CMS-R-131 Comments #27 thru #29

1 < , l I ~ l O l . I3~'SlSF.SS
~ ~ ~ ~ ~ ' \l.\x:l(;F.\lEST~

III I
Buildlng the Business of Radiology

10300 Eat011 Place
S u ~ e4 6 0
Fairlax. VA 22030

703-621-3355 O ~ r e c t
8 8 8 - 2 2 4 - 7 2 6 2 Toll F r e e
703-621-3356 Fax

r

February 23, 2007

I

Michelle Shortt
Director, Regulations Development Group
Office of Strategic Operations and Regulatory Affairs
Division of Regulations Development
Centers for Medicare & Medicaid Services
Attn: Bonnie L Harkless, Room C4-26-05
7500 Security Boulevard
Baltimore, PID 21244-1850
Re: CMS-R-131 (OMB#: 0938-0566) - Advance Beneficiary Notice of Noncoverage
Dear Ms. Shortt:
The Radiology Business Management Association (RBMA) appreciates the opportunity t o
comment on the Advance Beneficiary Notice of Noncoverage (ABN) pursuant t o the agency's
Comment Request as published in the February 13, 2007 Federal Register.
Founded in 1968, the RBMA represents over 2,000 radiology practice managers and other
radiology business professionals. RBMA is the leading professional organization for
radiology business management, offering quality education, resources and solutions for its
members and the healthcare community, and helping shape the profession's future.
I n general, RBMA commends CMS' efforts t o improve the user-friendliness of the ABN.
Many of the proposed revisions are a step in the right direction. For example, adding "1800-MEDICARE" is a welcomed improvement. RBMA also supports proposed ABN revisions
including more payment options, space for other insurance information, and a description of
the significance of the signature.
However, RBMA has a fundamental concern about the ABlV process in the hospital radiology
environment. Hospital-based radiology is a fast-paced, fluid environment with an emphasis
on speed and efficiency - essential elements in good radiological patient care. As such,
hospital-based radiologists depend on the patient-specific information provided t o them by
the hospital and/or the referring physician. Since time is of the essence and medical
necessity decisions are made elsewhere in the patient care continuum, it is unreasonable to
deny payment to hospital-based radiologists when ABNs are not obtained. Additionally,
given this high patient volume through hospital radiology departments, the ABN
requirement imposes a significant administrative burden on radiology department staff.
RBMA, therefore, recommends that a hospital's notice of non-coverage (either an
ABN or Hospital Issued Notice of Noncoverage) provide "umbrella" notification to
the Medicare beneficiary of any and all financial liability stemming from in-hospital
Medicare noncovered services during his/her hospital encounter.
RBMA offers the following specific comments on the revised ABN:
Estimated Cost (Item F) is ill-defined, as the term can have multiple meanings, and is
potentially confusing to patients, physicians, and administrative staff. RBMA
recommends that CMS clarify what the phrase means.

RBMA: CMS-R-131 (OMB#: 0938-0566)
February 23, 2007
Page 2
With respect to (Item G) O ~ t i o n s the
,
current "provide me with" language reads
awkwardly. RBMA suggests rewording the first sentence (to be printed in bold) as
follows:

1. Ido not wish to have the item(s)/service(s) listed above.
2. Ido wish to have the item(s)/service(s) listed above.
3. Ido wish to have the item(s)/service(s) listed above.
We believe the proposed revision conveys the intent of the ABNs language while making
the options more readable and understandable.
RBMA also would favor adding more information why Medicare does not cover the
service in question. Language such as, "the service(s)/item(s) listed below may
not be covered by Medicare because these services/items do not meet
Medicare's reasonability and necessity criteria for coverage" could be helpful to
patients.
The RBlYA appreciates the opportunity to comment on CMS' revised ABN. I f questions arise
or additional information is needed, please feel free to contact RBMAfs Executive Director
Michael R. Mabry at 703.621.3363 or [email protected].
Sincerely,

Gregory M. Kusiak, MBA
President, RBMA Board of Directors

College of American Pathologists
325 Waukegan Road, Northfield, lllinois 60093-2750

