PRINTER'S NO. 1269

THE GENERAL ASSEMBLY OF PENNSYLVANIA


HOUSE BILL

No. 1152 Session of 1993


        INTRODUCED BY DeLUCA, TRICH, COLAIZZO, MIHALICH, ROEBUCK,
           KUKOVICH, TRELLO, SCRIMENTI, WOZNIAK, FEE, GEORGE, MARKOSEK,
           STEELMAN, PISTELLA, YANDRISEVITS, JOSEPHS, MELIO, GERLACH,
           TIGUE, KASUNIC, CLARK, BELARDI, PETRONE, LAUGHLIN, CORNELL,
           GIGLIOTTI, McNALLY, LINTON, STETLER, McCALL, ROBINSON,
           OLIVER, ACOSTA, RIEGER, STEIGHNER, DALEY, STISH, CIVERA,
           CESSAR, PESCI, SAURMAN, VEON, VAN HORNE, STABACK, TOMLINSON,
           DRUCE, MICHLOVIC, ITKIN, MURPHY, HANNA AND FREEMAN,
           APRIL 19, 1993

        REFERRED TO COMMITTEE ON INSURANCE, APRIL 19, 1993

                                     AN ACT

     1  Relating to medical practice; prohibiting certain financial
     2     arrangements between referring health care providers and
     3     those who provide health care; prohibiting certain kickbacks;
     4     prohibiting markups on charges for services rendered by
     5     another entity; providing for disclosure of financial
     6     interests; requiring periodic analysis of financial data and
     7     determination of compliance; establishing a fee schedule for
     8     data collection and analysis; providing powers; prescribing
     9     crimes, offenses and penalties; providing for applicability;
    10     and making a repeal.

    11     The General Assembly of the Commonwealth of Pennsylvania
    12  hereby enacts as follows:
    13  Section 1.  Short title.
    14     This act shall be known and may be cited as the Patient Self-
    15  Referral Act.
    16  Section 2.  Legislative intent.
    17     The General Assembly declares the following to be the
    18  purposes of this act:


