CMS Reaches Different Conclusions on Provision of Pap Smear Collection Supplies

In two separate advisory opinions issued in October, the Centers for Medicare and Medicaid Services (CMS) reached different conclusions regarding the provision of liquid-based Pap smear collection kits and biopsy brushes by laboratories to referring physicians. In one opinion (AO-2013-02) CMS says it is a violation of Stark law for a laboratory to provide free disposable cervical biopsy brushes to referring physicians. In another opinion (AO-2013-01) the agency says it is legal for a lab for provide free Pap smear collection kits to clinicians. Requestors in both cases certify that the items provided are used solely to collect Pap smears and that they have procedures in place to monitor the number of items provided and the number of Pap smears received to ensure they are not providing excessive supplies the physician can use for other purposes. Collection Kit OK In the first advisory opinion, the requestor states that it creates a Pap smear collection kit by packaging one or two collection tools with a vial of fixative and labeling the kits with the lab’s name and brand. All components of the kit are Food and Drug Administration (FDA)-cleared, disposable, single-use instruments used to collect specimens for Pap smear examination or liquid-based cytology. Under the proposed arrangement, the lab would provide the kits to referring physicians at no charge. In its analysis, CMS concludes that the collection kits are not “surgical items, devices, or supplies” for purposes of the physician self-referral law. Information publicly available from the manufacturers of the component parts of the kits indicates that the collection tools are all disposable and intended for a single use only, the agency notes. Based on the specific facts provided by the requestor, CMS concludes that the arrangement would not result in remuneration to referring physicians and therefore would not violate the physician self-referral law. However, CMS also notes that the provision of a kit containing a collection tool that is not a “single-use” item could result in a different conclusion. Biopsy Brush Not OK In the second advisory opinion, the requestor is a lab that provides a patented, sterile, disposable, single-use biopsy brush used to obtain tissue from areas of the cervix appearing to be abnormal during vaginal examinations. The device is intended as an alternative to the traditional punch biopsy, which pierces and removes tissue to obtain a sample for testing. The requestor certified that the CPT code reported to document the collection of specimens using the biopsy brush is the same as that used to document collection via punch biopsies (CPT 57454). According to the requestor, when the device is used, its tip is broken off and sent to the laboratory in a small specimen bottle with formalin to preserve the specimen. The device cannot be reused. In its analysis, CMS concludes that the biopsy brush is a “surgical item, device, or supply.” According to CMS, the FDA defines a “manual surgical instrument for general use” as a nonpowered, handheld, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. Under the relevant provision, the FDA lists approximately 50 types of devices intended for use in various surgical procedures, including a biopsy brush. In reaching its conclusion, CMS also considered the intended purpose of the device and whether it is “routinely used as part of a surgical or medical procedure.” Because all biopsies are categorized by the American Medical Association as surgical procedures, and in light of the agency’s review of the 510(k) premarket notification, CMS concludes that the biopsy brush is routinely (if not predominantly) used as part of a surgical procedure. Based on the facts presented, CMS concludes that the proposed arrangement would result in remuneration to referring physicians and thereby create a “compensation arrangement” that implicates the physician self-referral law. ‘Rumeneration’ Definition Key Robert Mazer, Esq., an attorney with Ober|Kaler (Baltimore), says that even though CMS reached different conclusions in the advisory opinions, they are not necessarily inconsistent with one another under the definition of “remuneration” under the Stark regulations. The Stark statute excludes from the definition of remuneration items, devices, or supplies that are used solely to collect specimens for the entity providing them to the physician. The definition of remuneration in the Stark regulations is similar, with one significant exception, notes Mazer. The regulations specifically state that “surgical items, devices, or supplies” can not be excluded from the definition of remuneration. “The opinions indicate that there may be no “one size fits all” rule as to whether a particular item, device, or supply that may be used to obtain a laboratory specimen can be given to physicians,” says Mazer. “Instead, laboratories will be required to analyze the particular use of the item, device, or supply and how related procedures are coded by physicians who use them. This may require knowledge regarding medical procedures other than pathology, which a laboratory may or may not have in-house.” Takeaway: Laboratories may provide referring physicians with Pap smear collection kits without fear of violating the physician self-referral law, but provision of biopsy brushes would implicate the law. Labs need to evaluate provision of supplies to physicians on a case-by-case basis.