CMS-R-131Comments #37 thru #39

AMERICAN SOCIETY FOR CLINICAL LABORATORY SCIENCE

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April 24,2007
CMS
Office of Strategic Operations and Regulatory Affairs
Division of Regulations Development-C
Attention: Bonnie L. Harkless
Room C4-26-05
7500 Security Boulevard
Baltimore, MD 2 1244-1850

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Dear Sir or Madam:
The American Society for Clinical Laboratory Science (ASCLS) is writing in response to
the proposed revisions of the Medicare Part B Advance Beneficiary Notice CMS-R-13 1
as published in the Federal Register Vol. 72, No. 36. ASCLS is the nation's oldest and
largest non-registry professional association for non-physician clinical laboratory
professionals. The Society's mission includes promoting high standards of practice in the
workplace and ensuring professional competence, while its ultimate goal is to ensure
excellent, cost-effective laboratory services for consumers of health care. Our
membership of nearly 12,000 includes clinical laboratory directors, managers,
administrators, supervisors, and staff at all levels of practice.
ASCLS questions the need to consolidate the general and laboratory versions of this
form. We ask CMS to explain the problem that is being addressed with this
consolidation. The current form for laboratory services has eliminated much confusion
on the part of the beneficiary and the physician office staff concerning why Medicare
might not pay for a laboratory test. The reasons were clearly represented by each column
on the form and it was simple to place the name of the test in the appropriate column.
The proposed form now asks the physician office staff to write not only the test but the
reason, which they usually do not remember. The net result of this change is that
laboratories will receive specimens with incorrectly executed ABN forms after the close
of the physician's office. Clinical laboratory professionals will be unable contact anyone
and face the ethical dilemma of performing a test that may not be billable to either the
patient or Medicare.
We would like to raise some additional concerns:
(G)Option - #3 does not clearly state that the beneficiary agrees to be financially
responsible for the testing if Medicare does not pay for the test. While financial
liability may be implied in option #3, it is not clearly stated as it is in option #2.

6701 Democracy Boulevard, Suite 300 Bethesda, Maryland 208 17 30 1.657.2768 30 1.657.2909fax

AMERICAN SOCIETY FOR CLINICAL LABORATORY SCIENCE

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We believe option #3 should clearly state that the patient is agreeing to be
financially responsible for payment if Medicare does not pay and their appeal is
not successful.
Section H - We question the necessity for the collection of information about
other insurance on an ABN form. Complete billing information should be
submitted with the requisition and having other insurance listed on the form does
not seem to add any little value to the purpose of the form.

ASCLS is pleased that the ABN lists the charge information for each specific procedure.
If a patient has more than one procedure ordered that is not medically necessary, it is
currently difficult for the beneficiary to determine the cost of each procedure in order to
make a decision as to whether he or she is willing to pay for each procedure.
ASCLS and its members thank you for your attention to these concerns and suggestions
and reaffirm our willingness to work with you and your colleagues to ensure that the
changes to this form are of benefit to the beneficiary and not burdensome to the
providers.
Sincerely,

Shirlyn McKenzie, President
American Society for Clinical Laboratory Science

6701 Democracy Boulevard, Suite 300 Bethesda, Maryland 20817 301.657.2768 301.657.2909fax

April 24,2007
Leslie Nonvalk, Esq.
Acting Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Room 445-G Hubert Humphrey Building
200 Independence Avenue, SW
Washington, DC 20201
Dear Administrator Nonvalk:
On behalf of the American Association for Homecare (AAHomecare), we are pleased to provide
comments on the proposed Advance Beneficiary Notice of Non-Coverage (ABN) notice. Our
comments incorporate the expert views of home medical equipment providers and association
who utilize this form for individuals seeking health care items, services and therapies under the
Medicare program.
AAHomecare is the largest national professional association representing the homecare
community. AAHomecare represents health care providers and manufacturers that serve the
medical needs of Americans who require oxygen equipment and therapy, sleep therapy
technologies and services, mobility assistive technologies, medical supplies, inhalation drug
therapy, home infusion, and other home medical equipment, therapies, services and supplies in
their homes. Our membership reflects a broad cross-section of the homecare community,
including national, regional and local providers operating in approximately 3,000 locations in all
50 states. AAHomecare and its members are committed to advancing the value and practice of
quality health care services in the home.
'fie Association's comments include both clarifications to the proposed ABN and accompanying
instructions and recommendations to facilitate a clear understanding of the requirements and
facilitate ease of use by providers and Medicare beneficiaries.
Clarifications and Recommendations

