CMS-R-131 Comment #40

April 24, 2007

Ms. Bonnie L. Harkless
Office of Strategic
Operations & Regulatory Affairs
Division of Regulations
Development-C
Room C4-26-05
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244-1850
Dear Ms. Harkless:
On behalf of the physician and medical student members of the American Medical Association
(AMA), I respectfully submit the following comments to the notice that the Centers for Medicare &
Medicaid Services (CMS) issued on February 23, 2007, concerning proposed changes to the content
and format of the Advance Beneficiary Notice (ABN) for health care items and services (ABN, form
CMS-R-131-G) and the ABN for laboratory tests (CMS-R-131-L). CMS requires physicians to
supply their patients with an ABN prior to providing certain services, items, or tests if it is anticipated
that such services, items, or tests will not be covered and paid by Medicare. Among other things,
CMS proposes to consolidate the two forms into one form.
While the AMA appreciates CMS efforts to streamline the ABN paperwork requirements, we have
serious reservations about the development of the new language and format without the input of
physicians and other stakeholders. The current language in the ABN is the product of a collaborative
effort among CMS, physicians and other stakeholders. As a result, use of the ABN forms has been
widespread. This previous successful collaboration is an example of how the current process should
be conducted. Given the heightened level of interest in the forms when they were last reengineered
several years ago, where the AMA and others including the Practicing Physicians Advisory Council
(PPAC) offered significant input, CMS should obtain additional feedback on the new, consolidated
form. We strongly urge CMS to seek PPAC feedback prior to implementing changes.

Ms. Bonnie L. Harkless
April 24, 2007
Page 2

There are a number of issues that need to be addressed and we would like to work with CMS
and other stakeholders to resolve them prior to the implementation of the new form. The
following recommendations are examples of how CMS would benefit from additional stakeholder
input. We would welcome the opportunity to engage in the previous collaborative process to fully
flesh out the following recommendations:
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Conduct a significant amount of outreach to physicians, providers, and patients in order to
educate them about the changed form.
Replace the phrase “Item(s)/Service(s)” wherever it appears in the document with “Item(s)
/Service(s)/Test(s)”
Revise the first paragraph above the table to read:
We think Medicare will not pay for the item(s)/service(s)/laboratory test(s) that are described
below. Medicare does not pay for all of your health care costs. Medicare only pays for
covered items, services, or laboratory tests when Medicare rules are met. The fact that
Medicare may not pay for a particular item, service, or laboratory test does not mean that you
should not receive it. There may be a good reason your doctor recommended it. Below are
the item(s)/service(s)/laboratory test(s) we don’t think Medicare will pay for, the reasons
why, and the estimated costs.
Re-format the first table so that the language concerning:
Why Medicare probably won’t pay for a laboratory test is retained since removing these
reasons could create confusion that could be averted. Under the revised form, this language
was removed and this could add to rather than streamline the ABN process by creating the
need for more frequent communication between a physician’s office and laboratory
concerning coverage, require more time filling out the form, and more time explaining the
form to patients.
Second, we disagree that a column for cost should be included. Frequently, physicians do not
know the cost of care for a particular item/service/test.
Revise the language found in the three bullets below the table in the following manner:
Understand your choices. Medicare wants us to be sure you make an informed choice about
whether or not you want to receive this item(s)/service(s)/laboratory test(s), knowing that you
might have to pay for it yourself. Before you make a decision about your options, you
should read this entire notice carefully.
• Ask us to explain, if you don’t understand why Medicare probably won’t pay.
• Ask us how much these items or services will cost you (Estimated Cost - if known):
$______)
• For questions on this notice or on Medicare billing, you can also call 1-800-MEDICARE
(1-800-633-4227/TTY: 1-877-486-2048).
Under (G) Options, we recommend retaining the language in the current ABN-G/ABN-L. The
language and way the information is presented in this table is easier to understand.
Under (H), we are unclear why CMS added this language since this information is already
included on claims.

Ms. Bonnie L. Harkless
April 24, 2007
Page 3

Finally, if CMS proceeds with implementation of the new form without stakeholder
collaboration, we strongly encourage the agency to test pilot the form with patients to ensure
the language and characteristics of the form such as table formats and fonts are widely
understood.
We appreciate the opportunity to offer this input and look forward to working with CMS and other
stakeholders prior to the adoption of any changes to these forms. If you have any questions about our
comments, please contact Mari Johnson at [email protected] or (202) 789-7414.
Sincerely,

Michael D. Maves, MD, MBA