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Homecare Industry Rallying Support to Kill
Reconciliation Act
Senate bill going back to House for final vote
freezes pay rate at 2005 level
Jan. 22, 2006 – Among the most active in fighting
to kill the Budget Reconciliation Act is the American Association for
Homecare, the industry group for home health care providers and those
who use this service. Despite home health care being a popular option
with senior citizens and studies showing it can be the least costly way
to care for the elderly, the bill has several provisions that negatively
impact the service. The most critical is a freeze on their pay rate for
services from the Centers for Medicare and Medicaid Services.
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The pay rate was scheduled to increase 2.8 percent
for 2006, but will be frozen at 2005 levels by the bill, which is
expected to be considered by February 1. Since the bill has not been
approved, the rate increase did take effect on Jan. 1, 2006, and CMS
says until the bill is final, they do not know if this money will have
to be repaid.
"Homecare is the preferred by seniors, and homecare
is by far the most cost-effective setting for healthcare in America, as
HHS Secretary Leavitt has argued," says AAH on their Website.
"A cut to home health agencies is clinically and
fiscally unwise given its tremendous value to both patients and to
taxpayers."
This is just is the most important but only one of
the reasons, however, that AAH is opposing the bill (S. 1931), when it
returns to the House for a final vote. A compromise bill approved
earlier by the House was also approved by the Senate but due to
technical points raised by Senate Democrats, it has to be voted on again
in the House.
Another key objection is that the bill eliminates
the beneficiaries' option to continue to rent home medical equipment,
eliminating the capped-rental category, transferring title of the
equipment to the beneficiary after 13 months, and eliminating the
maintenance fee.
The bill also makes home oxygen equipment a
rent-to-purchase item, forcing transfer of ownership to beneficiaries
after 36 months, which AAH opposes.
"Beneficiaries choose to rent rather than purchase
this medical equipment because renting allows worry-free, professional
maintenance of complex medical equipment and lowers costs to seniors,"
says a message from AAH to members.
"Forcing seniors to take title of complex medical
equipment after a capped rental period is unfair and dangerous."
The association also says, "Oxygen equipment in
particular is critical to approximately one million Americans who suffer
from respiratory illnesses such chronic obstructive pulmonary disease
(COPD) and who require oxygen therapy. Oxygen is a federal legend drug
and the devices are prescription only. Transferring the burden of
maintenance and repair of sophisticated oxygen technologies to the
beneficiary presents a serious risk to patient safety and care."
The association says many state homecare
associations and homecare providers report that – when asked – homecare
beneficiaries are turning out in force to voice opposition to the budget
bill, S. 1932.
One example of beneficiary action AAH cites is from
Shawn M. Steffey of Respiratory Care Associates in Winchester, VA. He
reports that "they sent more than 400 letters to their beneficiaries
regarding the changes to oxygen policy in S. 1932."
As a result - “We are receiving three to five calls
per hour from patients either asking for more information about what to
say to their congressman or to tell us that they have called.
"For the most part, every patient we have heard
from is extremely opposed to the O2 cap. Several patients have told us
that the congressman’s office asked how they were getting this
information and that they were ‘unaware’ of this provision being in the
bill," reported Steffey.
"I am estimating that at least 50 to 75 of our
patients have called their congressman in the past three days. Imagine
the result if every member did the same thing. I truly believe that if
we can defeat this bill, it will only be through the voices of our
patients."
At the AAHomecare’s Website,
www.aahomecare.org are provided two sample letters that can be sent
to beneficiaries.
"While a number of Republicans in the House voted
against the bill the first time it was considered, it is vital to
convince additional Republicans to vote NO in the final up or down
vote," says the AAH message to members.
There is some benefit to the home health industry
in the bill. Despite proposing a freeze on the primary rates, it does
re-instate the rural add-on of 5 percent for 2006. The rural add-on
expired last April 1.
The Oxygen Proposal
An alarming provision in the bill for many seniors
is a new rent-to-purchase payment policy for home oxygen equipment after
36 months. Based on language in the bill, after a maximum 36 month
rental period, all home oxygen stationary and portable technologies will
be considered “purchased” and the title of the equipment and
responsibilities for the maintenance, service, and repair of the devices
transferred to the Medicare beneficiary.
"This is a drastic, unprecedented and inappropriate
shift," according to AAHomecare.
Oxygen cylinders and liquid vessels are the drug’s
container/closure. Oxygen concentrators and oxygen concentrators with
add-on compressor units are devices that - when properly serviced and
maintained - are used for the safe administration of medical oxygen,
says the association.
The list below identifies some of the key FDA
regulatory, patient, and public-safety issues that could result from the
forced conversion of medical oxygen administration devices to private
ownership.
Currently, medical oxygen can only be prescribed by
a physician specifically for individual patient use because it is a
drug. While oxygen has many therapeutic benefits, it can be dangerous if
not properly administered or used.
● With the transfer of ownership of the medical
device to the patient, the control over the dosage levels becomes the
patient’s responsibility and the opportunity of self medication to their
own detriment is increased significantly.
● Today many of the home oxygen patients are
prescribed liquid and/or high pressure oxygen to assist and enhance
their rehabilitation and mobility. Under the proposed legislation, the
use of liquid oxygen and high pressure cylinder oxygen may be greatly
diminished as viable modalities, and patients could be forced to accept
stationary systems as their only source.
● There is a potential for patients who may,
based on cost and/or ease of procurement, shift to industrial oxygen to
meet their needs.
Many Safety Issues Arise
● Ongoing patient education and monitoring
regarding oxygen usage and safety will no longer be performed, creating
the potential for unsafe use of oxygen (e.g., smoking while using
oxygen).
● The use of life enhancing medical oxygen
equipment is imperative to the overall well being of patients on oxygen
therapy. Homecare companies currently provide 24-hour on-call service
to assist patients with trouble shooting equipment malfunctions or
improper use. Lack of 24-hour on-call support will undoubtedly increase
patient visits to emergency rooms and the need for readmissions to
hospitals.
● Homecare companies would no longer perform
routine maintenance on concentrators and liquid oxygen systems after 36
months with potential detrimental effects to the patients (e.g.
equipment malfunction, low O2 percentage delivery, etc.). In addition,
once ownership of medical oxygen equipment is transferred to the
patient, homecare companies will no longer be able to assist the
equipment manufacturer with potential recalls.
● Once ownership has converted to the patient and
the patient expires, relatives may decide to dispose of cylinders
containing hazardous oxidizing material into the trash leading to
potentially unsafe conditions for the general public. These cylinders
may also be used by inexperienced, untrained, and unqualified
individuals in ways that are inappropriate and dangerous.
● Discarded medical equipment may find its way
back into service.
● Typical cylinder filling is currently performed
using a multi-cylinder manifold following cGMPs. Filling only one or a
few cylinders based on an individual patient request is not practical.
When patients take ownership of high pressure cylinders, the potential
exists for them to attempt to fill their own cylinders using one-to-one
cylinder filling. The supply cylinder may be industrial product. In
addition, the potential exists for non-compliant companies to arrive at
a patient’s doorstep and offer to fill his or her cylinder curbside
without following cGMPs (e.g., proper pre-fill inspections, evacuation,
testing, labeling, etc.).
● Additional concerns include hydrostatic
testing, product traceability, drug product labeling with the potential
for misbranding, chain of custody and control issues, and other
hazardous material concerns.
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