     1         (1)  To address the potential conflict of interests that
     2     arises when a health care provider refers a patient to an
     3     entity providing health care goods or services with whom the
     4     health care provider has a financial relationship.
     5         (2)  To eliminate referral practices that may restrict
     6     health care access, limit or eliminate competitive health
     7     care goods or services alternatives, increase health care
     8     costs and affect the quality of health care.
     9         (3)  To provide health care provider guidelines as to
    10     prohibited types of joint ventures.
    11         (4)  To protect the citizens of this Commonwealth from
    12     unnecessary and costly health care expenditures.
    13  Section 3.  Definitions.
    14     The following words and phrases when used in this act shall
    15  have the meanings given to them in this section unless the
    16  context clearly indicates otherwise:
    17     "Board."  Any one of the following boards: the State Board of
    18  Chiropractic, the State Board of Dentistry, the State Board of
    19  Medicine, the State Board of Occupational Therapy Education and
    20  Licensure, the State Board of Optometry, the State Board of
    21  Osteopathic Medicine, the State Board of Pharmacy, the State
    22  Board of Physical Therapy, the State Board of Podiatry or the
    23  State Board of Psychology.
    24     "Council."  The Health Care Cost Containment Council.
    25     "Department."  The Department of Health of the Commonwealth.
    26     "Designated health services."  The term includes clinical
    27  laboratory services, physical therapy services, comprehensive
    28  rehabilitative services, diagnostic imaging services and
    29  radiation therapy services.
    30     "Entity."  Any individual, partnership, firm, corporation or
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     1  other business entity.
     2     "Fair market value."  Value in arm's length transactions,
     3  consistent with the general market value, and, with respect to
     4  rentals or leases, the value of rental property for general
     5  commercial purposes, not taking into account its intended use,
     6  and, in the case of a lease of space, not adjusted to reflect
     7  the additional value the prospective lessee or lessor would
     8  attribute to the proximity or convenience to the lessor where
     9  the lessor is a potential source of patient referrals to the
    10  lessee.
    11     "Group practice."  A group of two or more health care
    12  providers legally organized as a partnership, professional
    13  corporation or similar association:
    14         (1)  in which each health care provider who is a member
    15     of the group provides substantially the full range of
    16     services which the health care provider routinely provides,
    17     including medical care, consultation, diagnosis or treatment,
    18     through the joint use of shared office space, facilities,
    19     equipment and personnel;
    20         (2)  for which substantially all of the services of the
    21     health care providers who are members of the group are
    22     provided through the group and are billed in the name of the
    23     group and amounts so received are treated as receipts of the
    24     group; and
    25         (3)  in which the overhead expenses of and the income
    26     from the practice are distributed in accordance with methods
    27     previously determined by members of the group.
    28     "Health care provider."  A licensed individual who, in the
    29  course of practicing his profession, may provide diagnoses,
    30  prescriptions and referrals for treatment.
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     1     "Immediate family member."  A health care provider's spouse,
     2  child, child's spouse, stepchild, stepchild's spouse,
     3  grandchild, grandchild's spouse, sibling, sibling's spouse,
     4  parent, parent-in-law, aunt, uncle, cousin or cousin's spouse.
     5     "Investment interest."  An equity or debt security issued by
     6  an entity, including, but not limited to, shares of stock in a
     7  corporation, units or other interests in a partnership, bonds,
     8  debentures, notes or other equity interests or debt instruments.
     9  This shall not include an investment interest in real property
    10  resulting in a landlord-tenant relationship between the health
    11  care provider and the entity in which the equity interest is
    12  held, unless the rent is determined, in whole or in part, by the
    13  business volume or profitability of the tenant or exceeds fair
    14  market value.
    15     "Investor."  A person or entity owning a legal or beneficial
    16  ownership or investment interest, directly or indirectly,
    17  including, without limitation, through an immediate family
    18  member, trust or another entity related to the investor within
    19  the meaning of 42 CFR 413.17 (relating to cost to related
    20  organizations), in an entity.
    21     "Kickback."  A remuneration or payback, pursuant to an
    22  investment interest, compensation arrangement or otherwise by a
    23  provider of health care services or items, of a portion of the
    24  charges for services rendered to a referring health care
    25  provider as an incentive or inducement to refer patients for
    26  future services or items, when the payment is not tax deductible
    27  as an ordinary and necessary expense.
    28     "Referral."
    29         (1)  Any referral of a patient by a health care provider
    30     for health care services, including, without limitation:
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     1             (i)  the forwarding of a patient by a health care
     2         provider to another health care provider or to an entity
     3         which provides or supplies designated health services or
     4         any other health care item or service; or
     5             (ii)  the request or establishment of a plan of care
     6         by a health care provider, which includes the provision
     7         of designated health services or other health care item
     8         or service.
     9         (2)  The following orders, recommendations or plans of
    10     care shall not constitute a referral by a health care
    11     provider for:
    12             (i)  Diagnostic imaging services by a radiologist.
    13             (ii)  Radiation therapy services by a physician
    14         specializing in radiation therapy.
    15             (iii)  Drugs and solutions to be prepared and
    16         administered intravenously to an oncology patient for the
    17         supplies and equipment used in connection therewith to
    18         treat the patient for cancer and the complications
    19         thereof by a medical oncologist.
    20             (iv)  Cardiac catheterization services by a
    21         cardiologist.
    22             (v)  By a pathologist for diagnostic clinical
    23         laboratory tests and pathological examination services if
    24         furnished by or under the supervision of the pathologist
    25         pursuant to a consultation requested by another
    26         physician.
    27             (vi)  Designated health services or other health care
    28         items or services that are prescribed or provided solely
    29         for the referring health care provider's or group
    30         practice's own patients and that are provided or
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     1         performed by or under the direct supervision of the
     2         referring health care provider or group practice.
     3             (vii)  Services provided by a licensed ambulatory
     4         surgical center.
     5             (viii)  Diagnostic clinical laboratory services where
     6         the services are directly related to renal dialysis.
     7             (ix)  Lithotripsy services by a urologist.
     8             (x)  By a dentist for dental services performed by an
     9         employee of or health care provider who is an independent
    10         contractor with the dentist or group practice of which
    11         the dentist is a member.
    12             (xi)  Infusion therapy services to a patient of that
    13         physician or a member of that physician's group practice.
    14             (xii)  Renal dialysis services and supplies by a
    15         nephrologist.
    16             (xiii)  An emergency situation where normal
    17         compliance with this act would lead to serious health
    18         risks including loss of life.
    19     "Rural area."  A county with at least 80% of its population
    20  living in an area defined by the United States Census Bureau as
    21  rural.
    22     "Self-referral."  Selection by a patient of an entity to
    23  provide additional health care services or items under the
    24  referral practices established by this act.
    25  Section 4.  Prohibited referrals and claims for payment.
    26     (a)  General rule.--A health care provider may not refer a
    27  patient for the provision of designated health services to an
    28  entity in which the health care provider or a member of the
    29  health care provider's immediate family is an investor or has an
    30  investment interest.
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     1     (b)  When self-referral permitted.--A health care provider
     2  may not refer a patient, for any health care item or service, to
     3  an entity in which the health care provider or a member of the
     4  health care provider's immediate family is an investor unless
     5  the conditions of paragraph (1), (2) or (3) are satisfied:
     6         (1)  The provider's investment interest is in registered
     7     securities purchased on a national exchange or over-the-
     8     counter market and issued by a publicly held corporation:
     9             (i)  whose shares are traded on a national exchange
    10         or on the over-the-counter market; and
    11             (ii)  whose total assets at the end of the
    12         corporation's most recent fiscal quarter exceeded
    13         $50,000,000.
    14         (2)  With respect to an entity other than a publicly held
    15     corporation described in paragraph (1) and with respect to a
    16     referring provider's investment interest in the entity, each
    17     of the following requirements are met:
    18             (i)  No more than 50% of the value of the investment
    19         interests are held by investors who are in a position to
    20         make referrals to the entity.
    21             (ii)  The terms under which an investment interest is
    22         offered to an investor who is in a position to make a
    23         referral to the entity are no different from the terms
    24         offered to investors who are not in a position to make
    25         such referrals.
    26             (iii)  The terms under which an investment interest
    27         is offered to an investor who is in a position to make
    28         referrals to the entity are not related to the previous
    29         or expected volume of referrals from that investor to the
    30         entity.
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     1             (iv)  There is no requirement that an investor make
     2         referrals or be in a position to make referrals to the
     3         entity as a condition for becoming or remaining an
     4         investor.
     5         (3)  With respect to either such entity or publicly held
     6     corporation:
     7             (i)  The entity or corporation does not loan funds to
     8         or guarantee a loan for an investor who is in a position
     9         to make referrals to the entity or corporation if the
    10         investor uses any part of the loan to obtain the
    11         investment interest.
    12             (ii)  The amount distributed to an investor
    13         representing a return on the investment interest is
    14         directly proportional to the amount of the capital
    15         investment, including the fair market value of a
    16         preoperations service rendered, invested in the entity or
    17         corporation by that investor.
    18     (c)  Enforcement.--Each board and department, where
    19  applicable, in the course of licensing or recertification, shall
    20  determine the applicability of this section or any rule adopted
    21  under this section as it applies solely to the licensee. Boards
    22  shall submit to the department the name of any entity in which a
    23  provider investment interest has been approved under this
    24  section.
    25     (d)  Relief.--No claim for payment may be presented by an
    26  entity to any individual, third-party payor or other entity for
    27  a service furnished pursuant to a referral prohibited under this
    28  act.
    29     (e)  Refunds.--If an entity collects any amount that was
    30  billed in violation of this section, the entity shall refund the
    19930H1152B1269                  - 8 -

