STARK II PHASE II

1. STARK II PHASE II AWPHD BOARD RETREAT AUGUST 12, 2004 By Lori K. Nomura

2. CMS issued Phase II of the Stark II final regulations on March 26, 2004Phase II became effective July 24, 2004

3. HISTORY • January 1, 1992 Stark I • August 14, 1993 Stark I Regulations • January 1, 1995 Stark II • January 9, 1998 Stark II Proposed Regulations • January 4, 2001 Stark II Regulations Phase I • July 24, 2004 Stark II Regulations Phase II

4. THE PROHIBITION • If a physician (or a physician’s family member) has a financial relationship with an entity, the physician may not refer Medicare patients to the entity for designated health services unless an exception applies. • Stark also prohibits an entity from billing for services provided as a result of a prohibited referral.

5. FINANCIAL RELATIONSHIP • Ownership and Investment Interests can be through debt, equity or other means. Examples of ownership or investment interests include: • physician group practice • investment in an ASC or imaging facility

6. COMPENSATION ARRANGEMENTS • Examples: • physician employment by a hospital • medical director agreement with a hospital • use of hospital hardware or software to access hospital electronic records system from physician office • physician use of hospital space, equipment or inventory for private practice patient services

7. REFERRAL Referral includes: • A physician’s request or order for any DHS for which payment may be made under Part B • The physician’s establishment of a plan of care

8. REFERRAL, continued Referral excludes: A request by a pathologist, radiologist or radiation oncologist for certain services if performed as a result of a consultation initiated by another physician and the service is furnished by or under the supervision of the pathologist, radiologist or radiation oncologist

9. DESIGNATED HEALTH SERVICES • Clinical lab services • PT and OT • Radiology services (MR, CT, ultrasound) • Radiation therapy • DME • Parenteral and enteral nutrients

10. DESIGNATED HEALTH SERVICES, continued • Prosthetics and orthotics • Home health • Outpatient prescription drugs • IP and OP hospital services

11. PENALTIES • Payment denial/recovery by Medicare • Refund to the individual • Civil monetary penalties of up to $15,000 per prohibited service/billing • Civil monetary penalties of up to $100,000 for a circumvention scheme • Program exclusion

12. ANALYTICAL APPROACH • Is there a direct or indirect financial relationship between the referring physician and hospital? If yes, • Does the physician refer Medicare patients to the hospital for DHS? If yes, • Does the arrangement comply with an exception? If no, any bill submitted for a DHS resulting from a prohibited referral violates the statute.

13. THE NEW PHASE II REGULATIONS • Physician Recruitment • Physician Retention • Community Health Information Systems • Intra Family Rural Referral • Temporary Lapses • Urban/Rural Designations

14. COMMUNITY HEALTH INFORMATION SYSTEM • Provision of information technology (including hardware and software) • Available to all providers in the community • Enable participation in a community-wide information system • Enhance community’s overall health

15. INTRA FAMILY RURAL REFERRAL Permits a referring physician to cross-refer to an immediate family member or an entity that has a financial relationship with the family member if certain conditions are met.

16. INTRA FAMILY RURAL REFERRAL, continued Conditions: • Patient must reside in a rural area • No other person or entity is available to furnish services in a timely manner within 25 miles of patient’s residence • Does not violate anti-kickback statute or other law

17. TEMPORARY LAPSES IN COMPLIANCE New exception in response to request for a grace period if parties fall out of compliance due to conditions outside their control.

18. TEMPORARY LAPSES IN COMPLIANCE, continued Conditions: • Arrangement must have satisfied an exception for at least 180 consecutive days • Noncompliance is beyond entity’s control • Entity promptly rectified the compliance within 90 days • Exception limited to once every three years with same physician

19. URBAN/RURAL DESIGNATIONS Rural Provider Exception: excludes from the category of ownership or investment interests ownership in an entity if substantially all of the entity’s DHS are furnished to people who live in a rural area.

20. URBAN/RURAL DESIGNATIONS, continued Urban and Rural Defined: “Urban Area” is an area within a Metropolitan Statistical Area as defined by the Office of Management & Budget or such similar area as the Secretary has recognized. “Rural area” is any area outside a Metropolitan Statistical Area or such similar area.

21. URBAN/RURAL DESIGNATIONS, continued Effective Date of Rural Definition: unclear. • OMB’s definitions were effective June 30, 2003 • CMS has delayed adoption of the new definition for payment purposes until October 1, 2004.

22. PHYSICIAN RECRUITMENT The rule now distinguishes between a recruitment arrangement directly with a recruit and recruitment through another physician or practice. New limitations on recruitment through another physician or practice.

23. PHYSICIAN RECRUITMENT, continued Arrangement Directly With A Recruit: A hospital may provide remuneration to a recruit to relocate to the hospital’s geographic area to join its medical staff if:

24. PHYSICIAN RECRUITMENT, continued • the arrangement is in writing, signed by the parties; • the arrangement is not conditioned on referrals from the recruit; • the remuneration is not determined based on referrals or other business generated; and • the recruit is allowed to establish privileges at and refer patients to other facilities.

25. PHYSICIAN RECRUITMENT, continued Geographic Area and Relocate Defined: “Geographic area” is defined as the area comprised of the lowest number of contiguous zip codes from which the hospital draws 75% of its patients.

26. PHYSICIAN RECRUITMENT continued “Relocate” means the physician moves his or her practice a minimum of 25 miles or the new practice derives a minimum 75% of its revenue from professional services to patients not treated by the physician in the past three years. Residents and physicians in practice less than one year are not subject to the relocation requirement.

27. PHYSICIAN RECRUITMENT, continued Recruitment Through Another Physician or Group: • except for actual recruiting costs incurred by the physician/group, the remuneration passes directly to the recruit; • in an income guarantee, costs allocated to recruit cannot exceed the actual additional incremental costs attributable to recruit;

28. PHYSICIAN RECRUITMENT, continued • physician/practice cannot impose practice restrictions on recruit, such as noncompete; and • records of actual costs and amounts paid to recruit must be maintained for five years and made available to CMS.

29. PHYSICIAN RETENTION • Only permitted in HPSAs • Payment must go directly to physician • Must have a written offer elsewhere that requires a move 25 miles or more and outside the hospital’s geographic area

30. PHYSICIAN RETENTION, continued • Payment can be lesser of: • the amount offered by other hospital minus current income, or • the hospital’s cost to recruit a new physician. • Use is limited to once every five years.

31. WHAT SHOULD YOU DO NOW? • Review all existing arrangements for compliance • Put procedures in place to ensure that all new financial arrangements with physicians comply with an exception and are properly documented