House Bill 2231e1

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                                          HB 2231, First Engrossed



  1                      A bill to be entitled

  2         An act relating to health care; amending s.

  3         455.654, F.S.; providing definitions; providing

  4         requirements for accepting outside referrals

  5         for diagnostic imaging; providing for

  6         disciplinary procedures against a group

  7         practice or sole provider that accepts an

  8         outside referral for diagnostic imaging

  9         services in violation of such requirements;

10         providing a fine; requiring the Agency for

11         Health Care Administration to study issues

12         relating to quality care in providing

13         diagnostic imaging services; authorizing the

14         agency to convene a technical assistance panel;

15         requiring a report to the Governor and

16         Legislature; providing for registration of all

17         group practices; prescribing registration

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

19         Florida; eliminating requirement that the

20         agency receive written confirmation from the

21         federal Health Care Financing Administration

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

23         not adversely affect assessments or state match

24         for the state's Medicaid program; providing an

25         effective date.

26

27  Be It Enacted by the Legislature of the State of Florida:

28

29         Section 1.  Section 455.654, Florida Statutes, 1998

30  Supplement, is amended to read:

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                                          HB 2231, First Engrossed



  1         455.654  Financial arrangements between referring

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

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

  4  "Patient Self-Referral Act of 1992."

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

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

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

  8  referring health care provider has an investment interest

  9  represents a potential conflict of interest.  The Legislature

10  finds these referral practices may limit or eliminate

11  competitive alternatives in the health care services market,

12  may result in overutilization of health care services, may

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

14  affect the quality of health care.  The Legislature also

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

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

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

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

19  Legislature to provide guidance to health care providers

20  regarding prohibited patient referrals between health care

21  providers and entities providing health care services and to

22  protect the people of Florida from unnecessary and costly

23  health care expenditures.

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

25  word, phrase, or term:

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

27  to the respective professions: the Board of Medicine as

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

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

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

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


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                                          HB 2231, First Engrossed



  1  463.003; the Board of Pharmacy as created in s. 465.004; and

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

  3         (b)  "Comprehensive rehabilitation services" means

  4  services that are provided by health care professionals

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

  6  486 to provide speech, occupational, or physical therapy

  7  services on an outpatient or ambulatory basis.

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

  9  of this section, clinical laboratory services, physical

10  therapy services, comprehensive rehabilitative services,

11  diagnostic-imaging services, and radiation therapy services.

12         (d)  "Diagnostic imaging services" means magnetic

13  resonance imaging, nuclear medicine, angiography,

14  arteriography, computed tomography, positron emission

15  tomography, digital vascular imaging, bronchography,

16  lymphangiography, splenography, ultrasound, EEG, EKG, nerve

17  conduction studies and evoked potentials.

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

19  physician who is present in the office suite and immediately

20  available to provide assistance and direction throughout the

21  time services are being performed.

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

23  firm, corporation, or other business entity.

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

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

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

27  property for general commercial purposes, not taking into

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

29  space, not adjusted to reflect the additional value the

30  prospective lessee or lessor would attribute to the proximity

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                                          HB 2231, First Engrossed



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

  2  source of patient referrals to the lessee.

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

  4  health care providers legally organized as a partnership,

  5  professional corporation, or similar association:

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

  7  of the group provides substantially the full range of services

  8  which the health care provider routinely provides, including

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

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

11  and personnel;

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

13  health care providers who are members of the group are

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

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

16  group; and

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

18  from the practice are distributed in accordance with methods

19  previously determined by members of the group.

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

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

22  chapter 461, or any health care provider licensed under

23  chapter 463 or chapter 466.

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

25  provider's spouse, child, child's spouse, grandchild,

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

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

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

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

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

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                                          HB 2231, First Engrossed



  1  interests or debt instruments. The following investment

  2  interests shall be excepted from this definition:

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

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

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

  6  or other debt instruments issued by an entity which provides

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

  8  such entity to acquire such investor's equity investment

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

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

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

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

13  1, 1996.

14         3.  An investment interest in real property resulting

15  in a landlord-tenant relationship between the health care

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

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

18  business volume or profitability of the tenant or exceeds fair

19  market value; or

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

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

22  nursing home facility licensed under chapter 400.

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

24  legal or beneficial ownership or investment interest, directly

25  or indirectly, including, without limitation, through an

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

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

28  entity.

