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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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The last setion of Table 7 shows the percentage change in payments by agency size, as determined by the number of first episodes. The agency size categories, for this rule, are based on the number of first episodes in a random 20 percent beneficiary sample of CY 2007 claims data. Initial episodes, under the HH PPS, are defined as the first episode in a series of adjacent episodes (contiguous episodes that are separated by no more than a 60-day period between episodes) for a given beneficiary. Initial, or first, episodes are a good estimate of agency size, because this method approximates the number of admissions experienced by the agency based on approximately onefifth of the total annual data. The size categories were set to have roughly equal numbers of agencies, except that the highest category has somewhat more agencies because added detail amongst the large size category was not needed. As such, the size categories for these impact analyses are: less than 19 first episodes, 20 to 49 first episodes, 50 to 99 first episodes, 100 to 199 first episodes, and 200 or more first episodes. Larger HHAs (those with 200 or more Medicare home health initial

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payments from CY 2009 to CY 2010 of approximately 2.27 percent.

Mid-size to small agencies are expected to see a decrease in their payments in CY 2010, ranging from 1.95 percent to 16.08 percent. However, we believe that the major contributors to the estimated decreases in payments for mid-size to small agencies are those agencies in areas of the country with high and suspect outlier payments. Consequently, as we did in the proposed rule, we have provided a more detailed discussion, and analysis in Table 8 below, that demonstrates where, in the country, these estimated large decreases for mid-size to small agencies are

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REGION KEY:

New England=Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont;

Middle Atlantic=Pennsylvania, New Jersey, New York; South Atlantic=Delaware, District of Columbia, Florida, Georgia, Maryland, North Carolina, South Carolina, Virginia, West Virginia; East North Central=Illinois, Indiana, Michigan, Ohio, Wisconsin; East South Central=Alabama, Kentucky, Mississippi, Tennessee; West North Central=Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota, South Dakota; West South Central=Arkansas, Louisiana, Oklahoma, Texas; Mountain=Arizona, Colorado, Idaho, Montana, Nevada, New Mexico, Utah, Wyoming; Pacific=Alaska, California, Hawaii, Oregon, Washington;

Outlying=Guam, Puerto Rico, Virgin Islands Percent change due to the effects of the update wage index, the 2.0% home health market basket update, the 2.75% reduction to the national standardized episode rates, the national per-visit rates, the LUPA add-on payment amount, and the NRS conversion factor for nominal increase in case-mix, the 2.5% increase in the rates due to the new approximate 2.5% target for outliers as a percentage of total HH PPS payments, a 0.67 FDL ratio, and a 10% outlier cap Given the overall large negative impact observed by smaller agencies, we performed more detailed analysis targeted at identifying where the large negative impacts were occurring. Table 8 below presents the results of the regional analysis for small agencies. Column 1, of Table 8, shows the regional and agency size classifications similar to those in Table 7. In column 2 we repeat the overall impacts (from Table 7) for those classifications.

In columns 3 through 7, we drill down in our analysis, looking at those classifications by the size of the agency (as defined by the number of first episodes). It is clear from this analysis that, for smaller agencies, the vast majority of the negative impact is occurring in areas of the country (such as the South and South Atlantic) where there exist high and suspect outlier payments.

Specifically, in columns 3, 4, and 5 of Table 8, for the South Atlantic area of the country (which includes MiamiDade, Florida), the negative percentage impacts in payment ranging from around 40 percent to just over 53 percent are evidence that it is the high and suspect outlier payments in areas such as this, that are skewing the results of the

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agencies in the South (negative impacts ranging around 15 percent to 22 percent) and the Pacific (negative impacts ranging from around 12 percent to 17 percent) areas of the country, reflect similar results. Conversely, small HHAs in most other parts of the country are estimated to see increases in payments in CY 2010, ranging from 0.20 percent to almost 5 percent. Consequently, we believe that small HHAs without high and suspect outlier payments, on average, will see a positive impact on their payments in CY 2010.

We do not believe there will be any significant impact on beneficiaries, as a result of the provisions of this rule.