Advancing Ercelknce

GOVERNMENT^

DIVISION OF
A N D P R O F E S S I O N A L AFFAIRS

1350 I Street, NW, Suite 590
Washington, DC 20005-3305
202-354-7 100 Fax: 202-354-7155
800-392-9994 http://www.cap.org

April 23, 2007
Bonnie L. Harkless
Office of Strategic Operations and Regulatory Affairs
Division of Regulations Development-C
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, M.D. 21 244-1 850

Attention: CMS-R-13 1, Room C4-26-05

Dear Ms. Harkless:
The College of American Pathologists (CAP) appreciates the opportunity to comment on the proposed
changes to the Advance Beneficiary Notice of Noncoverage (ABN) published in the February 23, 2007
Federal Register. The CAP is a national medical specialty society representing more than 16,000
physicians who practice anatomic and/or clinical pathology. College members practice their specialty in
clinical laboratories, academic medical centers, research laboratories, community hospitals and federal
and state health facilities.
CMS is proposing a number of changes to the format and content of the ABN form, including combining
two existing ABN forms - the ABN-G for general use and the ABN-L for physician-ordered laboratory
tests - into a single form. The CAP believes that many of the proposed changes will make the ABN more
usable for providers and beneficiaries alike; however, the CAP is concerned with several aspects of the
new combined form. First, the CAP is concerned that new combined form will not allow the necessary
flexibility to address laboratory testing issues. Second, the CAP is concerned that the new form mandates
inclusion of an estimated cost instead of making the information optional. Lastly, the CAP is concerned
with financial liability under the new beneficiary payment option and collection of upfront payment by a
different entity than the supplier of a laboratory testing service. To respond to these concerns the CAP
asks CMS to:
1 . Confirm that the new combined form can be customized for laboratory testing, as is permitted for
the current ABN-L;

2. Confirm that the inclusion of an estimated cost for laboratory testing is optional and that the lack
of an estimated cost amount will not invalidate the ABN; and
3. Confirm that selection of the new beneficiary payment option and collection of upfront payment
will not make a supplier of any portion of the laboratory testing service financially liable or
responsible for a refund to the benefic~aryif a different entity executes the ABN for laboratory
testing services.

Bonnie L. Harkless
April 23, 2007
Page 2
Confirmation that the New Combined Form can be Customized
1.
On the current ABN-L, providers can customize the columns for "Items/Service" and "Because" for their
specific needs. Customization of these columns is addressed in the Medicare Claims Processing Manual,
CMS Pub. 100-04, Chapter 30, Section 50.5.6. The CAP asks CMS to clarify the ability to customize the
new combined form. Specifically, the CAP asks CMS to confirm that on the columns on the new
combined form to identify the "ltem/Service" and "Reasons" can be customized in a similar manner as
the ABN-L, including the use of check off boxes and a preprinted list of tests linked to captioned reasons
for denial. Without the ability to customize the form, the form cannot meet the needs for laboratory
testing.
Because customization with lists of laboratory testing can be lengthy, CMS has been flexible in the font
size and format of the ABN-L. The Form Instructions released with the new combined form recommend
a font size of 12-point. The CAP asks CMS to verify that it will continue to allow a font size range of 10
to 12 point and will remain flexible with the formatting of customized forms for laboratory testing
services.
2.

Confirmation that Lack of an Estimated Cost Will Not Invalidate the New Combined Form

On the current ABN-L there is no column for Estimated Cost, rather, there is line for estimated costs and
completion of this line is optional. For the current ABN-L form CMS provides the following instructions:
"The user may provide the patient with an estimated cost of the items andlor services.
The patient may ask about the cost and jot down an amount in this space. Users should
respond to such inquiries to the best of their ability. The lack of an amount on this line,
or an amount which is different from the final actual cost, does not invalidate the ABN."'
The Form Instructions released with the new combined form state for the column for Estimated Cost that
users "must enter a cost estimate in this blank" (emphasis added). This language infers a mandate to
include an estimated cost and fails to address the implication of a blank line or a discrepancy between the
estimated and actual cost.
There are legitimate reasons why a provider may not be able to include an estimated cost. For example,
an ordering clinician may not have readily available a current or complete clinical laboratory fee
schedule. Moreover, the cost elements of complex non-routine testing may be difficult to estimate. The
CAP asks CMS to make column for the estimated costs optional for laboratory testing services and to
confirm that the lack of an estimated cost amount or a discrepancy between the estimated and actual costs
will not invalidate the new combined form.
3.

