanced diagnostic imaging.
Response: In this final rule we do not apply the provisions of part 488 to accreditation of the technical component of ADI suppliers, so the question is moot.
Comment: We received no comments about our proposal to remove the 20 percent representative sample survey disparity rate as an automatic trigger for our review of an AO's program. However, a number of commenters expressed concern that our reliance upon state validation surveys is seriously flawed. One commenter indicated that issues associated with the current validation survey framework include the following: (1) Assessment is one-way, in that CMS instructs its contractors, the SAs, to use the
Similarly, but in less detail, other commenters expressed objections to our reliance upon state representative sample validation surveys. One commenter called for us to establish a process for an AO to request reconsideration of a state's validation survey findings when the state's findings differ from the AO's findings. Another commenter said that state validation surveys are widely reported to be "punitive" in nature and often do not accurately reflect a provider's compliance. The commenter also noted variation among states in the size and scope of the survey teams and how deficiencies are identified. The commenter urged development of performance metrics for how the surveys will be used to evaluate AO performance. Another commenter indicated that CMS uses unannounced validation surveys to evaluate the AO's performance. It indicated a clear validation survey process based on unambiguous and understandable performance indicators is necessary to accurately evaluate an AO's performance.
Response: Section 1865(d) and section 1864(c) of the Act provide for validation surveys by SAs of providers and suppliers that have deemed status. Further, section 1875(b) of the Act specifically requires us to conduct a continuing "validation" of AO programs provided for in section 1865(a) of the Act and to report our findings annually. While we believe that the term "validation" in section 1875(b) of the Act is intended to cover a wider range of AO performance than the results of validation surveys, we do not believe the Act provides us discretion to omit state validation surveys from our analysis of an AO's performance.
With regard to the issue of the validation assessment being one-way and using the
The allegation that states use larger survey teams and conduct longer surveys than do AOs has been raised in the past for hospital validation surveys. We reviewed our data concerning survey team size and hours and found that states tend to vary the size/length of survey according to the size of a hospital, as measured by the number of certified beds. We found no evidence that states fielded larger survey teams or conducted longer surveys when conducting validation surveys of deemed status hospitals as compared to their surveys of non-accredited hospitals. We note that section 1865(a)(2) of the Act requires us to consider in our review of an AO's
We note that our methodology for calculating the representative sample validation survey disparity rate gives AOs the benefit of the doubt in a number of ways. We do not compare state and AO surveys where they state found only lower-level deficiencies; instead, we compare only those surveys where they state identified substantial noncompliance, on the theory that substantial noncompliance is likely systemic, and therefore, was likely already present when the AO conducted its survey up to 60 days earlier. However, despite comparing only this more limited subset of surveys, for the denominator in the disparity rate calculation we use all representative sample validation surveys conducted in the given fiscal year. We have been criticized in the past for this methodology and urged to calculate instead a "disagreement rate" using for the denominator only those surveys where states found substantial noncompliance. We did in fact report a disagreement rate for several years in our report to
In response to comments about the variability in state surveys, we acknowledge that there is variability and we employ a variety of mechanisms to assess and improve SA performance. As we noted previously, SAs are not contractors in the normal sense, but this does not mean that we do not provide ongoing oversight of their performance. We are also convinced that variability in SA performance is not relevant to the discussion of our use of validation survey results to evaluate AO performance. Consistently among the SAs and over time the largest source of disparate findings between states and AOs has been AO difficulties in assessing compliance with the LSC, compliance with which is designed to prevent fires in health care facilities and to reduce the adverse impact should a fire occur. Various AO practices may have contributed to their LSC compliance assessment difficulties, including purportedly issuing LSC waivers to providers, though they lack authority to do so, choosing not to issue citations requiring corrective action for what the AO considers to be minor LSC noncompliance, or focusing their survey activities on areas that they consider more important than fire protection requirements. Nevertheless, we expect all AOs with accreditation programs for providers or suppliers that are subject to LSC requirements to be able to assess compliance with the LSC.
We disagree with the comment objecting to our view that a long list of minor LSC deficiencies cited by a state could end up with a finding of substantial noncompliance. In accordance with
We also disagree with the comment concerning state validation surveys being perceived as "punitive" in addition to being unannounced. We require both states and AOs to conduct unannounced surveys, and assuring compliance with our regulations is not "punishment" but part of our responsibility to protect patients and their families. Further, to the extent that a state survey finds substantial noncompliance, we are required to take appropriate enforcement action to bring the provider or supplier back into compliance or to take adverse action if it fails to do so. We expect that AOs finding the same noncompliance also take swift action within their accreditation programs to bring the provider or supplier back into compliance or to take adverse accreditation action when an accredited provider or supplier fails to correct its deficient practices.
Finally, for the comment about immediate jeopardy, the comment is not directly pertinent to the issue of validation surveys and our calculation of the disparity rate. As noted in this section of this final rule, in calculating the amount of the disparity, we do not consider the level of an AO's citation in its survey report so long as it identifies a deficiency comparable to the one that the state survey team found. Further, the comment incorrectly describes the criteria for immediate jeopardy situations, at least for non-long term care providers or suppliers. Since there are no approved long-term care accreditation programs, the comment incorrectly describes a supposed policy difference that currently exists between AO and state practices in citing an immediate jeopardy. For non-long term care providers and suppliers we assess only their current compliance, at the time of the survey, with the
Comment: Several commenters requested clarification on the criteria that would trigger a program review other than the disparity rate, changes to CMS requirements, or changes to an AO's standards.
Response: In our proposal we indicated that we would consider the AO's survey activity (for example, whether it was conducting timely re-accreditation surveys), the results of validation surveys, and its continued fulfillment of the requirements in our proposal at
* We proposed at
We received comments on both this and the parallel provision at proposed
* We proposed at
We received comments about this provision in conjunction with our proposal for
* We proposed at
Comment: One commenter proposed that we strengthen this provision by changing the language from "CMS may initiate a program review . . ." to "CMS must initiate . . ." making this an automatic requirement whenever substantial non-compliance is determined to be present in a CMS-approved program. The commenter also proposed reducing the maximum timeframe for an AO to implement corrective action from 180 days to 60 days, and also urged that we review any survey activity of the AO conducted during this 60-day period. The commenter indicated that allowing 180 days to correct identified deficiencies is much too long since that may subject patients to substandard care.
