1、1,By JONELL B. WILLIAMSON,UNDERSTANDING AND WORKING WITH THE LATEST STARK LAW DEVELOPMENTS,January 5, 2009,26th Annual National CLE Conference Law Education Institute January 3-7, 2009,2,Stark Prohibition,Physician may not refer: Medicare or Medicaid patients For “designated health services” (DHS) T
2、o an “entity” with which the physician or an “immediate family member” has a “financial relationship”; Unless covered by an exception 42 U.S.C. 1395 nn,3,Sanctions,Denial of payment Refund of amounts collected due to improper billing Civil Money Penalties Civil Money Penalties for circumvention sche
3、mes Exclusion Potential False Claims Act Liability,4,Designated Health Services (“DHS”),Clinical laboratory services Physical therapy, occupational therapy, and speech-language pathology services Radiology and certain other imaging services Radiation therapy services and supplies Durable medical equ
4、ipment and supplies Parenteral and enteral nutrients, equipment and supplies Prosthetics, orthotics and prosthetic devices and supplies,5,DHS - cont.,Home health services Outpatient prescription drugs Inpatient and outpatient hospital services Except: DHS does not include services reimbursed under c
5、omposite rate: ASC or SNF Part A. Exception not available for home health services Note: Outpatient speech-language pathology services is now a specific category of DHS,6,Entity,A physicians sole practice or a practice of multiple physicians or any other person, sole proprietorship, public or privat
6、e agency or trust, corporation, partnership, limited liability company, foundation, nonprofit corporation, or unincorporated association that furnishes DHS.,7,Entity -cont.,Does not include referring physician, but does include his or her medical practice. Does not include a physicians practice when
7、 it bills Medicare for a purchased diagnostic test.,8,Entity - cont.,Changed definition of “Entity” at 411.351 Prior to October 1, 2009, a person or entity is considered to be furnishing DHS if it is the person or entity to which CMS makes payment for the DHS On and after October 1, 2009, both parti
8、es to an arrangement may be considered an “entity” if one party performs DHS and the other party bills for DHS Affects services provided “under arrangements” with DHS entities,9,Financial Relationship 411.354,A direct or indirect ownership or investment interest in an entity that furnishes DHS; or A
9、 direct or indirect compensation arrangement with an entity that furnishes DHS,10,Indirect Ownership/Investment,Unbroken chain of persons or entities between physician and DHS entity DHS Entity has actual knowledge (or reckless disregard or deliberate ignorance) of interest,11,Indirect Compensation,
10、Unbroken chain of entities between physician and entity Aggregate compensation to physician from closest link in chain varies with volume or value or referrals to DHS entity Entity furnishing DHS has actual knowledge or acts in reckless disregard of relationship,12,Direct Compensation: Stand in the
11、Shoes Concept,Physician deemed to have direct compensation arrangement with DHS Entity if only intervening entity between the physician and the entity is his or her physician organization; and physician has an ownership or investment interest in the physician organization Physician is permitted to “
12、stand in the shoes” of physician organization if only intervening entity between physician and DHS entity is the physician organization 42 C.F.R. 411.354 (c)(1),13,Stand in the Shoes cont.,Stand in the Shoes concept does not apply to physician whose ownership or investment interest is titular only.
