Application Of RCW 19.68.010 To Donations For Electronic Health Record

MEDICINE—PHYSICIANS—Application Of RCW 19.68.010 To Donations For Electronic Health Record

RCW 19.68.010, Washington’s anti-rebate statute, precludes a donation by a clinical laboratory to a physician for the purpose of paying a portion of the cost of software for the physician’s electronic health record system, in connection with the receiving physician either continuing or establishing a referral arrangement with the donating laboratory.

 November 20, 2012

Dear Representative Cody:

    By letter previously acknowledged, you have requested our opinion on the following questions:

1. Under RCW 19.68.010, can a clinical laboratory licensed by the State of Washington lawfully make a monetary donation to a physician to cover 85 percent of the software cost of that physician’s electronic health record (EHR) when the physician’s office that is the recipient of the EHR donation either continues a referral arrangement with the laboratory, or subsequently initiates an arrangement for the referral [of] specimens to the donating laboratory for analysis?
   
2. If such donations are in fact permissible under RCW 19.68.010, will a subsequent initiation or increase in specimen referrals between the physician recipient of the donation, who orders clinical laboratory services, and the donating laboratory be a violation, or a potential violation, of the code and thus subject to investigation by the Medical Quality Assurance Commission?

BRIEF ANSWER

    A clinical laboratory’s donating money to a physician to be used for a portion of the cost of an electronic health record, when the donations are made only to those physicians who maintain or create arrangements for the physician’s referral of specimens to the laboratory, would violate the anti-rebate provisions in RCW 19.68.010.  Given the answer to the first question, we do not reach the second question.

[original page 2]

BACKGROUND

    RCW 19.68.010 generally prohibits the payment or receipt of rebates when certain licensed medical professionals refer patients to others to obtain services or supplies. [1]   The state legislature enacted the law in 1949 during a period when the Federal Trade Commission and the Justice Department were cracking down on rebate or kickback schemes.  See Wright v. Jeckle, 158 Wn.2d 375, 380, 144 P.3d 301 (2006) (mentioning a 1948 class action lawsuit against 2000 physicians who directed their patients to fill prescriptions at the American Optical Company, which company then provided kickbacks to the referring doctors).  The FTC promulgated federal anti-kickback rules, and numerous states, including Washington, followed suit with their own legislation.  See Recent Developments:  Medical Profession—Anti-Kickback Statute, 45 Wash. L. Rev. 838, 839 (1970).  The goals of anti-kickback legislation “were protection of the public from hidden rebates and charges, and the elimination of a potential motive to make unnecessary prescriptions.”  Id. at 839-40.  The codified legislative intent statute supports this interpretation.  See RCW 19.68.040 (indicating that licensed professionals covered by the chapter shall only receive compensation for services actually rendered).

    With this background in mind, we turn to the text of the first subsection:

    It shall be unlawful for any person, firm, corporation or association, whether organized as a cooperative, or for profit or nonprofit, to pay, or offer to pay or allow, directly or indirectly, to any person licensed by the state of Washington to engage in the practice of medicine and surgery, drugless treatment in any form, dentistry, or pharmacy and it shall be unlawful for such person to request, receive or allow, directly or indirectly, a rebate, refund, commission, unearned discount or profit by means of a credit or other valuable consideration in connection with the referral of patients to any person, firm, corporation or association, or in connection with the furnishings of medical, surgical or dental care, diagnosis, treatment or service, on the sale, rental, furnishing or supplying of clinical laboratory supplies or services of any kind, drugs, medication, or medical supplies, or any other goods, services or supplies prescribed for medical diagnosis, care or treatment.

RCW 19.68.010.

    Opinions of both the Washington Supreme Court and our office have parsed the meaning of this single, dense, 156-word sentence on several occasions.  See Wright, 158 Wn.2d at

[original page 3]

377 n.1, 381 (describing the statute as “not a model of clarity”); see also AGO 2005 No. 13, at 3 4 (construing the statute and citing an earlier opinion).  It may be helpful in understanding the statute to analytically divide it into two halves, with each half containing two separate clauses.  The statutory language can be quoted verbatim in the following divided fashion, designating the two clauses of the first half with A and B, and the two clauses of the second half with 1 and 2:

