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CLIA [Clinical Laboratory Improvement Amendments]
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CLIA [Clinical Laboratory Improvement Amendments]
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Records of the Domestic Policy Council (Clinton Administration)
Jennifer Klein's Files
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11-08-95
12:46PM
FROM
COMM.
AGING
P002/005
O:\BAI\BAI95.B44
S.L.C.
1
PROPOSED AGREEMENT REGARDING CLINICAL
2
LABORATORIES
3 SEC. CLINICAL LABORATORIES.
4
(a) REGISTRATION OF CERTAIN LABORATORIES.-
5 Section 353 of the Public Health Service Act (42 U.S.C.
6 263a) is amended—
7
(1) in subsection (d)—
8
(A) in paragraph (2), to read as follows:
9
(2) REQUIREMENTS NOT APPLICABLE-A lab-
10
oratory which only performs laboratory examinations
11
and procedures described in paragraph (3) shall be
12
exempt from the requirements of registration and
13
certification under this section."; and
14
(B) by striking paragraph (4); and
15
(2) in subsection (m)(1), by striking "shall
16
only" and all that follows through the period and in-
17
serting "may not impose a fee for the issuance and
18
renewal of certificates of waiver.".
19
(b) PROVIDER PERFORMED MICROSCOPY TEST-
20 ING.-Section 353(d) of the Public Health Service Act (42
21 U.S.C. 263a(d)) (as amended by subsection (a)(1)) is fur-
22 ther amended by adding at the end thereof the following
23 new paragraph:
24
"(4) APPLICABILITY OF REQUIREMENTS TO
25
PROVIDER PERFORMED MICROSCOPY TESTING -
O:\BAI\BAI95.B44
S.L.C.
2
1
Notwithstanding any other provision of law, a lab-
2
oratory that is certified under this subsection and
3
that performs provider performed microscopy testing
4
shall be subject only to those requirements under
5
this section that the Secretary dotermines are rel-
6
evant to the examinations and procedures performed
7
by such laboratory."
"PERSONNEL STANDARDS - For purposes of determining qualified
laboratory personnel, purusant to the standards applicable to
such personnel under this section, the Secretary shall recognize
certifications provided to such personnel by private sector
certifying entities. Furthermore, the Secretary shall require,
withinn five years hereof, that all laboratory personnel demonstrate
their qualifications, pursuant to the standards applicable to
such personel under this section, by such certifcations from
private sector certifying entities or by an alternative qualification
as determined by the Secretary"
18
(d) PROFICIENCY TESTING.-Section 353(f)(3)(D) of
19 the Public Health Service Act (42 U.S.C. 263a(f)(3)(D))
20 is amended by adding at the end thereof the following new
21 sentence: "With respect to a laboratory that successfully
22 participates in three consecutive proficiency testing events
23 under this paragraph, the Secretary shall, at the request
24 of the laboratory, waive the next scheduled on-site inspec-
O:\BAI\BAI95.B44
S.L.C.
3
1 tion and permit the laboratory to complete a self-assess-
2 ment."
3
(e) CLARIFICATION OF NOTIFICATION REQUIRE-
4 MENTS.-Section 353(f) of the Public Health Service Act
5 (42 U.S.C. 263a(f)) is amended by adding at the end
6 thereof the following new paragraph:
7
"(5) CLARIFICATION OF NOTIFICATION RE-
8
QUIREMENTS.-
9
"(A) CHANGES IN METHODOLOGY.-With
10
respect to a laboratory that is certified under
11
this section, the Secretary may not require such
12
laboratory to provide notice to the Secretary of
13
any modifications in the methodology utilized
14
by the laboratory if such methodology does not
15
affect the specialities for which the laboratory is
16
certified or the complexity levels for which such
17
certification is provided.
18
"(B) TECHNICAL SUPERVISORS.-With re-
19
spect to a laboratory that is certified under this
20
section, the Secretary may not require such lab-
21
oratory to provide notice to the Secretary of
22
changes in the personnel who act as technical
23
supervisors at such laboratory.".
24
(f) INSPECTIONS.-Section 353(g)(1) of the Public
25 Health Service Act (42 U.S.C. 263a(g)(1)) is amended by
O:\BAI\BAI95.B44
S.L.C.
4
1 striking "on an announced or unannounced basis" and in-
2 serting "on an announced or, where the Secretary deter-
3 mines that public safety is in jeopardy, unannounced
4 basis".
5
(g) WAIVED TEST REGULATION.-Not later than
6 June 1, 1996, the Secretary of Health and Human Serv-
7 ices shall promulgate final regulations with respect to pro-
8 posed regulations concerning laboratory examinations and
9 procedures that are not subject to the requirements of sec-
10 tion 353 of the Public Health Service Act.
1995
Key Issues In Medicare Reform
The American Optometric Association
1505 Prince Street Suite 300
Alexandria, VA 22314
Phone: (703) 739-9200
FAX: (703) 739-9497
Optometrists understand and share Congress' commitment to slowing
down the cost growth of federal health care programs. As primary eye care pro-
viders, optometrists support systemic efforts to control costs while emphasizing
high quality care in Medicare and other federal health programs. As a profession
that has historically maintained relationships with individual patients who pay
for most of their care with out-of-pocket dollars, optometry also understands and
supports Congress' efforts to induce greater competition in Medicare through
reliance on expanded consumer choices and individual incentives to compare
costs.
However, for market forces to truly take hold in Medicare, Congress must
ensure that all providers are given the opportunity to compete fairly. And Con-
gress must take proactive steps to ensure that patients are given access to the full
spectrum of competing providers. Optometry does not seek broad mandatory
contracting requirements on health plans, as some "any willing provider" pro-
posals would require. However, to ensure that the transition to a more competi-
tive Medicare program goes smoothly, and to ensure that all providers can com-
pete on a level playing field in the reformed Medicare system, optometrists be-
lieve some basic standards of conduct are necessary. To ensure real and vigorous
competition, on both price and quality issues, the American Optometric Associa-
tion urges Congress to include provisions addressing the following three issues in
any bill establishing new "health plans" for Medicare recipients.
Provider
Congress should not allow any health plan to arbitrarily discriminate
against any provider based solely on academic degree, or license, or artificial
Nondiscrimination
guidelines such as hospital privileges, but should recognize and promote patient
access to the diverse mix of health providers which have been licensed by the
states under their traditional regulatory authority.
Anti-discrimination protections to prohibit plans from arbitrarily exclud-
ing whole classes of health professionals from their provider networks, would
respect the licensing authority of the states and protect duly licensed providers
and their patients from the unfair predatory contracting practices that have been
employed by some managed care plans in the past.
Nondiscrimination provisions to prevent these kinds of unfair practices
will help ensure that future Medicare patients have access to a greater range of
capable providers, and that they enjoy the benefit of the increased competition
that will result from the inclusion of a broader range of providers in the plan's
panel negotiations.
Key Issues In Medicare Reform
Access Standards
Minimum contracting standards to ensure that patients have access to an
for Health Plans
appropriate mix, number, and distribution of qualified practitioners are neces-
sary to protect patient's access to high quality health care. While a managed plan
must necessarily be able to restrict its pool of available providers, these minimum
access standards would ensure that patients have access to the full range of li-
censed health providers and that plans maintained sufficient provider capacity to
guarantee prompt access to care, regardless of a patient's place of residence, their
particular health needs, or the time of day.
Access standards requiring an appropriate mix, number and geographic
distribution of the full range of providers would also facilitate expanded patient
choice and greater competition between provider groups with overlapping clini-
cal authority.
Out-of-Network
Quality of care and patient choice could also be augmented by requiring
all plans to offer an "out-of-network option" for all covered services. While a
Service Option
recent study (Milliman and Robertson, Inc.; March 14, 1995) concluded that the
"inclusion of out-of-network coverage does not, in itself, either increase or
decrease claims costs", patients exercising this option could be required to a pay
a reasonable additional fee to help cover any additional related administrative
expense. In exchange, Medicare beneficiaries who respond to congressional in-
centives and enroll in managed care plans would be assured that they could al-
ways seek alternative care or continue to see a chosen provider if their expecta-
tions of a plan didn't materialize or the plan's panel of providers was later changed.
While many states have already gone far beyond these requirements and
implemented "any willing provider" laws which compel managed care plans to
contract with any provider who agrees to accept the plan's terms, this approach
emphasizes the patient's interests, and by allowing for an additional fee, responds
to the administrative concerns expressed by the managed care community.
An out-of-network option would also allow the full range of licensed
health providers to continue to compete for patients regardless of the
beneficiary's chosen health plan or the make-up of the plan's provider panel. If
a plan used predatory contracting strategies to acquire patient share, only to
later withhold care or reduce the size of its provider panel, this requirement
would ensure that patients had other viable options.
Given the popularity of plans with this feature in the private sector, and
the general apprehension about Medicare reform in the senior community, it
would seem that the inclusion of an out-of-network option requirement would
be a prudent way to gain increased support for Medicare reform, from provid-
ers and patients alike.
American Optometric Association
11/08/95 15:42 AOA/ALEXANDRIA -> 703 527 3830
NO.787 P011
DRAFT LETTER PLEASE REVISE AS APPROPRIATE
AND REWRITE ON PERSONAL LETTERHEAD
The Honorable Robert Dole:
Majority Leader
United States Senate
c/o Ms. Sheila Burke
Room S-230, U.S. Capitol
Washington, D.C. 20510
Dear Bob:
I hope the incredible schedule you're maintaining these days doesn't
completely drain you of all your good charm! We are all very proud of you
back home in Russell. And while I know you've never been busier, I hope I'll
get to see you back in the office sometime - at least before your second
inauguration! In the meantime, Dad and I wish you the best in the tough
months ahead. We will certainly continue to be here to help you and your
campaign in anyway we can.
The reason I'm writing today though is to bring to your attention some
very real and important concerns optometry has with the Medicare package now
pending in Congress. We fear that the current proposals would unnecessarily
restrict optometry's ability to continue serving Medicare patients, as we've
done effectively since you first helped US get included in the program back in
1987.
The problem is that many managed care companies do not currently include
optometrists in their provider panels. And despite the profession's
recognition under the traditional Medicare program, and our ever widening
scope of clinical authority under state law, our efforts to educate plan
administrators as to our abilities and secure positions on managed care panels
have often times been rebuffed.
The enclosed letter suggests what we are up against. Many plans simply
refuse to even consider including optometrists in their networks. As is the
case with the enclosed letter, it often times seems that this decision is made
for purely arbitrary reasons -- not on some justifiable economic basis. While
some of us believe this treatment is due in part to an inherent professional
bias on the part of these largely MD-dominated plans, there also seems to be a
lack of understanding of modern optometry's capabilities in the managed care
community. This has resulted in the widespread use of blased credentialing
requirements that disproportionately impact optometry.
