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IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA


American Chiropractic Association, Inc.
a non-profit corporation,
Plaintiff,

v.

Donna Shalala, Secretary of the
Department of Health and Human ) Services,
Defendant.
Civil Action No._________________

COMPLAINT

Introduction

1. The plaintiff, the American Chiropractic Association, Inc. ("ACA"), brings this action, on behalf of its members, doctors of chiropractic, and their patients to force the Department of Health and Human Services ("HHS") to ensure access to chiropractic care by Medicare patients enrolled in health maintenance organizations ("HMOs") as is required by the laws of Congress. Specifically, plaintiff asks this Court to order HHS, pursuant to 42 USCA § 1395mm, Section 4204(f) of Pub.L. 101-508, 104 Stat. 1388 (1990) (as amended by Pub.L. 103-432, 108 Stat. 4442 (1994)), to submit to Congress a report ordered by Congress detailing a study of the extent to which chiropractic services are being provided to Medicare patients enrolled in HMOs. The submission to Congress should include, as required by law, recommendations for legislative and regulatory changes that are necessary to ensure access to chiropractic services. Additionally, plaintiff asks this Court to order the Secretary of HHS to refrain from publishing any new regulations, rules, policy statements and/or guidelines, and to correct or rescind any extant regulations, rules, policy statements and/or guidelines which have as their intended purpose any effort to deny Medicare HMO patients the Congressionally ordered chiropractic benefit of manual manipulation of the spine to correct a subluxation delivered by a licensed doctor of chiropractic.

2. Chiropractors have long suffered from illegal, competitive prejudice at the hands of the medical community. In 1988, a United States District Court, in an antitrust action brought by a group of chiropractors, found that the American Medical Association ("AMA"), by far the largest and most powerful association of medical doctors, organized and led an illegal conspiracy to "contain and eliminate" the profession of chiropractic in the United States. The conspiracy included, inter alia, an effort to ban all voluntary professional association between medical doctors, medical institutions, insurance programs, etc., and doctors of chiropractic. The decision was affirmed by the United States Court of Appeals For The Seventh Circuit:

Indeed, the court found that the AMA intended to "destroy a competitor, "namely chiropractors." [p. 361]

• • • • •

The district court's form of injunction and method of ensuring its publication (and thus its efficacy) was a reasonable attempt at eliminating the consequences of the AMA's lengthy, systematic, successful, and unlawful boycott. [p. 371]

Wilk v. AMA, 895 F.2d 352 (7th Cir. 1990), cert. den.

3. Anti-chiropractic bias in the world of health care, such as that demonstrated by the AMA, and its related medical doctor and health care organizations, has existed throughout the later half of this century and continues today in spite of the fact that chiropractic care has been demonstrated to be as effective, or more effective, than traditional medicine for certain common painful and debilitating ailments. Over the years anti-chiropractic bias has existed in HHS in spite of certain laws passed by Congress to insure access to chiropractic care by patients enrolled in government sponsored, managed healthcare programs. The refusal to report to Congress complained of here, and the bias demonstrated by HHS, is, on information and belief, a result of medical doctors' strong influence on, and dominating presence within this administrative body. Recent changes to the Medicare laws have created the need for modifications in HHS's rules, regulations and policies governing Medicare HMO plans. HHS has embarked on this rulemaking process without regard to the fact that current Medicare HMO plans have severely restricted, or eliminated altogether, access to chiropractic care by Medicare patients. Plaintiff brings this action to prevent HHS from contravening the will of Congress and denying Medicare patients in HMOs their rightful claim to chiropractic services delivered by licensed doctors of chiropractic.

"We are mindful of the expertise of agencies charged with implementing statutory directives. Chevron, 467 U.S. at 843, 104 S.Ct. at 2781-82. We cannot, however, allow an agency, hostile from the start to the very idea of making the payments at issue, to rewrite the will of Congress. As the Supreme Court has explained:

[t]he judiciary is the final authority on issues of statutory construction and must reject administrative constructions, which are contrary to clear Congressional intent. If a court, employing traditional tools of statutory construction, ascertains that Congress had an intention on the precise question at issue, that intention is the law and must be given effect. Chevron, 467 U.S. at 843 n. 9 104 S.Ct. at 2782 n. 9 (citations omitted). Here, Congress had an intention: to make DSH payment calculations based on the number of patients eligible for state Medicaid. The agency had a contrary intention: to make such calculations based on the number of patients entitled to Medicaid payment for inpatient hospital care. In the case of conflict, it is clear whose interpretation shall prevail.

