CCLA 2013 Annual Conference

1. CCLA 2013 Annual Conference Michael J. Arnold Kristian E. Foy CALIFORNIA CLINICAL LABORATORY ASSOCIATION Sacramento Legislative and Regulatory Update

2. Woman Stops Grizzly Attack With 25 Caliber Pistol!

3. Beretta Jetfire • This is a story of self-control and marksmanship with an "itsy-bitsy shooter“ by a woman facing a fierce predator.  • What is the smallest caliber you trust to protect yourself? • The 25 cal. Beretta Jetfire:

4. “While out hiking in British Columbia, Canada, with my husband we were surprised by a huge grizzly bear charging at us from out of nowhere.  She must have been protecting her cubs because she was extremely aggressive.  If I had not had my little Beretta Jetfire with me I would not be here today! Just one shot to my husband's knee cap was all it took. The bear got him and I was able to escape by just walking away at a brisk pace.”   Here’s Her Story

6. Legislative Status Report Periodic listing of all bills being followed by CCLA. Shows bill, author, summary, location, hearing date, etc. Available to any member, anytime Click on the bill number and it takes one to a copy of the bill, analyses, and other information.

8. 2013 – 2014 State budget Proposition 25 is working – On Time Budget Proposition 30 – Increase in Revenue Governor Demanded Fiscal Restraint

9. Key 2013 Legislation • AB 399 • Fox, Steve D • Clinical laboratories • Text Version: Introduced 2/15/2013 • Position: Co-Sponsor • Status: 5/3/13 Failed Deadline pursuant to Rule 61(a)(2). (Last location was B.,P. & C.P. on 3/7/2013) This will be a two year bill. This bill would authorize the Department of Public Health to charge appropriate license fees whenever it determines that a new category of licensure is necessary.

10. Key 2013 Legislation • AB 446 • Mitchell, Holly D • HIV testing • Text Version: Amended- 9/6/13 • Position: Oppose Unless Amended • Amended per input from the CAB • Amendments avoid filing reports on multiple HIV test results, as opposed to the final result. • Status: Signed into law. AB 446 changed the informed consent provided to individuals being tested for HIV. Amended so that it no longer impacts communicable disease reporting.

11. Key 2013 Legislation • AB 830 • Holden, Chris D • Clinical laboratories • Position: Watch/Expressed Concern • Status: 5/3/13 Failed Deadline pursuant to Rule 61(a)(2). (Last location was B.,P. & C.P. on 4/1/2013) • Author dropped the bill based upon negative comments. State Department of Public Health will be required to create regulations to require hospitals and health care facilities that employ clinical laboratory scientists and medical laboratory technicians to provide training to those individuals and any other employees charged with supervising those individuals. A violation of the provisions governing clinical laboratory technology is a misdemeanor under existing law; this bill expands the definition of a crime, thereby imposing a state-mandated local program.

12. Key 2013 Legislation • SB 264 • Pavley, Fran D • Accountable care organizations • Text Version: Introduced- 2/13/13 • Position: Watch • Status: 5/3/13 Failed Deadline pursuant to Rule 61(a)(2). (Last location was HEALTH on 2/21/2013) This bill would require an accountable care organization, as defined, operating in the state to have a clinical laboratory testing advisory board, as specified, to recommend testing guidelines that the accountable care organization may adopt.

13. Medi-Cal Cut - 2011 10% provider payment reduction from 2011 now being applied to virtually all providers Provider groups lost lawsuit and TRO was lifted Reduction RETROACTIVE to June 1, 2011!!! DHCS now implementing reduction plus “claw back” for “over payment” during retro period! Since labs were not part of the lawsuit, our claw back is shorter.

14. Medi-Cal Payment Cut to labs in 2012 – AB 1494 • 10% cut in lab reimbursement—retroactive to July 1, 2012. (In addition to 2011 10% cut!) • CMS has not yet approved this cut! • AB 1494 also requires DHCS to produce a new rate development methodology-with stakeholder input • 10% cut to stop when new rate methodology is approved by CMS • DHCS “Rate Development” staff is overwhelmed by amount of data and variability in rates for lab testing • AB 82, 2013, extends lab exemption from “lowest charge” regulation 50501(a) for additional nine months to March 2014.

15. Medi-Cal Lowest Price Reg Ca Administrative Code Section 51501(a): “…no provider shall charge (Medi-Cal) for any service…more than would have been charged for the same service…to other purchasers of comparable services…under comparable circumstances.” CA False Claims Act: Section 12650 of the Government Code

16. MolDx Pricing • Palmetto GBA Issued pricing for molecular and genetic testing. • The proposed prices were far too low. • CMS was approached to address this issue and we were somewhat successful in obtaining price increases. • The low MolDx pricing has had a “chilling impact” on VC investment in labs.

17. Covered California 2013

18. 12 Health Plans Alameda Alliance for Health Anthem Blue Cross of California Blue Shield of California Chinese Community Health Plan Contra Costa Health Plan Health Net Kaiser Permanente L.A. Care Health Plan Molina Healthcare Sharp Health Plan Valley Health Plan Western Health Advantage

19. Covered California Implementation Website went live October 1, 2013 Coverage begins January 1, 2014

22. State Level Lab Issues Reimbursement from Public Programs Frequency Limits Staffing requirements and standards Licensure regulations and fees Moratorium on new lab provider numbers Contracting for lab services Operational issues - e.g. auto verification, use of personnel Anti-mark up/direct billing legislation Direct access testing for any test sold OTC—other tests? Safe needle mandate Phlebotomy certification Specimen lock box mandates Cap on number of tests which may be provided to patients Medicaid “Lowest Charge” requirement Etc., etc., etc….