Confirmation that Laboratory Testing Service Supplier is Not Financially Liable or Responsible
for Refund for Upfront Payments Collected by a Different Entity

The new combined form offers three beneficiary options that affect the financial liability and refund
responsibility. The third option grants a beneficiary an official decision on payment, but also allows
collection of upfront payment from the beneficiary, to be refunded in the event Medicare pays for the item
or service. It is likely that a physician will execute the new combined ABN for multiple items and
services, including ordered laboratory tests. It is also likely that if the beneficiary selects the third option
on the form that the physician will collect upfront payment for some of the items and services. The

I

1

Medicare Claims Processing Manual, CMS Pub. 100-04, Chapter 30, Section 50.5.7 (emphasis added).

College of American Pathologists

Bonnie L. Harkless
April 23. 2007
Pagc 3
'4

collection of upfront payment can create confusion for beneficiaries regarding their financial liability and
the refund responsibilities, if any, of the ordering physician and the supplier of the laboratory tests.
In particular, if Medicare denies payment for the laboratory tests and the supplier of the testing services
bills the beneficiary for the uncovered services, the beneficiary may refuse to pay and challenge their
financial liability because of a mistaken belief that the upfront payment satisfied their payment
obligations for all described services. This situation may be further exacerbated if the ordering physician
provided inaccurate cost estimates of the services. Conversely, if Medicare pays for the laboratory tests
the beneficiary may demand a refund from the supplier of the testing service even though the upfront
payment was made to a different entity.
The CAP asks CMS to clarify that the supplier of the laboratory testing services will not be held
financially liable or responsible for refund if a different entity executes the ABN and collects upfront
payment from the beneficiary. The CAP asks CMS to further clarify that the supplier of the laboratory
testing services will not be financially liable or responsible for refund if a different entity executes the
ABN with inaccurate cost estimates, resulting in a higher financial responsibility to the beneficiary than
described in the ABN.
If CMS cannot confirm that the new combined ABN form can be used and construed in a manner
consistent with the current ABN-L as described above, then the CAP strongly urges CMS to retain the
ABN-L as a separate form for physician-ordered laboratory tests.
The College of American Pathologists is pleased to have the opportunity to comment on these changes
and appreciates your consideration of our comments. Any questions regarding the comments should be
directed to Donna Meyer at 202-354-71 12.)-(
Sincerely,

Thomas M. Sodeman, MD, FCAP
President

College of American Pathologists

AMERICAN COUE

OF

RADIOLOGY
April 23, 2007
Michelle Shorn
Director, Regulations Development Group
Centers for Medicare and Medicaid Services
Office of Strategic Operations and Regulatory Affairs
Division of Regulations Development
Attn: Bonnie L Harkless, Room C4-26-05
7500 Security Boulevard
Baltimore, MD 2 1244-1850
Re: Advance Beneficiary Notice
Dear Ms. Shortt:
The American College of Radiology (ACR), representing over 32,000 diagnostic radiologists,
interventional radiologists, radiation oncologists, nuclear medicine physicians and medical
physicists, is pleased to submit comments on the proposed notice, "Agency Information
Collection: Proposed Collection," published in the Federal Register on February 23, 2007. We
will address the Advanced Beneficiary Notices (ABN) proposal.
The ACR appreciates the Center for Medicare and Medicaid Services' (CMS) effort to develop a
a more comprehensible ABN. The new form instructions are an improvement in making the
ABN easier to understand and complete. However, the ACR believes the following hrther
clarifications can make the ABN easier for patients to understand and easier to use in the hospital
and office settings.
The ACR is aware that in order for physicians to collect payment for non-covered Medicare
services, that an advanced beneficiary notice must be signed prior to providing the medical
service. Therefore, many patients are asked in the hospital outpatient and ofice setting to sign
one ahead of time, "just in case" the ABN is needed to receive payment after a claim denial.
The ACR believes that the ABN form should be worded in such a way that the patient
understands why their doctor ordered a procedure or test and that it may or may not be covered.
The ACR offers the following suggested changes that make this form more informative,
understandable and in compliance with Medicare regulations.
The ACR suggests adding additional clarification to lessen the likelihood of patients not
understanding why Medicare does not cover the service. Simplified language and further
explanation can help beneficiaries understand why Medicare does not cover a particular service.
Adding language, such as "the service(s)/item(s) listed below may not be covered by Medicare
because these services/items do not meet the reasonability and necessity criteria for coverage,"
can clarify the reason why Medicare is not covering the service.
Headquarters
1891 Preston White Dr
Reston, VA 20191
(703) 648-8900

