CODING: Words stricken are deletions; words underlined are additions.





                                                  SENATE AMENDMENT

    Bill No. CS for SB 2438

    Amendment No.    

                            CHAMBER ACTION
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10                                                                

11  Senator Latvala moved the following amendment:

12

13         Senate Amendment (with title amendment) 

14          Delete everything after the enacting clause

15

16  and insert:

17         Section 1.  Section 455.654, Florida Statutes, 1998

18  Supplement, is amended to read:

19         455.654  Financial arrangements between referring

20  health care providers and providers of health care services.--

21         (1)  SHORT TITLE.--This section may be cited as the

22  "Patient Self-Referral Act of 1992."

23         (2)  LEGISLATIVE INTENT.--It is recognized by the

24  Legislature that the referral of a patient by a health care

25  provider to a provider of health care services in which the

26  referring health care provider has an investment interest

27  represents a potential conflict of interest.  The Legislature

28  finds these referral practices may limit or eliminate

29  competitive alternatives in the health care services market,

30  may result in overutilization of health care services, may

31  increase costs to the health care system, and may adversely

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                                                  SENATE AMENDMENT

    Bill No. CS for SB 2438

    Amendment No.    





 1  affect the quality of health care.  The Legislature also

 2  recognizes, however, that it may be appropriate for providers

 3  to own entities providing health care services, and to refer

 4  patients to such entities, as long as certain safeguards are

 5  present in the arrangement.  It is the intent of the

 6  Legislature to provide guidance to health care providers

 7  regarding prohibited patient referrals between health care

 8  providers and entities providing health care services and to

 9  protect the people of Florida from unnecessary and costly

10  health care expenditures.

11         (3)  DEFINITIONS.--For the purpose of this section, the

12  word, phrase, or term:

13         (a)  "Board" means any of the following boards relating

14  to the respective professions: the Board of Medicine as

15  created in s. 458.307; the Board of Osteopathic Medicine as

16  created in s. 459.004; the Board of Chiropractic Medicine as

17  created in s. 460.404; the Board of Podiatric Medicine as

18  created in s. 461.004; the Board of Optometry as created in s.

19  463.003; the Board of Pharmacy as created in s. 465.004; and

20  the Board of Dentistry as created in s. 466.004.

21         (b)  "Comprehensive rehabilitation services" means

22  services that are provided by health care professionals

23  licensed under part I or part III of chapter 468 or chapter

24  486 to provide speech, occupational, or physical therapy

25  services on an outpatient or ambulatory basis.

26         (c)  "Designated health services" means, for purposes

27  of this section, clinical laboratory services, physical

28  therapy services, comprehensive rehabilitative services,

29  diagnostic-imaging services, and radiation therapy services.

30         (d)  "Diagnostic imaging services" means magnetic

31  resonance imaging, nuclear medicine, angiography,

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                                                  SENATE AMENDMENT

    Bill No. CS for SB 2438

    Amendment No.    





 1  arteriography, computed tomography, positron emission

 2  tomography, digital vascular imaging, bronchography,

 3  lymphangiography, splenography, ultrasound, EEG, EKG, nerve

 4  conduction studies and evoked potentials.

 5         (e)  "Direct supervision" means supervision by a

 6  physician who is present in the office suite and immediately

 7  available to provide assistance and direction throughout the

 8  time services are being performed.

 9         (f)(d)  "Entity" means any individual, partnership,

10  firm, corporation, or other business entity.

11         (g)(e)  "Fair market value" means value in arms length

12  transactions, consistent with the general market value, and,

13  with respect to rentals or leases, the value of rental

14  property for general commercial purposes, not taking into

15  account its intended use, and, in the case of a lease of

16  space, not adjusted to reflect the additional value the

17  prospective lessee or lessor would attribute to the proximity

18  or convenience to the lessor where the lessor is a potential

19  source of patient referrals to the lessee.