11/08/95 15:42 AOA/ALEXANDRIA 703 527 3830
NO.787 P012
For instance, in some cases plans require every professional provider in
their panel to have admitting privileges at a hospital, even though this 1s
clinically unnecessary for the provision of primary eye care services. In
other cases, plans have required all applicants for their provider panels to
have DEA registration numbers, even though optometrists who are trained and
authorized to prescribe and administer a variety of medicines in their eye
health practices rarely need or are authorized to prescribe controlled
substances. In Kansas this situation got so bad we had to go to the state
legislature and get a law passed to ensure that DEA numbers could not be
misused in this unintended fashion.
While many of us understand and have accepted the fact that managed care
is here to stay, these kinds of biased credentialing requirements make it
impossible in many instances for US to even compete for managed care
contracts. As the enclosed letter demonstrates, when panel decisions are made
on these grounds, we rarely get a chance to discuss our comparative clinical
and economic attributes with plan managers.
Given this frustrating history with managed care, you can see why
optometry is concerned about the pending Medicare reform legislation. The
Republican plans to slow down cost growth in the system rely heavily on an
expanded use of managed care. After fighting for twenty years to get the
right to see Medicare patients, and spending more than twenty years expanding
our scope of practice and education to be able to effectively serve seniors
many primary eye health needs, optometry doesn't want to lose access to these
patients overnight.
What we need is some assurances that optometrists will be given a
legitimate chance to compete for spots on Medichoice plans' provider panels.
Ideally, we would like to see a requirement that plans include at least some
optometrists to provide primary eye care services for their enrollees. This
would not only ensure that seniors electing managed care options maintained
access to optometry, but it would help preserve the gains our profession made
when we became defined as physicians under the program in 1987.
Provisions that would prohibit MediChoice plans from excluding
optometrists based simply on their license or degree, or any of the other
arbitrary factors discussed earlier, are also essential. Our ability to
provide high quality, cost-effective care should be the only issue. As long
as plans refuse to consider our applications simply because we are not MDs,
this will not be the case. If nothing else, plans should at least be
required to justify their panel selection criteria to an independent third
party. This alone would help prompt plans to reconsider their current
contracting policies, and give US a better opportunity to be heard when we
approach plans and try to educate them as to our potential value as
cost-effective, primary eye care providers.
Unfortunately. as things stand now, the only certainty for optometry in
the current Medicare reform bill is that the opportunities we've traditionally
had through Medicare's fee-for-service program will be reduced. On the other
hand, the bill promises managed care an unprecedented opportunity to expand
its reach into the $160 billion Medicare market. Since managed care plans
only serve about 8% of the program's beneficiaries now, you can see why we are
so concerned about securing at least some assurances that we will be given a
fair and legitimate opportunity to compete for Medicare managed care contracts
In the future.
11/08/95
15:42
HOR/ALEXANDRIA
703
527
3830
NO. 787 P013
I understand the American Optometric Association has already been in
contact with you and many others in the Congress about this issue. They have
apparently offered some suggestions about how to resolve this problem. I am
sure there are other potential solutions as well. In any case, as an old
friend and supporter, I would ask that you personally consider this matter.
As you know, many optometrists have worked hard to support Republican
candidates across the country. Most do more than just write a check. Often
times we are the ones that host the fundraisers and volunteer our time and
energies at the grassroots level. Overall, I believe optometrists support and
more closely identify with the Republican party's agenda. And I would think
most will continue to do so regardless of the outcome of this one issue.
However, I know many have read about the concessions that were given to the
AMA, and believe that the proposed transformation of Medicare will make a very
wealthy and influential insurance community all the more so. All optometry
seeks is some equal consideration.
I realize you are extremely busy. But please, on behalf of my profession,
I ask you to use your position to help remedy this situation. Thank you very
much for taking the time to consider my concerns.
Most sincerely,
1597S
11/08/95 15:42 ADA/ALEXANDRIA -> 703 527 3830
NO.787 P014
in 531 1936
Preferred '95 03:20PM DRS MORRISONILEATHERS Plan 7705311936 of Georgia Pe1/1
A TakeCare Preferred Network
January 5, 1995
Bill Morrison, O.D.
1201 Sherwood Park Drive, NE
Gainesville, Gs 30501
Dear Dr. Morrison:
Thank you for your interest in Preferred Plan of Georgia. Our organization is always looking for
quality providers. However, PPOG does not accept applications from optometrist. We only
contract with ophthalmologist for eye conditions for our members.
IfI can be of any further assistance please feel free to give me a call at (800) 662-5665, ext. 230.
Dana Sincerely, Y Lalleriath
Dans Y. Galbresth
Provider Relations Representative
Your Partner in Managed Health Care
3150 Polcoders Bridge Road. Suire 210 Noreross. Casege 30021-1312
(404) **0-11e2
1-800-067-3065
11/08/95 15:41 AOA/ALEXANDRIA 703 527 3830
NO. 787 P004
American Optometric Association
1505 Prince Street Alexandria, VA 22314 (703) 739-9200
1
FAX: (703) 739-9497
MEMORANDUM
TO:
Rep. Bob Franks
FROM:
Chris Carey
DATE:
October 20, 1995
RE:
Medicare reform bill
Thank you for your willingness to sit down and listen to optometry's
concerns about the current Medicare package. Per your request. I've attached
the language we discussed on Tuesday. I'll try to briefly explain our reasons
for requesting these changes, and what we believe would be the practical
effects on MedicarePlus plans if these changes were adopted.
First, the second part of our proposed amendment would simply say a plan
could not deny a provider the right to participate in the plan's panel simply
because of their license or certification under state law. Currently,
although our members are legally authorized to provide primary eye care
services under state medical practice acts, many plans simply refuse to even
consider an O.D.'s application for participation in their panel. From the
rejection letters and reasoning given to interested optometrists in many
regions, it seems this decision is made on a purely aribitrary basis. In
fact, reports from our members indicate that inquiries rarely even proceed to
a discussion of fees. While this language by itself would not prevent a plan
from excluding or limiting their provider panels on other legitimate business
or clinical grounds, we believe it would force plans to reevaluate their
credentialling policies, and prevent any competing health profession who
influences a plan's contracting decisions from using the rubric of managed
care to unlawfully boycott optometrists.
The first paragraph of the proposed amendment would give some teeth to the
anti-discrimination language discussed above. As we discussed, it is not an
any-willing-provider proposal. However, it would require a plan to include a
diverse mix of providers In their panels. Presumably, this would require a
plan to include at least some optometrists (but not all who apply). While we
understand and acknowledge your concerns about this being perceived as a
mandate. we think It is not only necessary to give optometrists a real
opportunity to compete for managed care contracts. but also warranted in light
of the new anti-trust protections the bill proposes giving to those
responsible for assembling the provider panels for the new MedicarePlus plans.
Headnuarters. 747 N Rlvd St Louis MO 63141 (314) 991-4100 FAX: (314) 991-4101
POUS
As we discussed, if a plan's medical director or another group of
influential providers in the plan's panel would seek to exclude optometrists,
clearly for anti-competitive reasons, the application of a "rule of reason"
standard for any suit challenging this conduct would put our members at a
considerable disadvantage. In protracted litigation, we believe the
comparatively deeper pockets of our chief competitors, MD-degreed
opthalmologists, would make the use of litigation in this area implausible.
As Dr. Wolbransky mentioned, competing MD's and OD's are already working
collaboratively in Medicare today. The requirement that plans include a
diverse mix of providers would help ensure that these kinds of competitive and
open practice patterns continue to develop in the future.
Finally, let me again thank you for your willingness to listen to our
concerns. As a profession that tends to identify more closely with the
Republican party, optometry has largely supported the Republican party's
overall efforts to reform Medicare. And many of members will undoubtedly
remain active supporters of Republican legislators In Washington, and back
home in the states. However, as things stand now, the only certainty for
optometry in the current Medicare reform bill is that the reimbursements
they've traditionally received through the fee-for-service program will be
reduced. Since managed care plans only serve about 8% of the program's
beneficiaires now, you can see why optometry is concerned about securing at
least some assurances that they will be given a fair and legitimate
opportunity to compete for managed care contracts in Medicare's future.
I've enclosed a copy of our letter to Speaker Gingrich regarding these
issues for your review. I hope this is helpful in further explaining our
concerns. I look forward to working with your office on this matter in the
days ahead. Again, thank you for listening.
11/08/95 15:41 AOA/ALEXANDRIA -> 703 527 3830
NO.787 P006
AMENDMENT TO H.R. 2485/MEDICARE FLOOR MARK
Page 20, strike line 34, and insert the following therein --
"(A) the organization establishes and maintains adequate arrangements with
a sufficient number, mix, and distribution of health professionals and
providers to assure that such benefits are made available"
Page 20, line 54, strike "." and insert therein, ";, and", and following
subsection (D), insert the following new subsection --
"(E) the organization does not deny any health care professional, based
solely on the professional's license or certification as applicable under
State law, the ability to participate In providing benefits under the product,
or be reimbursed or indemnified for providing such benefits."
15775
11/08/95
15:42
AOA/ALEXANDRIA
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527
3830
NO. 787 P007
F:\95REC\MCARE\REP\FLOOR\H2425.FLR
Subtitle 4, Part 1
20
"PATIENT PROTECTION STANDARDS
"SEC. 1853. (a) DISCLOSURE TO ENROLLEES.- MedicarePlus
organization shall disclose in clear. accurate, and standardized
form. information regarding all of the following for each
MedicarePlus product it offers:
"(1) Benefits under the MedicarePlu product offered, in-
cluding exclusions from coverage and. if it is a high deductible/
medisave product, a comparison of benefits under such a prod-
uct with benefits under other MedicarePlus products.
"(2) Rules regarding prior authorization or other review re-
quirements that could result in nonpayment.
"(3) Potential liability for cost-sharing for out-of-network
services.
"(4) The number, mix, and distribution of participating
providers.
"(5) The financial obligations of the enrollee, including pre-
miums, deductibles, co-payments, and maximum limits on out-
of-pocket losses for items and services (both in and out of net-
work).
"(6) Statistics on enrollee satisfaction with the product and
organization. including rates of reenrollment.
"(7) Enrollee rights and responsibilities, including the
grievance process provided under subsection (f).
"(8) A statement that the use of the 911 emergency tele.
phone number is appropriate in emergency situations and an
explanation of what constitutes an emergency situation.
"(9) A description of the organization's quality assurance
program under subsection (d).
Such information shall be disclosed to each enrollee under this part
at the time of enrollment and at least annually thereafter.