Response: We appreciate the concerns of the commenter, but believe that reducing the timeframe for an AO to implement corrective action from 180 days to 60 days may not provide adequate time for the AO to identify and implement the systemic changes typically needed to effect sustained improvement. Depending on the nature of the AO program's deficiencies, we have the discretion to employ greater use of validation surveys during this period to ensure patient safety. We also note that we have the authority to immediately withdraw our approval of an accreditation program if we determine that continued approval poses an immediate jeopardy situation for the patients of the AO's accredited entities. For the commenter's suggestion that a program review be mandatory, we do not see the need to limit our discretion in this manner. A program review is a formal process that entails a comprehensive review of an AO's program. We also address specific problems we have identified in an AO's program outside the formal program review process, and have found this to be an efficient and effective way to correct such problems. Therefore, we believe it is essential for CMS to retain discretion about when to use a more focused approach and when to initiate a formal program review. After due consideration of the public comment, we are implementing this provision in this final rule without change.
* We proposed at
* We proposed at
* We proposed at
* We proposed at
* We proposed at
* We proposed at
Comment: One commenter proposed that withdrawal of our approval be automatic if an immediate jeopardy situation is found, stating that this would provide a greater incentive to AOs to remain in compliance.
Response: We believe that an automatic withdrawal of our approval of an accreditation program is unnecessary and would be more vulnerable to challenge. We are confident that we will use our enforcement discretion appropriately to take prompt action should we ever make a determination that a CMS-approved accreditation program's continued approval puts patients in immediate jeopardy. After due consideration of the public comments we are adopting this provision in this final rule with one minor typographical correction.
* We proposed at
Comment: One commenter proposed extending notification to all patients impacted by CMS withdrawing approval of an AO's CMS-approved accreditation program. This notification would be in addition to CMS publishing a notice of such action in the
Response: As we indicated in response to a similar comment on proposed
Comment: Several commenters noted that there might be a contradiction between this proposed provision and the one at proposed
Response: We revised proposed
* We proposed at
Comment: One commenter proposed retaining the existing language referring to "deeming authority" and for CMS to publish a definition that communicates the intent of this language. The commenter states that changing this term to "CMS-approved accreditation program" will impact recognition, reputation, and marketing for AOs.
Response: Consistent with our action in other areas of this rule, we have removed reference to "deeming authority" for AOs and instead refer to their
* We proposed
Comment: One commenter expressed its opposition to this provision, saying that suppliers of the technical component of advanced diagnostic imaging services should not have to submit notice to the SA when applying for another accreditation, since SAs do not oversee such suppliers. It proposed instead that the accreditation period of such suppliers be transferred to another AO when the original AO is no longer approved by CMS, stating that the suppliers should not be penalized when an AO loses its status with CMS.
Response: We agree that it is not appropriate to require suppliers of the technical component of advanced diagnostic imaging services to notify SAs when they apply for accreditation with another AO, after we have removed our approval of the supplier's AO's ADI program. This is one of the many reasons we decided in this final rule to remove all reference to accreditation of suppliers of the technical component of ADI services from part 488. We will consider the commenter's alternative proposal for future rulemaking concerning ADI accreditation.
Comment: Several commenters expressed appreciation for our proposal to lengthen the period of continued deemed status, but questioned why we did not instead extend deemed status until the provider's or supplier's next scheduled accreditation survey. Since all
Response: If we remove our approval of an AO's
Comment: One commenter proposed that we require providers and suppliers to provide written notice to patients when it submits an application to another AO, that we place the provider or supplier under the oversight of the SA during the transition period between AOs, and that we provide patients with information on how to contact the SA with any complaints.
Response: As we indicated in response to similar comments about other provisions, we believe it would be unduly burdensome to require notice to patients when a provider or supplier applies to another accreditation program, and we do not believe this information would be useful to patients. In our view it is also unnecessary to provide patients with special notice about how to contact the SA with any complaints, since it is already routine for patients to submit their complaints about certified providers and suppliers to the SA, regardless of whether they have deemed status or not, and, when appropriate, we authorize substantial allegation validation surveys to investigate the complaint.
Commenters on this provision, as well as on the provisions we originally proposed at
* We proposed at
Comment: One commenter requested we provide as much advance notice as possible prior to an onsite visit, noting that the
Response: Our proposal was not intended to modify our existing policy and practices for on-site inspections of accrediting organizations. Generally we work with an AO in advance to find a mutually convenient time for both our observation of surveys and our visit to their corporate offices, and we intend to continue to do so. However, we reserve the right to make an unannounced visit or survey observation, should there be circumstances that warrant our doing so. We also do not believe it is necessary to state in this provision that we only assess the performance of an AO's CMS-approved accreditation programs when we are on-site, since we believe that is clear in
10. Validation Surveys (
We proposed revising the title of this section, indicating that proposed
Comment: Several commenters stated this provision broadened the scope of the statutory provision governing substantial allegation validation surveys. They cited the statutory language, which authorizes the Secretary to enter into an agreement with states to survey ". . . because of substantial allegations of the existence of a significant deficiency or deficiencies which would, if found to be present, adversely affect health and safety of patients . . ." and suggested that this language is narrower than a "substantial allegation of noncompliance." One commenter provided as an example that there may be a substantial allegation that a provider is noncompliant in dating and timing medical record entries, but this type of noncompliance does not rise to the level of a significant deficiency that affects health and safety. The commenter went on to state that CMS conducts between 3500 and 5000 complaint surveys in accredited hospitals each year and yet only finds significant problems in 4 percent to 6 percent of those surveys, which is a tremendous waste of resources for the federal government and an unnecessary burden for hospitals.
Response: There has been no modification of our longstanding interpretation of the statutory language at section 1864(c) of the Act in our proposed rule and we are neither broadening nor narrowing the application of our statutory authority to conduct substantial allegation validation surveys. We note, however, that in response to similar comments we modified the definition of "substantial allegation of noncompliance" at
For wasting federal resources on substantial allegation validation surveys, we note for the record that the number of such surveys since FY 2012 has hovered around 3400, not 5,000, and that 7.4 percent have resulted in findings of substantial noncompliance. We also point out that the statutory and regulatory threshold for conducting a validation survey is not that an allegation must be accurate, but rather that if the alleged noncompliance was found to be present, it would represent substantial noncompliance. It is to be expected that a significant portion of substantial allegation surveys would not result in citations of substantial noncompliance, either because the allegation was never true, or because the provider or supplier corrected its deficient practices prior to our survey. We also note that we have been emphasizing in recent years to the states and our regional office staff that a complaint concerning a "deemed status" provider or supplier must meet the threshold of being a substantial allegation for a federal survey to be authorized. We also wish to point out that states often have broader authority to investigate complaints under their licensure authority, and that such state licensure complaint investigations are sometimes confused by providers or suppliers with federal substantial allegation validation surveys, since often the same personnel conduct both.