20         (h)(f)  "Group practice" means a group of two or more

21  health care providers legally organized as a partnership,

22  professional corporation, or similar association:

23         1.  In which each health care provider who is a member

24  of the group provides substantially the full range of services

25  which the health care provider routinely provides, including

26  medical care, consultation, diagnosis, or treatment, through

27  the joint use of shared office space, facilities, equipment,

28  and personnel;

29         2.  For which substantially all of the services of the

30  health care providers who are members of the group are

31  provided through the group and are billed in the name of the

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                                                  SENATE AMENDMENT

    Bill No. CS for SB 2438

    Amendment No.    





 1  group and amounts so received are treated as receipts of the

 2  group; and

 3         3.  In which the overhead expenses of and the income

 4  from the practice are distributed in accordance with methods

 5  previously determined by members of the group.

 6         (i)(g)  "Health care provider" means any physician

 7  licensed under chapter 458, chapter 459, chapter 460, or

 8  chapter 461, or any health care provider licensed under

 9  chapter 463 or chapter 466.

10         (j)(h)  "Immediate family member" means a health care

11  provider's spouse, child, child's spouse, grandchild,

12  grandchild's spouse, parent, parent-in-law, or sibling.

13         (k)(i)  "Investment interest" means an equity or debt

14  security issued by an entity, including, without limitation,

15  shares of stock in a corporation, units or other interests in

16  a partnership, bonds, debentures, notes, or other equity

17  interests or debt instruments. The following investment

18  interests shall be excepted from this definition:

19         1.  An investment interest in an entity that is the

20  sole provider of designated health services in a rural area;

21         2.  An investment interest in notes, bonds, debentures,

22  or other debt instruments issued by an entity which provides

23  designated health services, as an integral part of a plan by

24  such entity to acquire such investor's equity investment

25  interest in the entity, provided that the interest rate is

26  consistent with fair market value, and that the maturity date

27  of the notes, bonds, debentures, or other debt instruments

28  issued by the entity to the investor is not later than October

29  1, 1996.

30         3.  An investment interest in real property resulting

31  in a landlord-tenant relationship between the health care

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                                                  SENATE AMENDMENT

    Bill No. CS for SB 2438

    Amendment No.    





 1  provider and the entity in which the equity interest is held,

 2  unless the rent is determined, in whole or in part, by the

 3  business volume or profitability of the tenant or exceeds fair

 4  market value; or

 5         4.  An investment interest in an entity which owns or

 6  leases and operates a hospital licensed under chapter 395 or a

 7  nursing home facility licensed under chapter 400.

 8         (l)(j)  "Investor" means a person or entity owning a

 9  legal or beneficial ownership or investment interest, directly

10  or indirectly, including, without limitation, through an

11  immediate family member, trust, or another entity related to

12  the investor within the meaning of 42 C.F.R. s. 413.17, in an

13  entity.

14         (m)  "Outside referral for diagnostic imaging services"

15  means a referral of a patient to a group practice or sole

16  provider for diagnostic imaging services by a physician who is

17  not a member of the group practice or of the sole provider's

18  practice and who does not have an investment interest in the

19  group practice or sole provider's practice, for which the

20  group practice or sole provider billed for both the technical

21  and the professional fee for the patient, and the patient did

22  not become a patient of your group practice or sole provider's

23  practice.

24         (n)  "Patient of a group practice" or "patient of a

25  sole provider" means a patient who receives a physical

26  examination, evaluation, diagnosis, or development of a

27  treatment plan if medically necessary by a physician who is a

28  member of the group practice or the sole provider's practice.

29         (o)(k)  "Referral" means any referral of a patient by a

30  health care provider for health care services, including,

31  without limitation:

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                                                  SENATE AMENDMENT

    Bill No. CS for SB 2438

    Amendment No.    





 1         1.  The forwarding of a patient by a health care

 2  provider to another health care provider or to an entity which

 3  provides or supplies designated health services or any other

 4  health care item or service; or

 5         2.  The request or establishment of a plan of care by a

 6  health care provider, which includes the provision of

 7  designated health services or other health care item or

 8  service.