Cabell Huntington Hosp., Inc. v. Shalala, et al., 101 F.3d 984, 990 (4th Cir. 1996).

Parties

4. The plaintiff, ACA is a non-profit corporation organized under the laws of the State of Delaware. The ACA's members include chiropractors within the meaning of 42 U.S.C. § 1395x(r)(5). The plaintiff's address is 1701 Clarendon Blvd., Arlington, Virginia 22209.

5. Defendant Donna Shalala (the "Secretary") is the Secretary of the Department of Health and Human Services. The Department of Health and Human Services ("HHS") is a department in the executive branch of the United States government.

Jurisdiction and Venue

6. This Court has jurisdiction over this action pursuant to 28 U.S.C. §§ 1331, 1361, 5 U.S.C. §§ 702 and 704 and 42 U.S.C. § 1395 et seq.

7. Venue is proper in this judicial district pursuant to 28 U.S.C. § 1391(e) and 5 U.S.C. § 703.

Background

8. In 1963, the AMA established a "Committee on Quackery" which considered "its prime mission to be, first, the containment of chiropractic and ultimately, the elimination of chiropractic."

9. The United States District Court for the Northern District of Illinois found that the AMA's purpose in its unlawful boycott of chiropractic was to prevent all medical physicians in the United States from referring patients to chiropractors and from accepting referrals of patients from chiropractors, to prevent chiropractors from obtaining access to hospital diagnostic services and membership on hospital medical staffs, to prevent medical physicians from teaching at chiropractic colleges or engaging in any joint research, and to prevent any cooperation whatsoever between the two professional groups in the delivery of health care services.

10. Despite the AMA's illegal efforts, chiropractic ultimately became licensed in all 50 states.

11. One primary method used by the AMA of achieving its goal of eliminating chiropractic was to conspire to prevent private insurance coverage for patients of doctors of chiropractic. This goal was also extended to government insurance programs by asserting influence on HHS (then HEW).

12. In 1965, Congress established the Medicare and Medicaid programs as Titles XVIII and XIX of the Social Security Act. Chiropractic services were not then included as a covered service.

13. In 1967, Congress asked HHS (then HEW) to conduct an unbiased study to determine the need for including coverage for chiropractic services under the Medicare Act. The actual study that was conducted was a "sham" engineered by the AMA and medical physician members of the Public Health Service of HHS (then HEW). The study panel considered the AMA directed, illegal boycott affects on professional relations between medical doctors and chiropractors:

The services of chiropractors and naturopaths could be provided in the Medicare program as employees of health care institutions. This would be an unrealistic method of coverage since presently nearly all of these practitioners practice independently, are not employees of a health care institution and do not work for doctors of osteopathy or medical doctors. To implement this alternative would mean a radical change in attitude on the part of the entire health care world, since most institutions, agencies, medical doctors or doctos [sic] of osteopathy would refuse to employ these practitioners.

• • • • •

The services of chiropractors and naturopaths could be provided in the Medicare program upon referral of a physician for diagnosis, treatment, or both. This is also unrealistic. The chiropractor and naturopathy associations would voice strong opposition to such a proposal. They have emphatically stated over and over again that they are an entirely separate and independent branch of the healing arts and that is [sic] is unnecessary for them to work under the supervision of a medical doctor or doctor of osteopathy. They would regard such a proposal as an attempt by the medical profession to destroy them as an independent group by incorporating them into the medical profession, as they claim medicine did in the case of osteopathy. The American Medical Association has stated that it is unethical for a physician to refer a patient to these practitioners and likewise could be expected to voice strong opposition to such a proposal. Even if such a proposal became law, its implementation would require mass and open defection on the part of medical doctors from the policy of its own association. Although it has been stated that physicians secretly refer patients to doctors of chiropractic and naturopathic doctors now, it would be quite another thing for them to sign a document stating they had referred a patient to a chiropractor or a naturopath, which would be necessary under this method of reimbursement.