-(b) ACCESS TO SERVICES.-
"(1) IN GENERAL. MedicarePlus organization offering a
MedicarePlus product may restrict the providers from whom
the benefits under the product are provided so long as-
-(A) the organization makes such benefits available
and accessible to each individual electing the product with.
insert capacity languag
in the product service area with reasonable promptness
here; paragraph
and in a manner which assures continuity in the provision
of benefits;
-(B) when medically necessary the organization makes
such benefits available and accessible 24 hours a day and
7 days a week:
"(C) the product provides for reimbursement with re-
spect to services which are covered under subparagraphs
(A) and (B) and which are provided to such an individual
other than through the organization, if-
"(i) the services were medically necessary and im-
mediately required because of an unforeseen illness.
injury, or condition. and
"(ii) it was not reasonable given the circumstances
to obtain the services through the organization: and
"(D) coverage is provided for emergency services (as
defined in paragraph (4)) without regard to prior author.
ization or the emergency care provider's contractual rela-
tionship with the organization/(;, and)
insert non-discriminati
"(2) MINIMUM PAYMENT LEVELS WHERE PROVIDING POINT.
OF-SERVICE COVERAGE If a MedicarePlus product provides
language paragraph
benefits for items and services (not described in paragraph
(1)(C)) through a network of providers and also permits pay.
ment to be made under the product for such items and services
not provided through such a network. the payment level under
the product with respect to such items and services furnished
outside the network shall be at least 70 percent (or. if the ef-
fective cost-sharing rate 15 50 percent, at least 40 percent) of
the lesser of-
Ortober 17 1004
SAME LETTER SENT TO HOUSE AND SENATE LEADERSHIP (List Attached)
BC:FRC BC:
American Optometric Association
1505 Prince Street Alexandria, VA 22314 (703) 739-9200
FAX: (703) 739-9497
October 12, 1995
The Honorable Newt Gingrich
Speaker
U.S. House of Representatives
Room H-230, U.S. Capitol
Washington, D. C. 20515
Dear Speaker Gingrich:
The American Optometric Association commends you for taking a leading role
in the ongoing efforts in Congress to reform and restore the short-term
solvency of the federal Medicare program. As Medicare providers, we
appreciate and share your commitment to slowing the rate of increase in the
program's annual costs, so that we can protect and preserve the system for
future generations.
More importantly, as a profession that continues to provide the bulk of
the nation's primary eye care through a variety of private payment
arrangements. we welcome Republican proposals to open up Medicare and provide
Medicare enrollees with the same kinds of coverage options privately insured
Americans now enjoy. We share your belief that the introduction of
competition between providers and between competing health plans will enable
Medicare to serve our nation's seniors in a more responsive and more
cost-effective manner.
Nonetheless, we are writing you today to express our deep concerns about
several features of the reform bills now being considered in Congress. We
believe these bills, as currently written, will only serve to stifle
competition and unnecessarily harm the interests of our patients and our
profession. We urge you to consider our concerns and appropriately remedy the
following inadequacies with the Medicare reform packages that were just
recently reported out of committee.
1) Provider Non-Discrimination.
While both the House and the Senate bills envision the migration of
millions of seniors to new managed care plans, neither bill provides
sufficient safeguards to protect against inter-professional discrimination or
collusive credentialling practices by plan administrators. The omission of
significant due process standards to protect providers once they join a plan,
and the failure to require plans to include an objectively determined number,
mix, and distribution of appropriately licensed health professionals in their
provider panels, invites abuse and threatens the patient's ability to select
and maintain relationships with providers of their liking.
Headquarters: 243 N. Lindbergh Blvd. St. Louis, MO 63141 (314) 991-4100 FAX: (314) 991-4101
11/08/95
15:42
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NO. 787 P009
-2-
As they have done in recent years, Medicare managed care plans would be
free to contract widely with a diverse and well distributed collection of
providers initially, to gain market share, then pare back their panels later
in an effort to reduce administrative costs and deter the enrollee's ready
access to and utilization of services. While optometry has proven its ability
to provide cost effective eye care and market our services directly to
fee-for-service and self-paying, non-insured patients, under the current
proposals there is no mechanism to ensure that we could negotiate in good
faith for contracts with MedicarePlus organizations.
The combination of enrollment incentives, toothless due process and access
requirements, and limitations on disenrollment, suggests that plans could
easily lure many of our current senior patients into their networks, then
arbitrarily restrict them from continuing to see us down the road. Although
we know that we could continue to provide high-quality care as participating
members of these plans' provider panels, our experience with managed care to
date has convinced US that our clinical abilities and cost-effectiveness alone
are often not enough to secure a spot on a plan's panel.
In fact, even though we are as accustomed to practicing primary eye care,
and more numerous and more widely distributed than our chief competitors,
MD-degreed ophthalmologists, we are often precluded from even applying for
participation In many plans. Very simply, as it stands today. despite our
authority under state law to practice primary eye care, many managed care
companies refuse to even talk to optometrists when forming their provider
panels. These discriminatory policies are not a result of economics or the
so-called market at work, as fees are never even discussed or compared. The
only plausible explanation for this reality seems to be professional bias on
the part of the plan. Not coincidently we feel, the medical directors who
control clinical policy decisions and many of the board members of these
organizations are medical doctors.
To prevent Medicare reform from becoming a vehicle for the codification of
these kinds of anti-competitive practices, and to ensure that Medicare
patients aren't unnecessarily forced to change providers, we ask that you
place: some specific provider non-discrimination and panel capacity
requirements on MedicarePlus plans. While we understand that the concept of
managed care necessarily requires plans to restrict the number of providers
they utilize, plans should not be allowed to arbitrarily prohibit an entire
class of licensed health care professionals from participating in their
networks. Without the inclusion of prospective due process protections that
would require plans to justify their contracting decisions to an independent
arbitrator, the proposals' current provisions pertaining to "access standards"
for MedicarePlus plans are inadequate to prevent the continuation of this
inter-professional discrimination. In fact, by clearly stating that a plan
could restrict the providers in its panel, without spelling out any
limitations or conditions on the exercise of this privilege, the legislation
your party has proposed would only serve to sanction these discriminatory
practices throughout the Medicare market.
11/08/95 15:42 A0A/ALEXANDRIA 703 527 3830
NO.787 P010
-3-
In order to retain the good will and continued support for Medicare
reforms in the optometric community, we respectfully request that you insert
some meaningful non-discrimination protections in the bill before proceeding
to floor votes. Many of our member optometrists have already contacted you
and your colleagues to explain the importance of these provisions to them
personally. We would be happy to bring in additional doctors of optometry to
describe the obstacles they currently face in this regard if you so desired.
2) Anti-trust Exemptions for Provider Service Organizations.
Finally, in light of the preceding discussion on the need for
non-discrimination provisions, we ask that you reconsider your proposal to
provide "provider service organizations" special treatment under the
anti-trust laws. As other consumer and competing Insurance groups have
already pointed out, the recent proliferation of physician sponsored health
plans in the market and the dearth of anti-trust enforcement actions taken
against such plans to date makes the need for these exemptions specious at
best.
What is clear, however, is the fact that these proposed changes would
greatly strengthen organized medicine's already significant advantages over
other licensed health professionals. If enacted, these provisions would
insulate PSN's from effective anti-trust scrutiny, as any public or private
complaint about a PSN's pricing or contracting practices (with regard to a
MedicarePlus product) would be destined to result in extended litigation under
a rule of reason analysis. Given the comparatively deeper pockets of MDs,
other health professionals, such as optometrists, would essentially lose the
one tool they now have at their disposal to enforce the rules of fair
competition. The most disturbing language concerns the protection, from per
se review, of conduct taken by a plan or by its individual member providers in
the establishment of the plan's panel. This amounts to an open invitation for
MD-dominated PSNs to boycott other competing health professionals. And given
the current omission of prospective non-discrimination contracting standards,
and our profession's collective experience with managed care products now on
the market, we believe many plans will seize this opportunity to protect their
own.
Fortunately, the Leadership still has time to correct these flaws before
the Medicare package is brought to the floor for a vote. We too want to make
this bill "better and better" as it moves through the legislative process. We
hope that you will work with us to do Just that with regard to these two very
critical issues for optometry. We look forward to hearing from you soon.
Sincerely,
Jeffrey Jeff May G. Mays
Washington Office Director
JM:cc
1575S/1579S
News
acr
from: AMERICAN COLLEGE OF RADIOLOGY
Contact:
Michael J. Bernstein
(703) 648-8910
For Release:
Keri J. Sperry
(703) 648-8912
October 30, 1995
Radiology Association Says Weakening Self-Referral Law
Hurts Patients, Wastes Money
The American College of Radiology (ACR) opposes the provisions passed
in the House of Representatives Medicare reform bill that remove the limits on
physician self referral because patients deserve better.
The ACR is a major national medical specialty association composed of
about 30,000 radiologists, radiation oncologists and radiological physicists.
The ACR has long held that physician self-referral arrangements lead to
inappropriate utilization of medical services and that the justification for
development of these abusive and unethical arrangements is largely contrived.
Studies from prestigious scientific publications, such as the New England
Journal of Medicine and the Journal of the American Medical Association, have
repeatedly found that where referring physician arrangements exist, the normal
economic forces of competition do not apply. The ACR believes these
investigations clearly show that this type of market control has led to increased
utilization and higher prices.
In addition to the ethical concerns, the Congressional Budget Office (CBO)
estimates that these proposed changes will cost taxpayers $400 million over
seven years. Combined with another provision that weakens the government's
ability to prosecute fraud and kickback scams, CBO has estimated that the overall
cost will be $1.1 billion.
Many groups oppose these self-referral practices, including the American
Medical Association. The AMA's current ethical policy states that "in general,
physicians should not refer patients to a health care facility which is outside their
office practice and at which they do not directly provide care or service when
they have an investment interest in that facility." Unfortunately, despite its
ethical policy, the AMA has supported the legislation to weaken self-referral
laws.
The ACR strongly believes that exploitive and unethical practices should
not be condoned under the guise of competition or deregulation. Easing limits
on self referral will waste tax dollars and ultimately hamper rather than
encourage competition.
Patients deserve better. Provisions to weaken self referral laws must be
opposed.
NOV- 2-95 THU 12:21
ACR
FAX NO. 703 391 0397
P.06
Rationale for Amending "NEW EXCEPTION FOR SHARED FACILITY SERVICES"
While stripping the shared facility services exception found in the House bill
is preferred for the conference report, the following changes to this section
would be a must inclusion to prevent huge - "747 variety" - loopholes that
would allow abusive arrangements to proliferate. Physicians and business
entrepreneurs will undoubtedly attempt to use any such exception to permit
joint ventures that have been properly excluded to date the current self-
referral laws. These changes to the House proposal should help to curtail
those who will attempt to abuse any shared facility exception.
