Global Warming in the Health Care Industry California Clinical Laboratory Association 2010 Annual Meeting November 5, 2010

Global Warming in the Health Care Industry

More Anti-Fraud Statutes Patient Protection and Affordable Care (PPACA) Fraud Enforcement and Recovery Act (FERA) False Claims Act (FCA)

More Anti-Fraud Teams and Tools Health Care Prevention and Enforcement Action Team (HEAT) Health Care Fraud and Abuse Control (HCFAC) Civil Investigative Demand (CID)

Senator Grassley Twitter “When you are a “hammer” u think everything is NAIL”

$1.7 Billion for Fraud Prevention in 2011 More Risk, Less Reward $1.7 Billion for Fraud Prevention in 2011 1.75% Cut in Lab Reimbursement over next 5 years

Front-End Focus “[W]e’re getting smarter about analyzing … claims in real time to flag potential scams. It is what credit card companies have been doing for decades: If 10 flat screen TV’s are suddenly charged to my card in one day, they know something’s not quite right. So they put a hold on payment and call me right away…We should be able to take the same approach when one provider submits ten times as many claims …as a similar operation just down the road. It’s about spotting fraud early before it escalates and the cost grows.” HHS Secretary Kathleen Sebelius

New Self Policing Requirements RETURN OVERPAYMENTS !!!

PPACA is a Game Changer

New Stark Self-Disclosure Protocol

Compliance Programs Now Required You need a Compliance Program to stay in… to get out!

Areas To Watch Out-of-Network Billing—Aetna v. LabCorp PPI breach disclosure: HITECH: Within 60 days if “poses a significant risk for financial, reputational, or other harm to the individual.” CA Health & Safety Code Sec 1280: Within 5 days if “unauthorized disclosure.” Stanford fined $250 for late disclosure to California Department of Public Health. Requisition signatures ICD-10 Direct access testing (patient ordered tests) DAT expansion/internet marketing Industry Consolidation

Good News? May level the playing field Stark Self-Disclosure? PPACA: Physicians who provide in-office ancillary services (so far MRI, PET and imaging) must notify patients in writing of alternate providers in the area…may be extended to labs

Questions?

Thank You For Attending! David Gee (206) 816-1351 dgee@gsblaw.com

DISCLAIMER These materials are provided for educational purposes only, and are not legal advice or intended to be substituted for legal advice. Parties affected by the issues discussed in these materials should consult with their legal counsel as the specific facts of any given case will greatly influence the legal advice given. It is important to note that these materials address an area of the law that is volatile and expected to have significant changes in the very near future which may completely alter the applicability of these materials to any situation.