 9         3.  The following orders, recommendations, or plans of

10  care shall not constitute a referral by a health care

11  provider:

12         a.  By a radiologist for diagnostic-imaging services.

13         b.  By a physician specializing in the provision of

14  radiation therapy services for such services.

15         c.  By a medical oncologist for drugs and solutions to

16  be prepared and administered intravenously to such

17  oncologist's patient, as well as for the supplies and

18  equipment used in connection therewith to treat such patient

19  for cancer and the complications thereof.

20         d.  By a cardiologist for cardiac catheterization

21  services.

22         e.  By a pathologist for diagnostic clinical laboratory

23  tests and pathological examination services, if furnished by

24  or under the supervision of such pathologist pursuant to a

25  consultation requested by another physician.

26         f.  By a health care provider who is the sole provider

27  or member of a group practice for designated health services

28  or other health care items or services that are prescribed or

29  provided solely for such referring health care provider's or

30  group practice's own patients, and that are provided or

31  performed by or under the direct supervision of such referring

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                                                  SENATE AMENDMENT

    Bill No. CS for SB 2438

    Amendment No.    





 1  health care provider or group practice; provided, however,

 2  that effective July 1, 1999, a physician licensed pursuant to

 3  chapter 458, chapter 459, chapter 460, or chapter 461 may

 4  refer a patient to a sole provider or group practice for

 5  diagnostic imaging services, excluding radiation therapy

 6  services, for which the sole provider or group practice billed

 7  both the technical and the professional fee for or on behalf

 8  of the patient, if the referring physician has no investment

 9  interest in the practice. The group practice or sole provider

10  may accept no more than 35 percent of their patients receiving

11  diagnostic imaging services from outside referrals, excluding

12  radiation therapy services.

13         g.  By a health care provider for services provided by

14  an ambulatory surgical center licensed under chapter 395.

15         h.  By a health care provider for diagnostic clinical

16  laboratory services where such services are directly related

17  to renal dialysis.

18         i.  By a urologist for lithotripsy services.

19         j.  By a dentist for dental services performed by an

20  employee of or health care provider who is an independent

21  contractor with the dentist or group practice of which the

22  dentist is a member.

23         k.  By a physician for infusion therapy services to a

24  patient of that physician or a member of that physician's

25  group practice.

26         l.  By a nephrologist for renal dialysis services and

27  supplies.

28         (p)  "Present in the office suite" means that the

29  physician is actually physically present; provided, however,

30  that the health care provider is considered physically present

31  during brief unexpected absences as well as during routine

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                                                  SENATE AMENDMENT

    Bill No. CS for SB 2438

    Amendment No.    





 1  absences of a short duration if the absences occur during time

 2  periods in which the health care provider is otherwise

 3  scheduled and ordinarily expected to be present and the

 4  absences do not conflict with any other requirement in the

 5  Medicare program for a particular level of health care

 6  provider supervision.

 7         (q)(l)  "Rural area" means a county with a population

 8  density of no greater than 100 persons per square mile, as

 9  defined by the United States Census.

10         (r)  "Sole provider" means a health care provider

11  licensed under chapter 458, chapter 459, chapter 460, or

12  chapter 461, who maintains a medical practice separate from

13  any other health care provider and who bills for his or her

14  services separately from the services provided by any other

15  health care provider.

16         (4)  REQUIREMENT FOR ACCEPTING OUTSIDE REFERRALS FOR

17  DIAGNOSTIC IMAGING.--

18         (a)  A group practice or sole provider accepting

19  outside referrals for diagnostic imaging services is required

20  to comply with the following conditions:

21         1.  All equity in the group practice or sole provider's

22  practice accepting outside referrals for diagnostic imaging

23  must be held by the physicians comprising the group practice

24  or the sole provider's practice, each of which must provide at

25  least 75 percent of his professional services to the group or

26  the group must be incorporated under chapter 617, Florida

27  Statutes, and be exempt under the provisions of the Internal

28  Revenue Code 501(c)(3) and be part of a foundation in

29  existence prior to July 1, 1999 that is created for the

30  purpose of patient care, medical education, and research.