The most telling omission in the House's current legislation is the fact that a
shared facility is permitted even when the medical building contains other
facilities providing the same services. The language noted under the general
section for "shared facility services" would eliminate this loophole.
In addition, the definition of "shared facility" needs to incorporate language
specifying that a "shared facility" should be a separate legal entity, in which
revenues are shared in a manner that does not take into account the volume
or value of referrals made by the shared facility physicians.
Finally, it is extremely important that any shared facility exception to the
physician self-referral laws not supersede the current kickback statute.
Consequently, incorporated by reference are the requirements for space and
equipment rental and lease revisions in the kickback act and for the "sale of
practice" provision of the "safe harbor" regulations for the kickback act as
promulgated by HHS.
NOV- THU 12:21
HCR
FAX NO. 703 391 0397
P.07
AMENDMENT OFFERED BY
FOR H.R. 2425
Beginning on Page 224, line 18, and ending on page 227,
line 10, to amend as follows:
(d) NEW EXCEPTION FOR SHARED FACILITY SERV-
ICES.-
(1) IN GENERAL.-Section 1877(b) (42 U.S.C.
1395nn(b)), as amended by section 15201(b)(3)(C), is
amended—
(A) by redesignating paragraphs (4)
through (7) as paragraphs (5) through (8); and
(B) by inserting after paragraph (3) the
following new paragraph:
"(4) SHARED FACILITY SERVICES.-In the case of
a designated health service consisting of a shared facility
service of a shared facility-
"(A) that is furnished—
"(i) personally by the referring physi-
cian who is a shared facility physician or
personally by an individual directly em-
ployed or under the general supervision of
by such a physician,
NOV c-95 THU 10.00
HCR
FAX NO. 703 391 0397
P.08
?
"(ii) by a shared facility in a building
in which the referring physicians furnishes
substantially all of the services of the phy-
sician that are unrelated to the furnishing of
shared facility services, and where the
building contains no other facility providing
the same services, and
"(iii) to-a only to patients of a shared
facility physician; and
"(B) that is billed by the referring
physician or a by the group practice of which the
physician is a member.".
(2) DEFINITIONS.-Section 1877(h) (42 U.S.C.
1395nn(h)), as amended by section 15201(b)(6), is
amended by inserting before paragraph (4) the fol-
lowing new paragraph:
"(1) SHARED FACILITY RELATED DEFINI-
TIONS.-
"(A) SHARED FACILITY SERVICE-The
term 'shared facility service' means, with re-
spect to a shared facility, a designated health
service furnished by the facility to patients of
shared facility physicians.
"(B) SHARED FACILITY.-The term
'shared facility' means an a separate legal entity,
including but not limited to a corporation,
partnership. professional corporation, faculty
NUV- 2-95 THU 12:22
ACK
FAX NO. 703 391 0397
P.09
3
practice plan, or similar entity that furnishes
shared facility services under a shared facility
arrangement.
"(C) SHARED FACILITY PHYSICIAN.-The
term 'shared facility physician' means, with
respect to a shared facility, a physician (or a
group practice of which the physician is a mem-
ber) who has a financial relationship under a
shared facility arrangement with the facility.
"D) SHARED FACILITY ARRANGEMENT.-
The term 'shared facility arrangement' means,
with respect to the provision of shared facility
services in a building, a financial arrange-
ment-
"(i) which is only between physicians
who are providing services (unrelated to
shared facility services) in the same build-
ing,
"(ii) in which the overhead expenses
of the facility are shared, in accordance
with methods previously determined by the
physicians in the arrangement, and where
revenues are shared in a manner that does
not take into account the volume or value
of referrals made by the shared facility
physicians. among the physicians in the
arrangement,and
NUV- 2-95 THU 12:23
ACR
FAX NO. 703 391 0397
P. 10
4
"(iii) which, in the case of a corpora-
tion, is wholly owned and controlled by
shared facility physicians,
"(iv) which meets the space and
equipment rental and lease provisions set
forth in section 1877(b) (42 U.S.C.
1395nn(e)(1)(A) and (B)), and
"(v) which, when one or all of the
shared facility physicians cease to maintain
their medical practices or no longer are
members of the group practice, is sold or
transferred in accordance with the "sale of
practice" regulations set forth at 42 CFR
Part 1001.".
NOV- 2-95 THU 12:23
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FAX NO. 703 391 0397
P. 11
224
1
"(E) with a contract with a State to pro-
2
vide services under the State plan under title
3
XIX (in accordance with section 1903(m)) or a
4
State MediGrant plan under title XXI; or
5
"(F) which is a MedicarePlus organization
6
under part C or which provides or arranges for
7
the provision of health care items or services
8
pursuant to a written agreement between the
9
organization and an individual or entity if the
10
written agreement places the individual or en-
11
tity at substantial financial risk for the cost or
12
utilization of the items or services which the in-
13
dividual or entity is obligated to provide, wheth-
14
er through a withhold, capitation, incentive
15
pool, per diem payment, or any other similar
16
risk arrangement which places the individual or
17
entity at substantial financial risk.".
18
(d) NEW EXCEPTION FOR SHARED FACILITY SERV-
19 ICES.--
20
(1) IN GENERAL-Section 1877(b) (42 U.S.C.
21
1395nn(b)), as amended by section 15201(b)(3)(C),
22
is amended-
23
(A) by redesignating paragraphs (4)
24
through (7) as paragraphs (5) through (8); and
HR 2425 RFS
NOV- 2-95 THU 12:24
ACR
FAX NO. 703 391 0397
P. 12
225
1
(B) by inserting after paragraph (3) the
2
following new paragraph:
3
"(4) SHARED FACILITY SERVICES.-Jn the case
4
of a designated health service consisting of a shared
5
facility service of a shared facility-
6
"(A) that is furnished-
7
"(i) personally by the referring physi-
8
cian who is a shared facility physician or
9
personally by an individual directly em-
10
ployed or under the 5g neral supervision of
11
such a physician,
12
"(ii) by a shared facility in a building
13
in which the referring physician furnishes
14
substantially all of the services of the phy-
15
sician that are unrelated to the furnishing
16
of shared facility services, and
17
"(iii) to a patient of a shared facility
18
physician; and
19
"(B) that is billed by the referring physi-
20
cian or a group practice of which the physician
21
is a member.".
22
(2) DEFINITIONS.-Section 1877(h) (42 U.S C
23
1395nn(b)), as amended by section 15201(b)(6), is
24
amended by inserting before paragraph (4) the fol-
25
lowing new paragraph:
HR 2425 RFS
NUV- 2-95 THU 12:24
ACR
FAX NO. 703 391 0397
P. 13
226
1
"(1) SHARED FACILITY RELATED DEFINI-
2
TIONS.-
3
"(A) SHARED FACILITY SERVICE.-The
4
term 'shared facility service' means, with re-
5
spect to a shared facility, a designated health
6
service furnished by the facility to patients of
7
shared facility physicians.
8
"(B) SHARED FACILITY.-The term
9
'shared facility' means an entity that furnishes
10
shared facility services under a shared facility
11
arrangement.
12
"(C) SHARED FACILITY PHYSICIAN.-The
13
term 'shared facility physician' means, with re-
14
spect to a shared facility, a physician (or a
15
group practice of which the physician is a mem-
16
ber) who has a financial relationship under a
17
shared facility arrangement with the facility.
18
"(D) SHARED FACILITY ARRANGEMENT.
19
The term 'shared facility arrangement' means,
20
with respect to the provision of shared facility
21
services in a building, a financial arrange-
22
ment-
23
"(i) which is only between physicians
24
who are providing services (unrelated to
HR 2425 RFS
NUV- 2-95 THU 12:25
ACK
FAX NO. 703 391 0397
P. 14
227
1
shared facility services) in the same build-
2
ing,
3
"(ii) in which the overhead expenses
4
of the facility are shared, in accordance
5
with methods previously determined by the
6
physicians in the arrangement, among the
7
physicians in the arrangement, and
8
"(iii) which, in the case of a corpora-
9
tion, is wholly owned and controlled by
10
shared facility physicians.".
11
(e) NEW EXCEPTION FOR SERVICES FURNISHED IN
12 COMMUNITIES WITH No ALTERNATIVE PROVIDERS.-
13 Section 1877(b) (42 U.S.C. 1395nn(b)), as amended by
14 section 15201(b)(3)(C) and subsection (d)(1), is amend-
15 ed-
16
(1) by redesignating paragraphs (5) through
17
(8) as paragraphs (6) through (9); and
18
(2) by inserting after paragraph (4) the follow-
19
ing new paragraph:
20
"(5) No ALTERNATIVE PROVIDERS IN AREA.-
21
In the case of a designated health service furnished
22
in any area with respect to which the Secretary de-
23
termines that individuals residing in the arca do not
24
have reasonable access to such a designated health
25
service for which subsection (a)(1) does not apply.".
HR 2425 RFS-8
NOV- 2-95 THU 12:19
ACR
FAX NO. 703 391 0397
P.03
AMENDMENT OFFERED BY
FOR H.R. 2425
Page 220, Strike line 1 through page 220, line 4, and
insert the following:
"(C) Outpatient physical or occupational
therapy services.
"(D) Radiology and other diagnostic services.
"(E) Radiation therapy services.".
Page 220, Strike line 11 and all that follows through
Page 220, line 20.
NOV- 2-95 THU 12:19
ACR
FAX NO. 703 391 0397
P.04
219
1
(C) in paragraph (2), by striking "or who
2
have such a compensation relationship with the
3
entity".
4
(6) In subsection (h)-
5
(A) by striking paragraphs (1), (2), and
6
(3);
7
(B) in paragraph (4)(A), by striking
8
clauses (iv) and (vi);
9
(C) in paragraph (4)(B), by striking
10
"RULES.--" and all that follows through "(ii)
11
FACULTY" and inserting "RULES FOR FAC-
12
ULTY"; and
13
(D) by adding at the end of paragraph (4)
14
the following new subparagraph:
15
"(C) MEMBER OF A GROUP.-A physician
16
is a 'member' of a group if the physician is an
17
owner or a bona fide employee, or both, of the
18
group.".
19 SEC. 15202. REVISION OF DESIGNATED HEALTH SERVICES
20
SUBJECT TO PROHIBITION.
21
(a) IN GENERAL-Section 1877(h)(6) (42 U.S.C.
22 1395nn(h)(6)) is amended by striking subparagraphs (B)
23 through (K) and inserting the following:
24
"(B) Parenteral and enteral nutrients,
25
equipment, and supplies.
HR 3425 RFS
NOV- 2-95 THU 12:20
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FAX NO. 703 391 0397
P.05
220
1
"(C) Magnetic resonance imaging and
2
computerized tomography services.