(Exhibit A, attached hereto.)

14. The fact that the AMA had privately met with and "coached" members of the study panel was concealed from Congress. At one point, a public meeting between the AMA and the study panel was considered but the notion was rejected. The reason a public meeting was rejected was revealed by an attorney for the AMA:

Doctor Cashman [an HEW medical physician] advised me [an AMA attorney] that the consultant group discussed the proposed meeting and determined that such a meeting may create legislative problems for their recommendations which are to be submitted to the Secretary for his report to the Congress.

(Exhibit B, attached hereto, emphasis added.)

15. As a result of the negative report of the study panel, Congress delayed including chiropractic care in Medicare for five more years.

16. In 1972, Congress, over the strenuous objections of organized medicine, passed the Social Security Amendments of 1972 that, in part, modified the Social Security Act to include chiropractic services as a covered service under Medicare. Specifically, Section 1861(r) of the Social Security Act (42 U.S.C. § 1395x(r)), which lists covered practitioner's services, was amended to add the following:

"(5) a chiropractor who is licensed as such by the State (or in a State which does not license chiropractors as such, is legally authorized to perform the services of a chiropractor in the jurisdiction in which he performs such services), and who meets uniform minimum standards promulgated by the Secretary, but only for the purpose of sections 1861(s)(1) and 1861(s)(2)(A) and only with respect to treatment by means of manual manipulation of the spine (to correct a subluxation demonstrated by X-ray to exist) which he is legally authorized to perform by the State or jurisdiction in which such treatment is provided".

(Exhibit C, attached hereto, emphasis added.)

17. Only chiropractors manually manipulated the spine to correct subluxations and this was considered to be a uniquely chiropractic service demanded by patients of chiropractors. The clear intent of 42 U.S.C. § 1395x(r)(5) was to include in Medicare a uniquely chiropractic service that was to be provided by a chiropractor, and that would allow direct access to doctors of chiropractic unhindered by the illegal AMA inspired boycott.

18. At the same time as 42 U.S.C. § 1395x(r)(5) was becoming law, in 1973 the AMA was working with medical doctor dominated insurance companies (many of which were to become Part B Medicare providers) to prevent any insurance payments for chiropractic services. For example, AMA staff met with Blue Shield to prevent insurance payments for chiropractic services:

CHIROPRACTIC COVERAGE UNDER BLUE SHIELD - [AMA] Staff will continue to maintain liaison with the National Association of Blue Shield Plans in regard to chiropractic attempts to gain coverage under Blue Shield. (NOTE: A productive meeting was held with representatives of Blue Shield on this point. They are actively considering various methods of excluding doctors of chiropractic from Blue Shield coverage.)

(Exhibit D, attached hereto, emphasis added.); and

1. We [Blue Shield] have filed and may use in 6 states an exclusion deleting manipulative services and subluxations for the purpose of removing nerve interference. Basically, the exclusion extends to services of a chiropractor by definition.

(Exhibit E, attached hereto, emphasis added.); and

Resistance to chiropractic payment may be indicated by the fact that fewer [Blue Shield]Plans make payment than the laws require.

(Exhibit F, attached hereto).

19. In 1977, the Health Care Financing Administration ("HCFA") was established under HHS to administer the Medicare and Medicaid programs.

20. Pursuant to 42 U.S.C. § 1395u, the Secretary of HHS is authorized to enter into contracts with private health insurance carriers to administer and pay claims for health care services rendered to Medicare patients. HHS has exercised its authority under 1395u by entering into contracts with private insurance carriers through the HCFA. The Medicare Part B program is administered nationwide by a network of private insurance carriers operating under such contracts. Under the "fee-for-service" Medicare Part B system, Medicare patients in need of chiropractic services have had varying degrees of success in obtaining those services.

21. In addition to the Medicare Part B system, in 1982 Congress established, pursuant to 42 U.S.C § 1395mm, a "managed care" Medicare HMO system. Under the Medicare HMO system, a Medicare patient may receive benefits through a private health insurance carrier's Medicare HMO plan. Congress directed that all benefits provided under the Medicare Part B system were to be provided to all patients enrolled in any Medicare HMO plan.