Comment: One commenter stated that hospitals report that it appears the numbers of citations have a direct impact on whether a validation survey is completed and that surveys not based on a representative sample cannot truly validate the AO's performance. Along these lines another commenter indicated that facilities selected by CMS for validation surveys have the least number of AO findings and that to be a truly representative sample, the validation survey site selection should not consider the number of findings on the accreditation survey, unless those findings meet the basis for a substantial allegation survey.
Response: We are puzzled as to what the commenters are referring, and their characterization of our selection process for validation surveys is inaccurate. At the time that we select providers or suppliers for inclusion in our representative sample for those validation surveys that are full surveys conducted within 60 days of the AO's accreditation survey the AO has not yet conducted its survey. Therefore, we do not and could not base our selection of the sample on an AO's findings.
Comment: A number of commenters reiterated their general criticisms of validation surveys conducted by states by stating that there is variation among the SAs in their survey findings and that state surveys should not be used as the benchmark for judging AO surveys.
Response: We addressed the substance of these criticisms in response to comments concerning
Comment: One commenter stated that validation surveys are essential to determine the adequacy of an AO's accreditation process and recommended that we require at least one validation survey annually for each year AO.
Response: Between the two different types of validation surveys under our current oversight program every AO has undergone more than one validation survey per year, with the exception of AOs that have only recently been approved for their first
Comment: One commenter proposed CMS take immediate enforcement action related to deficiencies identified in a state substantial allegation validation survey instead of directing the SA to conduct another survey. The commenter indicated that a second survey is duplicative and wastes resources, and delays enforcement action that may negatively impact the health and safety of home health patients.
Response: We generally agree that it is preferable for us to take prompt enforcement action when a validation survey identifies substantial noncompliance with
11. State Survey Agency Review: Statutory Provisions (
We proposed to revise
Comment: We received one comment from a commenter who stated that the statute requires that validation surveys fall into two categories and then quoted the exact language at section 1864(c) of the Act regarding the two types of validation surveys. The commenter called for our regulatory text to adhere more closely to the statutory language and recommended we reword the provision as follows: "Section 1864(c) of the Act authorizes the Secretary to enter into agreements with SAs for the purpose of conducting validation surveys in institutions accredited by an accreditation program recognized by the Secretary on a selective sample basis, or where the Secretary finds that a survey is appropriate because of substantial allegations of the existence of a significant deficiency or deficiencies which would, if found to be present, adversely affect the health and safety of patients."
Response: Both the existing and the proposed regulations refer to the two different types of validation surveys referred to in the Act, using the same language: "conducted on a representative sample basis, or in response to substantial allegations of noncompliance." We assume the commenter is building on comments related to proposed
12. State Survey Agency Functions (
We proposed to revise
Comment: One commenter requested that we replace the term "deemed facilities" with "deemed organizations," saying that not all health care providers operate out of a facility. This commenter also stated that the parameters for conducting validation surveys be the same as that which the commenter recommended for proposed
Response: We indicated our disagreement with the commenter's remarks concerning validation surveys in our response to the comments concerning proposed
13. Effect of Survey Agency Certification (
Currently SEC 488.12 addresses provider or supplier certification recommendations made by the SA to CMS and
14. Loss of Accredited Status (
We proposed a new provision at
15. Providers or Suppliers, Other Than SNFs and NFs, With Deficiencies (
We proposed to revise
Comment: Several commenters expressed concerns related to how immediate jeopardy is cited.
Response: These issues are addressed in section II.B.17. of this final rule in our discussion of the definition of "immediate jeopardy" at
We are also taking this opportunity to make a technical correction in this final rule, replacing the term "the Secretary" with "CMS," to be consistent with our usage throughout this rule.
16. Statutory Basis (
We proposed to revise
Likewise, we pointed out that neither the certified supplier-specific rules governing termination of their agreements, nor the current termination of provider agreement rules at
Accordingly, we proposed amending
We also proposed redesignating the current language in
We received no comments on the proposed revisions. However, we are making a technical correction in this final rule to add the definition of "immediate jeopardy" at
17. Definitions (
We stated that the current regulations at
Comment: One commenter proposed to expand the definition to include harm to staff and visitors as well as residents and patients, saying that there are hazardous environments in imaging centers with Magnetic Resonance Imaging (MRI) suites or Computed Tomography (CT) scanners.
Response: We appreciate the commenter's concerns, but believe that it would inappropriately expand the scope of federal surveys to require assessment of potential harm to staff and visitors. An immediate jeopardy must involve non-compliance with a
Comment: A number of commenters took issue with including in the definition the phrase "likely to cause" serious injury, harm, impairment of death. Most commenters indicated that they believe there is a great deal of subjectivity in the application of this definition, and that as a result there is considerable variability among states and CMS regional offices in immediate jeopardy citation practices. Some of these commenters called for removing the phrase "likely to cause" and limiting immediate jeopardy citations to those that have actually caused serious harm. Another commenter suggested substituting the phrase "more likely than not." Some commenters did not request a modification of the definition, but did ask for more specific guidance in the SOM about examples of immediate jeopardy situations.
Response: Our proposal did not introduce the phrase "likely to cause" into the definition of immediate jeopardy; rather, this is a longstanding component of the existing definition. Moreover, we believe it is entirely appropriate and necessary for patient safety to treat as immediate jeopardy situations we identify that have the potential to cause serious harm if they are not addressed immediately, regardless of whether we are able to identify any harm already caused by the situation.
The commenters who called for more guidance may not be aware of the SOM, Appendix Q, "Guidelines for Determining Immediate Jeopardy". Among the guidance contained in this document is a discussion of the three components that must all be present to cite immediate jeopardy: Potential or actual harm that is serious; immediacy; and culpability on the part of the provider or supplier. The Appendix provides a detailed, albeit not exhaustive, list of triggers that should lead surveyors to consider whether there is immediate jeopardy, as well as examples of hypothetical and real cases. We acknowledge that there is some variability in the tendency to cite immediate jeopardy, but continue to work with SAs and our Regional Office staff to achieve greater consistency. After consideration of the public comments we are in this final rule adopting this provision without change.