Areas where negative impacts have been estimated for HHAs, are primarily urban, and thus we believe that beneficiaries have a reasonable pool of HHAs from which to receive home

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REGION KEY:

New England=Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont;

Middle Atlantic=Pennsylvania, New Jersey, New York; South Atlantic=Delaware, District of Columbia, Florida, Georgia, Maryland, North Carolina, South Carolina, Virginia, West Virginia; East North Central=Illinois, Indiana, Michigan, Ohio, Wisconsin; East South Central=Alabama, Kentucky, Mississippi, Tennessee; West North Central=Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota, South Dakota; West South Central=Arkansas, Louisiana, Oklahoma, Texas; Mountain=Arizona, Colorado, Idaho, Montana, Nevada, New Mexico, Utah, Wyoming; Pacific=Alaska, California, Hawaii, Oregon, Washington;





Outlying=Guam, Puerto Rico, Virgin Islands

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Whenever a rule is considered a significant rule under Executive Order 12866, we are required to develop an Accounting Statement showing the classification of the expenditures associated with the provisions of this rule.

Table 9, below provides our best estimate of the decrease in Medicare payments under the HH PPS as a result of the changes presented in this rule based on the best available data. The expenditures are classified as a transfer to the Federal Government of $140 million.

TABLE 9: Accounting Statement: Classification of Estimated Expenditures, from the 2009 HH PPS Calendar Year to the 2010 HH PPS Calendar Year

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NRS conversion factor to account for the case-mix change adjustment, is approximately $140 million in CY 2010 savings. The $140 million impact reflects the distributional effects of an updated wage index (-$10 million) as well as the final 2.0 percent home health market basket increase (an additional $350 million in CY 2010 expenditures attributable only to the CY 2010 home health market basket), and the 2.75 percent decrease (-$480 million for the third year of a 4-year phase-in) to the national standardized 60-day episode rates and the NRS conversion factor to account for the case-mix change adjustment under the HH PPS. This analysis above, together with the remainder of this preamble, provides a Regulatory Impact Analysis.

In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management

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List of Subjects 42 CFR Part 409 Health facilities, Medicare 42 CFR Part 424 Emergency medical services, Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements 42 CFR Part 484 Health facilities, Health professions, Medicare,

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For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services amends 42 CFR chapter IV

as set forth below:

PART 409-HOSPITAL INSURANCE BENEFITS

1. The authority citation for part 409 continues to

read as follows:

Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).

2. Section 409.42 is amended by revising paragraph (c)(1) to read as follows:

§409.42 Beneficiary qualifications for coverage of services.

* * * * *

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(1) Intermittent skilled nursing services that meet the criteria for skilled services and the need for skilled services found in §409.32. (Also see §409.33(a) and (b) for a description of examples of skilled nursing and rehabilitation services.) These criteria are subject to

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(i) 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. To be considered a skilled service, the complexity of the necessary unskilled services that are a necessary part of the medical treatment must require the involvement of licensed nurses to promote the patient’s recovery and medical safety in view of the overall condition. Where nursing visits are not needed to observe and assess the effects of the non-skilled services being provided to treat the illness or injury, skilled nursing care would not be considered reasonable and necessary, and the management and evaluation of the care plan would not be considered a skilled service. In some cases, the condition of the patient may cause a service that would originally be considered unskilled to be considered a skilled nursing service. This would occur when the patient’s underlying condition or complication requires that only a registered

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achieving its purpose. The registered nurse is ensuring that service is safely and effectively performed. However, a service is not considered a skilled nursing service merely because it is performed by or under the supervision of a licensed nurse. Where a service can be safely and effectively performed (or self administered) by nonlicensed staff without the direct supervision of a nurse, the service cannot be regarded as a skilled service even if a nurse actually provides the service.

(ii) In the home health setting, skilled education services are no longer needed if it becomes apparent, after a reasonable period of time, that the patient, family, or caregiver could not or would not be trained. Further teaching and training would cease to be reasonable and necessary in this case, and would cease to be considered a skilled service. Notwithstanding that the teaching or training was unsuccessful, the services for teaching and training would be considered to be reasonable and necessary prior to the point that it became apparent that the

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services were appropriate to the patient’s illness, functional loss, or injury.

* * * * *

3. Section 409.43 is amended by revising paragraph (e)(1)(ii) to read as follows:

§409.43 Plan of care requirements.

* * * * *

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(1) * * * (ii) Significant change in condition; or * * * * *

4. Section 409.44 is amended by revising the

introductory text of paragraph (b)(1) to read as follows:

§409.44 Skilled services requirements.

* * * * *

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(1) Skilled nursing care consists of those services that must, under State law, be performed by a registered nurse, or practical (vocational) nurse, as defined in §484.4 of this chapter, meet the criteria for skilled

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qualifications for coverage of skilled services specified in §409.42(c). See §409.33(a) and (b) for a description of skilled nursing services and examples of them.