22. Since the implementation of Medicare HMO plans, many Medicare patients have been denied access to chiropractic services by Medicare HMO carriers. Medicare HMO carriers, which are largely operated and/or influenced by medical doctors, wrongly asserted that, medical physicians, osteopathic physicians or, even, physical therapists could be substituted for chiropractors to provide "manual manipulation of the spine (to correct a subluxation demonstrated by X-ray to exist)", a service that is unique to chiropractic. Furthermore, many Medicare HMO carriers use medical doctors as "gatekeepers" to screen patients before referring them to another practitioner. These "gatekeeper" physicians are, as a result of the illegal AMA conspiracy, largely biased against chiropractors and, in any event, have insufficient training to determine when a patient is in need of chiropractic services. These actions are contrary to 42 U.S.C. §1395x(r). Recently, Harvard Medical School advertised a seminar on alternative care as follows:

Alternative (a.k.a. "complementary," "integrative") medical therapies encompass a broad spectrum of practices and beliefs. Functionally defined, these are medical interventions neither taught widely in U.S. medical schools nor generally available in U.S. hospitals. Examples include chiropractic, acupuncture, homeopathy, massage and herbal therapies.

(Exhibit G, attached hereto.)

23. As a result of the actions of Medicare HMO carriers and their gatekeepers, and paralleling the AMA's conspiracy to contain and eliminate chiropractic, Medicare HMO patients were denied the Congressionally mandated chiropractic benefit of "manual manipulation of the spine (to correct a subluxation demonstrated by X-ray to exist)."

24. On October 2, 1990, Senator George Mitchell of Maine wrote to Louis Sullivan, then the acting Secretary of HHS:

I am writing to express my concern about Medicare coverage for manual manipulation of the spine to correct a subluxation for beneficiaries enrolled in Health Maintenance Organizations (HMOs) and Competitive Medical Plans (CMPs).

The only service of chiropractors recognized as a physician service under Medicare is the manual manipulation of the spine to correct subluxation. All Medicare beneficiaries, including those enrolled in managed care, are entitled to this benefit. I am concerned about reports which indicate that these benefits may not be available to beneficiaries enrolled in certain HMOs and CMPs.

I would like HCFA to clarify its position on this matter with regard to a beneficiary's right to receive this treatment in HMOs and CMPs. I would also be interested in any information HCFA may have which would support the contention by chiropractors that beneficiaries are denied this procedure in some managed care plans under Medicare contract.

If we are to encourage expansion of Medicare enrollment in managed care plans we must assure beneficiaries that all covered services will be made available to them.

(Exhibit H, attached hereto, emphasis added).

25. On November 5, 1990, Congress passed a law as a part of the Omnibus Budget Reconciliation Act of 1990 requiring the Secretary of HHS to conduct a study of the extent to which Medicare HMO's were providing chiropractic services to Medicare patients. This law, Pub. L. 101-508, § 4204(f), 104 Stat. 1388, 112 (1990) states:

Study of Chiropractic Services

(1) The Secretary shall conduct a study of the extent to which health maintenance organizations with contracts under section 1876 of the Social Security Act make available to enrollees entitled to benefits under title XVIII of such Act chiropractic services that are covered under such title.

(2) The study shall examine the arrangements under which such services are made available and the types of practitioners furnishing such services to such enrollees.

(3) The study shall be based on contracts entered into or renewed on or after January 1, 1991, and before January 1, 1993.

(4) The Secretary shall issue a final report to the Committees on Ways and Means and Energy and Commerce of the House of Representatives and the Committee on Finance of the Senate on the results of the study not later than January 1, 1993. The report shall include recommendations with respect to any legislative and regulatory changes that the Secretary determines are necessary to ensure access to such services.

(Exhibit I, attached hereto, emphasis added).

26. On April 17, 1991, Senator Mitchell again wrote to HHS regarding the mandated study of chiropractic services under Medicare HMO plans:

At my request, the Omnibus Budget Reconciliation Act of 1990 directed the Secretary of HHS to study the extent to which chiropractic services are provided to enrollees by contracted HMO Medicare Plans.

The American Chiropractic Association has met with Mr. Edmund Moy, with the Office of Prepaid Health Care, to express their concern about the design of the HMO study, and to clarify the goals of the study.