18. Termination by CMS (
We proposed to revise
We proposed adding language in
We proposed adding language at
Further, we proposed adding a new
Finally, we proposed a technical correction to
Comment: One commenter expressed concern that inclusion of the term "supplier" would require physicians to accept all
Response: We believe that revised
We are making a technical revision in this final rule at
III. Collection of Information Requirements
While this rule does contain information collection requirements, we believe they are exempt under 5 CFR 1320.3(c)(4). The requirements would affect less than 10 entities in a 12-month period. To date, there have only been a total of nine entities that meet the criteria necessary to become accrediting organizations with CMS-approved
IV. Regulatory Impact Statement
We have examined the impact of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999) and the Congressional Review Act (5 U.S.C. 804(2).
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This rule does not reach the economic threshold and thus is not considered a major rule.
The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $7.5 million to $38.5 million in any 1 year. Individuals and states are not included in the definition of a small entity. We are not preparing an analysis for the RFA because we have determined, and the Secretary certifies, that this rule will not have a significant economic impact on a substantial number of small entities.
In addition, section 1102(b) of the Social Security Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for
Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2014, that threshold level is currently approximately $141 million. This rule has no consequential effect on state, local, or tribal governments or on the private sector.
In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.
V. Waiver of Proposed Rulemaking
We generally publish a notice of proposed rulemaking in the Federal Register and invite public comment on the proposed rule in accordance with 5 U.S.C. 553(b) of the Administrative Procedure Act (APA). The notice of proposed rulemaking includes a reference to the legal authority under which the rule is proposed, and the terms and substances of the proposed rule or a description of the subjects and issues involved. This procedure can be waived, however, if an agency finds good cause that a notice-and-comment procedure is impracticable, unnecessary, or contrary to the public interest and incorporates a statement of the finding and its reasons in the rule issued.
This final rule includes several technical corrections that were not included in the proposed rule and for which a notice-and-comment period is unnecessary, because they are purely technical and conforming, or because they clarify possible ambiguities in the proposed rule. Specifically, we are revising:
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The changes outlined in this section are purely technical, and a period of comment is unnecessary because the changes are either purely technical and conforming, or clarify possible ambiguities in the proposed rule. We do not believe any of these changes to be substantive. We believe it would be contrary to the public interest to delay codifying the technical corrections outlined in this section, and therefore find good cause to waive the notice of proposed rulemaking for the technical revisions and corrections.
List of Subjects
42 CFR Part 401
Claims, Freedom of information, Health facilities,
42 CFR Part 488
Administrative practice and procedure, Health facilities,
42 CFR Part 489
Health facilities,
For the reasons set forth in the preamble, the
PART 401--GENERAL ADMINISTRATIVE REQUIREMENTS
1. The authority citation for part 401 continues to read as follows:
Authority: Secs. 1102, 1871, and 1874(e) of the Social Security Act (42 U.S.C. 1302, 1395hh, and 1395w-5).
2. In
3. In
PART 488--SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES
4. The authority citation for part 488 is revised to read as follows:
Authority: Secs. 1102, 1128l, 1864, 1865, 1871 and 1875 of the Social Security Act, unless otherwise noted (42 U.S.C 1302, 1320a-7j, 1395aa, 1395bb, 1395hh) and 1395ll.
5. Section 488.1 is amended by--
a. Removing the definitions of "Accredited provider or supplier" and "AOA".
b. Revising the definition of "Certification".
c. Adding the definitions of "Conditions for certification" and "Deemed status" in alphabetical order.
d. Revising the definition of "Full review".
e. Adding the definition of "Immediate jeopardy" in alphabetical order.
f. Removing the definition of "JCAHO".
g. Adding the definition of National accrediting organization" in alphabetical order.
h. Revising the definitions of "Provider of services or provider", "Reasonable assurance", "State survey agency", and "Substantial allegation of noncompliance".
i. Removing the definition of "Validation review period".
The revisions and additions read as follows:
* * * * *
Certification means a determination made by the state survey agency that providers and suppliers are in compliance with the applicable conditions of participation, conditions for coverage, conditions for certification, or requirements.
Conditions for certification means the health and safety standards RHCs must meet to participate in the
* * * * *
Deemed status means that CMS has certified a provider or supplier for
Full review means a survey of a provider or supplier for compliance with all of the
Immediate jeopardy means a situation in which the provider's or supplier's non-compliance with one or more
* * * * *
National accrediting organization means an organization that accredits provider entities, as that term is defined in section 1865(a)(4) of the Act, under a specific program and whose accredited provider entities under each program are widely located geographically across
Provider of services or provider refers to a hospital, critical access hospital, skilled nursing facility, nursing facility, home health agency, hospice, comprehensive outpatient rehabilitation facility, or a clinic, rehabilitation agency or public health agency that furnishes outpatient physical therapy or speech pathology services.
* * * * *
Reasonable assurance means that an accrediting organization has demonstrated to CMS's satisfaction that its accreditation program requirements meet or exceed the
* * * * *
State survey agency refers to the state health agency or other appropriate state or local agency CMS uses to perform survey and review functions provided for in sections 1864, 1819(g), and 1919(g) of the Act.
Substantial allegation of non-compliance means a complaint from any of a variety of sources (such as patient, relative, or third party), including complaints submitted in person, by telephone, through written correspondence, or in newspaper or magazine articles, that would, if found to be present, adversely affect the health and safety of patients or residents and raises doubts as to a provider's or supplier's compliance with any
* * * * *
6. Section 488.2 is amended by--
a. Adding the following statutory provisions in numerical order.
b. Revising the description of section 1883 of the Social Security Act.
The additions and revisions read as follows:
* * * * *
1138(b)--Requirements for organ procurement organizations and organ procurement agencies.
* * * * *
1820--Requirements for CAHs.
1832(a)(2)(C)--Requirements for Organizations that provide outpatient physical therapy and speech language pathology services.
1832(a)(2)(F)--Requirements for ASCs.
1832(a)(2)(J)--Requirements for partial hospitalization services provided by CMHCs.
1861(e)--Requirements for hospitals.
* * * * *
1861(p)(4)--Requirements for rehabilitation agencies.
* * * * *
1861(aa)--Requirements for RHCs and FQHCs.
1861(cc)(2)--Requirements for CORFs.
1861(dd)--Requirements for hospices.
* * * * *
1861(ff)(3)(A)--Requirements for CMHCs.
* * * * *
1863--Consultation with state agencies, accrediting bodies, and other organizations to develop conditions of participation, conditions for coverage, conditions for certification, and requirements for providers or suppliers.