1) Proposed ABN form instructions contain a field for the beneficiary's name (Blank B).
Notice instructions indicate that, "Notifiers must enter the first and last name of the

beneficiary receiving the notice and the middle/initial also if used on the beneficiary's
Medicare card. The Association requests guidance from CMS that a provider makes the
best intent to accurately reflect the beneficiary's name, however since other identifying
information is included on the ABN, a missing middle initial or misspelled name should
not invalidate the ABN.
2) ABN form instructions contain a field for the beneficiary's identification number. The
instructions state, "notifier should enter an identification number for the beneficiary that
helps to link the notice with a related claim when applicable. When a number such as a
Medicare number of HICN is used the notice must be delivered in a secure manner
consistent with federal privacy requirements." The association requests that an
identifying number be optional to help better identify a patient to a database, however it
does not invalidate an ABN if left blank. The Association recommends that the
requirement for an H lCN be eliminated from the notice. Medicare beneficiaries are
becoming increasingly concerned with providing personal identification information.
3) Field F on the proposed form requires the "notifier must enter a cost estimate in this
blank for items or services described in Blank (D)" This requirement is a departure from
the previous ABlV form, which indicates that, "You may provide the patient with an
estimated cost of the items and/or services." The Association's recommendation is to
continue the requirement that a provider may provide a cost estimate. Since services
provided by DME suppliers may have monthly, daily, per dosage charges, it is impossible
to accurately reflect all potential charges for a course of therapy.
4) The Association is fully supportive of the wording of Blank (G) option 2. We
recommend that CMS include additional information in the instructions that provide an
example of its application. For instance, an example could be, "Patient wishes to
purchase a wheelchair rather than rent or the patient wants to purchase additional diabetic
supplies beyond those covered in the medical policy."
5) Under Blank (G) options, the instructions indicate "If a beneficiary cannot or will not
make a choice, the notice should be annotated." We request that CMS provide an
acceptable example of an appropriate annotation. Our recommendation for an example
is; patient not available to sign, family member requested purchase of wheelchair on
patients behalf. Also, if no choice is made but an annotation is made it is deemed a valid
ABN.

6 ) The current ABlV allows for cases when the patient refuses to sign the ABN. In these
circumstances, suppliers can have a witness sign and date the form, noting that the ABN
was given to the patient who refused to sign the notice. Will this policy still be
permissible under the proposed ABN?
7) Will the proposed ABN be needed for a DMEPOS item or service that is not covered or
simply for medical necessity denials?

8) W c would like guidance from CMS indicating the effective period of an ABN. There has
been inconsistent guidance from the DME MACs on this issue. We would recommend
that an ABN is valid for the full period of medical necessity. This would allow suppliers
to get only one document per therapy.
9) The Association strongly recommends that CMS provide fbr a sufficient transition to the
use of the new form. The proposed form is dated "June 2007." We want to be sure that
older forms are not considered invalid, and therefore, the ABN is invalid because an old
version of the form was used. There should be a grace period of at least 90 days when
either form may be used and considered valid.

10) We recommend revising the wording in number 3 under option G. The wording in the
second sentence of the proposed notice states, "1 want you to bill Medicare for an official
decision of payment." We propose revising this sentence to, "1 want the provider or
supplier to bill Medicare for an official decision on payment." We also would
recommend that sentence 3 in Option G number 3 be eliminated. This sentence is
confusing and does not take into consideration non-assigned claims.
We appreciate your consideration of the Association-s comments and recommendations on the
proposed Advance Beneficiary Notice of Non-Coverage notice. We hope to work closely with
CMS 011 the proposed form and may provide additional comments that we receive from our
members. If you have any questions about the recommendations and clarifications contained in
our comments, please contact Walter Gorski at (703) 535-1 894.

Tyler Wilson
President
American Association for Homecare

Federation of

PROVEN LEADERSHIP
1 9 6 6

Charles N. Kahn I11
President

2 0 0 6

April 23,2007

BY OVERNIGHT MAIL

Centers for Medicare & Medicaid Services
Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development-C
Attention: Bonnie L. Harkless
Room C4-26-05
7500 Security Boulevard
Baltimore, MD 21244 - 1850

RE:

CMS-R-131 (OMB#: 0938-0566); Agency Information Collection
Activities: Proposed Collection; "Comment Request - Advance
Ben eficiarv Notice o f Non coverane (ABN) "

Dear Ms. Harkless:
The Federation of American Hospitals ("FAH") is the national representative of
investor-owned or managed community hospitals and health systems throughout the
United States. Our members include teaching and non-teaching hospitals in urban and
rural parts of the United States. We appreciate the opportunity to comment on the
Centers for Medicare & Medicaid Services' ("CMS") Notice, issued in accordance with
the Paperwork Reduction Act of 1995, regarding agency information collection activities
involving the Medicare Advance Beneficiary Notice of Noncoverage ("ABN"). (See 72
Fed. Reg. 8167 (Feb. 23,2007).)
I.