It is my hope that HCFA, specifically the Office of Prepaid Health care, will take into consideration the suggestions made by the American Chiropractic Association in designing and implementing this study. It is important that Medicare beneficiaries have access to the full range of benefits to which they are entitled, whether they receive benefits in a fee-for-service model or a managed care model.

(Exhibit J, attached hereto, emphasis added.)

27. On May 2, 1991, the ACA wrote to HHS, concerning the design of the mandated study of chiropractic services under HMO Medicare plans stating:

Consequently, you will realize that the study mandated by the Omnibus Budget Reconciliation Act of 1990, if it is to be effective and meaningful, must be designed to determine if the nation's HMO enrollees are receiving 'manual manipulation of the spine to correct a subluxation as demonstrated by x-ray to exist,' i.e., spinal adjusting, at the skill level (and necessarily for the stated purposes) possessed by doctors of chiropractic or those trained like chiropractors.

(Exhibit K, attached hereto, emphasis added.)

28. On June 10, 1991, HHS wrote back to the ACA stating:

Work is under way on the study of chiropractic services in HMOs and CMPs mandated by OBRA 90. This study is due to Congress on January 1, 1993. Your considerations will be considered as we proceed.

(Exhibit L, attached hereto, emphasis added.)

29. On October 2, 1991, Senator Strom Thurmond of South Carolina made the following statement regarding chiropractic care in the Congressional record (reported at 137 Cong. Rec. S14124-02 (1991)):

On September 23, Time magazine published an extensive article about the revolution in health care, concentrating specifically on the increasing acceptance of chiropractic as an alternative treatment for some conditions.

The Time article referred to a new body of research which is validating the effectiveness of chiropractic care in treating various complaints - especially low back pain, one of the most common and costly reasons for job absenteeism in the Nation. The article stresses the fact that the chiropractic profession - is daily gaining more respect from practitioners of traditional medicine.

I ask unanimous consent that the article in Time, entitled "Is There a Method to Manipulation?," be included in the record following my remarks.

(Exhibit M, attached hereto.)

30. On information and belief, the Secretary of HHS did not issue a report on chiropractic services to Congress on January 1, 1993.

31. On September 24, 1993, Senator Tom Daschle of South Dakota made the following statement regarding chiropractic care in the Congressional record (reported at 139 Cong. Rec. S12251-05 (1993)):

Mr. President, I recently received a copy of a report funded by the Ontario Ministry of Health entitled "The Effectiveness and Cost-Effectiveness of Chiropractic Management of Low-Back Pain." This report concludes that chiropractic care provided by qualified professionals is safe and effective. In addition, it suggests that, for certain diagnoses, chiropractors often provide high quality care at a lower cost than physicians. I am intrigued by the results of this report and commend it to my colleagues' attention as we continue our efforts to reform our health care system.

(Exhibit N, attached hereto.)

32. Also on September 24, 1993, the following appeared in a Conference Report H.R. 103-256 on Bill 2403 (reported at 139 Cong. Rec. H6983-01, 6992 (1993)):

OPM Study of Chiropractic Services

The conferees are concerned that the Office of Personnel Management has failed to proceed with a study, as directed in last year's bill, on how chiropractic services for treatment of back pain in federal employees could reduce cost in the Federal Employees Health Benefits Program. The conferees direct OPM to proceed with this important study.

(Exhibit O, attached hereto, emphasis added.) (The OPM study referenced here is not the "study" at issue in this complaint. The OPM study reference is included only to demonstrate the reluctance of the agencies of the Executive to carry out studies involving chiropractic services as mandated by Congress.)

33. On September 16, 1994, the ACA wrote to HCFA regarding its concern over the improper limitation of coverage of chiropractic services by a particular Medicare HMO carrier acting under the constraints of a medical physician's attitude toward chiropractic. While this Medicare HMO carrier, Kaiser Permanente of California, purported to offer "chiropractic services" to its Medicare HMO patients, the following statements were made in its marketing material:

Medicare covers manual manipulation of the spine for subluxation that is demonstrated by physician read x-ray. It is extremely rare for physicians to make a diagnosis of subluxation as the cause of back discomfort.