* * * * *
1875(b)--Requirements for performance review of CMS-approved accreditation programs.
* * * * *
1881--Requirements for ESRD facilities.
1883--Requirements for hospitals that furnish extended care services.
* * * * *
7. Section 488.3 is revised to read as follows:
(a) Basic rules. To be approved for participation in, or coverage under, the
(1) Meet the applicable statutory definitions in section 1138(b), 1819, 1820, 1832(a)(2)(C), 1832(a)(2)(F), 1832(a)(2)(J), 1834(e), 1861, 1881, 1883, 1891, 1913 or 1919 of the Act.
(2) Be in compliance with the applicable conditions, certification requirements, or long term care requirements prescribed in part 405 subparts U or X, part 410 subpart E, part 416, part 418 subpart C, parts 482 through 486, part 491 subpart A, or part 494 of this chapter.
(b) Special conditions. The Secretary shall consult with state agencies and national AOs, as applicable, to develop CoP, CfC, conditions for certification and long term care requirements.
(1) The Secretary may, at a state's request, approve health and safety requirements for providers or suppliers in the state that exceed
(2) If a state or political subdivision imposes requirements on institutions (that exceed the
8. Section 488.4 is revised to read as follows:
(a) The following requirements apply when a national accrediting organization has applied for CMS approval of a provider or supplier accreditation program and CMS has found that the program provides reasonable assurance for providers or suppliers accredited under the program:
(1) When a provider or supplier demonstrates full compliance with all of the accreditation program requirements of the accrediting organization's CMS-approved accreditation program, the accrediting organization may recommend that CMS grant deemed status to the provider or supplier.
(2) CMS may deem the provider or supplier, excluding kidney transplant centers within a hospital and ESRD facilities, to be in compliance with the applicable
(b) [Reserved]
9. Section 488.5 is revised to read as follows:
(a) Information submitted with application. A national accrediting organization applying to CMS for approval or re-approval of an accreditation program under
(1) Documentation that demonstrates the organization meets the definition of a "national accrediting organization" under
(2) The type of provider or supplier accreditation program for which the organization is requesting approval or re-approval.
(3) A detailed crosswalk (in table format) that identifies, for each of the applicable
(4) A detailed description of the organization's survey process to confirm that a provider or supplier meets or exceeds the
(i) Frequency of surveys performed and an agreement by the organization to re-survey every accredited provider or supplier, through unannounced surveys, no later than 36 months after the prior accreditation effective date, including an explanation of how the accrediting organization will maintain the schedule it proposes. If there is a statutorily-mandated survey interval of less than 36 months, the organization must indicate how it will adhere to the statutory schedule.
(ii) Documentation demonstrating the comparability of the organization's survey process and surveyor guidance to those required for state survey agencies conducting federal
(iii) Copies of the organization's survey forms, guidelines, and instructions to surveyors.
(iv) Documentation demonstrating that the organization's survey reports identify, for each finding of non-compliance with accreditation standards, the comparable Medicare CoP, CfC, conditions for certification, or requirements.
(v) Description of the organization's accreditation survey review process.
(vi) Description of the organization's procedures and timelines for notifying surveyed facilities of non-compliance with the accreditation program's standards.
(vii) Description of the organization's procedures and timelines for monitoring the provider's or supplier's correction of identified non-compliance with the accreditation program's standards.
(viii) A statement acknowledging that, as a condition for CMS approval of a national accrediting organization's accreditation program, the organization agrees to provide CMS with information extracted from each accreditation survey for a specified provider or supplier as part of its data submissions required under paragraph (a)(11)(ii) of this section, a copy of all survey reports and related information for applicants seeking initial participation in
(ix) A statement acknowledging that the accrediting organization will provide timely notification to CMS when an accreditation survey or complaint investigation identifies an immediate jeopardy as that term is defined at
(5) The criteria for determining the size and composition of the organization's survey teams for the type of provider or supplier to be accredited, including variations in team size and composition for individual provider or supplier surveys.
(6) The overall adequacy of the number of the organization's surveyors, including how the organization will increase the size of the survey staff to match growth in the number of accredited facilities while maintaining re-accreditation intervals for existing accredited facilities.
(7) A description of the education and experience requirements surveyors must meet.
(8) A description of the content and frequency of the organization's in-service training it provides to survey personnel.
(9) A description of the organization's evaluation systems used to monitor the performance of individual surveyors and survey teams.
(10) The organization's policies and procedures to avoid conflicts of interest, including the appearance of conflicts of interest, involving individuals who conduct surveys or participate in accreditation decisions.
(11) A description of the organization's data management and analysis system for its surveys and accreditation decisions, including all of the following:
(i) A detailed description of how the organization uses its data to assure the compliance of its accreditation program with the
(ii) A statement acknowledging that the organization agrees to submit timely, accurate, and complete data to support CMS's evaluation of the accrediting organization's performance. Data to be submitted includes, but is not limited to, accredited provider or supplier identifying information, survey schedules, survey findings, and notices of accreditation decisions. The organization must submit necessary data according to the instructions and timeframes CMS specifies.
(12) The organization's procedures for responding to, and investigating, complaints against accredited facilities, including policies and procedures regarding referrals when applicable to appropriate licensing bodies and ombudsman programs.
(13) The organization's accreditation status decision-making process, including its policies and procedures for granting, withholding, or removing accreditation status for facilities that fail to meet the accrediting organization's standards or requirements, assignment of less than full accreditation status or other actions taken by the organization in response to non-compliance with its standards and requirements. The organization must furnish the following:
(i) A description of all types and categories of accreditation decisions associated with the program for which approval is sought, including the duration of each.
(ii) A statement acknowledging that the organization agrees to notify CMS (in a manner CMS specifies) of any decision to revoke, withdraw, or revise the accreditation status of a specific deemed status provider or supplier, within three business days from the date the organization takes an action.
(14) A list of all facilities currently accredited by the organization under the program for which CMS approval is sought, including the type and category of accreditation currently held by each provider or supplier, and the expiration date of each provider's or supplier's current accreditation.
(15) A schedule of all surveys expected to be conducted by the organization for the accreditation program under review during the 6-month period following submission of the application.
(16) The three most recent audited financial statements of the organization that demonstrate that the organization's staffing, funding, and other resources are adequate to perform the required surveys and related activities.