31         2.  The group practice or sole provider accepting

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                                                  SENATE AMENDMENT

    Bill No. CS for SB 2438

    Amendment No.    





 1  outside referrals for diagnostic imaging may not be managed by

 2  the same entity or any related entity that either owns,

 3  manages, or otherwise has any interest in the group practice

 4  or sole provider referring the patient.

 5         3.  The group practice or sole provider accepting

 6  outside referrals for diagnostic imaging services must bill

 7  for both the professional and technical component of the

 8  service on behalf of the patient and no portion of the

 9  payment, or any type of consideration, either directly or

10  indirectly, may be shared with the referring physician.

11         4.  Group practices or sole providers that have a

12  Medicaid provider agreement with the Agency for Health Care

13  Administration must furnish diagnostic imaging services to

14  their Medicaid patients and may not refer a Medicaid recipient

15  to a hospital for outpatient diagnostic imaging services

16  unless the physician furnishes the hospital with documentation

17  demonstrating the medical necessity for such a referral. If

18  necessary, the agency is authorized to seek a federal waiver

19  to implement this provision.

20         5.  All group practices and sole providers accepting

21  outside referrals for diagnostic imaging shall annually report

22  to the Agency for Health Care Administration providing the

23  number of outside referrals accepted for diagnostic imaging

24  services and the total number of all patients receiving

25  diagnostic imaging services.

26         (b)  If a group practice or sole provider accepts an

27  outside referral for diagnostic imaging services in violation

28  of this subsection or if a group practice or sole provider

29  accepts outside referrals for diagnostic imaging services in

30  excess of the percentage limitation established in

31  subparagraph 3.f. of this subsection, the group practice or

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                                                  SENATE AMENDMENT

    Bill No. CS for SB 2438

    Amendment No.    





 1  sole provider shall be subject to the penalties of subsection

 2  (5) of this section.

 3         (5)(4)  PROHIBITED REFERRALS AND CLAIMS FOR

 4  PAYMENT.--Except as provided in this section:

 5         (a)  A health care provider may not refer a patient for

 6  the provision of designated health services to an entity in

 7  which the health care provider is an investor or has an

 8  investment interest.

 9         (b)  A health care provider may not refer a patient for

10  the provision of any other health care item or service to an

11  entity in which the health care provider is an investor

12  unless:

13         1.  The provider's investment interest is in registered

14  securities purchased on a national exchange or

15  over-the-counter market and issued by a publicly held

16  corporation:

17         a.  Whose shares are traded on a national exchange or

18  on the over-the-counter market; and

19         b.  Whose total assets at the end of the corporation's

20  most recent fiscal quarter exceeded $50 million; or

21         2.  With respect to an entity other than a publicly

22  held corporation described in subparagraph 1., and a referring

23  provider's investment interest in such entity, each of the

24  following requirements are met:

25         a.  No more than 50 percent of the value of the

26  investment interests are held by investors who are in a

27  position to make referrals to the entity.

28         b.  The terms under which an investment interest is

29  offered to an investor who is in a position to make referrals

30  to the entity are no different from the terms offered to

31  investors who are not in a position to make such referrals.

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                                                  SENATE AMENDMENT

    Bill No. CS for SB 2438

    Amendment No.    





 1         c.  The terms under which an investment interest is

 2  offered to an investor who is in a position to make referrals

 3  to the entity are not related to the previous or expected

 4  volume of referrals from that investor to the entity.

 5         d.  There is no requirement that an investor make

 6  referrals or be in a position to make referrals to the entity

 7  as a condition for becoming or remaining an investor.

