01-28807. Medicare Program; Withdrawal of Medicare Coverage of Certain Positron Emission Tomography (PET) Scanners

AGENCY:

Centers for Medicare & Medicaid Services, HHS.

ACTION:

Notice.

SUMMARY:

This notice announces our decision to withdraw Medicare coverage from certain 2-[F-18] Fluoro-D-Glucose Positron Emission Tomography (PET) scanners.

EFFECTIVE DATE:

This notice is effective January 1, 2002 for clinical indications already covered by Medicare for 2-[F-18] Fluoro-D-Glucose PET scans before July 1, 2001.

FOR FURTHER INFORMATION CONTACT:

Mitchell Burken, M.D., [phone].

SUPPLEMENTARY INFORMATION:

On April 27, 1999, we published a notice (64 FR 22619) that established the procedures used for making national coverage decisions. The April 27, 1999 notice also described the procedures we used to implement national coverage decisions. Under that section of the notice, we stated that if we chose to “withdraw or reduce coverage for a service,” we would publish the decision as a general notice in the Federal Register.

This notice announces our decision to reduce Medicare coverage of certain 2-[F-18] Fluoro-D-Glucose (FDG) Positron Emission Tomography (PET) scanners. For those clinical indications already covered by Medicare before July 1, 2001, PET imaging must be performed on either FDA-approved full- or partial-ring scanners, or coincidence systems that have the following features:

• Crystal at least 5/8-inch thick.
• Techniques to minimize or correct for scatter and/or randoms.
• Digital detectors and iterative reconstruction.

Scans performed with gamma camera PET systems with crystals thinner than 5/8-inch will not be covered. In addition, scans performed with systems with crystals greater than or equal to 5/8-inch in thickness, which do not meet the other listed design characteristics, are not covered.

Authority: Sections 1862, 1869(b)(3), and 1871 of the Social Security Act (42 U.S.C. 1395y, 1395ff(b)(3), and 1395hh).

(Catalog of Federal Domestic Assistance Program No. 93.773 Medicare—Hospital Insurance Program; and No. 93.774, Medicare—Supplementary Medical Insurance Program)

Dated: November 7, 2001.

Thomas A. Scully,

Administrator, Centers for Medicare & Medicaid Services.