(17) A statement that it will:
(i) Provide written notification to CMS and to all providers or suppliers accredited under a CMS-approved accreditation program at least 90 calendar days in advance of the effective date of a decision by the organization to voluntarily terminate its CMS-approved accreditation program, including the implications for their deemed status in accordance with
(ii) Adhere to the requirements for written notice to its accredited providers or suppliers at
(18) A statement that it will provide written notification to CMS of any proposed changes in the organization's CMS-approved accreditation program and that it agrees not to implement the proposed changes without prior written notice of continued program approval from CMS except as provided for at
(19) A statement that, in response to a written notice from CMS to the organization of a change in the applicable conditions or requirements or in the survey process, the organization will provide CMS with proposed corresponding changes in the organization's requirements for its CMS-approved accreditation program to ensure continued comparability with the CMS conditions or requirements or survey process. The organization must comply with the following requirements:
(i) The proposed changes must be submitted within 30 calendar days of the date of the written CMS notice to the organization or by a date specified in the notice, whichever is later. CMS will give due consideration to an organization's request for an extension of the deadline.
(ii) The proposed changes will not be implemented without prior written notice of continued program approval from CMS, except as provided for at
(20) A statement acknowledging that, as a condition for CMS's approval of an accreditation program, the organization will agree to permit its surveyors to serve as witnesses in a legal proceeding if CMS takes an adverse action against a provider or supplier on the basis of the organization's accreditation survey findings, and will cooperate with CMS to make surveyors and other staff available when needed.
(b) Additional information needed. If CMS determines that additional information is necessary to make a determination for approval or denial of the organization's initial application or re-application for CMS's approval of an accreditation program, CMS will notify the organization and afford it an opportunity to provide the additional information.
(c)(1) Withdrawing an application. An accrediting organization may withdraw its initial application for CMS's-approval of its accreditation program at any time before CMS publishes the final notice described in paragraph (e)(2) of this section.
(2) Voluntary termination of a CMS-approved accreditation program. An accrediting organization may voluntarily terminate its CMS-approved accreditation program at any time. The accrediting organization must notify CMS of its decision to voluntarily terminate its approved accreditation program at least 90 calendar days in advance of the effective date of the termination. In accordance with the requirement at
(d) Re-submitting a request. (1) Except as provided in paragraph (d)(2) of this section, an organization whose request for CMS's approval or re-approval of an accreditation program has been denied may resubmit its application if the organization satisfies all of the following requirements:
(i) Revises its accreditation program to address the issues related to the denial of its previous request.
(ii) Demonstrates that it can provide reasonable assurance.
(iii) Resubmits the application in its entirety.
(2) If an accrediting organization has requested, in accordance with subpart D of this part, a reconsideration of CMS's determination that its request for approval of an accreditation program is denied, it may not submit a new application for approval of an accreditation program for the type of provider or supplier at issue in the reconsideration until the reconsideration is administratively final.
(e) Federal Register when the following conditions are met:
(1) Proposed notice. When CMS receives a complete application from a national accrediting organization seeking CMS's approval of an accreditation program, it publishes a proposed notice. The proposed notice identifies the organization and the type of providers or suppliers to be covered by the accreditation program and provides 30 calendar days for the public to submit comments to CMS.
(2) Final notice. When CMS decides to approve or disapprove a national accrediting organization's application, it publishes a final notice within 210 calendar days from the date CMS determines the AO's applications was complete, unless the application was for a skilled nursing facility accreditation program. There is no timeframe for publication of a final notice for a national accrediting organization's application for approval of a skilled nursing facility accreditation program. The final notice specifies the basis for the CMS decision.
(i) Approval or re-approval. If CMS approves or re-approves the accrediting organization's accreditation program, the final notices describes how the accreditation program provides reasonable assurance. The final notice specifies the effective date and term of the approval (which may not be later than the publication date of the notice and which will not exceed 6 years.
(ii) Disapproval. If CMS does not approve the accrediting organization's accreditation program, the final notice describes, except in the case of a skilled nursing facility accreditation program, how the organization fails to provide reasonable assurance. In the case of an application for a skilled nursing facility accreditation program, disapproval may be based on the program's failure to provide reasonable assurance, or on CMS's decision to exercise its discretion in accordance with section 1865(a)(1)(B) of the Act. The final notice specifies the effective date of the decision.
10. Section 488.6 is revised to read as follows:
A provider or supplier that has been granted "deemed status" by CMS by virtue of its accreditation from a CMS-approved accreditation program is eligible to participate in the
11. Section 488.9 is removed.
12. Section 488.7 is redesignated as new
13. New
A Medicare participating provider or supplier deemed to meet program requirements in accordance with
(a) CMS may determine that a provider or supplier does not meet the applicable
(b) With the exception of home health agency surveys, general disclosure of an accrediting organization's survey information is prohibited under section 1865(b) of the Act. CMS may publically disclose an accreditation survey and information related to the survey, upon written request, to the extent that the accreditation survey and survey information are related to an enforcement action taken by CMS.
14. Section 488.8 is revised to read as follows:
(a) Performance review. In accordance with section 1875(b) of the Act, CMS evaluates the performance of each CMS-approved accreditation program on an ongoing basis. This review includes, but is not limited to the following:
(1) Review of the organization's survey activity.
(2) Analysis of the results of the validation surveys under
(3) Review of the organization's continued fulfillment of the requirements in
(b) Comparability review. CMS assesses the equivalency of an accrediting organization's CMS-approved program requirements to the comparable
(1) CMS imposes new
(i) CMS provides written notice of the changes to the affected accrediting organization.
(ii) CMS specifies in its written notice a timeframe, not less than 30 calendar days from the date of the notice, for the accrediting organization to submit its proposed equivalent changes, including its implementation timeframe, for CMS review. CMS may extend the deadline after due consideration of a written request for extension by the accrediting organization, submitted prior to the original deadline.
(iii) After completing the comparability review CMS provides written notification to the organization whether or not the accreditation program, including the proposed revisions and implementation timeframe, continues to meet or exceed all applicable
(iv) If, no later than 60 calendar days after receipt of the organization's proposed changes, CMS does not provide the written notice to the organization required in paragraph (b)(1)(iii) of this section, then the revised program will be deemed to meet or exceed all applicable
(v) If an organization fails to submit its proposed changes within the required timeframe, or fails to implement the proposed changes that have been determined by CMS or deemed to be comparable, CMS may open an accreditation program review in accordance with paragraph (c) of this section.
(2) An accrediting organization proposes to adopt new requirements or to change its survey process.
(i) An accrediting organization must provide written notice to CMS of any proposed changes in its accreditation requirements or survey process and must not implement any changes before receiving CMS's approval, except as provided below.