* * * * *

PART 424-CONDITIONS FOR MEDICARE PAYMENT

5. The authority citation for part 424 continues to

read as follows:

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Act (42 U.S.C. 1302 and 1395hh).

6. Section 424.22 is amended as follows:

A. Revising paragraph (a)(1)(i);

B. Revising paragraph (b)(2).

§ 424.22 Requirements for home health services.

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(1) * * * (i) The individual needs or needed intermittent skilled nursing care, or physical or speech therapy, or (for the period from July through November 30, 1981) occupational therapy. If a patient’s underlying condition or complication requires a registered nurse to ensure that

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necessitates a registered nurse be involved in the development, management, and evaluation of a patient’s care plan, the physician will include a brief narrative describing the clinical justification of this need. If the narrative is part of the certification or recertification form, then the narrative must be located immediately prior to the physician’s signature. If the narrative exists as an addendum to the certification or recertification form, in addition to the physician’s signature on the certification or recertification form, the physician must sign immediately following the narrative in the addendum.

* * * * *

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recertification statement must indicate the continuing need for services and estimate how much longer the services will be required. Need for occupational therapy may be the basis for continuing services that were initiated because the individual needed skilled nursing care or physical therapy or speech therapy. If a patient’s underlying

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ensure that essential non-skilled care is achieving its purpose, and necessitates a registered nurse be involved in the development, management, and evaluation of a patient’s care plan, the physician will include a brief narrative describing the clinical justification of this need. If the narrative is part of the certification or recertification form, then the narrative must be located immediately prior to the physician’s signature. If the narrative exists as an addendum to the certification or recertification form, in addition to the physician’s signature on the certification or recertification form, the physician must sign immediately following the narrative in the addendum.

* * * * *

7. Section 424.540 is amended by revising paragraph (b)(3) to read as follows:

§424.540 Deactivation of Medicare billing privileges.

* * * * *

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by the State survey agency or the establishment of a new provider agreement.

(i) An HHA whose Medicare billing privileges are deactivated under the provisions found at paragraph (a) of this section must obtain an initial State survey or accreditation by an approved accreditation organization before its Medicare billing privileges can be reactivated.

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* * * * *

8. Section 424.550 is amended by adding paragraph (b)(1) and adding and reserving paragraph (b)(2), to read

as follows:

§424.550 Prohibitions on the sale or transfer of billing privileges.

* * * * *

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(1) If an owner of a home health agency sells (including asset sales or stock transfers), transfers or relinquishes ownership of the HHA within 36 months after the effective date of the HHA’s enrollment in Medicare, the

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convey to the new owner. The prospective provider/owner of

the HHA must instead:

(i) Enroll in the Medicare program as a new HHA under the provisions of §424.510, and (ii) Obtain a State survey or an accreditation from an approved accreditation organization.

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Act (42 U.S.C.1302 and 1395(hh)).

Subpart C—Furnishing of Services

10. Section 484.55 is amended by revising paragraph (d)(1)(ii) to read as follows:

§484.55 Condition of participation: Comprehensive assessment of patients.

* * * * *

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(ii) Significant change in condition; or * * * * * Subpart E—Prospective Payment System for Home Health Agencies

11. Section 484.210 is amended by revising paragraph

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§484.210 Data used for the calculation of the national prospective 60-day episode payment.

* * * * * (e) OASIS assessment data and other data that account for the relative resource utilization for different HHA Medicare patient case-mix. An HHA must 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.

12. Revise §484.250 to read as follows:

§484.250 Patient assessment data.

An HHA must submit to CMS the OASIS data described at

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payment rate methodologies described in §§484.215, 484.230, and 484.235.

CMS-1560-F (Catalog of Federal Domestic Assistance Program

Authority:

No. 93.773, Medicare--Hospital Insurance; and Program No. 93.774, Medicare--Supplementary Medical Insurance Program) Dated: October 15, 2009 ______________________

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1 All counties within the State are classified as urban, with the exception of Massachusetts and Puerto Rico. Massachusetts and Puerto Rico have areas designated as rural, however, no short-term, acute care hospitals are located in the area(s) for CY 2010 CMS-1560-F 310

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[FR Doc. 2009-26503 Filed 10/30/2009 at 4:15 pm;

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