13、Titular ownership or investment interest is an ownership or investment interest that excludes the ability or right to receive financial benefits of ownership or investment such as distribution of profits, dividends, proceeds of sale, or similar returns on investment.,14,Referral,Request/ordering or
14、certifying medical necessity (including tests ordered pursuant to consult) Does not include personally performed services Does not include “incident to” services Imputed to physician who “directs” or “controls” person making referral (ex. NPs & PAs),15,Referral - cont.,Special rules for pathologists
15、, radiologists and radiation oncologists Ordering additional services is not referral if: Pursuant to request for consultation Physicians opinion sought Request documented on chart Written report delivered Under supervision of consulting physician,16,Other Key Definitions,“physician organization” A
16、physician, a physician practice, or a group practice that complies with the requirements of 411.352 Term used in applying “Stand in the Shoes” concept,17,Types of Exceptions,General - Related to both ownership/investment interests and compensation arrangements (411.355) Related only to ownership or
17、investment interests (411.356) Related only to compensation arrangements (411.357),18,General Exceptions Related to Ownership and Compensation (411.355),Physician Services In-office Ancillary Services Services Furnished by an Organization to Enrollees Academic Medical Centers Implants Furnished by A
18、SC EPO and Other Dialysis-related Drugs Furnished in ESRD Facility Preventive Screening, Immunizations & Vaccines Eyeglasses & Contact Lenses following Cataract Surgery Intra-family Rural Referrals,19,Exceptions Related only to Ownership or Investment Interests (411.356),Publicly-traded Securities a
19、nd Mutual Funds Hospitals Located in Puerto Rico Rural Providers Ownership Interest in a Whole Hospital,20,Exceptions Related only to Compensation Arrangements (411.357),Rental of Office Space Rental of Equipment Bona Fide Employment Personal Service Arrangements Physician Recruitment Isolated Trans
20、actions Remuneration Unrelated to DHS Group Practice Arrangements with a Hospital,21,Exceptions Related only to Compensation Arrangements (411.357) cont.,Payments by a Physician Charitable Donations by a Physician Nonmonetary Compensation Fair Market Value Compensation Medical Staff Incidental Benef
21、its Risk-sharing Arrangements Compliance Training Indirect Compensation Arrangements,22,Exceptions Related only to Compensation Arrangements (411.357) cont.,Referral Services Obstetrical Malpractice Insurance Subsidies Professional Courtesy Retention Payments in Underserved Areas Community-Wide Heal
22、th Information,23,Statutory Framework and Regulatory History,Section 1877 of Social Security Act, in effect since January 1, 1995 January 9, 1998 Proposed rule (63 FR 1659) January 4, 2001 Phase I final rule, effective January 4, 2002 (66 FR 856) March 26, 2004 Phase II interim final rule, effective
23、 July 26, 2004 (69 FR 16054),24,Regulatory History cont.,July 12, 2007 Proposed rule (72 FR 38122,38179 September 5, 2007 Phase III final rule, effective December 4, 2007 (72 FR 51012) November 15, 2007 Final rule delaying effective date of “stand in the shoes” provisions of certain compensation arr
24、angements (72 FR 64161) April 30, 2008 Proposed rule (73 FR 23683) August 19, 2008 Final rule (73 FR 48434),25,Significant Issues in Final Rule,Effective October 1, 2008 Burden of Proof Period of Disallowance Physician “Stand in the Shoes” provisions Alternative method of compliance for missing sign
25、atures Revisions to obstetrical malpractice insurance subsidies Ownership/investment interest in retirement plans,26,Significant Issues in Final Rule - cont.,Effective October 1, 2009 Percentage-based compensation formulae prohibitions addressing exceptions applicable to office space and equipment l
26、ease arrangements Prohibition of certain unit-of-service (“per-click”) payments in lease arrangements Revisions to definition of “Entity”) (referred to as “services provided under arrangements” proposal),27,Burden of Proof,Burden of proof at each level of appeal is on provider submitting claim for p
27、ayment Must establish that service was not furnished pursuant to prohibited referral Burden of production is initially on claimant; but may shift to CMS or its contractors,28,Period of Disallowance,Begins when financial relationship fails to satisfy applicable exception Ends no later than: Date fina
28、ncial relationship satisfies exception (where not related to compensation); or Date excess compensation is returned by party that received it, or if additional compensation is owed, on the date additional compensation is paid by party owing it, and all other requirements of exception are met,29,Stan
29、d in the Shoes,Physician deemed to Stand in the Shoes of his or her Physician Organization if the physician has an ownership or investment interest in the Physician Organization Exception: Physician with “Titular” only ownership or investment interest,30,Alternative Method of Compliance: Missing Sig
30、natures,Grace period to obtain signatures on written agreement of 90 consecutive calendar days for “inadvertent noncompliance” with signature requirement 30 consecutive calendar days for knowing noncompliance with signature requirement,31,Obstetrical Malpractice Insurance Subsidy,Retains existing ex
31、ception that incorporates Anti-kickback Safe Harbor Applies to subsidies provided by any entity Provides alternative criteria - 411.357(r)(2) Applies to subsidies provided by hospitals, FQHCs and rural health clinics,32,OB Malpractice Insurance Subsidy - cont. 411.357(r)(2),Physicians practice is Lo
