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«DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Parts 409, 424, and 484 [CMS-1560-F] RIN 0938-AP55 Medicare ...»

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Response: CMS is aware that some home health agencies have

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already. They have been able to make such investments under the current payment system. We urge continued investments in these technologies in the interests of improving care management and efficiency in the home health industry. CMS is committed to improving health setting transitions to minimize unnecessary errors and burdens on patients and providers. For example, under the QIO program, we will continue to work with the hospital industry and others to disseminate information about smoothing transitions.

III. Provisions of the Final Rule Generally, this final rule incorporates the provisions of the August 6, 2009 proposed rule (republished on August 13, 2009 with corrected wage index tables), except as noted in the specific response to comments in the applicable section of this rule.

IV. Collection of Information Requirements Under the Paperwork Reduction Act of 1995, we are required to provide 30-day notice in the Federal Register and solicit public comment before a collection of information (COI) requirement is submitted to the Office of Management and Budget

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whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995

requires that we solicit comment on the following issues:

● The need for the information collection and its usefulness in carrying out the proper functions of our agency.

● The accuracy of our estimate of the information collection burden.

● The quality, utility, and clarity of the information to be collected.

● Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.

We solicited public comments on each of aforementioned issues for the information collection requirements discussed below. In this final rule, we are restating the discussion of the information collection requirements as it appeared in the HH PPS proposed rule that published on August 13, 2009 (74 FR 40948).

A. ICRs Regarding the Requirements for home health services.

In §424.22 we stated that if a patient’s underlying

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that essential non-skilled care was achieving its purpose, and necessitated a registered nurse be involved in the development, management, and evaluation of a patient’s care plan, the physician would include a written narrative describing the clinical justification of this need.

The burden associated with this requirement will be the time and effort put forth by the physician to include the written narrative. We estimate it will take one physician approximately 5 minutes to meet this requirement. We estimate the frequency of such a situation to occur in about 5 percent of episodes (or about 345,600 episodes a year); therefore, the total annual burden associated with this requirement will be 28,800 hours for CY 2010.

Comment: Two commenters wrote that the time and burden estimates presented in section IV. of the proposed rule were underestimated. One noted that these regulations would increase costs of operation. For section IV.A., the other wrote that the time to educate the physician regarding the type of documentation needed to support unlicensed care from a Management and Evaluation perspective would be astronomical, in addition to the time required trying to obtain the documentation

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spend collecting information on each client to document medical necessity was greater than 5 minutes.

Response: We disagree that the time to educate the physician regarding the type of documentation that would be needed to fulfill the requirement for a physician’s written narrative, in these rare instances, as astronomical. Nor do we agree that the time required to obtain the narrative will be excessive. The physician should already have considered what his/her clinical justification is for the certification or recertification of the beneficiary to receive Medicare’s home health benefit, as well as the ordering and approving of these skilled services on the plan of care. Consequently, the physician should have already synthesized their clinical justification, and need only to record it into the certification or recertification.

The requirements and associated information collection burden contained in §424.22 will be submitted to OMB for approval. As part of the approval process, we will seek public comments in an additional notice separate from this final rule.

B. ICRs Regarding Deactivation of Medicare Billing Privileges.

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privileges are deactivated under the provisions found in §424.540(a) must obtain an initial state survey or accreditation by an approved accreditation organization before its Medicare billing privilege can be reactivated. The burden associated with this requirement will be the time and effort put forth by the HHA to obtain a State survey or accreditation. We estimate it will take the prospective provider/owner 60 hours to obtain a State survey or accreditation. We estimate that there will be 2,000 such occurrences annually. (We believe that this figure is an extremely high-end estimate, but will utilize it for purposes of this final rule so as to ensure that we do not underestimate the potential burden on HHAs. Therefore, the total annual burden associated with this requirement will be 120,000 hours.





Comment: Two commenters wrote that the time and burden estimates presented in section IV. of the proposed rule were underestimated. One noted that these regulations would increase costs of operation. For section IV.B, a commenter wrote that the time required to receive an initial survey was months from an accrediting organization since in her state, the State survey agency was no longer performing initial surveys.

Response: With respect to the estimated survey timeframe,

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provider spends: (1) in undertaking specific activities in preparation for the survey, and (2) undergoing the survey itself. The calculation does not include the time waiting for the survey to take place.

The requirements and associated information collection burden contained in §424.540(b)(3) will be submitted to OMB for approval. As part of the approval process, we will seek public comments in an additional notice separate from this final rule.

C. ICRs Regarding Prohibition against Sale or Transfer of Billing Privileges.

At §424.550(b)(1) we require that an HHA undergoing an ownership change will have to obtain an initial State survey or accreditation by an approved accreditation organization if the change takes place within 36 months after the effective date of the HHA’s participation in Medicare.

Between April 2008 and April 2009, approximately 2,000 Medicare-enrolled HHAs – or 22.5 percent of the 9,000 total number of HHAs enrolled in Medicare – underwent a change of ownership. Naturally, the magnitude of the ownership changes varied by HHA, but the fact that almost one-quarter of all Medicare-enrolled HHAs changed ownership in

–  –  –

the preamble to this rule, significant.

