With Congress back in business after its two-week April spring break, here’s a quick guide to the status of major legislation affecting clinical laboratories and pathologists that awaits action in the House and the Senate.

Bill: H.R. 1237, the Cytology Proficiency Improvement Act of 2007. Introduced: February 28, 2007, as bipartisan bill. Lead sponsor: Rep. Bart Gordon (D-TN). Co-sponsors: 14. Latest action: Referred to the Committee on Energy & Commerce.

Purpose: Revise PT standards under CLIA (the Clinical Laboratory Improvement Amendments) to include requirements that each clinical lab (1) ensure that all individuals who screen and interpret cytological preparations participate annually in an approved continuing medical education program that provides each participant with gynecologic cytologic preparations designed to improve locator, recognition, and interpretive skills; and (2) maintain a record of program results. The Health & Human Services Secretary would be required to terminate the CLIA individual PT program in effect before enactment of H.R. 1237.

Bill: H.R. 493, the Genetic Information Non-Discrimination Act of 2007. Introduced: January 16, 2007, as bipartisan bill. Lead sponsor: Rep. Louise McIntosh Slaughter (D-NY). Co-sponsors: 224. Latest action: The bill as amended has cleared the committees of jurisdiction and is ready for House floor action.

Purpose: Prohibit health insurers and employers from discriminating against individuals based on genetic information and establish penalties for violations. Bar employers from using genetic information when making decisions on hiring, firing, job placement, or promotion. Prohibit group health plans and other health insurers in the group and individual market from using genetic information to deny coverage or set premium rates and from requiring that individuals undergo genetic testing. The prohibitions also apply to employment agencies, labor unions, and Medicare supplemental policy plans.

Bill: S. 358, the Genetic Information Non-Discrimination Act of 2007. Introduced: January 22, 2007, as bipartisan bill. Lead sponsor: Sen. Olympia J. Snowe (R-ME). Co-sponsors: 28. Latest action: Reported out of the HELP Committee on April 10, ready for Senate floor action.

Purpose: Similar to H.R. 493, barring employers and health plans from discriminating based on an individual’s genetic information and establishing penalties for violations.

Bill: S. 736, the Laboratory Test Improvement Act. Introduced: March 1, 2007, as bipartisan bill. Sponsors: Edward Kennedy (D-MA), chairman of the Health, Education, Labor & Pensions (HELP) Committee, and ranking Republican Gordon Smith (OR). Latest action: Referred to the HELP Committee.

Purpose: Expand the Food & Drug Administration’s regulation of lab-developed tests (LDTs), aka home-brews. Most LDTs would be designated as class II or III medical devices requiring premarket review. The bill would require LDT labeling for intended use and regulatory status, registration of manufacturers and their LDT tests, and reporting of adverse events. It also would establish a genetic testing specialty under CLIA and direct the HHS Secretary to find ways to enhance payment for genetic tests and increase patient access to such testing.

Bill: S. 976, the Genomics & Personalized Medicine Act. Introduced: March 23, 2007, as bipartisan bill. Sponsors: Barack Obama (D-IL) and Richard Burr (R-NC), both of them members of the HELP Committee. Latest action: Referred to the HELP Committee.

Purpose: Calls for studies to advise Congress on further regulation of genetic testing and genomics and the impact on patient access, along with a decision matrix to help labs and test makers know which level of review is required and who is responsible. The bill also would expand research on genetic testing and genomics and the sharing of data; medical workforce training; and monitoring of direct-to-consumer marketing practices. In addition, it would establish a CLIA specialty for genetic testing and direct the HHS Secretary to increase payment for new genetic tests, where appropriate.

Bill: S. 605, the Allied Health Reinvestment Act. Introduced: February 15, 2007, as bipartisan bill. Lead sponsor: Sen. Maria Cantwell (D-WA). Co-sponsors: 8, including HELP Committee chairman Edward Kennedy (D-MA). Latest action: Referred to the HELP Committee.

Purpose: Authorize funding for Title VII programs to promote careers in allied health and to educate and train allied health personnel, especially in critical shortage areas. Support would include grants to facilitate and expand student enrollment and to develop internship and resident programs; loans for faculty development; and scholarships for students who agree to provide service in rural and other medically underserved areas. S. 605 specifically includes clinical lab sciences, medical technology, and cytotechnology. To carry out the above provisions, the bill would authorize appropriations of such sums as are necessary for fiscal 2008 through 2013.

Leading lab and pathology organizations support the bill, noting that the lab workforce is already identified in numerous studies as a critical personnel shortage area. Legislation similar to S. 605 was introduced in the House in 2005, but after being referred to committee, no further action was taken.

Currently, the Title VII allied health account is funded at $4 million through fiscal 2007. This follows the steep cut in 2006, when funding was slashed from the FY 2005 level of $11.8 million, or 66%, according to the Association of American Medical Colleges. The Bush administration’s FY 2008 budget request would eliminate allied health funding and make major cuts in most other Title VII health professions programs, except nursing education and aid for disadvantaged students.

Bill: H.R. 1105, the Physician Pathology Services Continuity Act of 2007. Introduced: February 15, 2007, as bipartisan bill. Lead sponsor: Rep. John Tanner (D-TN). Co-sponsors: 4. Latest action: Referred to the Ways & Means Subcommittee on Health.

Purpose: Make permanent the statutory provision that allows certain independent clinical laboratories to bill Medicare directly for the technical component of pathology services to hospital inpatients and outpatients. This provision, known as the "grandfather" protection, is set to expire at the end of 2007.

Bill: S. 458, the Physician Pathology Services Continuity Act of 2007. Introduced: January 31, 2007, as bipartisan bill. Lead sponsor: Sen. Blanche Lincoln (AR). Co-sponsors: 3. Latest action: Referred to the Finance Committee.

Purpose: Identical to H.R. 1105.

The "grandfather" protection applies to hospital-lab arrangements for certain pathology TC billings in effect as of July 22, 1999, the date when the Centers for Medicare & Medicaid Services first proposed eliminating such billings. CMS argued that Medicare pays for the TC as part of the hospital’s DRG payment; thus, labs should seek TC reimbursement from the hospital, not from Part B. Congress has intervened repeatedly, however, to block CMS from going forward.

Under CMS policy, the hospital is the "protected" entity, not the lab. Hospitals may switch labs without losing the protection; however, independent labs cannot switch hospitals and still be protected. CMS also has defined the TC of pathology services to include anatomic services, cytopathology, and surgical pathology.

The above bills are backed by the College of American Pathologists, the American Society for Clinical Pathology, and the American Clinical Laboratory Association. Similar legislation was introduced in Congress last year but failed to move. Congress instead extended the "grandfather" protection for an additional year, through December 31, 2007.

April 23, 2007 - Table of Contents

NIR April 23, 2007 (full PDF issue)

CMS Discloses More Details on NPI Compliance Policy

Industry Dodges the Bullet, for Now, on Lab-Developed Tests

CMS Gears Up for New Medicare Quality Reporting Program

Congressional Scorecard on Major Pending Bills

CMS Updates Lab Coalition on Medicare Bidding Demo

Follow-Up on the ‘Lab Lobbying Blitz’