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Medicare News
Medicare Tightening Rules for Transplant Center
Approvals
Goal to ensure effective oversight of transplant
centers
March 23, 2007 Transplant centers will face
tighter acceptance regulations on approval of a final rule published
today at the Office of the Federal Registry by the Centers for Medicare
& Medicaid Services.
CMS) says the rule sets forth the requirements that
transplant centers must meet to participate in the Medicare program that
moves Medicare covered transplant programs toward an outcome-focused
system. (See more information below from KaiserNetwork.org.)
It will move Medicare-covered transplant programs
toward a system that reflects the clinical experience, resources and
commitment of the transplant program, according to CMS.
The rule contains comprehensive conditions of
participation for transplant programs serving Medicare beneficiaries.
It will ensure effective oversight of transplant
centers by advancing coordination between CMS, State survey agencies,
the Health Resources and Services Administration, the Organ Procurement
and Transplantation Network and the Scientific Registry of Transplant
Recipients.
This is a major milestone in our efforts to make
sure that people needing transplants get the best possible care, while
giving transplant centers and physicians comprehensive and reliable
guidance, said Leslie V. Norwalk, CMS acting administrator.
This rule both improves the current transplant
outcome measure requirements and strengthens the protection of the
health and safety of patients and living donors.
In recent decades, remarkable strides in
transplantation technology and pharmacology have turned organ
transplantation into a mainstream treatment for many patients in end
stage organ failure.
CMS issued coverage decisions related to heart
transplants in 1987, liver transplants in 1991, lung transplants in
1995, and intestine transplants in 2001 and updated in 2006. Kidney
transplant centers have been regulated in the Code of Federal
Regulations since 1976. This rule will consolidate all transplant
center requirements into one regulation.
All transplant centers that continue to participate
in Medicare, including kidney transplant centers, are required to submit
a request for initial approval. Once approved by Medicare, transplant
centers are eligible for re-approval every 3 years.
Transplant centers with current Medicare approval,
that have applied for initial approval within 180 days from the
effective date of the final rule may continue to provide transplant
services and receive payment from Medicare until CMS makes a decision on
the transplant centers request for approval.
CMS
Announces New Standards for Living Organ Donors
CMS on
Thursday announced new standards for organ donation
programs that would remove federal funding from failing
programs, the
Los Angeles Times
reports. The rules, which took two years to finalize,
aim to prevent "poor or marginal performers" from
receiving Medicare funding, according to a report that
accompanied the new rules. Under the new rules,
transplant programs would be required to do the
following to continue to receive funding:
-
Perform
an average of 10 transplants a year;
-
At least
match expected survival rates, accounting for the
national average and unique situations in programs
and patients;
-
Reveal to
potential recipients how many patients and organs
have survived or functioned at least one year after
surgery, along with how many were expected to do so;
-
Notify
patients in programs with only one transplant
surgeon that the surgeon might not be available at
the time of the transplant, in addition to stating
whether provisions have been made to find a
substitute surgeon (Weber/Ornstein, Los
Angeles Times, 3/23);
-
Use donor
advocates to inform living donors about medical and
psychological risks; the surgical procedure,
including post-operative treatment; and availability
of alternative treatments for the recipient;
-
Use donor
advocates to inform living donors that
donation-related future health problems might not be
covered by the donor's health insurance and that
they might have problems obtaining health,
disability or life insurance in coming years
(Meckler, Wall Street Journal, 3/23);
and
-
Immediately alert Medicare if the program is not
meeting these standards.
Under old
rules, which were not strictly enforced, heart and liver
centers were required to perform 12 transplants
annually; lung and intestine centers were required to
perform 10; and kidney centers had to perform 15
transplants within four years of opening. Centers also
had to meet set survival rates without taking into
account complicating factors. A Times
analysis determined that if the new rules were strictly
applied today, 64 transplant centers -- nearly 13% of
the nation's 500 programs -- would lose approval and
funding, including 29 centers for heart transplants, 21
for kidney, seven for liver, six for lung and one for
intestinal transplants.
Implementation
The CMS transplant rules will take effect in 90 days.
Centers will have six months to seek approval of their
programs, and those that do not meet the minimum
requirements will have a "reasonable time period" to
correct problems. Once approved, centers will be up for
review every three years. Medicare officials expect 2%
of centers, or 10 per year, to lose certification (Los
Angeles Times, 3/23). Leslie Norwalk, acting
administrator of CMS, said, "This is a major milestone
in our efforts to make sure that people needing
transplants get the best possible care" (Wall
Street Journal, 3/23).
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