Combination of the Advance Beneficiarv Notice and the Notice of Exclusion
from Medicare Benefits

The proposed revisions to the ABN include combining the current General Use
ABN (Form CMS-R-13 1-G) and the Laboratory Use ABN (Form CMS-R-13 1-L) into a
single notice, called the Advance Beneficiary Notice of Noncoverage. In addition,
according to the proposed form's instructions, this single general notice would be used in
place of the Notice of Exclusion from Medicare Benefits (NEMB) to provide voluntary

801 Penmylvania Ave., NW, Suite 245 Washington, DC 20004-2604 202-624-1500 Fax: 202-737-6832

Ms. Harkless
April 23,2007
Page 2

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notification of financial liability. The FAH supports combining the Forms CMS-R- 131G and CMS-R-13 1-L, and appreciates the agency's action to streamline the ABN process
to use one form.
However, for several reasons discussed below, we do not believe the ABN and
NEMB forms and related processes should be combined. First, the instructions for the
revised form state that "Physicians, providers.. .. must complete the ABN as described
below, and deliver the notice to the affected beneficiary.. ." Form instructions at p. 1.
This means that a completed ABN form is mandatory if a provider wishes to bill
Medicare and hold the beneficiary liable should Medicare deny payment. Conversely,
completion of the NEMB form for statutorily excluded services or services that do not
meet the definition of a Medicare benefit is optional, and the provider may bill the
beneficiary for such services even if an NEMB is not completed.
Also, the billing rules for statutorily excluded services (NEMB) and nonmedically necessary services (ABN) are not equivalent. When an ABN is obtained for
services that the provider does not believe are medically necessary, the provider
bill
the services to Medicare in order for the Medicare Contractor to make a coverage
determination. When reporting ABN services to Medicare, the services are listed as
covered with occurrence code 32 andlor the GA modifier present on the claim. Medicare
Claims Processing Manual (CMS Pub. 100-04), Chapter 1, $5 60.1.2 and 60.4.1.
If a provider decides to obtain an NEMB for statutorily excluded services and the
provider submits a claim to Medicare, the services are reported as non-covered with the
GY modifier. The Medicare administrative contractor always will deny these services.
Medicare Claims Processing Manual. (CMS Pub. 100-04), Chapter 1, $ 60.3.1.
If the forms are combined and both non-medically necessary and statutorily
excluded services are included on the same ABN, the provider billing process would be
more difficult, e.g.,determining which services require the GA modifier versus the GY
modifier when both were on the same ABN. In addition, CMS billing rules state that
ABN and demand billing should not be on the same claim. Medicare Claims Processing
Manual (CMS Pub. 100-04), Chapter 1, 5 60.3.1.
As a result, because the specific requirements for obtaining the two forms differ,
we believe it is not reasonable to combine the forms and related billing processes, and
doing so is likely to create confusion in the provider and beneficiary communities.
I

It is also not clear from the proposed form and accompanying instructions whether the single general
notice would replace the American Dental Association NEMB used for dental exclusions and the American
Pediatric Medical Association NEMB used for foot care exclusions under Medicare. While these forms are
not published by CMS, they are reviewed and approved by the agency and are used as part of the NEMB
process.

Ms. Harkless
April 23,2007
Page 3

Accordingly, we believe that Option 2 should be removed from Section G of the
proposed ABN form because it applies only to statutorily excluded services.
If CMS decided to continue with its plan to combine the ABN and NEMB forms,
the billing instructions for these two distinct types of items or services in the Medicare
Claims Processing Manual, Chapter 1, Section 60 and Chapter 30, Section 90 will need to
be revised. In accordance with revisions to these rules, Medicare claims processing
systems also would need to be evaluated and potentially modified to process and
adjudicate claims appropriately. Also, providers would need to im lement system
changes, develop new processes, and furnish extensive education.

4

The amount of time needed to publish new rules, update claims processing
systems and conduct provider education should be considered when determining an
effective date of the new ABN form. At a minimum, we estimate that this is likely to
take as long as six months to accomplish. Therefore, if CMS decides to move forward
with this proposal, we request a significant transition period to allow both providers and
Medicare Contractors to modify their operations to implement these changes.
11.