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

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

31  provider for diagnostic imaging services by a physician who is


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                                          HB 2231, First Engrossed



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

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

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

  4  group practice or sole provider billed for both the technical

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

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

  7  practice.

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

  9  sole provider" means a patient who receives a physical

10  examination, evaluation, diagnosis, or development of a

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

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

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

14  health care provider for health care services, including,

15  without limitation:

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

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

18  provides or supplies designated health services or any other

19  health care item or service; or

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

21  health care provider, which includes the provision of

22  designated health services or other health care item or

23  service.

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

25  care shall not constitute a referral by a health care

26  provider:

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

28         b.  By a physician specializing in the provision of

29  radiation therapy services for such services.

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

31  be prepared and administered intravenously to such


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                                          HB 2231, First Engrossed



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

  2  equipment used in connection therewith to treat such patient

  3  for cancer and the complications thereof.

  4         d.  By a cardiologist for cardiac catheterization

  5  services.

  6         e.  By a pathologist for diagnostic clinical laboratory

  7  tests and pathological examination services, if furnished by

  8  or under the supervision of such pathologist pursuant to a

  9  consultation requested by another physician.

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

11  or member of a group practice for designated health services

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

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

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

15  performed by or under the direct supervision of such referring

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

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

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

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

20  diagnostic imaging services, excluding radiation therapy

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

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

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

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

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

26  diagnostic imaging services from outside referrals, excluding

27  radiation therapy services.

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

29  an ambulatory surgical center licensed under chapter 395.

30

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                                          HB 2231, First Engrossed



  1         h.  By a health care provider for diagnostic clinical

  2  laboratory services where such services are directly related

  3  to renal dialysis.

  4         i.  By a urologist for lithotripsy services.

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

  6  employee of or health care provider who is an independent

  7  contractor with the dentist or group practice of which the

  8  dentist is a member.

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

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

11  group practice.

12         l.  By a nephrologist for renal dialysis services and

13  supplies.

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

15  physician is actually physically present; provided, however,

16  that the health care provider is considered physically present

17  during brief unexpected absences as well as during routine

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

19  periods in which the health care provider is otherwise

20  scheduled and ordinarily expected to be present and the

21  absences do not conflict with any other requirement in the

22  Medicare program for a particular level of health care

23  provider supervision.

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

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

26  defined by the United States Census.

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

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

29  chapter 461, who maintains a medical practice separate from

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

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                                          HB 2231, First Engrossed



  1  services separately from the services provided by any other

  2  health care provider.

  3         (4)  REQUIREMENT FOR ACCEPTING OUTSIDE REFERRALS FOR

  4  DIAGNOSTIC IMAGING.--

  5         (a)  A group practice or sole provider accepting

  6  outside referrals for diagnostic imaging services is required

  7  to comply with the following conditions:

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

  9  practice accepting outside referrals for diagnostic imaging

10  must be held by the physicians comprising the group practice

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

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

13  the group must be incorporated under chapter 617, Florida

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

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

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

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

18         2.  The group practice or sole provider accepting

19  outside referrals for diagnostic imaging may not be managed by

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

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

22  or sole provider referring the patient.

23         3.  The group practice or sole provider accepting

24  outside referrals for diagnostic imaging services must bill

25  for both the professional and technical component of the

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

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

28  indirectly, may be shared with the referring physician.

29         4.  Group practices or sole providers that have a

30  Medicaid provider agreement with the Agency for Health Care

31  Administration must furnish diagnostic imaging services to


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                                          HB 2231, First Engrossed



  1  their Medicaid patients and may not refer a Medicaid recipient

  2  to a hospital for outpatient diagnostic imaging services

  3  unless the physician furnishes the hospital with documentation

  4  demonstrating the medical necessity for such a referral. If

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

  6  to implement this provision.

  7         5.  All group practices and sole providers accepting

  8  outside referrals for diagnostic imaging shall annually report

  9  to the Agency for Health Care Administration providing the

10  number of outside referrals accepted for diagnostic imaging

11  services and the total number of all patients receiving

12  diagnostic imaging services.

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

14  outside referral for diagnostic imaging services in violation

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

16  accepts outside referrals for diagnostic imaging services in

17  excess of the percentage limitation established in

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

19  sole provider shall be subject to the penalties of subsection

20  (5) of this section.