     1  amount on a timely basis to the payor or individual, whichever
     2  is applicable.
     3     (f)  Penalties.--
     4         (1)  Any person that presents or causes to be presented a
     5     bill or a claim for service that the person knows or should
     6     know is for a service for which payment may not be made under
     7     subsection (d), or for which a refund has not been made under
     8     subsection (e), shall be subject to a civil penalty of not
     9     more than $15,000 for each service, to be imposed and
    10     collected by the appropriate board.
    11         (2)  Any health care provider or other entity that enters
    12     into an arrangement or scheme, such as a cross-referral
    13     arrangement, which the physician or entity knows or should
    14     know has a principal purpose of assuring referrals by the
    15     physician to a particular entity which, if the physician
    16     directly made referrals to the entity, would be in violation
    17     of this section, shall be subject to a civil penalty of not
    18     more than $100,000 for each circumvention arrangement or
    19     scheme, to be imposed and collected by the appropriate board.
    20     (g)  Disciplinary actions.--A violation of this act by a
    21  health care provider shall constitute grounds for disciplinary
    22  action to be taken by the applicable board. A hospital or health
    23  care facility licensed by the Commonwealth found in violation of
    24  this act shall be subject to disciplinary action to be taken by
    25  the department.
    26     (h)  Discrimination for compliance prohibited.--Any hospital
    27  or health care facility licensed by the Commonwealth is
    28  prohibited from discriminating against or otherwise penalizing a
    29  health care provider for compliance with this act.
    30     (i)  Exception for radiation therapy services.--The
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     1  provisions of subsection (a) shall not apply to referrals to the
     2  offices of radiation therapy centers managed by an entity or
     3  subsidiary or general partner thereof, which performed radiation
     4  therapy services at those same offices prior to April 1, 1991,
     5  and shall not apply also to referrals for radiation therapy to
     6  be performed at no more than one additional office of any entity
     7  qualifying for the foregoing exception which, prior to February
     8  1, 1992, had a binding purchase contract on and a nonrefundable
     9  deposit paid for a linear accelerator to be used at the
    10  additional office. The physical site of the radiation treatment
    11  centers affected by this provision may be relocated as a result
    12  of the following factors: acts of God, fire, strike, accident,
    13  war, eminent domain actions by any governmental body or refusal
    14  by the lessor to renew a lease. A relocation for the foregoing
    15  reasons is limited to relocation of an existing facility to a
    16  replacement location within the county of the existing facility
    17  upon written notification to the department.
    18     (j)  Disclosure to patients.--A health care provider who
    19  meets the requirements of subsections (b) and (i) must disclose
    20  his investment interest to his patients as provided in section
    21  7(c).
    22     (k)  Exemption for rural area.--The department may, in cases
    23  where the department determines that the provision of adequate
    24  health care services in a rural area necessitates, wave the
    25  requirement contained in section 4(b)(2)(i), provided that the
    26  reason for said waiver is described on the disclosure forms
    27  prepared for the patient under section 7.
    28  Section 5.  Kickbacks prohibited.
    29     It is unlawful for any health care provider or any provider
    30  of health care services to offer, pay, solicit or receive a
    19930H1152B1269                 - 10 -