Option Box

The proposed instructions state:
Ifa beneficiary chooses to receive some, but not all of the items or services that
are subject of the notice, the items and services in Blank (D) that they do not wish
to receive may be crossed out, ifthis can be done in a way that also clearly strikes
the reason(s) and cost information in Blanks (E) and (F) that correspond to that
care. I f this cannot be done clearly, a new ABN must be prepared.
We do not feel that it is appropriate to cross out those items that the beneficiary
chooses not to receive without further action. This does not allow the beneficiary to
choose an option from Section G of the form. In the scenario where there are multiple
services listed on the ABN and the beneficiary chooses to receive some but not all of the
services, a new ABN should be created; therefore allowing the beneficiary to choose
Option 1 on the form for the services that they do not want to receive and either Option 2
or 3 on the other form for those services that they want to receive.
111.

Other Insurance

We believe that Section H should be removed from the ABN form as this
information already is obtained from the beneficiary during the registration process by
2

We also assume, although it is not stated in the Notice, that CMS intends to publish an English and
Spanish version of the single ABN.

Ms. Harkless
April 23,2007
Page 4

collecting Medicare Secondary Payer data. To ask for this information again would be
redundant.
IV.

Estimated Cost

Regarding Section F Estimated Cost, the instructions for the revised form state,
"Notifiers must enter a cost estimate in this blank for the items or services described in Blank
(D)." Form Instructions at p. 3. Current instructions (Medicare Claims Processing Manual,
Chapter 30, Section 50.5.7) regarding Estimated Cost state:

The user may provide the patient with an estimated cost of the items and/or services.
The patient may ask about the cost andjot 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 dflerent from the final actual cost, does not
invalidate the ABN; an ABN will not be considered to be defective on that basis. In
the case of an ABN which includes multiple items and/or services, it is permissible for
the user to give estimated amounts for the individual items and/or services rather
than an aggregate estimate of costs. Amounts may be provided either with the
description of items and services or on the "Estimated Cost" line.
We would ask CMS to clarify whether the Estimated Cost is mandatory. In addition,
we request that CMS define if an estimate is different from the actual cost how much
variance is allowed before the ABN would be considered defective.

The instructions for the revised form state for Section D Item(s)/Service(s):

Notifiers must enter the name/description of all item(s) and/or service(s) that are the
subject of the notice. Whenever possible, language that is easy for beneficiaries to
understand should be used. Iftechnical language must be used, it must be explained
verbally to the beneficiary or representative.
Current instructions (Medicare Claims Processing Manual, Chapter 30, $9 50.5.5 and
50.5.6) state:

...the user speczfies the health care items or services for which he/she/it expects
Medicare will not pay. The items or services at issue must be described in sufficient
detail so that the patient can understand what items or services may not be furnished.
HCPCS codes by themselves are not acceptable as descriptions.
We would request that CMS clarify what degree of specificity is required when
completing this section. For example, a physician orders an MRI of the head without
contrast to be performed at XYZ Hospital. The patient is registered and an ABN is
obtained based on a Local Coverage Determination. The Item listed is "MRI of head

Ms. Harkless
April 23,2007
Page 5

without contrast." Upon consultation with the patient's physician, the radiologist
performs an MRI of the head with and without contrast. CMS should define whether the
ABN would be valid in this type of scenario.

VI.

Burden Estimate

We believe the Burden Estimate is understated in several aspects. While we do
not disagree with the seven minutes on average to deliver an ABN, but do not feel that
the estimate accurately includes all aspects of the process. In addition to delivering the
ABN, there are additional steps during the billing and collection process that are affected
by the ABN. We believe that each claim that includes services for which an ABN has
been obtained, takes an additional five minutes to process by the provider. Also, if
Medicare denies the ABN service, the provider will incur additional costs to collect the
funds from the beneficiary, including producing patient billing statements and follow-up
phone calls.
Also, the estimated volume of ABNs delivered is based on the current ABN form
and does not appear to be inclusive of the volume of NEMBs delivered.
We would request that the Burden Estimate be recalculated taking these points
into consideration.

We appreciate the opportunity to comment on this information collection activity
and hope that the agency carefully considers the comments in this letter. If appropriate,
we would welcome the opportunity to meet, at your convenience, to discuss our views. If
you have any questions, please feel free to contact me or Jeffrey Micklos of my staff at
(202) 624-1500.