21         (5)(4)  PROHIBITED REFERRALS AND CLAIMS FOR

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

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

24  the provision of designated health services to an entity in

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

26  investment interest.

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

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

29  entity in which the health care provider is an investor

30  unless:

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                                          HB 2231, First Engrossed



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

  2  securities purchased on a national exchange or

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

  4  corporation:

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

  6  on the over-the-counter market; and

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

  8  most recent fiscal quarter exceeded $50 million; or

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

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

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

12  following requirements are met:

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

14  investment interests are held by investors who are in a

15  position to make referrals to the entity.

16         b.  The terms under which an investment interest is

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

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

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

20         c.  The terms under which an investment interest is

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

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

23  volume of referrals from that investor to the entity.

24         d.  There is no requirement that an investor make

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

26  as a condition for becoming or remaining an investor.

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

28  corporation:

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

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

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                                          HB 2231, First Engrossed



  1  referrals to the entity or corporation if the investor uses

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

  3         b.  The amount distributed to an investor representing

  4  a return on the investment interest is directly proportional

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

  6  market value of any preoperational services rendered, invested

  7  in the entity or corporation by that investor.

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

  9  Agency for Health Care Administration, shall encourage the use

10  by licensees of the declaratory statement procedure to

11  determine the applicability of this section or any rule

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

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

14  Administration the name of any entity in which a provider

15  investment interest has been approved pursuant to this

16  section, and the Agency for Health Care Administration shall

17  adopt rules providing for periodic quality assurance and

18  utilization review of such entities.

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

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

21  service furnished pursuant to a referral prohibited under this

22  section.

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

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

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

26  is applicable.

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

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

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

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

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


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                                          HB 2231, First Engrossed



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

  2  by the appropriate board.

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

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

  5  arrangement, which the physician or entity knows or should

  6  know has a principal purpose of assuring referrals by the

  7  physician to a particular entity which, if the physician

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

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

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

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

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

13  provider shall constitute grounds for disciplinary action to

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

15  459.015(2), s. 460.413(2), s. 461.013(2), s. 463.016(2), or s.

16  466.028(2).  Any hospital licensed under chapter 395 found in

17  violation of this section shall be subject to the rules

18  adopted by the Agency for Health Care Administration pursuant

19  to s. 395.0185(2).

20         (h)  Any hospital licensed under chapter 395 that

21  discriminates against or otherwise penalizes a health care

22  provider for compliance with this act.

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

24  referrals to the offices of radiation therapy centers managed

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

26  performed radiation therapy services at those same offices

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

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

29  additional office of any entity qualifying for the foregoing

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

31  purchase contract on and a nonrefundable deposit paid for a


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                                          HB 2231, First Engrossed



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

  2  physical site of the radiation treatment centers affected by

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

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

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

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

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

  8  replacement location within the county of the existing

  9  facility upon written notification to the Office of Licensure

10  and Certification.

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

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

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

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

15  Administration is directed to study issues relating to the

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

17  practices, hospitals, and health systems providing diagnostic

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

19  study include:

20         (a)  The parameters of quality of care;

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

22  or the entities providing diagnostic imaging services for the

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

24  and procedures of the entity;

25         (c)  The extent to which requiring group practices

26  providing diagnostic imaging services to participate in

27  nationally recognized accrediting organizations would enhance

28  quality assurance processes; and

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

30  and health systems providing diagnostic imaging services

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                                          HB 2231, First Engrossed



  1  ensure appropriate utilization of services in order to prevent

  2  overutilization of these services.

  3         (2)  The agency may convene a technical assistance

  4  panel for purposes of this study which is representative of

  5  group practices providing diagnostic imaging services, group

  6  practices, group practices generally, various professional

  7  organizations representing providers and hospitals, and

  8  representatives of the public.

  9         (3)  The agency shall submit its findings and

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

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

12  2000.

13         Section 3.  The agency shall require registration by

14  all group practices providing diagnostic imaging services,

15  regardless of ownership. Registration information must include

16  the medical specialty of each physician; address and phone

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

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

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

20  December 31, 1999.

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

22  Florida, is amended to read:

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

24  except that the amendment of section 395.701 and 395.7015,

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

26  Agency for Health Care Administration receiving written

27  confirmation from the federal Health Care Financing

28  Administration that the changes contained in such amendments

29  will not adversely affect the use of the remaining assessments

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

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


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