     1  kickback, directly or indirectly, overtly or covertly, in case
     2  or in kind, for referring or soliciting patients.
     3  Section 6.  Markup on charges prohibited.
     4     A health care provider may not charge an additional amount
     5  for services rendered by an entity outside of that provider's
     6  practice.
     7  Section 7.  Financial disclosure and data collection.
     8     (a)  Requirement to provide financial information.--An entity
     9  providing designated health services or any other health care
    10  item or service licensed by the Commonwealth must submit the
    11  financial information necessary for the determination of
    12  compliance with this act on an annual basis.
    13         (1)  The council shall prescribe and collect the
    14     ownership disclosure provisions required under this section
    15     in accordance with the act of July 8, 1986 (P.L.408, No.89),
    16     known as the Health Care Cost Containment Act.
    17         (2)  The council shall submit to the appropriate board
    18     all information collected by the council under this act.
    19         (3)  The council shall provide, for a fee designed to
    20     cover the costs of duplication, all information collected by
    21     the council under this act, on request, to any insurer
    22     licensed to provide health insurance in this Commonwealth.
    23     (b)  Disclosure to licensing board.--A health care provider
    24  shall disclose to his licensing board all investment interests
    25  in entities providing designated health services or any other
    26  health care item or service. The Department of State shall
    27  develop and provide to all health care providers covered by this
    28  act a standardized form and procedures for the reporting of
    29  investment interests covered under this section.
    30     (c)  Written disclosure.--A health care provider shall not
    19930H1152B1269                 - 11 -