3
"(D) Outpatient physical or occupational
4
therapy services.".
5
(b) CONFORMING AMENDMENTS.-
6
(1) Section 1877(b)(2) (42 U.S.C.
7
1395nn(b)(2)) is amended in the matter preceding
8
subparagraph (A) by striking "services" and all that
9
follows through "supplies)-" and inserting "serv-
10
ices-".
11
(2)
Section
1877(h)(5)(C)
(42
U.S.C.
12
1395nn(h)(5)(C)) is amended—
13
(A) by striking ", a request by a radiolo-
14
gist for diagnostic radiology services, and a re-
15
quest by a radiation oncologist for radiation
16
therapy," and inserting "and a request by a ra-
17
diologist for magnetic resonance imaging or for
18
computerized tomography", and
19
(B) by striking "radiologist, or radiation
20
oncologist" and inserting "or radiologist".
21 SEC. 15203. DELAY IN IMPLEMENTATION UNTIL PROMUL-
22
GATION OF REGULATIONS.
23
(a) IN GENERAL-Section 13562(b) of OBRA-1993
24 (42 U.S.C. 1395nn note) is amended—
HR OACK DES
10-20-95
OFFICE OF LEGISLATIVE &
INTER-GOVERNMENTAL AFFAIRS
FAX COVER SHEET
# of Pages: Cover + 26
DATE: 10/20/95
TO:
FROM:
Chris Jennings
Joan striber
Peter Hickman
HCFA/OLIGA HCFA/ OLIGA
Fax: (202) 456-7431
Fax:
(202) 690 - 8168
Phone: (202)456-5560
Phone: (202) 690 - 6884
REMARKS:
Attached makerial on CL/A:
I
Example Deficiencies and implications for
Patients 17 page 5)
2
HHS briefing package on CLIA ( fact
sheets + charts) (13 pages)
I
myths 1. Facts about CLIA (distoributed
by Reg Dingell's office) (6 pages)
HEALTH CARE FINANCING ADMINISTRATION
Washington, D.C.
PU2
THE CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 (CLIA)
AND PHYSICIAN OFFICE LABS (POLs)
EXAMPLE DEFICIENCIES AND IMPLICATIONS FOR PATIENTS
The following examples are taken from reports by CLIA surveyors, describing
actual deficiencies found in POLs. These examples represent common problems In
POLs, discovered through CLIA surveys and proficiency testing. Many of these problems
would have gone undetected without CLIA and would likely reappear if CLIA is repealed.
Congress is currently considering legislation that would exempt POLs from all CLIA
requirements (except for Pap smears).
IMPROPER STORAGE OF TEST SPECIMENS AND MATERIALS
Example 1:
Spacimens collected for gonorrhea cultures were stored in a refrigerator or freezer
for up to 30 days. However, gonorrhea bacteria are very sensitive to cold and will
die if kept below body temperature. If handled properly, the specimens would
have been placed in a special medium so that the test process would begin
immediately. No positive test results for gonorrhea were reported by this
laboratory.
Implication for patients: Possible complications from undetected and untreated
gonorrhea include sterility, pelvic inflammatory disease, urethritis, amniotic
Infection syndrome, and premature births. Untreated infections may also lead to
further spreading of the disease.
Example 2:
All chemistry specimens for an enzyme test were frozen for up to two weeks. The
laboratory ignored the test instructions, which warned that freezing specimens
would cause falsely low test values.
Implication for patients: Physicians use enzyme tests to screen for heart disease,
liver disease, and muscular and bone disorders. A falsely low value for a cardiac
(heart) enzyme can result in failure to detect a heart attack. A false liver enzyme
level may conceal hepatitis, cirrhosis, congestive heart failure, pancreatitis, or
infectious mononucleosis. In each case, inaccurate testing may result in failure to
provide appropriate treatment for these serious conditions.
Example 3:
A lab refrigerated specimens for rapid strep testing for four days before the test
was performed. However, the instructions for the test used by this laboratory
warned that specimens should be refrigerated for no more than three days before
testing.
implication for patients: Rapid strep tests are used to confirm suspected
streptococcus A infections ("strep throat"). Failure to perform the test promptly
defeats the purpose of the "rapid" test, which allows treatment with antibiotics to
begin immediately. Using specimens that are too old to be properly tested may
also cause inaccurate results. Failure to detect and treat a contagious strep
infection (due to a "false negative" result) may allow the infection to spread, and
can lead to rheumatic heart disease. Inappropriate use of antibiotics (due to a
Yalse positive" result) can also affect patients' health, and may facilitate the growth
of drug-resistant bacteria, which present a serious public health problem.
Example 4:
The instructions for a hemoglobin A1C test specified that specimens are stable
for up to seven days, If refrigerated. However, when Interviewed, a lab's staff
stated that specimens are stable for 8-10 days. Testing in this laboratory was
completed within 10-12 days.
Implication for patients: Hemoglobin A1C tests are commonly used to monitor
diabetic patients, providing physicians a measure of the patient's blood glucose
(sugar) level over a period of time. This information is used to help determine the
patient's insulin dosage. If specimens are not tested within the test manufacturer's
recommended time, the results may be falsely low, affecting the patient's
treatment. Inappropriate treatment for diabetes (e.g. too much or too little Insulin)
can lead to coma or death.
Example 5:
A laboratory left a urine culture specimen in an Incubator for 11 days. rendering
It unacceptable for testing. Such samples are generally incubated for 24-48 hours
before testing. There was no evidence that the laboratory was aware of the error,
which would invalidate any test results. In fact, no test results were reported for
this patient, of which the lab was also unaware.
Implication for patients: Undetected and untreated urinary infections can cause
uremic poisoning, kidney damage, and renal failure.
Example 6:
A gynecologist who had been in practice for over 30 years used the office radiator
to Incubate fungal cultures. Most fungal cultures should be incubated at room
temperature or 30 degrees centigrade with 40-50% humidity. Radiators have
fluctuating temperatures and excessive heat may kill the fungus by drying out the
culture media.
2
10-20-95
FROM
Implication for patients: Failure to accurately diagnose and treat fungal infections
may cause unnecessary discomfort and, in patients with diabetes or impaired
immune systems, can lead to more serious infections.
Example 7:
An obstetrician/gynecologist performed glucose tolerance tests on pregnant
women using equipment that had no records of calibration. maintenance, or
quality control procedures. An inspection of the lab found quality control materials
that were frozen and outdated.
Implication for patients: Inaccurate glucose test results in pregnant women can
lead to misdiagnosed gestational diabetes, which may endanger the life of the
mother and the baby.
Example 8:
A laboratory stored "dexacola" (a sugar drink used in glucose tolerance testing for
diabetes) in the same refrigerator as potentially infectious biological specimens.
Implication for patients: Patients were unintentionally exposed to infectious agents.
INADEQUATE LABELING AND TRACKING OF TEST SPECIMENS AND RESULTS
Example 1:
Lab staff labeled a patient specimen with the name "Brown" and ordered a test for
this patient. However, during a survey of the lab, they said the patient's name was
actually "Brownville". When this name could not be found in the lab's computer
records, staff concluded that it must be "Browntown", since a patient by that name
had been seen in the office that week. (While this incident is real. the names are
fictitious.)
Implication for patients: Identification of patient specimens was based on a
process of elimination. This procedure as or lack thereof -- offered no guarantee
that the test results reported for a patient actually belonged to that patient, or that
treatment was based on the proper test results.
Example 2:
"Post-it" notes (which fall off easily) were used to label patient specimens while
awaiting testing. No other identification appeared on the specimens.
Implication for patients: There was no certainty that patient specimens were
identified correctly.
3
FAILURE TO FOLLOW MANUFACTURER'S IN ISTRUCTIONS IN PERFORMING TESTS
Example 1:
A laboratory performing strep testing never had a positive strep result. The test
kit included three bottles of chemical reagents, with Instructions to add them in
the order of bottles 1, 2, and 3. However, the laboratory's staff was adding them
in the order of bottles 1, 3, and 2. They had inadvertently switched the bottles and
did not take the time to read the bottle labels as they performed the test. Quality
control checks were never performed and all test results were negative.
implication for patients: Rapid strep tests are used to confirm suspected
streptococcus A infections ("strep throat"). Failure to detect and treat a strep
infection, based on a "false negative" result, may allow the infection to spread,
which can lead to rheumatic heart disease and death.
Example 2:
A physician's wife conducted lab tests In her husband's office laboratory. She
used her own blood as the quality control material for cholesterol tests, since her
cholesterol level was routinely checked by her doctor. However, cholesterol levels
fluctuate as much as 40% over time, based on overall health, physical condition,
and activities (e.g. exercise, diet, alcohol consumption, infections, time of day or
year, pregnancy, medication, etc.). Thus, an individual's cholesterol level cannot
be relied on as control material.
Implication for patients: Failure to accurately diagnose and treat high cholesterol
can lead to arteriosclerosis (hardened arteries), strokes, coronary heart disease
and heart attacks.
USE OF MALFUNCTIONING TEST EQUIPMENT AND MATERIALS
Example 1:
Function checks that signal whether an instrument is operating properly showed
that a testing Instrument was not in good condition. Hematology controls
(samples of known value tested before patient specimens to ensure the test is
capable of producing accurate results) were run up to 26 times before obtaining
an acceptable reading. However, the laboratory ignored these quality control
alarms and ran tests on patient specimens, some of which produced abnormal
results.
Implication for patients: Hematology tests are routinely used to diagnose anemia,
bleeding disorders, Infections, dehydration, or inflammation, and to monitor
cancer patients on chemotherapy. There was no way of knowing whether the
results produced by this lab were accurate.
4
PUb
10-20-95
Example 2:
A laboratory continued to test patient specimens even though its chemistry
analyzer needed repair and its water source was contaminated. The lab also used
quality control materials and chemical reagents beyond their expiration dates. In
addition, the lab's system for Identifying specimens failed to clearly link them with
the correct patient.
Implication for patients: All patients tested during this period should have been
retested. However, because of the lab's faulty tracking system, patients could not
be identified and no retesting was done. Patients received questionable test
results and were not informed of this fact.
Example 3:
A laboratory performed testing on an instrument that was not calibrated because
they had lost the equipment's calibrator strip. The staff also ignored bullt-in alarms
indicating instrument failure, and did no quality control tests to check the
instrument's condition. Based on results obtained from this instrument, four
patients were diagnosed and treated for iron deficiency anemia.
Implication for patients: There was no way to determine whether the test results
were accurate. Unnecessary treatment for iron deficiency anemia (iron
supplements, blood transfusions. etc.) can be harmful to patients, as well as
adding financial costs.
