Source: http://slideplayer.com/slide/4269400/
Timestamp: 2016-12-06 04:02:15
Document Index: 253372322

Matched Legal Cases: ['§ 1320', '§ 1320', '§ 650', '§ 650', '§ 1242', '§ 1246', '§ 1395', '§1320']

“Navigating Labs to Make Informed Decisions” David W. Gee and Kristen R. Blanchette David Wright Tremaine LLP - ppt download
“Navigating Labs to Make Informed Decisions” David W. Gee and Kristen R. Blanchette David Wright Tremaine LLP
Published byGeorgia Banks
Presentation on theme: "“Navigating Labs to Make Informed Decisions” David W. Gee and Kristen R. Blanchette David Wright Tremaine LLP"— Presentation transcript:
“Navigating Labs to Make Informed Decisions” David W. Gee and Kristen R. Blanchette David Wright Tremaine LLP 2
COMPLIANCE ROAD TRIP 1. % BASED CONTRACT MARKETING 2. IN-OFFICE PHLEBOTOMISTS 3. MOBILE PHLEBOTOMISTS 4. LEASING SPACE FROM DOCTORS 5. LAB PRICING PRACTICES ST. AVE. BLVD. RD. WAY 3
1. % BASED CONTRACT MARKETING FEDERAL  PROHIBITED  Why? AKS and No Safe Harbor CA  PROHIBITED  Why? Medi-Cal AKS  BUT: May be PERMITTED by PORA Safe Harbor Unless Medicare or Medi-Cal Involved YIELD AHEAD ST. 4
REFERENCES 1. % BASED CONTRACT MARKETING FEDERAL  42 U.S.C. § 1320-a-7(b) [AKS]  42 C.F.R. § [Safe Harbors]  42 U.S.C. § 1320-a-7b (b)(3)(B); 42 C.F.R. § (i) [Bona Fida Employees]  42 C.F.R. § (d) [Pers. Svs./ and Mgmt.] CA  Cal. Bus. & Prof. Code § 650(a) [CA AKS – PORA]  Cal. Welf. & Inst. Code § (a) + (b) [Medi-Cal AKS]  Cal. Welf. & Inst. Code § (c) [Medi-Cal AKS Safe Harbor] ST. 5
REFERENCES 1. % BASED CONTRACT MARKETING FEDERAL CASE LAW  U.S. v. Polin, 194 F.3d 863 (7th Cir. 1999)  U.S. v. Starks, 157 F. 3d 833 (11th Cir. 1998)  Joint Tech. v. Weaver, CIV M (W.D. Okla. 1/23/14)  Zimmer v. NuTech Medical, 54 F. Supp. 2d (N.D.Ind.1999)  Nursing Home Con. v. Quantum Health Services, 926 F. Supp. 835 (E.D. Ark. 1996)  Modern Med. Labs v. Smith-Kline Beecham Clinical Labs, 1994 U.S. Dist. LEXIS (N.D. Ill. 8/16/94) CA CASE LAW  People v. Duz-Mor Diagnostic Laboratory, 68 Cal.App.4th 654, 671 (1998)  People v. Palma, 40 Cal.App.4th 1559 (Cal. Ct. App. 1995)  People v. Guiamelon, 205 Cal.App.4 th 383, 413, 140 Cal.Rptr.3d 584 (2012) ST. 6
REFERENCES 1. % BASED CONTRACT MARKETING FEDERAL SETTLEMENTS  OIG - Kickback and Physician Self-Referral ( ) [Zimmer-Deptula (ZDI) paid $123K]  OIG - Kickback and Physician Self-Referral ( ) [FCA case; two owners of DME co. agreed to be excluded for 20 yrs]  OIG Archives - Kickback and Physician Self- Referral ( ) [ TLC paid $130K to resolve CMP liability] CA LEGIS. COUNSEL OPINION  California Legislative Counsel Bureau Opinion # , “Clinical Laboratory Referral Practice” (Apr. 20, 2012) (adresses the legality under both federal and state law of a commission- based contract marketing arrangement) ST. 7
2. IN-OFFICE PHLEBOTOMISTS FEDERAL  PERMITTED, IF  Solely collecting and processing lab specimens CA  PROHIBITED  Why? LFS has provided guidance on this issue AVE. 8
REFERENCES 2. IN-OFFICE PHLEBOTOMISTS FEDERAL  CMS Commentary to Final Stark II Regs., 66 Fed. Reg. 856, (Jan. 4, 2001)  OIG Special Fraud Alert: Special Arrangements for the Provision of Clinical Lab Services, 59 Fed. Reg (Dec. 19, 1994) CA  Legis. Counsel of CA, Clinical Lab Personnel: Placement in Physician’s Offices - #2433 (Feb. 29, 1996)  Memo re: Legal opinions re: phleb. issues from Karen Nickel, Ph.D., Chief, LFS (July 11, 1997) [AKS] AVE. 9