 8         3.  With respect to either such entity or publicly held

 9  corporation:

10         a.  The entity or corporation does not loan funds to or

11  guarantee a loan for an investor who is in a position to make

12  referrals to the entity or corporation if the investor uses

13  any part of such loan to obtain the investment interest.

14         b.  The amount distributed to an investor representing

15  a return on the investment interest is directly proportional

16  to the amount of the capital investment, including the fair

17  market value of any preoperational services rendered, invested

18  in the entity or corporation by that investor.

19         4.  Each board and, in the case of hospitals, the

20  Agency for Health Care Administration, shall encourage the use

21  by licensees of the declaratory statement procedure to

22  determine the applicability of this section or any rule

23  adopted pursuant to this section as it applies solely to the

24  licensee. Boards shall submit to the Agency for Health Care

25  Administration the name of any entity in which a provider

26  investment interest has been approved pursuant to this

27  section, and the Agency for Health Care Administration shall

28  adopt rules providing for periodic quality assurance and

29  utilization review of such entities.

30         (c)  No claim for payment may be presented by an entity

31  to any individual, third-party payor, or other entity for a

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                                                  SENATE AMENDMENT

    Bill No. CS for SB 2438

    Amendment No.    





 1  service furnished pursuant to a referral prohibited under this

 2  section.

 3         (d)  If an entity collects any amount that was billed

 4  in violation of this section, the entity shall refund such

 5  amount on a timely basis to the payor or individual, whichever

 6  is applicable.

 7         (e)  Any person that presents or causes to be presented

 8  a bill or a claim for service that such person knows or should

 9  know is for a service for which payment may not be made under

10  paragraph (c), or for which a refund has not been made under

11  paragraph (d), shall be subject to a civil penalty of not more

12  than $15,000 for each such service to be imposed and collected

13  by the appropriate board.

14         (f)  Any health care provider or other entity that

15  enters into an arrangement or scheme, such as a cross-referral

16  arrangement, which the physician or entity knows or should

17  know has a principal purpose of assuring referrals by the

18  physician to a particular entity which, if the physician

19  directly made referrals to such entity, would be in violation

20  of this section, shall be subject to a civil penalty of not

21  more than $100,000 for each such circumvention arrangement or

22  scheme to be imposed and collected by the appropriate board.

23         (g)  A violation of this section by a health care

24  provider shall constitute grounds for disciplinary action to

25  be taken by the applicable board pursuant to s. 458.331(2), s.

26  459.015(2), s. 460.413(2), s. 461.013(2), s. 463.016(2), or s.

27  466.028(2).  Any hospital licensed under chapter 395 found in

28  violation of this section shall be subject to the rules

29  adopted by the Agency for Health Care Administration pursuant

30  to s. 395.0185(2).

31         (h)  Any hospital licensed under chapter 395 that

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                                                  SENATE AMENDMENT

    Bill No. CS for SB 2438

    Amendment No.    





 1  discriminates against or otherwise penalizes a health care

 2  provider for compliance with this act.

 3         (i)  The provision of paragraph (a) shall not apply to

 4  referrals to the offices of radiation therapy centers managed

 5  by an entity or subsidiary or general partner thereof, which

 6  performed radiation therapy services at those same offices

 7  prior to April 1, 1991, and shall not apply also to referrals

 8  for radiation therapy to be performed at no more than one

 9  additional office of any entity qualifying for the foregoing

10  exception which, prior to February 1, 1992, had a binding

11  purchase contract on and a nonrefundable deposit paid for a

12  linear accelerator to be used at the additional office.  The

13  physical site of the radiation treatment centers affected by

14  this provision may be relocated as a result of the following

15  factors: acts of God; fire; strike; accident; war; eminent

16  domain actions by any governmental body; or refusal by the

17  lessor to renew a lease.  A relocation for the foregoing

18  reasons is limited to relocation of an existing facility to a

19  replacement location within the county of the existing

20  facility upon written notification to the Office of Licensure

21  and Certification.