FAILURE TO DETECT CLEARLY INACCURATE TEST RESULTS
Example 1:
A laboratory failed to detect test results that were much lower than the normal
expected range for a chemistry test that measures potassium levels. The error
was not investigated and incorrect results were reported to the patients. The fact
that the lab was performing the test incorrectly was not discovered until it failed
proficiency testing (required by CLIA).
Implication for patients: Potassium tests are commonly used to monitor treatment
for hypertension (high blood pressure), which without medication can lead to
coma, stroke, or death. Inaccurate lab testing that shows falsely high or low
potassium levels can result in failure to provide appropriate treatment and
increased health care costs.
Example 2:
Patients treated with coumadin (a blood thinner) for heart disease are regularly
monitored for the ability of their blood to clot (using "protime" and "partial
prothrombin time" laboratory tests). At one HMO satellite office, all test results
5
PUT
were typical of patients not on coumadin i.e. shorter clotting times), including for
those who actually were taking the drug. When these patients were retested by
the HMO's other satellite office, the results were higher (i.e. longer clotting times),
as expected for patients on coumadin therapy.
Implication for patients: Test results cannot be accurately interpreted without
regard to the patient's history (e.g. age, gender, medication usage, etc). This lab
failed to discover that its tests were producing Inaccurate results because it did
not consider whether the results were appropriate for the particular patients
involved. As a result, inappropriate treatment may have been prescribed.
Example 3:
A laboratory doing lipid profile testing (cholasterol and triglyceride tests) reported
results 60 excessively unusual that they were clearly meaningless. Some
percentage results were recorded as greater than 100%, and some choleeterol
results were as high as 31,000 mg/dl (normal ranges are typically between 140
and 220 mg/dl). The lab also reported potassium levels (critical for patients with
high blood pressure) and platelet counts (essential in blood clotting) that were
obviously inconsistent with life.
Implication for patients: Test results were reported without regard to their quality,
making accurate diagnosis and treatment of patients impossible.
Example 4:
A laboratory failed to accurately interpret "sensitivity tests that show which
antiblotics will be effective In treating a bacterial disease. These tests involve
measuring the distance between bacteria growth and a particular antibiotic so that
physicians can choose the most appropriate drug. However, many laboratories
merely look for an absence of bacteria growth around an antibiotic (rather than
measuring the distance between them), and reporting the bacteria as "sensitive"
to the drug. Without a standard measurement procedure, the result may be
inaccurate or misleading.
Implication for patients: If bacteria are incorrectly reported as "sensitive", patients
may be treated with an Ineffective antibiotic that only serves to create a stronger,
more deadly bug. When bacteria are falsely reported as "resistant" (the opposite
of "eensitive"), patients may receive a stronger and more expensive drug than
necessary, which may be harmful to both their health and their pooketbooks.
Example 5:
A laboratory performing syphills tests reported negative results for 800
consecutive tests. They very seldom had a positive syphills result. The surveyor
inspecting the lab believed there were errors in the lab's testing procedure and
questioned the lab's supervisor about the testing results. The supervisor stated
6
that people in her area were less prom'scuous than people in the surveyor's
home town (a large city), which explained the lack of positive results.
Implication for patients; Failure to accurately diagnose and treat syphilis can lead
to dementia, blindness, and sterility. Failure to identify contagious syphilis carriers
also has serious implications for public health.
RELIANCE ON SUBSTANDARD TESTING PERSONNEL
Example 1:
A laboratory director failed to recognize that testing personnel hired under
contract were performing far below acceptable standards. For example, the staff
failed to follow test manufacturers' instructions and often failed to do quality
control checks to ensure accurate results. When control tests were performed and
indicated equipment failures, patient specimens were tested anyway.
Implication for patients: None of the test results produced by this substandard
laboratory could be relied on as valid. While the testing personnel were hired
under contract to the lab, the laboratory director was responsible for ensuring that
quality standards for the laboratory were met.
7
CLIA FACT SHEET
WHAT IS CLIA?
The Clinical Laboratory Improvement Amendments of 1988 superseded the
original Clinical Laboratory Improvement Act of 1967. CLIA '88 set uniform quality
standards for all clinical labs and was passed with broad bipartisan support.
CLIA applies to all labs that conduct tests on human specimens for health
purposes -- for example, tests on tissue, blood, urine and other samples to detect
cancer, HIV, diabetes, and other diseases.
CLIA PROVISIONS ARE BASED ON COMPLEXITY OF TESTS
CLIA provisions are based on the complexity of tests, not the type of lab where
the testing occurs. Thus, labs performing similar tests must meet similar
standards, whether located in a hospital, doctor's office, or other site.
CLIA established three categories of tests: waived tests, moderate complexity
tests, and high complexity tests. Walved tests -- simple tests with small chance
of error or risk -- are exempt from virtually all CLIA rules.
PROVISIONS FOR MODERATE AND HIGH COMPLEXITY TESTS
Personnel and proficiency testing: CLIA sets minimum qualifications for all
persons performing or supervising lab tests. Labs must also participate in an
approved proficiency testing program.
Quality control: Labs must have systems for monitoring testing processes and
equipment to ensure proper operation and accurate results.
Cytology testing: CLIA sets special rules for cytology testing Including workload
limits, specialized proficiency testing and personnel standards, and quality control
procedures.
REGISTRATION, INSPECTIONS AND FEES
CLIA was designed as a self-funded program.
All clinical labs must register with HHS and pay a nominal certificate fee.
Most labs performing moderate or high complexity tests are Inspected
every two years, with fees assessed to cover Inspections and other
program costs.
Labs exempt from routine federal inspections Include those performing only
waived tests, labs in which specified practitioners do only certain microscopic
tests, labs accredited by approved accrediting organizations, and labs in states
that approve or license clinical labs under standards at least as stringent as CLIA.
PROFILE OF PHYSICIAN OFFICE LABS (POLs) AFFECTED BY
THE CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 (CLIA)
MOST LABS REGISTERED UNDER CLIA ARE PHYSICIAN OFFICE LABS.
Of the 152,000 clinical labs registered under CLIA in 1995, 89,000 (almost 59%)
are POLs, most of which had no quality oversight prior to 1992.
In contrast: 8.8% of all registered labs are in nursing facilities, 5.8% in hospitals,
4.8% in home health agencies, and 3.8% are Independent labs. Smaller
categories include labs in HMOs, schools, dialysis units, and other facilities.
In 1993, POLs billed the Medicare program approximately $ 2.7 billion for
diagnostic laboratory tests.
59% OF PHYSICIAN OFFICE LABS FACE MINIMAL REGULATION UNDER CLIA.
Virtually all CLIA requirements are waived for 35% of POLs. These labs do only
simple tests deemed by HHS to have very small chance of error or risk to
patients.
An additional 24% of POLs are exempt from routine inspections under CLIA.
These labs conduct certain moderate complexity tests ("provider-performed
microsoopy") performed by physicians or other practitioners as part of a patient
exam.
OTHER PHYSICIAN OFFICE LABS DO MORE COMPLEX TESTS, SOME AT HIGH
VOLUME.
The remaining 41% of POLs conduct moderate and/or high complexity tests,
which, If done incorrectly, would place patients at significant risk.
These POLs do a broad range of tests with most certified for more than one
laboratory specialty.
17% of these POLs conduct more than 10,000 tests per year.
Only moderate and high complexity POLs are subject to all of CLIA's quality
standards, with stricter standards for high complexity tests.
SURVEYS & PROFICIENCY TESTING IMPROVE QUALITY IN LABS.
Initial CLIA surveys identified more deficiencies In POLs than in other clinical labs.
For example:
o
35% of POLs falled to adequately assess whether tests were producing
accurate results, compared to 23% of hospital labs and 13% of
independent labs.
2
28% of POLs failed to follow test manufacturers' instructions, compared to
20% of hospital labs and 11% of independent labs.
9% of POLs failed to check whether materials used to culture and Identify
disease-causing bacteria worked, compared to 4% of hospital labs and 2%
of independent labs.
8% of POLs failed to ensure reliable identification of patient specimens,
compared to 4% of hospital labs and 3% of independent labs.
A study published in the Journal of the American Medical Association in 1993
suggests the consequences for patients of improperly performed lab tests.
The study showed that patients were significantly more likely to have a
second heart attack or stroke following a prothrombin time (blood-clotting)
test in a low-volume POL than patients tested by a higher-volume POL or
a commercial lab.
These results were believed to be at least partly related to inaccurate test
results in the low-volume POLs, which led doctors to prescribe
inappropriate dosages of anticoagulant drugs.
Proficiency testing (PT) directly measures testing performance, as well as
providing invaluable feedback to POLs. It is widely recognized as a key ingredient
for maintaining quality testing in labs.
In 1994, POLs were far more likely than hospital or independent labs to fail
proficiency tests for hemoglobin, cholesterol, microbiology, prothrombin
time, and potassium. For example, 8% of POLs had PT failures for
hemoglobin, almost 10 times that of hospital and Independent labs.
Hemogiobin testing is performed by more than 30% of all POLs, and is the
second most common POL laboratory test.
By Identifying and overseeing the correction of deficiencies, CLIA has already
improved the quality of testing In POLs.
In 2, 186 POLs that had undergone a second CLIA survey by August 1995,
serious deficiencies decreased 26% between their first and second
inspections.
Total deficiencies decreased 23%, with a 51% drop in the average number
of deficiencies per lab.
HHS' educational approach to surveys and PT promotes cooperation with
providers while ensuring minimum quality standards for laboratory tests.
3
PHYSICIAN OFFICE LABS DO MANY DIFFERENT KINDS OF TESTS.
Most common moderate and high complexity tests done by physician office labs:
Triglycerides (used to evaluate risk of heart attack or stroke)
Blood urea nitrogen (used to evaluate kidney disease)
Uric acid (detects gout and other disorders)
High density lipoproteln (HDL) cholesterol (used to evaluate risk of heart
disease or stroke)
Group A Strep antigen (detects strep throat and other strep infections)
Most common waived tests done by physician office labs:
Urine pregnancy tests
Dipstick urinalysis (detects urinary infections and other diseases)
Glucose (detects diabetes, helps evaluate other diseases)
Occult blood (detects colon cancer)
Hemoglobin (detects anemia and other blood disorders)
Cholesterol (detects coronary artery disease, risk of heart attack or stroke)
Hematocrit (detects anemia and other blood disorders)
4
STEPS TAKEN BY THE DEPARTMENT OF HEALTH AND HUMAN SERVICES
TO REDUCE CLIA BURDEN ON PHYSICIAN OFFICE LABS
WAIVERS
Virtually all CLIA requirements are waived for labs doing only simple tests deemed
by HHS to have very small chance of error or risk to patients.
Waiver labs are only required to:
register with HHS and pay a nominal certificate fee;
follow manufacturers' instructions for performing tests; and
permit Inspections for investigation of bona fide complaints.
