Source: https://www.federalregister.gov/documents/2007/10/31/07-5400/revisit-user-fee-program-for-medicare-survey-and-certification-activities
Timestamp: 2018-08-18 07:08:22
Document Index: 282314590

Matched Legal Cases: ['art 488', '§\u2009101', '§\u2009101', 'art 488', 'art 488', '§\u2009101']

Federal Register :: Revisit User Fee Program for Medicare Survey and Certification Activities
Revisit User Fee Program for Medicare Survey and Certification Activities
A Rule by the Centers for Medicare & Medicaid Services on 10/31/2007
72 FR 61540
61540-61545 (6 pages)
CMS-2278-IFC
0938-AP22
07-5400
B. Impact on Providers/Suppliers
Final Fee Schedule for Onsite and Offsite Revisit Surveys
Costs for All Revisit User Fees Assessed
List of Subjects in 42 CFR Part 488
https://www.federalregister.gov/d/07-5400 https://www.federalregister.gov/d/07-5400
This interim final rule with comment period implements the continuation of the revisit user fee program for Medicare Survey and Certification activities, in accordance with the statutory authority in the Continuing Appropriations Resolution (“Continuing Resolution”) budget legislation passed by the Congress and signed by the President on September 29, 2007. On September 19, 2007, we published a final rule that established a system of revisit user fees applicable to health care facilities that have been cited for deficiencies during initial certification, recertification or substantiated complaint surveys and require a revisit to confirm that Start Printed Page 61541corrections to previously-identified deficiencies have been corrected.
Effective date: These regulations are effective October 1, 2007.
Comment date: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on December 31, 2007.
In commenting, please refer to file code CMS-2278-IFC. Because of staff and resource limitations, we cannot accept comments by facsimile (Fax) transmission.
2. By regular mail. You may mail written comments (one original and two copies) to the following address only: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-2278-IFC, P.O. Box 8010, Baltimore, MD 21244-8016.
3. By express or overnight mail. You may send written comments (one original and two copies) to the following address only: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-2278-IFC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
Kathryn Linstromberg, (410) 786-8279.
Submitting Comments: As the public was provided an opportunity to comment on the substance of the rule during the comment period prior to the publication of the September 19, 2007 final rule, and as the substance of the rule is not changed by this interim final rule with comment period, we are accepting comments only to the extent that they pertain to the applicability of the new authority for the rule. You can assist us by referencing the file code CMS-2278-IFC.
Comments received timely will be also available for public inspection as they are received, generally beginning approximately three weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.
In the June 29, 2007 Federal Register (72 FR 35673), we published the proposed rule entitled, “Establishment of Revisit User Fee Program for Medicare Survey and Certification Activities” and provided for a 60-day comment period. In the September 19, 2007 Federal Register (72 FR 53628) we published the Revisit User Fee Program final rule. That final rule set forth final requirements and a final fee schedule for providers and suppliers who require a revisit survey as a result of deficiencies cited during an initial certification, recertification, or substantiated complaint survey.
The Centers for Medicare & Medicaid Services (CMS) has in place an outcome-oriented survey process that is designed to determine whether existing Medicare-certified providers and suppliers or providers and suppliers seeking initial Medicare certification are actually meeting statutory and regulatory requirements, conditions of participation, or conditions for coverage. These health and safety requirements apply to the environments of care and the delivery of services to residents or patients served by these facilities and agencies. The Secretary of the Department of Health and Human Services (HHS) has designated CMS to enforce the conditions of participation/coverage and other requirements of the Medicare program. The revisit user fee will be assessed for revisits conducted in order to determine whether deficiencies cited as a result of failing to satisfy federal quality of care requirements have been corrected.
Pursuant to the requirements of the Continuing Appropriations Resolution budget bill for fiscal year (FY) 2007, which was passed by the Congress and signed by the President, we were directed by the Secretary to implement the revisit user fees for FY 2007 for certain providers and suppliers for which a revisit was required to confirm that previously-identified failures to meet federal quality of care requirements had been remedied. The fees recover the costs associated with the Medicare Survey and Certification program's revisit surveys. The primary purpose for implementing the revisit user fees is to ensure the continuance of CMS Survey and Certification quality assurance functions that improve patient care and safety. The fees became effective upon publication September 19, 2007, when the final rule was published.
