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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: We disagree with the commenter’s statement that the revisions to the skilled nursing management and evaluation of the care plan will make it more difficult for Medicare patients to obtain this skilled service. We also point out that we would expect the home health agency rather than the patient or caregiver to gauge the effectiveness of the services being provided. As we stated earlier, the proposed regulation changes reflect long-standing manual guidance. We also believe that the commenter’s concern about no clear guidance to assess the complexity of the unskilled services further reveals the need for the certifying physician to clearly describe what unique aspect about the patient’s condition would require skilled management and evaluation of these unskilled services. However, we understand the commenter’s concern. The proposed regulation text stated, “….in the home health setting, management and evaluation of a patient care plan is considered a reasonable and necessary skilled service only when underlying conditions or complications are such that only a registered nurse can ensure that essential non-skilled care is achieving its purpose.”

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For better consistency with long standing manual guidance, we will remove the word “only” after “reasonable and necessary skilled services…”. The modified regulation text is more consistent with long standing manual guidance. The finalized regulation text reads, “….in the home health setting, management and evaluation of a patient care plan is considered a reasonable and necessary skilled service when underlying conditions or complications are such that only a registered nurse can ensure that essential non-skilled care is achieving its purpose.” Comment: One commenter stated that additional physician visits, phone calls, or paying more for oversight is unlikely to produce meaningful genuine physician involvement. These proposals do not address the fundamental problem of too little physician time to fully support the patient at home. Additional requirements are likely to produce paper or rote compliance at best and at worst will discourage some physicians from referring appropriate patients to homecare. Another commenter stated that the best approach to involving physicians in homecare rests in new models of chronic care management that integrate primary care practice that are committed to home-based care with HHAs into a single, consolidated chronic care service.

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consider the suggestions regarding innovative approaches to increasing physician involvement in the plan of care in future rulemaking. However, we again remind commenters that by signing the certification and recertification, the physician is accountable for attesting that the beneficiary is in need of Medicare’s home health services, and that the certification and recertification are part of the patient’s medical record. And, Medicare reimburses physicians for their work associated with the certification, recertification and plan of care oversight.

Comment: Some commenters expressed concerns with CMS’ clarification which described that skilled education services would be deemed to be no longer needed when it became apparent, after a reasonable period of time, that the patient, family member or caregiver could not or would not be trained. Some commenters asked that CMS better clarify timeframes that would be appropriate for these skilled training services. Other commenters stated that unless CMS defines what is a “reasonable period of time”, the clarification isn’t helpful. Other commenters stated that when a patient or caregiver appears incapable of learning, more training would be justified. Another commenter suggested that instead of clarifying this in regulation, we should increase the educational and outreach efforts of our contractors.

Response: This regulation clarification codifies long

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Policy Manual. We believe it inappropriate to assign specific timeframes for patient education services because the length of time a patient or family or caregiver needs should be determined by assessing each patient’s individual condition and other pertinent factors such as the skill required to teach the activity and the unique abilities of the patient. It is important to know that teaching activities must be related to the patient’s functional loss, illness, or injury. However, we disagree with the commenter who suggested that when a patient or caregiver is incapable of learning that more education is needed.

Medicare’s home health benefit is not intended to provide training and education to patients, families, caregivers for an infinite period of time.

To summarize, we are finalizing a number of provisions as they relate to skilled services in the home health setting.

Specifically, we are clarifying what constitutes skilled services in the home health setting with the following revisions to §409.42. We are adding a qualifying instruction to §409.42(c)(1) to explain that intermittent skilled nursing services meeting the criteria for skilled services and the need for skilled services found in §409.32 (with examples in §409.33 (a) and (b)) are subject to certain limitations in the home health setting.

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to refer to the new limitations of skilled services in the home health benefit at §409.42(c)(1)(i) and §409.42(c)(1)(ii). The clauses under the revised paragraphs (i) through (iv) will remain unchanged.

We are also revising §424.22(a)(1)(i) and §424.22(b)(2) to require a written narrative of clinical justification on the physician certification and recertification for the targeted condition where the patient’s overall condition supports a finding that recovery and safety could be ensured only if the care was planned, managed, and evaluated by a registered nurse.

To clarify for home health agencies what specific circumstances would necessitate the involvement of a registered nurse in the development, management, and evaluation of a patient’s care plan when only unskilled services are being provided, we are finalizing additions to the home health certification content requirements as described at §424.22(a)(i) and recertification content requirements at §424.22(b)(2).

F. OASIS for Significant Change in Condition: No longer Associated with Payment In the CY 2010 proposed rule we proposed to remove an obsolete reference to “new case-mix assignments” as a result of

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CFR 484 subpart E at §484.55(d)(1)(ii). The significant change in condition (SCIC), as it relates to new case-mix assignments affecting payment, was an element of the HH PPS at the time of its first implementation in fiscal year 2000. However, as part of the HH PPS payment refinements implemented in CY 2008, we eliminated the SCIC policy, and the assignment of subsequent case-mix assignments under the HH PPS. However, it should be noted that it was not the SCIC payment policy that required the HHA to perform the assessment, but rather the significant change in the patient’s condition. In the proposed rule we did not propose to change that requirement. A HHA would still be required to perform an assessment in the event that a patient experienced a significant change in condition. The proposed modification is only that a new case-mix assignment is no longer associated with this assessment.

In addition, we proposed to revise §484.250 to delete an obsolete reference to §484.237. Section 484.237 referred to the SCIC payment policy and was removed in the CY 2008 HH PPS final rule (72 FR 49879).