It is also important to note that of the 2,000 ownership changes, approximately 20 percent occurred in Texas, another 20 percent in Florida, and 14 percent in California, meaning that over one-half of all changes in ownership occurred in three States. Though it is likely that, once this provision is implemented, the number of total annual ownership changes will decrease, we will assume for purposes of this final rule that the figure of 2,000 will remain constant so as to ensure that we do not underestimate the potential burden on HHAs.

The burden associated with this requirement in §424.550(b)(1) is twofold. First, the HHA will need to complete and submit a Medicare enrollment application (paper or electronic) as an initial applicant. This can be done electronically via the Internet-Based Provider Enrollment, Chain and Ownership System (PECOS) or by using the paper CMS-855 enrollment application. The estimated burden of completing the entire application as a new enrollee is 3 hours. Thus, the estimated annual burden for the approximately 2,000 HHAs that will change ownership will be 6,000 hours. Second, the provider will need to undergo a survey (or obtain accreditation in lieu

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therewith. We estimate that the total hourly burden to the HHA for stated activities will be 60 hours, for an annual burden of 120,000 hours (2,000 HHAs x 60 hours).

Therefore, we estimate that the total annual burden of compliance with §424.550(b)(1) will be 126,000 hours (120,000 hours + 6,000 hours).

The requirements and associated information collection burden contained in §424.550(b)(1) will be submitted to OMB for approval. As part of the approval process, we will seek public comments in an additional notice separate from this final rule.

Comment: Two commenters wrote that the time and burden estimates presented in section IV. of the proposed rule were underestimated. One noted that these regulations would increase costs of operation. For section IV.C, one of the commenters believed that the time to complete the enrollment form needed when a sale/transfer of ownership occurs is far greater than 3 hours, taking several days to complete the form and gather all required documentation. Additionally, if a deficiency in completing this complex form is noted, the time to correct it is not factored in.

Response: We believe that the timeframe we have used for

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past estimates that CMS has used for the completion of the Medicare enrollment application (for example, CMS-855A).

D. ICRs Regarding Patient Assessment Data.

Section 484.210 will require an HHA to submit to CMS the OASIS data described at §484.55(b)(1) and (d)(1) in order for CMS to administer the payment rate methodologies described in §§484.215, 484.230 and 484.235.

The burden associated with this is the time and effort put forth by the HHA to submit the OASIS data. This burden is currently accounted for under OMB# 0938-0761.

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If you comment on these information collection and

recordkeeping requirements, please do either of the following:

1. Submit your comments electronically as specified in the ADDRESSES section of this rule; or

2. Submit your comments to the Office of Information and Regulatory Affairs, Office of Management and Budget,

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E. ICRs Regarding Annual update of the unadjusted national prospective 60-day episode payment rate.

Section 484.225(i) requires the submission of quality measures as specified by the Secretary. As part of this requirement, each HHA sponsoring a Home Health Care CAHPS (HHCAHPS) Survey must prepare and submit to its survey vendor a file containing patient data on patients served the preceding month that will be used by the survey vendor to select the sample and field the survey. This file (essentially the sampling frame) for most home health agencies can be generated from existing databases with minimal effort. For some small HHAs, preparation of a monthly sample frame may require more time. However, data elements needed on the sample frame will be kept at a minimum to reduce the burden on all HHAs.

The burden associated with this requirement is the time and effort put forth by the HHA to prepare and submit the file containing patient data on patients. The survey instrument and procedures for completing the instrument are designed to minimize burden on all respondents. No significant burden is expected for small agencies beyond providing their contracted

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Initially, we estimate it will take one HHA 5 hours for the first month to meet this requirement. The subsequent monthly burden is estimated to be 30 minutes per HHA. We estimate approximately 7,000 HHAs will be submitting this data annually.

Based on that number, the burden associated with the first month is estimated at 35,000 hours. The burden will decrease to 2,100 for subsequent months. Therefore, the total annual burden for the first year will total 58,100.

The burden associated with the home health patient’s submission of the HHCAHPS survey is currently pending OMB approval (CMSOMB# 0938-NEW). Once OMB approval has been obtained, we will revise the package to include the burden on the HHAs as discussed above.

Comment: Two commenters wrote that the time and burden estimates presented in section IV. of the proposed rule were underestimated. One noted that these regulations would increase costs of operation. For section IV.E on the HHCAHPS, one commenter wrote that time and burden were severely underestimated as HHAs must implement both procedural and technological changes which are not included in the estimates.

Response: In the beginning, it will take HHAs a little

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information on a monthly basis for their respective survey vendors. However, from several years of experience with Hospital CAHPS, we have observed that the participating hospitals are able to deliver their monthly files to their respective survey vendors with minimal effort. Regarding section IV.E of the Information Collections Requirements, CMS is adopting three changes to the proposed HHCAHPS implementation that may alleviate some of the “burden”: (1) delayed HHCAHPS linkage to CY 2012 payment and not to CY 2011 payment; (2) the eligible patient list that HHAs need to give to their survey vendors include only Medicare and/or Medicaid patients; (3) HHAs may give V Codes to their survey vendors if ICD-9 codes are unavailable; (4) HHAs will have the opportunity to voluntarily implement HHCAHPS for a year (October 2009 through September

2010) for “practicing” the implementation procedures before data collection “counts” toward an annual payment update.

V. Regulatory Impact Analysis

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We have examined the impacts of this final rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993) the Regulatory Flexibility Act (RFA)

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