Government Relations
1701 Pennsylvania Ave NW, Suite 610
Washington, DC 20006
(202) 223-1670

CAnlcal Research
1818 Market St, Suite 1600
Philadelphia. PA 19103
(215) 574-3150

ACR appreciates the fact that a toll-free number will be added on the new notice in order to
provide further explanation.
We are very concerned about proposed option 2. As described in the Federal Register notice,
this new option is intended "to allow beneficiaries' the right to pay out of pocket when they
desire." However, the circumstances under which a beneficiary might select this proposed
option are not described. Consequently, we hesitate to endorse this change out of concern that:
(1) beneficiaries might select this option and pay out-of-pocket for a service that might have
been covered by Medicare; and, (2) physicians might be at risk of civil monetary penalties for
failing to submit a claim or for charging more than is allowed under the balance billing
requirements of the Medicare fee schedule.
Normally, physicians and practitioners are required to submit claims on behalf of beneficiaries
for all items and services they provide for which Medicare payment may be made under Part B.
Also, they are not allowed to charge beneficiaries in excess of the limits on charges that apply to
the item or service being furnished. In fact, as described in section 40 Effect of Beneficiary
Agreements Not to Use Medicare Coverage in Chapter 15 of the Medicare Benefit Policy
Manual (Pub. 100-02):

"Where a physiciadpractitioner, or other supplier,fails to submit a claim to Medicare on
behalf of a beneficiaryfor a covered Part B service within one year ofproviding the service,
or knowingly and willfully charges a beneficiary more than the applicable charge limits on
a repeated basis, he/she/it may be subject to civil monetary penalties under jj1848(g)(l)
and/or 1848(g)(3) of the Act. Congress enacted these requirementsfor the protection of all
Part B beneficiaries. Application of these requirements cannot be negotiated between a
physiciadpractitioner or other supplier and the beneficiary except where a
physician/practitioner is eligible to opt out of Medicare under $40.4 and the remaining
requirements of jj40.1 - 40.38 are met."
We understand that a physician may opt out of Medicare and that a physician who opts out is not
required to submit claims on behalf of beneficiaries. In addition, an opt-out physician is not
subject to balance billing limits. For physicians who do not opt out of Medicare, the manual
section cited above states that:

The only situation in which non-opt-out physicians or practitioners, or other suppliers,
are not required to submit claims to Medicare for covered services is where a beneficiary
or the beneficiary's legal representative refises, of hidher ownji-ee will, to authorize the
submission of a bill to Medicare. However, the limits on what the physician, practitioner,
or other supplier may collect from the beneficiary continue to apply to charges for the
covered service, notwithstanding the absence of a claim to Medicare.