Comment: A commenter wrote that since there is no additional payment for SCICs, there is no incentive for HHAs to

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This commenter stated she disagreed with this requirement, and suggested that if we wanted this additional assessment, we should increase reimbursement for it.

Response: We believe the commenter has misunderstood the text of the proposed rule. As noted in the proposed rule, we eliminated the SCIC payment policy and the assignment of subsequent case-mix assignments under the HH PPS in our 2007 (CY

2008) final rule. However it was not the SCIC payment policy that required the HHA to perform the assessment, but rather the significant change in the patient’s condition. We did not propose any changes this requirement. The proposed modification was only that a new case-mix assignment is no longer associated with this assessment. Therefore there was no proposal for any additional assessments beyond those that have been requirements for some time now.

We are finalizing the provision to remove an obsolete reference to “new case-mix assignments” as a result of significant changes in a patient’s condition that appeared in 42 CFR 484 subpart E at §484.55(d)(1)(ii). We are also finalizing the provision to revise §484.250 to delete an obsolete reference

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G. Payment Safeguards for Home Health Agencies In the Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2010, we also proposed several payment safeguard provisions designed to: (1) improve our ability to verify that home health agencies (HHAs) meet minimum enrollment criteria; (2) ensure that HHAs that are changing ownership meet and continue to meet the Conditions of Participation for HHAs found in 42 CFR Part 484; and (3) improve the quality of care that Medicare beneficiaries receive from HHAs.

1. Program Integrity Concerns Involving HHAs We stated in the proposed rule that the fraudulent business practices of certain HHAs continue to cost the Medicare program millions of dollars nationwide. This issue was discussed in a recent report issued by the Government Accountability Office (GAO) entitled ‘‘Improvements Needed to Address Improper Payments in Home Health’’ (GAO–09–185). This report stated that, nationwide, ‘‘spending on the Medicare home health benefit grew about 44 percent from 2002 through 2006, despite an increase of just less than 17 percent in the number of beneficiaries using the benefit during that 5-year period.’’ It

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number of HHAs that billed Medicare and the increase in the number of Part A beneficiaries. For instance, between 2002 and 2006, the number of HHAs that billed Medicare rose in Florida by 100 percent, in Michigan by 62 percent, in Illinois by 59 percent, in Ohio by 42 percent, in Arizona by 32 percent, and in the District of Columbia by 67 percent. However, the GAO reported, the increases in the number of Part A beneficiaries who used HHA services in these six jurisdictions were as follows: Florida—28 percent; Michigan—19 percent; Illinois—23 percent; Ohio—14 percent; Arizona—4 percent; and the District of Columbia—2 percent.

The disparity in many jurisdictions between the increase in the number of HHAs and the rise in the number of beneficiaries is so overwhelming that it cannot be attributed solely to an aging populace. The fact that, as shown above, between 2002 and 2006, the number of HHAs in Arizona rose at a rate 8 times greater than the number of Part A beneficiaries that use HHA services and that the rate was an astounding 33 times greater in Washington, DC must raise serious questions as to the legitimacy of some of these entities.

As explained in the preamble to the proposed rule, the GAO

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fraudulent activities on the part of HHAs. In a particularly

glaring example in Houston, Texas, the GAO noted the following:

“One PSC (Program Safeguard Contractor) interviewed 670 Houston beneficiaries who had the most severe clinical rating and who were patients of HHAs identified by the PSC as having aberrant billing patterns. The PSC found 91 percent of claims for these beneficiaries to be in error. Nearly 50 percent of the beneficiaries were not homebound and therefore were not eligible to receive any Medicare home health services. The investigators also found that while 39 percent of the beneficiaries they interviewed were eligible for the benefit, their clinical severity had been exaggerated. The PSC concluded that only 9 percent of claims for the 670 beneficiaries were properly coded.

In addition, the PSC found that other home health beneficiaries it interviewed were not homebound; for instance, some were mowing their lawns when investigators came to interview them.” In its report, the GAO also cited a number of court cases and actions of the Office of Inspector General (OIG) that resulted in the criminal convictions of or settlements with owners of various HHAs. In one 2007 case, the owner of a Louisiana HHA was convicted of defrauding Medicare over a 5-year

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In 2004, the owner of the two largest HHAs in California pled guilty to defrauding the Medicare program of approximately $40 million and filing false tax return to conceal the income. In 2008, an HHA in Florida, pursuant to an OIG settlement, agreed to pay $178,000 to settle a case in which it was alleged that the provider paid kickbacks for beneficiary referrals. In another OIG settlement, this time in 2005, a Pennsylvania HHA agreed to pay $300,000 to settle a case in which it was alleged to have paid kickbacks under Medicare.

In light of all this, the GAO concluded, in part, that “In the absence of greater prevention, detection, and enforcement efforts, the Medicare home health benefit will continue to be a ready target for fraud and abuse. “More specifically, it stated that “gaps in screening potential and current HHAs may allow problem providers to enter and remain in the Medicare program.” The problem of fraudulent activity has been especially acute in the States of Texas and California. As we stated in the proposed rule, in Los Angeles County in California, the amount of money for which HHAs in that county billed Medicare between Fiscal Years 2003 and 2006 rose from $569 million to $921 million,an increase of 62 percent, and one that was not

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beneficiary population. There has also been an abnormal proliferation of HHAs in California as a whole. Between October 2002 and May 2007, the number of HHAs in the State rose by 25 percent — again, without a concomitant upswing in the number of Medicare beneficiaries in California, all of which suggested that there may also be an increase in improper billing.

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