In Brief

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 [email protected]

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.”