     1  refer a patient to an entity in which the provider is an
     2  investor unless, prior to referral, the provider furnishes the
     3  patient with a written disclosure form, informing the patient
     4  of:
     5         (1)  The existence of the investment interest.
     6         (2)  The name and address of each applicable entity in
     7     which the referring health care provider is an investor.
     8         (3)  The patient's right to obtain the items or services
     9     for which the patient has been referred at the location or
    10     from the provider or supplier of the patient's choice,
    11     including the entity in which the referring provider is an
    12     investor.
    13         (4)  The names, addresses and telephone numbers of at
    14     least two alternative sources available to the patient within
    15     reasonable travel distances.
    16         (5)  A toll-free telephone number established by the
    17     department for the reporting of any suspected violations of
    18     this act.
    19     (d)  Acknowledgment.--An entity may not provide items or
    20  services to a patient unless, before providing the item or
    21  service, the entity obtains the signature of the patient on a
    22  written disclosure form informing the patient of the following:
    23         (1)  The existence or nonexistence of any financial
    24     relationship with the health care provider who referred the
    25     patient.
    26         (2)  A schedule of typical fees for items or services
    27     usually provided by the entity or, if impracticable because
    28     of the nature of the treatment, a written estimate specific
    29     to the patient.
    30         (3)  The patient's right to obtain the items or services
    19930H1152B1269                 - 12 -

     1     for which the patient has been referred at a location or from
     2     a supplier of the patient's choice, including an entity with
     3     which the referring health care provider may have a financial
     4     relationship.
     5         (4)  The names, addresses and telephone numbers of at
     6     least two reasonable alternative sources of such items or
     7     services available to the patient.
     8         (5)  A toll-free telephone number established by the
     9     department for the reporting of any suspected violations of
    10     this act.
    11     (e)  Duty to postdisclosure statements.--The health care
    12  provider and the entity providing health care items or services
    13  shall post a copy of their respective disclosure forms in
    14  conspicuous public places in the offices.
    15  Section 8.  Data analysis and compliance.
    16     (a)  Determinations of compliance.--Licensing boards shall
    17  determine compliance under this act through the use of data
    18  collected under this act and all other sources allowed under
    19  law.
    20     (b)  Reviews.--Reviews shall occur periodically and in no
    21  case shall reviews occur less frequently than once every two
    22  years.
    23  Section 9.  Fee schedules for data collection and analysis.
    24     (a)  Establishment of fees.--Licensing boards, the Department
    25  of Health and the Department of State are hereby authorized to
    26  develop fee schedules to be paid by the appropriate health care
    27  provider and entity providing health care items or services
    28  which are designed to cover and limited to the costs of data
    29  collection and analysis provided for under this act.
    30     (b)  Duty to pay fees.--All health care providers and
    19930H1152B1269                 - 13 -

     1  entities providing health care items or services shall pay the
     2  fees for data collection and analysis as provided for in
     3  subsection (a).
     4  Section 10.  Powers and duties.
     5     The Department of Health, Department of State and the
     6  licensing boards shall promulgate regulations necessary to
     7  implement the provisions and intent of this act.
     8  Section 11.  Crimes, offenses and penalties.
     9     (a)  Additional penalties.--In addition to the penalties
    10  provided for in section 4, each violation of this act shall
    11  constitute a misdemeanor of the first degree punishable by a
    12  fine of not more than $10,000 or imprisonment for up to five
    13  years, or both.
    14     (b)  Suspension.--Health care providers found in violation of
    15  this act shall be subject to disciplinary action by the
    16  licensing boards, including, but not limited to, a suspension of
    17  professional licensure for a period not to exceed five years.
    18  Section 12.  Applicability.
    19     This act shall apply to referrals made on or after the
    20  effective date of this act, provided that, with respect to an
    21  investment interest acquired before December 31, 1992, section
    22  4(a) shall not apply to referrals for designated health services
    23  occurring before October 1, 1995.
    24  Section 13.  Repeal.
    25     The act of May 26, 1988 (P.L.403, No.66), entitled "An act
    26  providing for certain disclosures by practitioners of the
    27  healing arts when making patient referrals; providing penalties;
    28  and conferring powers and duties on the several licensing boards
    29  in the Bureau of Professional and Occupational Affairs," is
    30  repealed.
    19930H1152B1269                 - 14 -

     1  Section 14.  Effective date.
     2     This act shall take effect in 60 days.



















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