35% of all physician office labs are currently waiver labs, and others may qualify
as HHS clarifies the waiver application process and criteria for waived tests.
EXEMPTION FROM ROUTINE INSPECTION FOR OTHER PHYSICIAN OFFICE LABS
In 1993, HHS regulations defined a sub-category of moderate complexity tests
that are exempt from routine inspections under CLIA. These tests -- now called
"provider-performed microscopy" (PPM) -- are commonly performed in physician
office labs as part of a patient exam.
A new rule published in April 1995 expands the sub-category to many more labs
by allowing mid-level practitioners (In addition to physicians) to perform PPM
tests. Three new tests were also added to the PPM list.
24% of physician office labs do only PPM tests (or PPM and walved tests), and
others may qualify based on the new expanded rule.
FLEXIBLE OPTIONS FOR ACCREDITATION AND STATE PROGRAMS
In addition to the waiver and PPM exemptions, CLIA is flexible in providing options for
how standards may be met.
Over 8,000 physician office labs accredited by private organizations are deemed
to meet all CLIA requirements. Organizations currently approved by HHS for this
purpose Include the Commission on Office Laboratory Accreditation (COLA), the
Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and
four other accreditors.
Labs located in states that approve or license labs under standards at least as
stringent as CLIA are exempt from CLIA rules. Washington state is currently
recognized for this purpose, exempting almost 1,300 physician office labs. (New
York is also exempt but its physician office labs are not, because they are not
inspected by the state program.) Applications from other states are under review.
5
GRANDFATHER PROVISIONS AND PHASE-INS FOR EXISTING PERSONNEL
Regulations published in 1992 and April 1995 allow many lab employees who
were already performing or supervising moderate or high complexity tests to
continue to do so based on their training and experience.
Personnel standards were phased in gradually to assure adequate time for lab
staff to qualify. Most physicians already met all required qualifications.
OTHER BURDEN REDUCTIONS IMPLEMENTED BY HHS
All routine inspections are scheduled ahead of time, rather than unannounced.
Labs need not reapply for a new certificate each survey cycle. They need only
confirm their status and note any changes they have made.
HHS has developed an educational program for new physicians to qualify as lab
directors.
Implementation of quality control and proficiency testing requirements was
phased In over time.
FURTHER PROVISIONS TO EASE CLIA BURDENS ON PHYSICIAN OFFICE LABS
ARE UNDER DEVELOPMENT WITHIN HHS.
HHS is revising Its survey procedures so that labs with excellent compliance
records and no proficiency testing fallures will be inspected on-site every four
years instead of every two years, as previously required.
HHS will be proposing a new sub-category for moderate complexity tests that use
"accurate and precise technology" (APT) and come with detailed manufacturer
Instructions. These tests will be subject to only random inspections and less
stringent rules than other moderate complexity tests.
6
OLIGA
CLIA Certified Laboratories
By Type
Hospitals
5.8%
Independents
Physician
3.8%
Offices
58.8%
All Others
31.6%
Total Number = 151,888
CDC
Corporation - Common
- Prevention
Key Points
the majority of clinical laboratories in the U.S.
are physician office laboratories, a group that was
largely unregulated prior to CLIA '88
the group "All Others" includes a diverse group
of testing sites including community clinics, nursing
facilities, health fairs and mobile units
the testing sites included in the "All Others"
group were also largely unregulated prior to
CLIA '88
Source: HCFA OSCAR System (as of 01/30/95)
Distribution of Test Volume
By Laboratory Type
Hospitals
41.7%
All Others
23.9%
Physician
Independents
Offices
27.4%
7.0%
Total Annual Test Volume = 4.2 billion
CDC
Total Estimated Annual Revenue* = $25.9 billion
can - - Coro
Key Points
although physician office laboratories are not
performing the majority of testing in the U.S.,
they still perform in excess of 294 million tests
annually
Source: CLIA Baseline - d Random Sample of HCFA 109 Forms
Data analyzed independently by CDC.
Revenue estimate based on 1993 Medicare data and test volume
information from the CLIA Baseline Sample of HCFA 109 Forms.
Distribution of Physician Office Laboratories
By Certificate Type
Microscopy
Accredited
24%
10%
Walver
Certificate
34%
31%
CDC
Comps - Cares
---
Key Points
Regulatory relief has been provided to 58% of
physician office laboratories by certificate of waiver and
provider performed microscopy CLIA provisions.
Many physician office laboratories (10%) are
accredited by nonprofit professional organizations.
Source: HCFA OSCAR System (as of 03/02/95)
Distribution of Annual Test Volumes
In Moderate & High Complexity POLs
2000
10000
8000
POL:
6000
4000
2000
0
1-2,000
2-10,000
10-25.000
25-100,000
100.000-
1,000,000
000000'1<
CDC
- - - Cued
Source: HCFA ODIE and CLIA Reports (as. of 03/31/95)
Most Common Deficiencies Cited
35
Physician Offices
30
Hospitals
25
Independents
% of Surveyed
20
Laboratories Cited
IS
10
S
0
Quality
Quality
Manufact
Delegate
Procedure
Test
Control
Assurance
Instructions
Responsibility
Manual
Reports
CDC
Corton - -
Key Points
Quality Control: The laboratory must perform and document control
procedur es using at least 2 levels of control materials each day of testing
Quality Assurance: Each laboratory must establish and follow written policies for
a comprehensive quality assurance program to evaluate the ongoing and overall
quality of the total testing process.
Manufacturer's Instructions: The laboratory must follow the manufacturer's
instructions for the tesi system operation and test performance.
Responsibilities: The laboratory dir ector must specify in writing the
responsibilities and duties of each consultant and each person engaged in the
performance of all phases of testing
Procedure Manual: The laboratory must have a procedure manual describing the
processes for testing and reporting patient results.
Test Reports: I he test report must indicate the name and address of the
laboratory. the test performed, the test result. and the units of measurement.
Source: HCΓA OSCAR System (as at 03/06/95) and the Code of Feder
Regulations.
Percentage of Proficiency Testing Failures:
CAP and Affiliates, 1994 Yearly Totals
20
15
% PT Failures
10
Phys. Offices
5
All Laboratories
$1515
-
That
Hospitals and Independent
0
Laboratories
Glucose
Choesteral
Hemoglobn
Prothrombin
Time
Bacteriology
Potersions
CDC
-
-
-
I
Key Points
for all sentinel analytes, physician office
laboratories had higher proficiency testing failure
rates than hospitals and independent laboratories
for all sentinel analytes, physician office
laboratories had higher proficiency testing failure
rates than the failure rates observed for all
participants
Source: Proticiency Testing Data from College of American
Pathologists & Affiliates for 1994 and the HCFA OSCAR System
Data analyzed independently by CDC.
IMPROVEMENT IN PHYSICIAN OFFICE LABORATORIES
BETWEEN FIRST AND SECOND CLIA INSPECTIONS
Table 1
CONDITION-LEVEL DEFICIENCIES* IN PHYSICIAN OFFICE LABS
(POLs)
FIRST VS SECOND SURVEY CYCLE
(N=2,186 POLs with both first and second surveys
completed as of August 16, 1995)
First survey
Second survey
r decrease
POLs with condition
175
129
26%
level deficiencies
(8%)
(6%)
Average # condition
.12
.09
25%
level deficiencies
per POL surveyed
* Condition level deficiencies are sufficiently serious to
lead to revocation of a lab's CLIA certificate unless
corrected within a designated period of time.
Source: Health Care Financing Administration CLIA data base.
Table 2
TOTAL DEFICIENCIES IN PHYSICIAN OFFICE LABS (POLs)
FIRST vs SECOND SURVEY CYCLE
(N=2,186 POLs with both first and second surveys
completed as of August 16, 1995)
First survey
Second survey
8 decrease
POLs with
1,886
1,449
23%
deficiencies
(86%)
(66%)
Average #
5.5
2.7
51%
deficiencies per
POL surveyed
Source: Health Care Financing Administration CLIA data base.
This document was developed and distributed by
Representative Dingell's office
THE CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 (CLIA)
AND PHYSICIAN OFFICE LABS (POLs)
MYTHS AND FACTS
MYTH #1: When CLIA was passed, Congress was only concerned about the quality of
Pap tests in large commercial laboratories.
FACT:
While Я high error rate for Pap tests was a major concern underlying the
passage of CLIA in 1988, Congress was motivated by other factors as well.
These included concern about the proliferation of physician office labs (POLs), most of
which were subject to no quality standards at all. Several hearings on CLIA were held in
both the Senate and the House, including testimony on inaccurate lab testing in physician
offices. These hearings and other legislative history clearly show that oversight of POLs was
an important goal of CLIA.
MYTH #2: CLIA requires "massive amounts of paperwork".
FACT:
All clinical labs must fill out a four-page application form when they first
register with HHS.
The form asks for such information as:
+
the lab's name, address, director's name, and hours of operation;
+
the type of facility (e.g. physician office, hospital, home health agency);
whether the lab is accredited by a private accrediting organization;
+
the type of certificate it is applying for (e.g. waiver or regular certificate);
the number of individuals involved in lab testing and annual volume of tests
the lab performs.
Many of these items are completed by checking off boxes on the form.
Labs doing only waived tests or "provider-performed microscopy" (59% of POLs)
only fill out a few sections of the application form, which take approximately 20
minutes to complete.
I abs doing moderate or high complexity tests must also check off the laboratory
specialties or subspecialties in which they perform tests, and give the annual test
volume for each.
The application form is only filled out once. To renew a CLIA certificate, most
POLs need only confirm their status on a customized statement sent to them by
HIIS, noting any changes in name, address, laboratory specialties. etc., in the last two
years. For other POLs, information is updated during their on-site inspection, which
involves no additional paperwork.
FACT:
Several other paperwork requirements (applying only to non-waived tests) can
be met through standard documentation maintained by any medical practice.
For example, recordkeeping requirements can be met using patients' medical records, and
manufacturers' instructions for testing equipment may qualify as procedure manuals.
MYTH #3: CLIA imposes "hefty fees" on physician office labs.
FACT:
Most physician office labs pay only nominal fees, since most are small and
many perform only waived tests.
All labs pay an application fee when they first register with HHS, and to renew their
CLIA certificate every two years. Labs doing only waived tests pay $100 every two
years, while those doing only "provider-performed microscopy" pay $150 every two
years. These labs (59% of all POLs) pay no other CLIA fees.
Other labs performing moderate or high complexity tests pay $100 to $600 in
certificate fees, with most POLs paying only $100 every two years. Moderate and
high complexity labs also pay compliance fecs to cover inspections and other
program costs. These fees vary by state and by the lab's annual volume of tests.
