In the Aug. 5 Federal Register, the Centers for Medicare
and Medicaid Services (CMS) announced its proposed implementation
of two HME provisions of last year's Medicare Modernization Act
(MMA). Part of a larger proposed regulation primarily affecting
physician services, the provisions propose (1) a requirement of a
face-to-face examination by the ordering physician before
prescribing power wheelchairs and other items, and (2) payment
methodology changes for 2005 based on average sales price (ASP) for
inhalation drugs.
Face-to-Face Exams
The law requires CMS to establish types of covered DME that
should require a prescription and face-to-face exam from a
physician or practitioner, and to apply this requirement to
motorized wheelchairs as of Dec. 8 last year.
The law also gives CMS authority to add items to the
requirement. And CMS did just that, proposing a face-to-face
examination by a physician, physician assistant, clinical nurse
specialist or nurse practitioner — independent from the
equipment supplier — to determine the medical necessity for
all durable medical equipment, prosthetics, orthotics and supplies
(DMEPOS). The exam should be sufficient to evaluate and treat the
patient's medical condition — and not be just for the sole
purpose of obtaining an order.
The proposed rule requires an order prior to delivery for all
DMEPOS, dated and signed within 30 days after the exam. The order
must include verification of the examination, and CMS is soliciting
comments on the appropriate verification process. The prescribing
physician or practitioner must also maintain appropriate and timely
documentation in the medical records that support the need for all
DMEPOS ordered.
The proposal also states that CMS would promulgate through
contractor instructions other criteria required for payment, such
as for prescription renewal requirements, repair, minor revisions
and replacement. The agency is seeking comments on whether it
should establish national renewal requirements or permit contractor
discretion.
Inhalation Drug Pricing
CMS anticipates that the first-quarter 2005 Medicare payment at
ASP plus 6 percent is estimated to be $0.04 per milligram for
albuterol sulfate and $0.30 per milligram for ipratropium bromide.
CMS states, “While these figures represent estimated
reductions from 2004 payment levels of about 90 percent, they are
not necessarily the actual payment amounts for the first quarter of
2005. The actual payment amounts will be based on ASPs calculated
from the manufacturer ASP to be submitted for the third quarter of
2004.”
CMS is proposing a separate dispensing fee for inhalation drugs
and is seeking specific comments about an appropriate dispensing
fee to cover “shipping, handling, compounding and other
pharmacy activities required to get these inhalation medications to
Medicare beneficiaries.”
The proposal also allows physicians to prescribe and for a
pharmacy to fill an inhalation drug order covering 90 days (the
current limit is a month's supply), and eliminates the requirement
that beneficiaries assign claims to suppliers in situations where
suppliers are already required to accept assignment. This would
eliminate the need for suppliers to obtain a signed Assignment of
Benefits form from a beneficiary.
Let the Dialog Begin
Comments on the proposals are due Sept. 24, with CMS planning to
issue a final regulation by the end of the year. Many comments
should be forthcoming. CMS realizes there are service costs
associated with inhalation drugs, and seeks comment on a
verification process for face-to-face exams.
The agency has thrown the ball in our court. So, let the dialog
begin.
To view CMS' proposed regulation and information on where to
send comments, visit
target="_blank">www.cms.gov/physicians.
A specialist in health care legislation, regulations and
government relations, Cara C. Bachenheimer is vice president,
government relations, for Invacare Corp., Elyria, Ohio.
Bachenheimer previously worked at the law firm of Epstein, Becker
& Green in Washington, D.C., and at the American Association
for Homecare and the Health Industry Distributors Association. You
can reach her by phone at 440/329-6226 or by e-mail at cbachenheimer@invacare.com.
