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This article was originally published in The Gray Sheet

Executive Summary

DME REGIONAL CARRIER DRAFT COVERAGE POLICIES are in "direct conflict" with national policy objectives and "current trends in health delivery to encourage cost-effective, patient-preferred services," the Health Industry Manufacturers Association asserts in a June 15 press release. The release comments on three series of draft policies that were written by the four new regional carriers selected to process Medicare Part B claims. According to HIMA, the three documents, which spell out Medicare coverage criteria for various categories of DME equipment, "appear to scale back the scope and benefit of home medical equipment to reduce budget outlays." The most recent policy in the series was released April 30. The policies were developed in preparation for a transition from 33 to four regional Medicare carriers ("The Gray Sheet" Jan. 4, p. 9). The transition is expected in October, and the coverage policies are expected to be finalized later in the summer. HIMA notes that "all four carriers have chosen to adopt the same policies, which will (in effect) create a national policy rather than regional policies." The release announces a June 24 media briefing in Washington sponsored by HIMA and the Home Care Coalition to air concerns about the "restrictive nature" of the draft policies. HCC participants include the Health Industry Distributors Association, the United Ostomy Association and the American Association for Respiratory Care among others. HIMA maintains that the policies are being developed through a "flawed process." Comments have not been solicited from "affected beneficiary/consumer groups." Also, commenters have been given only 45 days to respond to the draft policies, and "DMERCs [DME regional carriers] have no plans to respond or react to the comments they receive on the draft medical policies." HIMA recommends that "the Oct. 1 transition date be postponed" until the issues of concern are resolved and that "the medical directors [of the DMERCs] be required to issue written responses to the comments they receive prior to" the release of final policies. The National Association of Medical Equipment Suppliers seconds HIMA's recommendations in June 14 comments on one of the three coverage policy documents ("the third series"). The series, released April 30, covers approximately 20 types of products/services including suction pumps, nebulizers, refractive lenses, parenteral and enteral nutrition, and continuous positive airway pressure systems. The other two draft documents, which were released in April and March, cover equipment such as home blood glucose monitors, infusion pumps, hospital beds and accessories, and walkers. NAMES says its members "remain deeply concerned that an initiative of this magnitude is being implemented so rapidly, after only limited conversations with select health care organizations and virtually no opportunity for public notice and comment." The association adds that "the very serious effect this governmental action will have on the ability of Medicare beneficiaries and other consumers to obtain home medical equipment (HME) warrants a vastly expanded timeframe for public notice and comment, as well as a delay in transition" of carriers to the four DMERCs. Among the association's criticisms of the third series is that it contains "unrealistic expectations of what a patient actually will require and use where there is medical necessity for certain HME and supplies." This is "particularly true," NAMES says, with ostomy supplies, surgical dressings and support surfaces. "As such, NAMES is deeply concerned about the adverse effects such policies may have on patient outcomes, in particular the potential for increased hospitalization or admission/readmission to acute care facilities and an almost certain decrease in patient activity and quality of life." For example, NAMES maintains that "the extremely restrictive draft coverage policies for wound care and related supplies may well result in an increased incidence of pressure ulcers. This in turn would lead to increased hospitalization costs due to admission or readmission to acute care facilities or, in extreme cases, increased patient morbidity rates." NAMES further criticizes the draft policy as containing "vaguely worded documentation requirements...subject to a myriad of subjective interpretations." The association lists "overwhelming majority" and "appropriate documentation" as phrases that "place the HME supplier at risk by rendering it virtually impossible for suppliers to ascertain when an 'acceptable' level of compliance has been met." NAMES recommends that the DMERCs revise such terminology. Noting that the draft policy, like the two earlier series, restricts use of HME "solely to the patient's home," NAMES argues that the document "seriously misinterprets existing law and [Health Care Financing Administration] policy." For example, the group says the Medicare Carriers Manual authorizes coverage of portable oxygen therapy devices when used outside the home. NAMES notes that "HCFA recently instructed the DMERCs to modify the 'in the home' position, in order to allow coverage of and payment for HME use outside the confines of 'four walls' of the home." Among the association's comments specific to individual types of devices is a concern that the DMERCs requirements for nebulizers and aerosol therapy "are overly restrictive, burdensome to beneficiaries and ultimately may result in significant cost increases to the Medicare program." For example, the draft policy indicates that nebulizer use is covered by Medicare only for patients with reversible bronchospasm. NAMES says that under the stipulation a nebulizer is covered only after a patient has undergone and failed therapy with a one-month course of a bronchodilator drug delivered via a metered dose inhaler. Reversible bronchospasm is also required for coverage of intermittent positive pressure breathing (IPPB) devices. NAMES recommends in its comments that "the 'reversible bronchospasm only' requirement be deleted from the indication requirements for IPPB therapy" as well as for nebulizers.

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