22         (j)  A health care provider who meets the requirements

23  of paragraphs (b) and (i) must disclose his or her investment

24  interest to his or her patients as provided in s. 455.701.

25         Section 2.  (1)  The Agency for Health Care

26  Administration is directed to study issues relating to the

27  need for quality-of-care standards applicable to group

28  practices, hospitals, and health systems providing diagnostic

29  imaging services. Issues to be addressed in the scope of this

30  study include:

31         (a)  The parameters of quality of care;

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                                                  SENATE AMENDMENT

    Bill No. CS for SB 2438

    Amendment No.    





 1         (b)  The need for periodic inspection of the facilities

 2  or the entities providing diagnostic imaging services for the

 3  purpose of evaluation of the premises, operation, supervision,

 4  and procedures of the entity;

 5         (c)  The extent to which requiring group practices

 6  providing diagnostic imaging services to participate in

 7  nationally recognized accrediting organizations would enhance

 8  quality assurance processes; and

 9         (d)  An assessment of how group practices, hospitals,

10  and health systems providing diagnostic imaging services

11  ensure appropriate utilization of services in order to prevent

12  overutilization of these services.

13         (2)  The agency may convene a technical assistance

14  panel for purposes of this study which is representative of

15  group practices providing diagnostic imaging services, group

16  practices, group practices generally, various professional

17  organizations representing providers and hospitals, and

18  representatives of the public.

19         (3)  The agency shall submit its findings and

20  recommendations to the Governor, the President of the Senate,

21  and the Speaker of the House of Representatives by January 15,

22  2000.

23         Section 3.  The agency shall require registration by

24  all group practices providing diagnostic imaging services,

25  regardless of ownership. Registration information must include

26  the medical specialty of each physician; address and phone

27  number of the group; UPIN number for the group and each group

28  number; and Medicare, Medicaid, and commercial billing numbers

29  for the group. The agency shall complete the registration by

30  December 31, 1999.

31         Section 4.  Section 4 of chapter 98-192, Laws of

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                                                  SENATE AMENDMENT

    Bill No. CS for SB 2438

    Amendment No.    





 1  Florida, is amended to read:

 2         Section 4.  This act shall take effect July 1, 1998,

 3  except that the amendment of section 395.701 and 395.7015,

 4  Florida Statutes, by this act shall take effect only upon the

 5  Agency for Health Care Administration receiving written

 6  confirmation from the federal Health Care Financing

 7  Administration that the changes contained in such amendments

 8  will not adversely affect the use of the remaining assessments

 9  as state match for the state's Medicaid program.

10         Section 5.  This act shall take effect July 1, 1999.

11

12

13  ================ T I T L E   A M E N D M E N T ===============

14  And the title is amended as follows:

15          Delete everything before the enacting clause

16

17  and insert:

18                      A bill to be entitled

19         An act relating to health care; amending s.

20         455.654, F.S.; providing definitions; providing

21         requirements for accepting outside referrals

22         for diagnostic imaging; providing for

23         disciplinary procedures against a group

24         practice or sole provider that accepts an

25         outside referral for diagnostic imaging

26         services in violation of such requirements;

27         providing a fine; requiring the Agency for

28         Health Care Administration to study issues

29         relating to quality care in providing

30         diagnostic imaging services; authorizing the

31         agency to convene a technical assistance panel;

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                                                  SENATE AMENDMENT

    Bill No. CS for SB 2438

    Amendment No.    





 1         requiring a report to the Governor and

 2         Legislature; providing for registration of all

 3         group practices; prescribing registration

 4         information; amending s. 4, ch. 98-192, Laws of

 5         Florida; eliminating requirement that the

 6         agency receive written confirmation from the

 7         federal Health Care Financing Administration

 8         that the amendment to s. 395.701, F.S., will

 9         not adversely affect assessments or state match

10         for the state's Medicaid program; providing an

11         effective date.

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