The current Continuing Resolution (Pub. L. 110-92, H. J. Res. 52 §§ 101 & 106(2007)) authorizes HHS to continue the revisit user fees until November 16, 2007, as follows:
Sec. 101. Such amounts as may be necessary, at a rate for operations as provided in the applicable appropriations Acts for fiscal year 2007 and under the authority and conditions provided in such Acts, for continuing projects or activities (including the costs of direct loans and loan guarantees) that are not otherwise specifically provided for in this joint resolution, that were Start Printed Page 61542conducted in fiscal year 2007, and for which appropriations, funds, or other authority were made available in the following appropriations Acts:
(3) The Continuing Appropriations Resolution, 2007 (division B of Public Law 109-289, as amended by Pub. L. 110-5). (H.J. Res. 20, § 101(2007)).
Sec. 106. Unless otherwise provided for in this joint resolution or in the applicable appropriations Act for fiscal year 2008, appropriations and funds made available and authority granted pursuant to this joint resolution shall be available until whichever of the following first occurs:
As directed by the Secretary, in the September 19, 2007 Federal Register (72 FR 53628), we established revisit user fees for revisit surveys and put forth in regulation the definitions, criteria for determining the fee, the fee schedule, collection of fees, reconsideration process for revisit user fees, enforcement and regulatory language addressing enrollment and billing privileges, and provider agreements. In the September 19, 2007 final rule, cost projections were based on FY 2006 actual data and were expected to amount to $37.3 million on an annual basis for FY 2007. These calculations were included in section IV of the final rule (72 FR 53642).
We stated in the final rule that, “if authority for the revisit user fee is continued, we will use the current fee schedule in [the final rule] for the assessment of such fees until such time as a new fee schedule notice is proposed and published in final form.” (72 FR 53628). The current Continuing Resolution continues the authority of the FY 2007 Continuing Resolution from October 1, 2007 through November 16, 2007. Accordingly, the revisit fees will continue to be assessed for the entire time period authorized by the current Continuing Resolution.
We ordinarily 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. section 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. We find that the notice-and-comment procedure is unnecessary in this circumstance because providers and suppliers have already been provided notice and an opportunity to comment on the substance of this rule. This interim final rule with comment merely updates the Congressional authority under which the rule operates.
We ordinarily provide a 30-day delay in the effective date of the provisions of a rule in accordance with the Administrative Procedure Act (APA) 5 U.S.C. 553(d). However, the delay in the effective date may be waived as, in pertinent part, “provided by the agency for good cause found and published with the rule” 5 U.S.C. 553(d)(3). The Secretary finds that good cause exists to waive the 30-day effective date delay.
The good cause exception to the 30 day effective date delay provision of section 553(d) of the APA is read to be broader than the good cause exception to the notice and comment provision of section 553(b)of the APA.
The legislative history of the APA indicates that the purpose for deferring the effectiveness of a rule under section 553(d) was to “afford persons affected a reasonable time to prepare for the effective date of a rule or rules or to take other action which the issuance may prompt.” S. Rep. No. 752, 79th Cong., 1st Sess. 15 (1946); H.R. Rep. No. 1980, 79th Cong. 2d Sess. 25 (1946). In this case, affected parties do not need time to adjust their behavior before this rule takes effect. This rule merely updates the authority under which the revisit fee is assessed and does not provide any additional requirements for the affected parties. Moreover, with or without a revisit fee, a provider or supplier must be found to have corrected significant deficiencies in order to avoid termination. Additionally, the application of a fee for the revisit does not place appreciable administrative burdens on the affected providers or suppliers. We do not expect appreciable cost to State survey agencies because we are undertaking the billing and collection of the revisit user fee.
We identified in the proposed rule the immediacy of this revisit user fee program and the limited nature of FY 2007, Continuing Resolution Appropriation (Pub. L. 110-5). Specifically, the Continuing Resolution required us to implement the revisit fee program in FY 2007. Accordingly, providers and suppliers have been on notice for some time that these fees will be imposed, and do not need additional time to be prepared to comply with the requirements of this regulation. We believe that given the short timeframe that we have to collect fees before the statutory authority of the current Continuing Resolution expires, there is good cause to waive the 30-day effective date.