A special compliance fee category was created for small labs, particularly POLs, that
perform less than 2,000 tests a year. These labs pay a "flat" compliance fee of $300.
55% of POLs subject to compliance fees fall into this low-volume category and pay
a total of $400 every two years ($100 for the certificate fee and $300 for the
compliance fee).
MYTH #4t Physician office labs can по longer perform urine pregnancy tests without
meeting burdensome requirements.
FACT:
Simple urine pregnancy tests are waived tests, which are exempt from virtually
all CLIA rules. Labs performing only waived tests are only required to:
register with HHS and pay a nominal certificate fee ($100 for a two year period);
follow manufacturers' instructions for performing tests; and
permit inspections for investigation of bona fide complaints.
MYTH #5:
Rapid strep tests (classified under CLIA as moderate complexity tests) can
be accurately performed by an untrained person with minimal Instruction.
(Some sources say members of Congress were taught in minutes to perform this test; another
says seventh graders could do SU after reading the package insert.)
FACT:
While the steps involved in performing a rapid strep test may seem relatively
simple, other factors make the tests more complex and risky than they appear.
2
For example:
+
Specimens are often mishandled or stored improperly, rendering test results
unreliable. While testing must occur within a set timeframe after obtaining a
strep specimen, some POLs have been found to refrigerate specimens for
longer periods. A practitioner who is unaware of such errors is likely to base
treatment decisions on inaccurate results.
+
Surveys have shown that personnel in POLs often fail to follow test
manufacturers' instructions, such as the proper sequence for performing the
steps of a test. In rapid strep tests, adding the chemical reagents in the wrong
order will produce "false negative" results. Quality control and proficiency
testing samples (required by CLIA) can be used to detect whether reagents
have been added in the wrong order.
+
Errors are often made in interpreting rapid strep tesis, especially when the
tests yield borderline results. Lab personnel who are not trained in the use of
these tests are more likely to interpret them erroneously.
Incorrectly handled, performed, or interpreted rapid strep tests may produce "false
negative" or "false positive" results.
+
Prompt treatment of strep infections provides rapid relief of symptoms and
decreases risk of contagion to others. When tests yield "false negative" results,
these benefits are unavailable. Failure to treat some types of strep infection
can lead to rheumatic fever and subsequent heart damage, which can cause
serious impairment or death. Such infections are also much more expensive
to treat if undetected until a more advanced stage.
+
"False positive" results also subject patients to risk and lead to increased costs.
For example, frequent use of penicillin (which is more likely with unnecessary
use) can cause patients to develop resistance to the drug. Such resistance
impairs the drug's effectiveness in treating subsequent infections, requiring
use of more expensive or more powerful antibiotics later on.
In categorizing lab tests under CLIA, HHS consults with the Clinical Laboratory
Improvement Advisory Committee (CLIAC), composed of physicians, lab
professionals, and other scientists. CLIAC has repeatedly considered and rejected
proposals to waive rapid strep tests from CLIA rules, based on the serious risks
involved when such tests are performed incorrectly or by untrained personnel, and
on variation in the quality of the test kits made by different manufacturers.
3
THE CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 (CLIA)
AND PHYSICIAN OFFICE LABS (POLs)
MYTHS AND FACTS ABOUT ACCESS TO LABORATORY TESTS
MYTH #1:
CLIA has reduced patients' access to laboratory tests.
FACT:
There is no evidence that this has occurred. In fact, a new study by the
Inspector General of the Department of Health and Human Services (HHS)
concludes that CLIA has had no effect on the availability of laboratory
services.
The volume of lab testing, number of tests per patient, and expenditures for lab tests
have increased since CLIA was passed in 1988.
+
In 1988, Medicare paid for 232 million lab tests compared to 403 million tests
in 1993.
+
In 1988, Medicare Part B enrollees received an average of seven lab tests per
patient, compared to 12 tests per patient in 1993.
+
Medicare expenditures for lab tests more than doubled since CLIA was
passed, rising from $2.8 billion in 1988 to $5.9 billion in 1993.
CLIA has not affected physicians' ability to obtain laboratory services for their
patients, including in rural areas.
+
None of 232 physician practices randomly surveyed by the Inspector General,
including rural practices, reported any trouble securing laboratory tests for
their patients. All had access to a clinical laboratory and 98% made use of
more than one lab.
+
While the mix of entities providing lab services is different in rural areas than
in urban areas, the Inspector General's report concludes that rural residents'
access to lab services is equivalent to that of non-rural residents.
The total number of physicians operating in-office labs has not changed since CLIA
was passed in 1988.
+
The number of office labs operated by physicians in solo practice declined by
an estimated 22% between 1988 and 1994, reflecting an on-going trend away
from solo practice and toward larger group practices.
4
P26
+
This decrease, however, was offset by an increase in the number of physicians
operating labs in group practices. While the total number of group practice
labs did not change between 1988 and 1994, the average number of physicians
per group increased. Overall, the number of physicians operating office labs
has remained unchanged.
When physician office labs have closed, they have often done so for reasons
unrelated to CLIA, while other physicians have opened new office labs since 1988.
+
The Inspector General's study explored the reasons why physicians closed
office labs between 1988 and 1994. Such closures were not attributable to any
single cause, and included both governmental and non-governmental factors.
These included low reimbursement rates, changesin the medical marketplace,
self-referral restrictions and OSHA requirements, as well as CLIA.
+
Marketplace influences may have had the greatest impact on POLs, including
mergers and sales of physician practices, and contracts with HMOs and other
managed care entities. Such contracts often mandate use of specific
laboratories and will not pay for testing done in physician offices. Widespread
purchase of physician practices by hospitals has also affected POLs. In almost
all such cases, the Inspector General found, the hospital required that all
moderate and high complexity testing be sent to the hospital's laboratory.
+
The Inspector General projected its survey results to physicians nationwide,
based on those in active practice in 1988 who were still practicing in 1994.
Within this group, approximately 17,000 POLs closed between 1988 and 1994,
including POLs that ceased testing altogether (not necessarily due to CLIA)
and those that merged with other lab testing sites. During the same period,
these physicians opened almost 15,000 new POLs, producing a net change of
about 2,000 POLs. The Inspector General believes this change was offset by
additional POLs opened by physicians who have entered practice since 1988.
MYTH #2: CLIA causes hardship for patients by forcing them to travel to outside labs
for testing ordered by their doctor. This is especially burdensome for elderly
and disabled patients, and those living in rural and underserved areas.
FACT:
It is unusual for patients to be sent from a doctor's office 10 another facility
for clinical lab testing.
Most physician offices are able to collect specimens from patients whether or not
they operate a clinical laboratory on-site. For tests not performed on-site, the
specimens are usually picked up by couriers and delivered to an outside lab for
analysis. The results of such tests are usually returned to the referring physician in
24 hours or less, who often informs patients of the results over the phone.
5
MYTH #3: Referring moderate and high complexity tests to outside laboratories causes
delays that lead to inappropriate diagnosis and treatment.
FACT:
By setting minimum quality standards that help ensure testing accuracy, CLIA
promotes proper treatment rather than hindering it.
Incorrectly handled, performed, or interpreted laboratory tests may produce "false
negative" or "false positive" results.
+
"False negative" results not only cause treatment delays, but may subject
patients to risk of serious impairment or death. Medical conditions are also
often more expensive to treat if undetected until a more advanced stage.
+
"False positive" results may lead to inappropriate treatment and further
diagnostic tests, exposing patients to unnecessary risks, anxiety, and costs.
Some moderate and high complexity tests take considerable time to complete
regardless of where they are performed. For example, cultures to diagnose bacterial
diseases take at least 24 hours to produce an accurate result. These tests, if
conducted properly, involve no more "delay" when sent to an outside lab than when
done on-site in a POL.
Nine moderate complexity tests. performed by physicians and other practitioners as
part of a patient exam, are included in a special sub-category called "provider-
performed microscopy" (PPM). Labs performing only these tests are exempt from
routine inspections under CLIA. 24% of POLs perform only PPM tests (or PPM and
waived tests), for which results are immediately available. Additional POLs do PPM
tests along with other moderate or high complexity tests.
Copics of the HHS Inspector General's report "CLIA's Impact on the Availability of
Laboratory Services" -- are available by calling the Inspector General's office at (202) 619-1142.
6
10/30/95
17:20
002
FOR IMMEDIATE RELEASE
CONTACT:
Amy Melnick
October 27, 1995
202/737-3600
Laboratory Coalition Warns About House Medicare Provision
House Medicare Reform Legislation could have Tragic Consequences for the Public
Washington, D.C. -- Members of the Coalition to Preserve Safe Patient Testing
(Coalition), representing the nation's major laboratory groups, today warned that a
provision in the House Medicare reform legislation could have tragic consequences
for the public.
The provision, which would exempt physician office laboratories from any safety
and quality standards, reverses many of the reforms contained in the Clinical
Laboratory Improvement Amendments (CLIA) which President Reagan signed into
law in 1988.
"CLIA was intended to address serious concerns related to the accuracy and
reliability of laboratory testing, particularly in Pap smear testing and physician office
laboratories," reported Amy Melnick, spokesperson for the Coalition.
"CLIA set basic minimum standards for all laboratory testing regardless of where
the tests are performed," added the Coalition's spokesperson. "If physician office
laboratories are exempted, they would be able to perform complex tests to detect
HIV, heart disease, cancer and genetic abnormalities without any regulation or
oversight. The coalition is deeply concerned about the implications for patient
care."
-more-
10/30/95
17:20
003
In response to concerns expressed by physicians and other groups that CLIA was
unnecessarily burdensome, changes have been made in the program to facilitate in-
office testing. Fifty-nine percent of the 89,000 physician office laboratories are in
CLIA categories that have minimal regulation and fees. Tests which require a high
degree of accuracy, are difficult to perform, or which put patients at risk if performed
inaccurately are subject to more stringent regulation.
"The Coalition supports these recent changes and would consider further
streamlining of CLIA regulations through legislative reform," the Coalition's
spokesperson said. "However, a wholesale exemption of physician office
laboratories is simply bad policy. We believe that the original intent of CLIA must
be protected. We must ensure that all laboratory testing, wherever it is performed,
is done accurately and according to good scientific practices. Patients deserve this
protection."
The organizations in the Coalition to Preserve Safe Patient Testing represent
bioanalysts, doctoral scientists, clinical laboratory scientists, laboratory managers and
supervisors, medical technologists and physicians working in hospitals,
independent laboratories, physician offices and industries nationwide as well as
owners and directors of clinical laboratories. Coalition members are committed to
retaining the basic minimum federal standards for clinical laboratory testing such as
quality control, quality assurance, personnel standards, proficiency testing and site
neutrality that CLIA ensures.
###