(ii) If, no later than 60 calendar days after receipt of the organization's proposed changes, CMS does not provide written notice to the organization that the accreditation program, including the proposed revisions, continues or does not continue to meet or exceed all applicable
(iii) If an organization implements changes that have neither been determined by CMS nor deemed to be comparable to the applicable
(c) CMS-approved accreditation program review. If a comparability or performance review reveals evidence of substantial non-compliance of an accrediting organization's CMS-approved accreditation program with the requirements of this subpart, CMS may initiate an accreditation program review.
(1) If an accreditation program review is initiated, CMS provides written notice to the organization indicating that its CMS-approved accreditation program approval may be in jeopardy and that an accreditation program review is being initiated. The notice provides all of the following information:
(i) A statement of the instances, rates or patterns of non-compliance identified, as well as other related information, if applicable.
(ii) A description of the process to be followed during the review, including a description of the opportunities for the accrediting organization to offer factual information related to CMS's findings.
(iii) A description of the possible actions that may be imposed by CMS based on the findings of the accreditation program review.
(iv) The actions the accrediting organization must take to address the identified deficiencies including a timeline for implementation not to exceed 180 calendar days after receipt of the notice that CMS is initiating an accreditation program review.
(2) CMS reviews the accrediting organization's plan of correction for acceptability.
(3) If CMS determines as a result of the accreditation program review or a review of an application for renewal of an existing CMS-approved accreditation program that the accrediting organization has failed to meet any of the requirements of this subpart, CMS may place the accrediting organization's CMS-approved accreditation program on probation for a period up to 180 calendar days to implement corrective actions, not to exceed the accrediting organization's current term of approval. In the case of a renewal application where CMS has placed the accreditation program on probation, CMS indicates that any approval of the application is conditional while the program is placed on probation.
(i) Within 60 calendar days after the end of any probationary period, CMS issues a written determination to the accrediting organization as to whether or not a CMS-approved accreditation program continues to meet the requirements of this subpart, including the reasons for the determination.
(ii) If CMS has determined that the accrediting organization does not meet the requirements, CMS withdraws approval of the CMS-approved accreditation program. The notice of determination provided to the accrediting organization includes notice of the removal of approval, reason for the removal, including the effective date determined in accordance with paragraph (c)(3)(iii) of this section.
(iii) CMS publishes in the Federal Register a notice of its decision to withdraw approval of a CMS-approved accreditation program, including the reasons for the withdrawal, effective 60 calendar days from the date of publication of the notice.
(d) Immediate jeopardy. If at any time CMS determines that the continued approval of a CMS-approved accreditation program of any accrediting organization poses an immediate jeopardy to the patients of the entities accredited under that program, or the continued approval otherwise constitutes a significant hazard to the public health, CMS may immediately withdraw the approval of a CMS-approved accreditation program of that accrediting organization and publish a notice of the removal, including the reasons for it, in the Federal Register .
(e) Notification of providers or suppliers. An accrediting organization whose CMS approval of its accreditation program has been withdrawn must notify, in writing, each of its accredited providers or suppliers of the withdrawal of CMS approval and the implications in accordance with paragraph (g)(1) of this section for the providers' or suppliers' deemed status no later than 30 calendar days after the notice is published in the Federal Register .
(f) Request for reconsideration. Any accrediting organization dissatisfied with a determination to withdraw CMS approval of its accreditation program may request a reconsideration of that determination in accordance with subpart D of this part.
(g) Continuation of deemed status. (1) Involuntary termination. After CMS removes approval of an accrediting organization's accreditation program, an affected provider's or supplier's deemed status continues in effect for 180 calendar days after the removal of the approval if the provider or supplier submits an application to another CMS-approved accreditation program within 60 calendar days from the date of publication of the removal notice in the Federal Register . The provider or supplier must also provide written notice to the SA that it has submitted an application for accreditation under another CMS-approved accreditation program within this same 60-calendar day timeframe. Failure to comply with the timeframe requirements specified in this section will place the provider or supplier under the SAs authority for continued participation in Medicare and on-going monitoring.
(2) Voluntary termination by accrediting organization. When an accrediting organization has voluntarily terminated its CMS-approved accreditation program and provides its accredited providers and suppliers the notice required at SEC 488.5(a)(17), an affected provider's or supplier's deemed status continues in effect for 180 calendar days after the termination effective date if the provider or supplier submits an application to another CMS-approved accreditation program within 60 calendar days from the date of the notice from the accrediting organization. The provider or supplier must also provide written notice to the SA that it has submitted an application for accreditation under another CMS-approved accreditation program within this same 60-calendar day timeframe. Failure to comply with the timeframe requirements specified in this section will place the provider or supplier under the SAs authority for continued participation in Medicare and on-going monitoring.
(h) Onsite observations of accrediting organization operations. As part of the application review process, the ongoing review process, or the continuing oversight of an accrediting organization's performance, CMS may conduct at any time an onsite inspection of the accrediting organization's operations and offices to verify the organization's representations and to assess the organization's compliance with its own policies and procedures. The onsite inspection may include, but is not limited to, the review of documents, auditing meetings concerning the accreditation process, observation of surveys, the evaluation of survey results or the accreditation decision-making process, and interviews with the organization's staff.
15. Newly designated SEC 488.9 is revised to read as follows:
SEC 488.9 Validation surveys.
(a) Basis for survey. CMS may require a survey of an accredited provider or supplier to validate the accrediting organization's CMS-approved accreditation process. These surveys are conducted on a representative sample basis, or in response to substantial allegations of non-compliance.
(1) For a representative sample, the survey may be comprehensive and address all Medicare conditions or requirements, or it may be focused on a specific condition(s) as determined by CMS.
(2) For a substantial allegation of noncompliance, the SA surveys for any condition(s) or requirement(s) that CMS determines is related to the allegations.
(b) Selection for survey. (1) A provider or supplier selected for a validation survey must cooperate with the SA that performs the validation survey.
(2) If a provider or supplier selected for a validation survey fails to cooperate with the SA, it will no longer be deemed to meet the Medicare conditions or requirements, but will be subject to a review by the SA in accordance with SEC 488.10(a), and may be subject to termination of its provider agreement under SEC 489.53 of this chapter.
(c) Consequences of a finding of non-compliance. (1) If a CMS validation survey results in a finding that the provider or supplier is out of compliance with one or more Medicare conditions or requirements, the provider or supplier will no longer be deemed to meet the Medicare conditions or requirements and will be subject to ongoing review by the SA in accordance with SEC 488.10(a) until the provider or supplier demonstrates compliance.