    (A)     It shall be unlawful for any person, firm, corporation or association, whether organized as a cooperative, or for profit or nonprofit, to pay, or offer to pay or allow, directly or indirectly, to any person licensed by the state of Washington to engage in the practice of medicine and surgery, drugless treatment in any form, dentistry, or pharmacy and

    (B)    it shall be unlawful for such person to request, receive or allow, directly or indirectly, a rebate, refund, commission, unearned discount or profit by means of a credit or other valuable consideration

    (1)    in connection with the referral of patients to any person, firm, corporation or association, or

    (2)    in connection with the furnishings of medical, surgical or dental care, diagnosis, treatment or service, on the sale, rental, furnishing or supplying of clinical laboratory supplies or services of any kind, drugs, medication, or medical supplies, or any other goods, services or supplies prescribed for medical diagnosis, care or treatment.

    The first half of the statute provides two categories of actors who can violate the statute.  Part A references a person, firm, corporation, or association making or offering to make payments to certain licensed medical professionals.  Part B describes medical professionals who ask for or receive any form of consideration.  Part B uses an indirect reference, “such person,” and that phrase is most reasonably interpreted as referencing those licensed professionals described at the end of Part A, because “such person” refers to one asking for or receiving valuable consideration.  In other words, A and B capture both sides of the same transaction, with A describing the persons offering the consideration to medical professionals, and B describing the medical professionals soliciting or accepting the consideration.

    The exchange of consideration described by A and B falls within the statutorily prohibited activity only when the transaction is coupled with the alternative circumstances described in the second half of the statute.  The exchange of consideration must either be (1) in connection with the referral of a patient, or (2) in connection with the provision of any medical supplies or services prescribed for medical diagnosis, care, or treatment.  When viewed in this segmented fashion, a statutory violation may occur in any one of four combinations:  A1, A2, B1, or B2.

[original page 4]

    This method of reading RCW 19.68.010 is consistent with prior analysis of the statute.  The Washington Supreme Court has analyzed RCW 19.68.010 in two recent decisions, in which the court summarized the statute as prohibiting two things:  “The first clause prohibits paying anything of value in return for a referral.  The second clause prohibits receiving anything of value in return for referring patients.”  Wright, 158 Wn.2d at 381, cited with approval in Columbia Physical Therapy, Inc., PS v. Benton Franklin Orthopedic Assocs., PLLC, 168 Wn.2d 421, 439, 228 P.3d 1260 (2010).  Our prior opinions have construed RCW 19.68.010 as containing three elements, concluding that the statute is violated when

    (1) there [is] a payment of a rebate, refund, commission, unearned discount, or profit by means of credit or other valuable consideration; (2) the payment [is] in connection with the referral of patients or in connection with the furnishing of medical, surgical, or dental care, diagnosis, treatment, or service; and (3) the recipient of the payment [is] licensed by the state of Washington to engage in the practice of medicine and surgery, drugless treatment in any form, dentistry, or pharmacy.

AGO 2005 No. 13, at 3 (citing AGO 1992 No. 30, at 3, which in turn cites AGO 1988 No. 28, at 3-4). [2]  

      Having clarified the scope and application of the prohibition in RCW 19.68.010, we turn to your specific questions.

ANALYSIS

1. Under RCW 19.68.010, can a clinical laboratory licensed by the State of Washington lawfully make a monetary donation to a physician to cover 85 percent of the software cost of that physician’s electronic health record (EHR) when the physician’s office that is the recipient of the EHR donation either continues a referral arrangement with the laboratory, or subsequently initiates an arrangement for the referral [of] specimens to the donating laboratory for analysis?

    Your question involves a laboratory making a monetary donation to a physician to cover 85 percent of the cost of EHR software.  First, the fact that such laboratory is licensed by the State of Washington is not relevant to application of RCW 19.68.010.  The only licensing requirement mentioned in the statute is that the person receiving consideration be a licensed medical professional, as is the physician referenced in your question.  Also, for purposes of answering the question, we presume that the laboratory and physician do not have common

[original page 5]

ownership or financial interests, so as to avoid implicating the exception addressed in RCW 19.68.010(2). [3]

    A laboratory’s donating money to a physician, to apply toward the cost of the physician’s EHR software, squarely fits within Part A of RCW 19.68.010.  A clinical laboratory constitutes a “person, firm, corporation or association,” the money being provided constitutes a payment, and the physician receiving the payment is a licensed medical professional covered by the statute.  The situation also fits within Part B, because it involves a medical professional accepting a monetary payment.

