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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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One commenter suggested we study the role of physicians in home care and determine which factors enhance the physician’s ability to conduct oversight activities, ensure appropriateness of care, and work collaboratively with home health agencies without burdening beneficiaries. Another commenter recommended we consider ways to improve communication between physicians and home health agencies, particularly as it relates to follow-up when a patient’s condition changes. One commenter suggested we consider the comments received upon solicitation in the Physician Fee Schedule rule, which encouraged a wider range of mechanisms to increase involvement, such as telehealth, photographic evidence, telephone, and use of advanced practice nurses (APNs) or physician assistants (PAs). Others suggested we continue the dialogue with physicians’ groups and with home health agencies about this issue. Several commenters echoed the suggestion to allow APNs or PAs, within state practice guidelines, and noted that these professionals are more accessible, more open to discussion of patient issues than physicians, would reduce the burden on physicians, and improve

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Another commenter suggested we test proposals to require encounters in demonstration projects, and establish whether the outcomes improve enough to merit the increase in costs. This commenter also suggested we consider requiring a Medicare Director, similar to those in hospice programs. In considering alternatives, another commenter wrote that physician home visits are unrealistic. This commenter noted that under current care plan oversight (CPO), physicians can count time for telephone interactions, and suggested we see if this method of oversight is widely used. He added that CMS should review practices that cannot be counted toward CPO time and consider allowing these.

He also suggested that surveyors focus more on the 60-day summary to physicians.

Several commenters recommended that CMS conduct a comprehensive study on the impact and value of physician encounters as a qualifying element of Medicare home health services. These commenters suggested that in the interim, physician payment rules could be modified to limit payment for care plan recertification to those physicians who can document a face-to-face encounter with the patient prior to care plan certification.

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this matter and will continue to address our concerns surrounding this issue, and analyze and consider those comments and suggestions in future policymaking and future rulemaking.

I. Routine Medical Supplies HHAs have expressed to the HHS Office of the Inspector General (OIG) some confusion regarding routine medical supplies and how we account for the cost of those supplies. Therefore, in the proposed rule we reiterated our policy regarding routine medical supplies and how they are reimbursed under the HH PPS.

Section 1895(b)(1) states that “all services covered and paid on a reasonable cost basis under the Medicare home health benefit as of the date of the enactment of this section, including medical supplies, shall be paid for on the basis of a prospective payment amount …”. The cost of routine medical supplies was included in the average cost per visit amounts derived from the audit sample. These average cost per visit amounts were used to calculate the initial HH PPS rates published in the July 3, 2000 HH PPS final rule (FR 65 41184).

Because reimbursement for routine medical supplies is bundled into the HH PPS 60-day episode rate and the per-visit rates,

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As noted in Chapter 7 - Home Health Services of the Medicare Benefit Policy Manual (Pub. 100-02), sections and, routine supplies are supplies that are customarily used in small quantities during the course of most home care visits. They are usually included in the staff's supplies and not designated for a specific patient. Routine supplies would not include those supplies that are specifically ordered by the physician or are essential to HHA personnel in order to effectuate the plan of care. Examples of supplies which are

usually considered routine include, but are not limited to:

A. Dressings and Skin Care

• Swabs, alcohol preps, and skin prep pads;

• Tape removal pads;

• Cotton balls;

• Adhesive and paper tape;

• Nonsterile applicators; and • 4 x 4's.

B. Infection Control Protection

• Nonsterile gloves;

• Aprons;

• Masks; and

• Gowns.

C. Blood Drawing Supplies

• Specimen containers.

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incontinence brief in this example would be covered as a routine medical supply.

E. Other

• Thermometers; and

• Tongue depressors.

There are occasions when the supplies listed in the above examples would be considered non-routine and thus would be considered a billable supply, that is, if they are required in quantity, for recurring need, and are included in the plan of care. Examples include, but are not limited to, tape, and 4x4s for major dressings.

Comment: A commenter requested clarification in the final rule on some routine medical supplies that were not included in the clarification in section III.I, such as wound care supplies and colostomy supplies. Additionally, the commenter was seeks clarification of the statement, “There are occasions when the supplies listed...a billable supply, that is, if they are required in quantity, for recurring need, and are included in the plan of care” on page 40974 at the end of section III.I.

The commenter asked if this represents a change from current practice.

Response: The law governing the Medicare home health

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requires that while the patient is under a home health POC, the HHA must bill and receive payment from Medicare for all covered home health services including routine and non-routine medical supplies, except DME Medical supplies, under the consolidated billing requirements. Routine, and non-routine medical supplies, are bundled into and paid for under the HH PPS rates and are subject to home health consolidated billing, which means that Medicare will not pay separately for these items for a beneficiary who is in an open home health care episode of care.

Section 50.4 of Chapter 7, “Home Health Services” of the Medicare Benefit Policy Manual (Pub. 100-02) defines medical supplies as “items that due to their therapeutic or diagnostic characteristics, are essential in enabling HHA personnel to conduct home visits or to carry out effectively the care the physician has ordered for the treatment or diagnosis of the patient’s illness or injury”. All supplies which would have been covered under the cost-based reimbursement system are bundled under the home health PPS. There is no limit on the number of supplies that a patient may receive from the HHA as long as the supplies are covered, reasonable and necessary and documented by the physician and kept in the patient’s record by

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Miscellaneous Comments Comment: A commenter wrote that most claims have Nonroutine Supplies (NRS) level 1 or 2, and almost none have NRS level 5. This commenter wrote that there was no information in HH PPS to capture the need for expensive pleurex catheters. The commenter felt that changes in the NRS methodology may be needed to more accurately reflect supply needs.