(2) CMS may take actions for the deficiencies identified in the state validation survey in accordance with SEC 488.24, or may first direct the SA to conduct another survey of the provider's or supplier's compliance with specified Medicare conditions or requirements before taking the enforcement actions provided for at SEC 488.24.
(3) If CMS determines that a provider or supplier is not in compliance with applicable Medicare conditions or requirements, the provider or supplier may be subject to termination of the provider or supplier agreement under SEC 489.53 of this chapter or of the supplier agreement in accordance with the applicable supplier conditions and any other applicable intermediate sanctions and remedies.
(d) Re-instating deemed status. An accredited provider or supplier will be deemed to meet the applicable Medicare conditions or requirements in accordance with this section if all of the following requirements are met:
(1) It withdraws any prior refusal to authorize its accrediting organization to release a copy of the provider's or supplier's current accreditation survey.
(2) It withdraws any prior refusal to allow a validation survey, if applicable.
(3) CMS finds that the provider or supplier meets all applicable Medicare CoP, CfC, conditions of certification, or requirements.
(e) Impact of adverse actions. The existence of any performance review, comparability review, deemed status review, probationary period, or any other action by CMS, does not affect or limit conducting any validation survey.
16. Section 488.10 is amended by revising paragraphs (b) through (d) to read as follows:
SEC 488.10 State survey agency review: Statutory provisions.
* * * * *
(b) Section 1865(a) of the Act provides that if an institution is accredited by a national accrediting organization recognized by the Secretary, it may be deemed to have met the applicable conditions or requirements.
(c) Section 1864(c) of the Act authorizes the Secretary to enter into agreements with state survey agencies for the purpose of conducting validation surveys in institutions accredited by an accreditation program recognized by the Secretary.
(d) Section 1865(c) provides that an accredited institution that is found after a validation survey to have significant deficiencies related to health and safety of patients will no longer meet the applicable conditions or requirements.
17. Section 488.11 is amended by revising paragraph (b) to read as follows:
SEC 488.11 State survey agency functions.
* * * * *
(b) Conduct validation surveys of deemed status providers and suppliers as provided in SEC 488.9.
* * * * *
18. Section 488.12 is amended by revising paragraph (a)(2) to read as follows:
SEC 488.12 Effect of survey agency certification.
* * * * *
(a) * * *
(2) A provider or supplier accredited under a CMS-approved accreditation program remains deemed to meet the Medicare conditions or requirements, or will be placed under the jurisdiction of the SA and subject to further enforcement actions in accordance with the provisions at SEC 488.9.
* * * * *
19. Section 488.13 is added to read as follows:
SEC 488.13 Loss of accreditation.
If an accrediting organization notifies CMS that it is terminating a provider or supplier due to non-compliance with its CMS-approved accreditation requirements, the SA will conduct a full review in a timely manner.
20. Section 488.28 is amended by revising paragraph (a) to read as follows:
SEC 488.28 Providers or suppliers, other than SNFs and NFs, with deficiencies.
(a) If a provider or supplier is found to be deficient in one or more of the standards in the conditions of participation, conditions for coverage, or conditions for certification or requirements, it may participate in, or be covered under, the Medicare program only if the provider or supplier has submitted an acceptable plan of correction for achieving compliance within a reasonable period of time acceptable to CMS. In the case of an immediate jeopardy situation, CMS may require a shorter time period for achieving compliance.
* * * * *
PART 489--PROVIDER AGREEMENTS AND SUPPLIER APPROVAL
21. The authority citation for part 489 is revised to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
22. Section 489.1 is amended by revising paragraph (b) to read as follows:
SEC 489.1 Statutory basis.
* * * * *
(b) Although section 1866 of the Act speaks only to providers and provider agreements, the following rules in this part also apply to the approval of supplier entities that, for participation in Medicare, are subject to a determination by CMS on the basis of a survey conducted by the SA or CMS surveyors; or, in lieu of an SA or CMS-conducted survey, accreditation by an accrediting organization whose program has CMS approval in accordance with the requirements of part 488 of this chapter at the time of the accreditation survey and accreditation decision, in accordance with the following:
(1) The definition of immediate jeopardy at SEC 489.3.
(2) The effective date rules specified in SEC 489.13.
(3) The requirements specified in SEC 489.53(a)(2), (13), and (18), related to termination by CMS of participation in Medicare.
* * * * *
23. Section 489.3 is amended by revising the definition of "Immediate jeopardy" to read as follows:
SEC 489.3 Definitions.
* * * * *
Immediate jeopardy means a situation in which the provider's or supplier's non-compliance with one or more requirements, conditions of participation, conditions for coverage, or conditions for certification has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident or patient.
* * * * *
24. Section 489.53 is amended by revising paragraphs (a) introductory text, (a)(2), (a)(13), and (d)(2)(i) introductory text and adding a new paragraph (a)(18) to read as follows:
SEC 489.53 Termination by CMS.
(a) Basis for termination of agreement. CMS may terminate the agreement with any provider if CMS finds that any of the following failings is attributable to that provider, and may, in addition to the applicable requirements in this chapter governing the termination of agreements with suppliers, terminate the agreement with any supplier to which the failings in paragraphs (a)(2), (13) and (18) of this section are attributable:
* * * * *
(2) The provider or supplier places restrictions on the persons it will accept for treatment and it fails either to exempt Medicare beneficiaries from those restrictions or to apply them to Medicare beneficiaries the same as to all other persons seeking care.
* * * * *
(13) The provider or supplier refuses to permit copying of any records or other information by, or on behalf of, CMS, as necessary to determine or verify compliance with participation requirements.
* * * * *
(18) The provider or supplier fails to grant immediate access upon a reasonable request to a state survey agency or other authorized entity for the purpose of determining, in accordance with SEC 488.3, whether the provider or supplier meets the applicable requirements, conditions of participation, conditions for coverage, or conditions for certification.
* * * * *
(d) * * *
(2) * * *
(i) Hospitals. If CMS finds that a hospital is in violation of SEC 489.24(a) through (f), and CMS determines that the violation poses immediate jeopardy to the health or safety of individuals who present themselves to the hospital for emergency services, CMS--
* * * * *
Dated: March 18, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
Dated: May 12, 2015.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2015-12087 Filed 5-21-15; 8:45 am]
BILLING CODE 4120-01-P
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