We have examined the impacts of this rule as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
Executive Order 12866 (as amended by Executive Order 13258, which merely reassigns responsibility of duties) directs 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 one year). This rule is not a major rule. The aggregate costs will total approximately $37.3 million in any one year.
The RFA requires agencies to analyze options for regulatory relief of small businesses. For purposes of the RFA, Start Printed Page 61543small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Individuals and States are not included in the definition of a small entity. Small businesses are small entities, either by nonprofit status or by having revenues of $6.5 million to $31.9 million or less in any one year for purposes of the RFA. The September 19, 2007 final rule provided an analysis on the impact of small entities (72 FR 53642-3). The analysis published in the final rule remains valid. Since this interim final rule with comment merely updates the Congressional authority under which the rule operates, we have determined, and the Secretary certifies, that this rule will not have a significant impact on small entities based on the overall effect on revenues.
Section 1102(b) of the 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 (superseded by Core Based Statistical Areas) and has fewer than 100 beds. This rule affects those small rural hospitals that have been cited for a deficiency based on noncompliance with required conditions of participation and for which a revisit is needed to make sure that the deficiency has been corrected. We identified in the September 19, 2007 final rule that for the effective period of that rule that less than 3 percent of all hospitals may be assessed a revisit user fee and that less than 1 percent of those hospitals would be rural hospitals (72 FR 53643). The analysis published in the final rule remains valid. Since this interim final rule with comment merely updates the Congressional authority under which the rule operates, we maintain that given the effective period of this rule, we have determined, and the Secretary certifies, that this rule will not have a significant impact on small rural hospitals.
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 one year of $100 million in 1995 dollars, updated annually for inflation. That threshold level is currently approximately $120 million. This interim final rule with comment will have no mandated effect on State, local, or tribal governments and the impact on the private sector is estimated to be less than $120 million and will only affect those Medicare providers or suppliers for which a revisit user fee is assessed based on the need to conduct a revisit survey to ensure deficient practices that were cited have been corrected.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. This interim final rule with comment will not substantially affect State or local governments. This rule establishes user fees for providers and suppliers for which CMS has identified deficient practices and requires a revisit to assure that corrections have been made. Therefore, we have determined that this interim final rule with comment will not have a significant effect on the rights, roles, and responsibilities of State or local governments.
There is no change on the impact on providers and suppliers with the publication of this interim final rule with comment. The impact remains as discussed in the final rule (72 FR 53643).
The FY 2007 fee schedule published on September 19, 2007 (72 FR 53647) in the final rule will be retained. As noted in the final rule, the published fee schedule will be utilized by CMS for the assessment of such fees until such time as a new fee schedule notice is proposed and published in final form. The calculations utilized to determine the fee as identified in the final rule will be the same (72 FR 53645-6). We will continue to assess a flat fee based on provider or supplier type and type of revisit survey conducted. Table A below identifies the final fee schedule.
Table A.—Final Fee Schedule
Fee assessed per offsite revisit survey
Fee assessed per onsite revisit survey
SNF & NF $168 $2,072
Hospitals 168 2,554
HHA 168 1,613
Hospice 168 1,736
ASC 168 1,669
RHC 168 851
ESRD 168 1,490
We anticipated that the combined costs for all providers and suppliers for all revisit surveys in FY 2007 would total approximately $37.3 million on an annual basis, with onsite revisit surveys amounting to approximately $34.6 million and offsite revisit surveys totaling approximately $2.7 million (72 FR 53645). However, actual fees assessed in FY 2007 were much less than this annual amount, since CMS did not charge for revisits that occurred prior to publication of the final regulation. Since we continue to operate under these same annual estimates, we provide here estimates of the impact for the period of the current continuing resolution as listed below in monthly estimates in Tables B and C. For the period of the current continuing resolution, we will use the FY 2007 fee schedule established in the final rule for the assessment of fees until a new fee schedule notice is proposed and published as final.
