[Place on your company letterhead or
insert logo and your address here]
[Insert date]
The Honorable [insert representative/senator’s name]
[insert address]
[insert city, state, zip]
RE:
Calendar Year 2016 Clinical Laboratory Fee Schedule Preliminary Determinations
The Honorable insert representative/senator’s name],
[Insert your company name] is a [enter accreditation] accredited laboratory with a principal place of business
in the State of [insert state], serving patients that require medically necessary urine drug monitoring and
toxicology testing services. The focus of its toxicology services is to support CDC’s highest priority of
controlling the proliferation of illicit drug use, while providing clinical data to support physicians in medication
monitoring.
In 2015, the Centers for Medicare and Medicaid Services (CMS) solicited industry experts, stakeholders, and
its own Protecting Access to Medicare Act (PAMA) Advisory Panel to comment on and provide feedback to
its proposed modifications of the Clinical Laboratory Fee Schedule. CMS listened to industry experts,
stakeholders, and the PAMA Advisory Panel at its annual meeting in July and received feedback on two
similar, proposed fee schedules that would reduce costs, be economically viable for physician offices and
laboratories. Nevertheless, CMS chose to ignore almost all recommendations, including those from its own
PAMA Advisory Panel. Instead, CMS has proposed a preliminary fee schedule that offers woefully
inadequate reimbursements for these necessary services. At a time when CDC has labeled the problem of
illicit drug use as its number one priority, the healthcare system can ill afford creating disincentives to provide
testing services essential for clinical decision support systems.
We are writing to ask your support for Congressional action to request CMS to reconsider and revise its
proposed fee schedule to address the negative impact and consequences that would ensue. The key impact
will ultimately filter through to commercial payers, which will negatively affect providers, patients, and
communities here at home and across the country. We are committed to combating drug abuse but without
the necessary tools to do so, our ability to support and address the CDC’s #1 plan to eradicate drug abuse in
America is undermined.
To provide quality care while preventing diversion and abuse, we invest a significant amount of resources
monitoring and test our patients. However, CMS’ pricing methodologies result in payments that do not cover
the minimal costs of testing necessary to treat these patients. These below-cost reimbursements, if allowed
to continue, will result in a greater risk of reduced services and noncompliance.
Calendar Year 2016 Clinical Laboratory Fee Schedule Preliminary Determinations
[Place on your company letterhead or
insert logo and your address here]
We are also concerned that the reimbursement changes will create a substantial financial incentive for the
independent labs to control costs by testing fewer drugs and reducing investment in innovation. As a result,
more drugs will likely go undetected.
Industry experts and stakeholders agreed, for the most part, with the recommendations from CMS’ own PAMA
Advisory Panel. We urge Congress to have CMS explain why such a pricing approach is not only 1)
reasonable, but also 2) protects and provides the necessary services to CMS beneficiaries, while 3) not
wasting money in the Medicare Trust Fund. Many of the issues described above would already be addressed
had CMS taken into consideration the unanimous comments and recommendations for tiered pricing. Please
help us continue serving the community and your constituents by urging CMS to adopt payment
methodologies in line with those recommended by industry experts and stakeholders, and CMS’ own PAMA
Advisory Panel.
Thank you very much for your consideration. We look forward to discussing this with you further and your
support for a public CMS review of these important issues.
Sincerely,
Ssgn here
[insert your name]
[Insert your title]
[insert your company/business name]
[insert your phone number]
[insert your email address]
Calendar Year 2016 Clinical Laboratory Fee Schedule Preliminary Determinations