Another commenter was concerned that certain non-routine supplies were being added to the HH PPS bundle, but were not represented in the original cost basis for PPS supply payment without appropriate payment increases. He felt this was a disincentive to adopt new technology, and fosters the use and application of older and less efficacious alternative treatments and supplies. This commenter expressed specific concern over a Pleura-evac and sophisticated but expensive wound care products, and noted that the application of these technologies cost more than the NRS allowances. He suggested we re-evaluate the classification of Pleura-evacs and establish a process to adjust the NRS allowance to accommodate the accretion of new, more

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Response: We appreciate the comments on this topic, but we are not, as part of this rule, refining either the case-mix model or the NRS severity model for the HH PPS. We will consider the comments received in future rulemaking.

Comment: In the proposed rule, CMS indicated that the 60day episode rate was based on 25.5 visits. This is incorrect because it uses LUPAs that had 4 or fewer visits that are not paid using the full 60-day episode rate. Rather 31.6 visits per episode is the correct number of visits per episode, as the initial factor used by CMS in computing the 60-day episode rate back in 2000. CMS should clarify how the 25.5 visits per episode relates to the 31.6 visits per episode that was the basis for the 60-day episode base rate.

Response: The commenter is correct that 25.5, which was the actuarial projection for FY 2001 for all episodes as spelled out in the July 3, 2000 HH PPS Final Rule, was not the proper number to use for comparison with the current non-LUPA visits per episode; we regret the error. The 31.6 was for CY 1998 (the last historical year for which data were available for the Rule), and trends at the time indicated that visits per episode were declining. While the July 3, 2000 HH PPS Final Rule did

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per episode, it can be gleaned mathematically from other numbers published in that final rule, and turns out to be a few visits lower than 31.6.

Comment: A few commenters wrote that LUPA rates were still less than an agency’s cost of providing a visit, and asked that the rates be reviewed and increased. One commenter suggested we apply the LUPA add-on to all LUPA episodes. Another could not find support for the prediction that LUPA episodes would drop from 15percent to 5percent, and noted that the most recent data for his state suggested LUPA episodes were running at just over 14%.

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description of the analysis supporting that the LUPA add-on apply only to first or only LUPA episodes can be found in the CY 2008 final rule (72 FR 49762). It can also be noted that an individual agency’s cost of providing a visit will differ from agency to agency, however, we believe that the LUPA rates, on average, are sufficient. One should note that LUPA incidence can vary greatly from agency to agency and area to area. We intend to monitor the trend in incidence of LUPA episodes in view of the change we made to LUPA payments (the LUPA add-on)

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nationally, the percentage of LUPA episodes continues to drop, our most recent data indicating that LUPA episodes have dropped to around 10 percent. As stated in a response to a previous comment, we believe that the appropriate time and place to deal with any re-estimates, in these multiple areas, is if and when a rebasing for the rates were to take place.

Comment: A commenter felt that the proposed rule fell short of adopting essential reform to home health payment model and regulatory processes as suggested by MedPAC and described in the Senate Finance Committee’s Chairman’s Mark. The commenter believes the proposed rule can be strengthened to be consistent with health care reform goals and avoid serious consequences for Medicare, its beneficiaries, and avoid undermining access to quality home health agencies. Various commenters stated that home health is an effective approach to reducing hospital admissions and managing the long term nature of chronic diseases such as heart failure, chronic respiratory diseases, and unstable diabetes, and that many patients, including those who are not homebound, could benefit from ongoing management at home. One of these commenters stated a concern that the proposed rule focuses on costs of home care without factoring in

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us to appreciate the services that HHAs provide, and how home health is a cost-effective, quality alternative to rising health care costs.

Response: We appreciate the commenters’ suggestions regarding broader reform associated with the home health benefit. We agree with the commenter that home health care may be an effective approach to reducing hospitalizations and overall Medicare costs. However, the commenters’ suggestions are outside the scope of the proposed provisions which we solicited comments about in the CY 2010 proposed rule. The commenter is suggesting a broader scope of benefit than that which is currently statutorily mandated for Medicare’s home health benefit.

Comment: A commenter felt that the actions of a few agencies are driving policy decisions for the entire home health program. The commenter was concerned about the proliferation of agencies in pockets of the country, and the negative behavior of many of these HHAs. The commenter wrote that we should work directly with States to address appropriate growth and minimize risk to Medicare without impacting access. He hopes that we will be sensitive to the impact policy decisions aimed at

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the commenter appreciated our continued open dialogue through teleconferences and open door forums.

Response: Data so far suggest the problem of growing, suspect outlier payments has been associated with individual agencies and specific areas of the country. Our proposal for addressing the outlier payment problem considered the impact on agencies generally; thus, we have proposed an outlier cap at a level, 10 percent, that far exceeds the typical agency ratio with respect to outliers. We have addressed other parts of our proposed, and finalized, policies in other responses to public comments in this final regulation.

Comment: A commenter suggested we seek new types of healthcare systems and promote innovation in this area. Another commenter suggested we implement policies and guidance to maximize utilization of electronic health records and other forms of health information technology within the home health setting. Another commenter wrote that because of the HIPAA law, hospitals are not providing home health agencies with needed discharge information; this impacts the patient’s transition to home and leaves the agency to rely on patient recall.

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