In Table B below, we provide the projected costs for the period of this continuing resolution based on the fee schedule of the final rule. We expect the combined costs for all providers and suppliers for all onsite revisit surveys for the period of this continuing resolution to total approximately $4.3 million. We first multiplied the total number of onsite revisit surveys in one year by the expected revisit user fees assessed per revisits as finalized in Table A above, estimated by provider or supplier, to obtain the annual cost of revisit surveys. We then divided this number by 12 to obtain the monthly cost of onsite revisit surveys and multiplied by the effective period of the continuing resolution (roughly 1.5 months) to obtain the total costs for onsite revisit surveys for the period of the continuing resolution. We then totaled all providers and suppliers to achieve the total costs for all onsite revisit surveys for the period of this continuing resolution. Start Printed Page 61544
Table B.—Onsite Revisit Surveys—Estimated Monthly Costs
Monthly number of onsite revisit surveys
Fee assessed per onsite revisit surveys (hrs × $112)
Monthly costs for onsite revisit surveys*
Total costs for onsite revisit surveys for period of CR **
SNF & NF 1,191 $2,072 $2,467,061 $3,700,592
Hospitals 48 2,554 122,379 183,569
HHA 89 1,613 143,557 215,336
Hospice 21 1,736 37,035 55,552
ASC 8 1,669 13,213 19,819
RHC 12 851 10,567 15,850
ESRD 58 1,490 86,668 130,003
Total 1,427 2,880,480 4,320,721
* Monthly costs may differ from the multiple of monthly revisits and fee per revisit due to rounding.
** Monthly costs were multiplied by the effective period of the CR (roughly 1.5 months) Total numbers of onsite revisit surveys were rounded up based on FY 2006 actual data presented in the final rule.
We expect the combined costs for all providers and suppliers for all offsite revisit surveys to total $343,875 for the period of the current continuing resolution. In Table C below, we first estimated by provider or supplier the number of offsite revisit surveys expected for an entire fiscal year, and multiplied this number by the expected revisit user fee of $168 per offsite revisit survey to obtain the annual cost of surveys. We then divided this number by 12 to obtain the monthly cost of offsite revisit surveys and multiplied this number by the effective period of the continuing resolution (roughly 1.5 months) to obtain the total costs for offsite revisit surveys for the period of the continuing resolution.
Table C.—Offsite Revisit Surveys—Estimated Monthly Costs
Monthly number of offsite revisit surveys
Fee assessed per offsite revisit survey ($112 × 1.5 hrs)
Monthly costs for offsite revisit surveys*
Total costs for offsite revisit surveys for period of CR **
SNF & NF 1,262 $168 $211,932 $317,898
Hospitals 23 168 3,892 5,838
HHA 43 168 7,238 10,857
Hospice 4 168 714 1,071
ASC 8 168 1,302 1,953
RHC 6 168 938 1,407
ESRD 19 168 3,234 4,851
Total 1,365 229,250 343,875
** Monthly costs were multiplied by the effective period of the CR (roughly 1.5 months).
As shown in Table D below, we provide the aggregate costs expected as projected for the entire FY 2007, as well as the costs we would expect to offset for the period of the current continuing resolution.
Table D.—Total Costs Combined for All Revisits Surveys per Fiscal Year & Period of CR
Period of CR *
Onsite Revisit Surveys $34,565,760 $4,320,512
Offsite Revisit Surveys 2,751,000 343,980
Total Costs All Revisits 37,316,760 4,664,492
* CR period's costs are based on CR period revisit surveys rounded up to the nearest whole number as shown in Table B & C.
CMS considered a number of alternatives to the Revisit User Fee. Such alternatives were discussed in the final rule published on September 19, 2007 (72 FR 53647). We affirm the continuing validity of that analysis. The current continuing resolution provides CMS with the authority to continue projects or activities as was otherwise provided for in FY 2007, and as such CMS is required to publish an interim final rule with comment. This interim final rule with comment merely updates the Congressional authority under which the rule operates.
End List of Subjects Start Printed Page 61545 Start Amendment Part
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services amends 42 CFR chapter IV, part 488 as set forth below:
1. The authority citation for part 488 is revised to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act, unless otherwise noted (42 U.S.C. 1302 and 1395(hh)); Pub. L. 110-92, H. J. Res. 52 §§ 101 & 106 (2007).
Approved: October 25, 2007.
[FR Doc. 07-5400 Filed 10-26-07; 12:02 pm]