    Whether the donation also falls within the second part of the statute depends upon the facts surrounding a specific donation.  The donation would fall within Part 1 of RCW 19.68.010, if it was made “in connection with the referral of patients to any person, firm, corporation or association.”  RCW 19.68.010 (emphasis added).  Your question references referral agreements under which the physician sends specimens for laboratory analysis.  If the physician obtains specimens from patients in the physician’s office, and the physician sends only the specimens to the laboratory, such action would not involve the referral of a patient and Part 1 may not be implicated.

    On the other hand, if the physician did refer patients to the laboratory for purposes of providing the specimens needed for analysis, then Part 1 could be implicated, but the critical question would be whether the laboratory’s donation of money towards EHR is made “in connection with” the patient referrals.  RCW 19.68.010.  Your question asks us to presume that the physician receiving the donation either continues an existing referral relationship with the donating laboratory, or later begins making referrals to the laboratory.  The fact that the EHR donations are made to those physicians who have such arrangements or who thereafter initiate such arrangements shows that the donations are made “in connection with” the referrals.

    If a physician did not refer patients to the donating laboratory, but rather sent specimens that the physician obtained from a patient in the physician’s own office, Part 2 of RCW 19.68.010 could be implicated.  The doctor’s sending specimens to the laboratory for diagnoses falls within the scope of language in Part 2, which includes “the furnishings of medical . . . diagnosis, treatment or service . . . or supplying of clinical laboratory . . . services of any kind . . . or any other goods, services or supplies prescribed for medical diagnosis, care or treatment.”  As with Part 1, the critical connection is whether the EHR donation is made “in connection with” the furnishing of laboratory services.  RCW 19.68.010.  The fact that donations are made to those physicians who maintain or initiate new specimen referral arrangements necessarily draws a connection between the donation and the referral, thereby triggering Part 2.

[original page 6]

    In the explanation leading up to your question, you reference the enactment of a federal safe harbor rule that does allow certain medical professionals to receive EHR software donations from third parties in certain circumstances without violating a federal anti-kickback statute.  The federal rule on this topic, 42 C.F.R. § 1001.952(y), does not alter the above analysis.  We generally decline to consider, in our official opinions, the question of whether a particular state law might be preempted by federal law, because such questions effectively call into question the validity of existing state law.  In this instance, and as you point out in your letter, the United States Department of Health and Human Services expressly acknowledged that it lacked federal statutory authority to preempt application of state anti-kickback statutes regarding the donation of electronic health record software.  See 71 Fed. Reg. 45114 (stating that Section 1128B(b)(3)(E) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Pub. L. 108-173, does not provide authority to preempt state anti-kickback laws with regards to EHR software, in contrast to a different part of the Act that did preempt state laws regarding electronic prescribing standards).  Because the federal agency promulgating the safe harbor rule for EHR software donations expressly states that the rule is not intended to preempt application of state laws, RCW 19.68.010 fully applies to your hypothetical. [4]

    Because your second question was contingent on the first question being answered affirmatively, and we have answered the first question in the negative, we do not further address the second question.

    We trust that the foregoing will be useful to you.

ROBERT M. MCKENNA
   Attorney General

JOSEPH V. PANESKO
   Assistant Attorney General

wros

   [1] This opinion uses the phrase “medical professional” as meaning professionals covered by RCW 19.68.010(1).  Those consist of individuals licensed by the State to practice in the fields of medicine and surgery, drugless treatment in any form, dentistry, or pharmacy.  Also, this opinion refers to RCW 19.68.010 without specifying subsections, with the understanding that the only portion of the statute at issue in this opinion is the language in subsection one.
   [2] The Court in Wright was aware of at least one of the Attorney General Opinions construing RCW 19.68.010 because the decision cites AGO 1988 No. 28, but Wright does not reference or endorse the three part test that was applied in the 1988, 1992, and 2005 AGOs.
   [3] RCW 19.68.010(2) allows a medical professional to have an ownership or financial interest in another entity that provides medical services, so long as the professional reveals the interest to the patient in writing, provides the patient with a list of alternative service providers, and assures the patient that the patient’s choosing an alternative provider will not result in different treatment by the professional.
   [4] We also note that the EHR federal safe harbor rule contains a sunset provision that lapses on December 31, 2013.  42 C.F.R. § 1001.952(y)(13).