3. MOBILE PHLEBOTOMISTS FEDERAL  NO GUIDANCE (besides authority re: phlebs) CA  CAUTION: LFS – NO “Roving phlebs”  WHY? Prohibited by Bus. & Prof. Code § 650 BLVD. 10
REFERENCES 3. MOBILE PHLEBOTOMISTS FEDERAL  42 C.F.R. § (2) CA  Memo re: Legal opinions re: phleb. issues from Karen Nickel, Ph.D., Chief, LFS (July 11, 1997) AKS]  Regs related to phleb: Cal. Bus. & Prof. Code § 1242, § , § 1246 BLVD. 11
4. LEASING SPACE FROM DOCTORS FEDERAL  PERMITTED, SUBJECT TO:  Stark Law  AKS Safe Harbor CA  PERMITTED, SUBJECT TO:  PORA RD. 12
REFERENCES 4. LEASING OFFICE SPACE FROM DOCTORS FEDERAL  42 C.F.R (b) [AKS Space Rental Safe Harbor]  42 U.S.C. § 1395nn (e) (1)(A); 42 C.F.R. § (a) [Stark Law Space Safe Harbor Exception]  OIG Special Fraud Alert (Feb. 2000) (listing requirements) CA  Cal. Bus. & Prof. Code § (PORA)  Cal. Bus. & Prof. Code § (b)(2) (exception to PORA re: leases) RD. 13
5. LAB PRICING PRACTICES FEDERAL  WHAT YOU NEED TO KNOW:  Medicare Usual Charge Rule  Discounting Rules and AKS CA  WHAT YOU NEED TO KNOW:  Anti-Markup Rules  Disclosure Rules  Direct Billing  Medi-Cal Lowest Charge Rule WAY 14
REFERENCES 5. LAB PRICING PRACTICES FEDERAL  42 U.S.C. §1320a-7(b)(6)(A) [Medicare Usual Charge Rule]  Ltr. from K. McAnaney, Chief, OIG (April 26, 2000) [Medicare Usual Charge Rule]  OIG Advisory Opinion CA  Cal. Bus. & Prof. Code § (anti- markup and disclosure req.)  Cal. Bus. & Prof. Code § (direct billing)  22 C.C.R. § (a) (Medi-Cal “Lowest Charge Rule”)  Hunter Labs v. Quest (settled in 2011)  AB 1494 WAY 15
COMPLIANCE ROAD TRIP SUMMARY 1.% BASED CONTRACT MARKETING FEDERAL & CA PROHIBITED (BUT SEE CA PORA) 1.% BASED CONTRACT MARKETING FEDERAL & CA PROHIBITED (BUT SEE CA PORA) 3. MOBILE PHLEBOTOMISTS FEDERAL = NO GUIDANCE CA = PROHBITED (per LFS guidance) 3. MOBILE PHLEBOTOMISTS FEDERAL = NO GUIDANCE CA = PROHBITED (per LFS guidance) 4. LEASING OFFICE SPACE FROM DOCTORS FEDERAL = PERMITTED, subject to Stark AND AKS CA = PERMITTED, subject to PORA 4. LEASING OFFICE SPACE FROM DOCTORS FEDERAL = PERMITTED, subject to Stark AND AKS CA = PERMITTED, subject to PORA 5. LAB PRICING PRACTICES SEE RULES FOR FEDERAL & CA 5. LAB PRICING PRACTICES SEE RULES FOR FEDERAL & CA ST. AVE. BLVD. RD. WAY 1.IN-OFFICE PHLEBOTOMISTS FEDERAL = PERMITTED (key word: “solely”) CA = PROHIBITED (per LFS guidance) 1.IN-OFFICE PHLEBOTOMISTS FEDERAL = PERMITTED (key word: “solely”) CA = PROHIBITED (per LFS guidance) AVE. 16
David W. Gee & Kristen R. Blanchette David Wright Tremaine LLP and Download ppt "“Navigating Labs to Make Informed Decisions” David W. Gee and Kristen R. Blanchette David Wright Tremaine LLP"
Similar presentations Davis Wright Tremaine LLP Stark Enforcement By Robert G. Homchick.
Viveca D. Parker Assistant United States Attorney 615 Chestnut Street, Suite 1250 Philadelphia, PA Phone: (215)
Perspectives From Experienced Government Counsel, Relator’s Counsel & Defense Counsel 17 th Annual FLABOTA Convention Friday, July 18 th, 2014 The Breakers.
1 Fundraising and Marketing Elizabeth C. Stone, J.D. University of Wisconsin-Madison Office of Administrative Legal Services Rebecca Hutton, J.D., M.S.