WASHINGTON — According to Washington insiders, an interim final rule for DMEPOS competitive bidding could be out soon, as publication by Dec. 19 would allow its enactment before a new administration is in place. CMS has sent the rule, which governs changes to the competitive bidding program under the Medicare Improvements for Patients and Providers Act, to the Office of Management and Budget where it is now in final clearance. MIPPA delayed Round 1 of bidding and also required several reforms to the controversial program, which went live July 1 but was halted when Congress passed the law July 15. Titled "Limited Changes to the Competitive Acquisition of Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS)(CMS-1561-IFC)," an abstract for the rule from HHS-CMS reads: "This interim final rule as mandated by section 154 of MIPPA requires the temporary delay of Round 1 of the DMEPOS Competitive Bidding Program such that a new competition occurs excluding certain services. Section 154 of MIPPA establishes other requirements for the program such as providing a process for giving suppliers feedback on missing financial documents and mandating the disclosure of subcontractors under a competitive bidding program. Section 154 also mandates additional refinements to be implemented before phasing in future rounds of the program."
BALTIMORE — Last week, CMS sent a clarification about exactly which professionals are exempt from the Sept. 30, 2009, DMEPOS accreditation deadline — and which aren't — under changes in the Medicare Improvements for Patients and Providers Act. According to the notice, the "eligible professionals" who are exempt include physicians, physical therapists, occupational therapists, qualified speech-language pathologists, physician assistants and nurse practitioners. In addition, "other persons" including orthotists, prosthetists, opticians and audiologists are also exempt from CMS' mandatory deadline. The notice said CMS will define — by rulemaking in 2009 — how the quality standards apply to these "eligible professionals and other persons." It also said pedorthotists, mastectomy fitters, orthopaedic fitters/technicians and athletic trainers are not exempt and must meet the accreditation deadline.
NASHVILLE, Tenn. — The Jurisdiction C DME MAC said it will be starting a prepayment medical review of randomly selected claims for glucose monitor test strips (A4253) and lancets (A4259). The review will focus on non-insulin treated beneficiaries (KS modifier) who are receiving quantities of supplies that exceed the utilization guidelines defined in the LCD for glucose monitors. Suppliers of claims selected for review will receive a documentation request letter in the mail. The documentation, accompanied by a copy of the request letter, must be returned by 30 days from the date of the letter or the claim will be denied as not medically necessary. Read the entire notice on Jurisdiction C DME MAC's Web site.
WASHINGTON — Bayer HealthCare has agreed to pay the United States $97.5 million plus interest to settle allegations that it paid kickbacks to 11 diabetic suppliers and caused those suppliers to submit false claims to Medicare. According to a Department of Justice press release, the settlement resolves allegations that Tarrytown, N.Y.-based Bayer engaged in a "cash-for-patient" scheme from 1998 through 2007 in which the company paid the diabetic suppliers more than $3 million to switch their patients to Bayer's products from those manufactured by its competitors. The largest share of the kickbacks — $2.5 million — went to Liberty Medical Supply, according to the DOJ, which said they were based on the number of patients the company converted to Bayer products and were disguised as payments for advertising between 1998 and 2002. The settlement also covers $375,000 in alleged payments to 10 other diabetic suppliers. Bayer also agreed to a corporate integrity agreement with HHS' Office of Inspector General that will "enable OIG to closely monitor company practices affectng federal health care programs and beneficiaries," the DOJ said. "If medical device manufacturers want to serve Medicare beneficiaries they must follow the law," said Gregory G. Katsas, assistant attorney general for the DOJ's Civil Division. "Paying health care suppliers to place a particular brand of device with Medicare beneficiaries violates the law and will not be tolerated."
INDIANAPOLIS — Effective Monday, Jan. 5, 2009, the NGS Common Electronic Data Interchange Helpdesk will be open from 9:00 a.m. to 7:00 p.m. ET Monday through Friday. The CEDI Helpdesk number is 866/311-9184, or you can email NGS.CEDIHelpdesk@wellpoint.com
BALTIMORE — The transcript of the CMS ICD-10-CM/PCS National Provider Conference Call for Other Part A and Part B Providers that was held Nov. 12 is now available. Download the transcript PDF from CMS's Web site.
BALTIMORE — CMS has rolled out its new Internet-based Provider Enrollment, Chain and Ownership System, or PECOS, that lets physicians and other practitioners in 24 states and the District of Columbia enroll in Medicare, check on the status of an application or make a change in their enrollment information. CMS said next year, it will make the system available to all suppliers — except DMEPOS providers.
WASHINGTON — A New Jersey entrepreneur who tried to register his company's 9 mm Palm Pistol as a Class I medical device had his hopes shot down last week by the U.S. Food and Drug Administration. The Palm Pistol is a single-shot firearm designed for the elderly and disabled who "may have limited strength or manual dexterity," as described by Maplewood, N.J.-based Constitution Arms. The oval-shaped Palm Pistol fits in the palm of a hand with the barrel protruding out from between the fingers and, instead of a trigger, has a button that can be pushed with the thumb. According to press reports, company owner Matthew M. Carmel said the elderly and disabled are easy targets for criminals and the Palm Pistol could offer them some protection. When Carmel decided to start advertising to seniors, he contacted the FDA and was advised to register Constitution Arms as a medical device facility and list the Palm Pistol as a a "daily activity assist device." But after a flurry of press reports and Internet commotion, the FDA released a statement saying it had determined the product is not a medical device. Carmel said he is disappointed in the decision, but will continue to market the Palm Pistol. He's taking deposits for an initial production run on the company's Web site, which says the ATF has classified the gun as a "standard pistol."