32、cated in rural area, primary care HPSA, or area with demonstrated need for OB services (determined by CMS Adv. Op.), or At least 75 % of OB patients of practice reside in MUA or are a medically underserved population Arrangement is In writing, signed by parties, specifies payments and terms Not cond
33、itioned on referrals Payment amount not determined based on volume or value of referrals or other business,33,OB Malpractice Insurance Subsidy - cont. 411.357(r)(2),Physician allowed to establish staff privileges at any hospital, FQHC or rural health clinic Payment made to organization providing ins
34、urance Physician treats Federal program OB patients in nondiscriminatory manner Bona Fide insurance Not violate Anti-kickback Law or other laws governing billing or claims submissions,34,Ownership/Investment Interest in Retirement Plan,Clarifies exception from definition of “ownership” Excepts: Inte
35、rest in entity that arises from retirement plan offered by entity to physician (or immediate family member) through physicians (or family members) employment with that entity Does not protect MD referrals to DHS Entity owned by Group Practices retirement plan,35,Percentage-based Compensation: Office
36、 Space and Equipment Leases,Rental charges can not be determined using formula based on Percentage of revenue raised, earned, billed, collected, or otherwise attributable to services performed on or business generated in the office space or by the use of the equipment,36,Percentage-based Compensatio
37、n: Office Space and Equipment Leases,Amends four compensation exceptions Office space lease arrangements Equipment lease arrangements Fair market value compensation arrangements Indirect compensation arrangements,37,Percentage-based Compensation,Applies only to office space and equipment leases Stil
38、l allowed for personal services arrangements, management contracts physician compensation,38,Per Click Payments: Office Space and Equipment Leases,Rental charges for rental of office space or equipment can not be determined using a formula based on Per-unit of service rental charges, to the extent t
39、hat such charges reflect services provided to patients referred between the parties,39,Per Click Payments: Office Space and Equipment Leases,Includes both physician as lessor and DHS entity as lessor Amends four compensation exceptions Office space lease arrangements Equipment lease arrangements Fai
40、r market value compensation arrangements Indirect compensation arrangements,40,Per Click Payments: Office Space and Equipment Leases,CMS intends to monitor block leases Caution: Block lease could be considered a “per click” payment depending on length of time for block use and number of procedures w
41、hich can be done during block time,41,Services Provided “Under Arrangements”,Under revised definition of Entity, a person or entity is considered to be furnishing DHS if it Is the person or entity that has performed services, that are billed as DHS to which CMS makes payment for the DHS, directly or
42、 upon assignment on patients behalf; or Is the person or entity that has presented a claim to Medicare for the DHS . . .,42,Hypothetical Discussions,Stand in the Shoes Definition of Entity Services Under Arrangement Per Click and Percentage-based Leases Period of Disallowance,43,“Stand in the Shoes”
43、 (SITS),Dr. O,Dr. E,Dr. IC,Physician Organization,DHS Entity,O “Owner” Stand in the Shoes is MandatoryE “Employee” Permissive SITS or analyze using indirect compensation rulesIC “Independent Same as “Employee” Contractor”,44,Services Under Arrangement,Dr. O,Dr. O,Billed Claims,Physician Organization
44、 (“PO”),Hospital,Items/Services,Payment (Per Procedure),Dr. E,Dr. E,Office,Equipment,Personnel,PO Becomes DHS Entity No exception for Physician Ownership,45,Per Click or Percentage Based Leases: Direct Compensation,Dr. O,Physician Organization,Dr. E,DHS Entity,Lease,Equipment or Space,Analyze Physic
45、ian ownership as Direct Compensation Arrangement under SITS Direct lease exceptions do not allow per click or percentage compensation,46,Per Click or Percentage Based Leases: Indirect Rules,Dr. O,Realty Company or Equipment Leasing Company,Hospital,Lease,$,Analyze under Indirect Rules; SITS does not
46、 applyIndirect Rules do not allow leases to have per click or percentage compensation,47,Examples of Periods of Disallowance,Date Stark Compliant Contract Expires,End 6 month holdover for lease and personal services,New Contract Signed,Period of Disallowance,Doctor begins Call Coverage,Contract Sign
47、ed 6 months later,Period of Disallowance,48,Examples of Periods of Disallowance cont.,Doctor receives Excess Comp,New Contract Signed,Doctor returns Excess Comp,Period of Disallowance,49,Disclosure of Financial Relationships Report,Collection Instrument used to Identify arrangements that potentially
48、 may not be in compliance with Stark Law and regulations Identify practices to assist CMS in future rulemaking Status of Distribution to Hospitals,50,Reporting Requirements - 411.361,All entities furnishing services for which payment may be made under Medicare must submit information to CMS or to OI
49、G concerning reportable financial relationships in form, manner and at times that CMS or OIG specifies Exception: Reporting requirements do not apply to entities that furnish 20 or fewer Part A and Part B services during calendar year, or to any Medicare covered services furnished outside US,51,Repo
50、rting Requirements - 411.361 cont.,Required information Name and UPIN or NPI of each physician who has a reportable financial relationship with entity Name and UPIN or NPI of each physician who has an immediate family member who has a reportable financial relationship with entity Nature of financial relationship,