Headquarters
1891 Preston White Dr
Reston, VA 20191
(703) 648-8900

Government Relations
1701 Pennsylvania Ave NW, Suite 610
Washington, DC 20006
(202) 223-1670

Clinlcal Research
1818 Market St, Suite 1600
Philadelphia, PA 19103
(215) 574-3150

AbERlcAN

C0un;E

OF

RADIOLOGY
Thus, it appears that the proposed option 2 is not consistent with existing Medicare policy.
However, we do not believe this policy is well understood by beneficiaries and physicians and
we are especially concerned that the proposed ABN does not convey the sense that the
beneficiary "rehses, of hidher own free will, to authorize the submission of a bill to Medicare."
We believe an example of the circumstances under which option 2 might be
selected should be included on the ABN so that beneficiaries will be hlly informed.
The ACR recommends rearranging the list of selections in item G (OPTIONS section) in the
way that is least alarming to patients. Patients can get alarmed by the perception of a financial
burden and decide not to have the needed procedure. If the list is rearranged by placing the least
alarming and most conducive to receiving care option first (e.g. Option 3) and the most alarming
option last (e.g. Option I), patients might elect to have needed procedures. Furthermore, the
ACR recommends adopting clearer language to describe the options under item G. A language
that is similar to the ABN used in home health setting, which is also stated below can clarify
beneficiaries' options.
Option 1. I want the items and/or services listed above, and I agree to pay for the
items and/or services myself if Medicare or my other insurance doesn't pay. Send the
claim to:
(Please check one or both boxes):
Medicare
My other insurance.
Option 2.
I want the items and/or services listed above, and I agree to pay myself
since I don't want a claim submitted to Medicare or any other insurance I have. I
understand that I have no appeal rights since a claim won't be submitted to Medicare.

Option 3.
I don't want the items and/or services listed above. I understand that I
won't be billed and that I have no appeal rights since I will not receive those items
and/or services.
Please note: If you select option 1 and a claim is submitted to Medicare, you will get a
Medicare Summary Notice (MSN) showing Medicare's off~cialpayment decision. If the
MSN indicates that Medicare won't pay all or part of your claim, you may appeal
Medicare's decision by following the appeal procedures in the MSN. If you don't receive
. TTY:
an MSN for your claim, you can call Medicare at:
. You may have to pay the h l l cost at the time you get the items and/or
services. If Medicare or your other insurance decides to pay for all or part of the items
andlor services that you have already paid for, you should receive a rehnd for the
appropriate amount.

u

Headquartem
1891 Preston White Dr
Reston. VA 20191
(703) 648-8900

Government Relations
1701 Pennsylvania Ave NW, Suite 610
Washington, DC 20006
(202) 223-1670

u

Clinical Research
1818 Market St, Suite 1600
Philadelphia,PA 19103
(215) 574-31 50

b E R I C A N COLLEtE OF

RADIOLOGY
The ACR also suggests including language such as "If you are still confused about why your
doctor ordered this specific test, if there is an alternative test, or if your doctor knew it may not
be covered then please contact your doctor." This will allow the patient to get information from
the referring physician.
The supporting statement in section B.12 (Burden Estimate) contains the method of evaluating
the cost to the provider for delivering the ABN. The ACR believes this method of evaluating the
cost for delivering the notice does not capture all the costs. Providers are the ones that share the
burden of educating referring physicians on Local Coverage Determinations (LCDs). The ACR
recommends CMS establish a method that factors an education cost into the burden, in addition
to the delivery cost.
Thank you for the opportunity to comment on this proposed notice. The ACR looks forward to a
continuing dialogue with CMS officials about these and other issues affecting radiology. If you
have any questions or comments on this letter, please contact Helen Olkaba at 800-227-5463 ext
4 132 or via email at holkaba@,acr.org.
Respectfully Submitted,

Harvey L. Neiman, MD, FACR
Executive Director
cc:

Bonnie L Harkless, CMS
John A, Patti, MD, FACR, Chair, ACR Commission on Econoinics
Bibb Allen, JR., MD, FACR, Vice-Chair, ACR Commission on Economics
Pamela J. Kassing, ACR

Headquarters
1891 Preston White Dr
Reston, VA 20191
(703) 648-8900

Government Relatlons
1701 Pennsylvania Ave NW, Suite 610
Washington, DC 20006
(202) 223-1670

Clinical Research
1818 Market St, Suite 1600
Philadelphia. PA 19103
(215) 574-3150