(Exhibit P, attached hereto, emphasis added.) (The "physicians" referred to are medical physicians, not doctors of chiropractic who are extensively trained to diagnose subluxations.)

34. On October 31, 1994, Congress reaffirmed its request to HHS for a report on the study of chiropractic services under HMO Medicare plans by amending Pub. L. 101-508, § 4204(f), 104 Stat. 1388, 112 (1990) to delete the requirement for a ³final² report. Pub. L. 101-508, § 4204(f), 104 Stat. 1388, 112 as amended by Pub. L. No. 103-432, §157, 108 Stat. 4398, 4442 (1994) now reads:

Study of Chiropractic Services

(1) The Secretary shall conduct a study of the extent to which health maintenance organizations with contracts under section 1876 of the Social Security Act [this section] make available to enrollees entitled to benefits under title XVIII of such Act [this subchapter] chiropractic services that are covered under such title [this subchapter].

(2) The study shall examine the arrangements under which such services are made available and the types of practitioners furnishing such services to such enrollees.

(3) The study shall be based on contracts entered into or renewed on or after January 1, 1991, and before January 1, 1993.

(4) The Secretary shall issue a report to the Committees on Ways and Means and Energy and Commerce of the House of Representatives and the Committee on Finance of the Senate on the results of the study not later than January 1, 1993. The report shall include recommendations with respect to any legislative and regulatory changes that the Secretary determines are necessary to ensure access to such services.

(Exhibit Q, attached hereto.)

35. On December 14, 1994, HHS and HCFA, without submitting the study mandated by Congress, issued a policy letter (Operational Policy Letter #23) stating:

MANUAL MANIPULATION OF THE SPINE - MEDICARE COVERAGE

Operational Policy Question:

Which practitioners are authorized by law to perform manual manipulation of the spine [not the full definition of the chiropractic benefit] as a Medicare-covered service?

Answer:

Section 1861(r) [42 U.S.C. § 1395x(r)] provides the definition of a physician for Medicare coverage purposes, which includes a chiropractor for treatment of manual manipulation of the spine to correct a subluxation demonstrated by x-ray [this is the chiropractic benefit defined by 42 U.S.C. § 1395x(r)]. The statute specifically references manual manipulation of the spine to correct a subluxation demonstrated by x-ray as a physician service. Thus, managed care plans may use physicians to perform this service.

Managed care plans contracting with Medicare are not required, however, to offer services of chiropractors, but may use other physicians to perform this service. In addition, managed care plans may offer manual manipulation of the spine as performed by non-physician practitioners, such as physical therapists, if allowed under applicable law.

(Exhibit R, attached hereto, emphasis added.)

36. Medical physicians, osteopathic physicians and physical therapists do not provide chiropractic services, e.g., the State of Washington specifically recognizes the fact, well known by Congress:

[RCW] 18.71.001. Definition of practice of medicine - Engaging in practice of chiropractic prohibited, when

A person is practicing medicine if he does one or more of the following:

• • • • •

Provided however, that a person licensed under this chapter shall not engage in the practice of chiropractic as defined in RCW 18.25.005.

(Exhibit S, attached hereto.)

37. On October 27, 1995, Senator Orrin Hatch of Utah made the following statement regarding chiropractic (reported at 141 Cong. Rec. S16067-01, at 16079-80 (daily ed. October 27, 1995)):

During consideration of the reconciliation bill in the Finance Committee, I offered an amendment to allow chiropractors to practice their profession under Medicare to the full extent of the scope of practice permitted under State law. The Committee agreed to accept this amendment subject to working out the press of business, it has not yet been possible to complete the task of fine tuning a mechanism that would achieve this goal without significantly increasing the cost to the Medicare program.

This is unfortunate because I believe that the time is ripe to discard the antiquated restrictions on chiropractors that permeate current law. Today chiropractic is recognized by the medical profession, and, indeed, a recent government report concluded that chiropractic treatment is among the most effective for the treatment of certain type of ailments. Many of us in this Chamber did not need a government study to tell us what we already know.

• • • •

[C]hiropractors should be allowed to be reimbursed under Medicare as long as the service they provide is an existing covered service, and that they are operating within the scope of their license as defined by State law.

(Exhibit T, attached hereto, emphasis added.)

38. On June 24, 1997, Senator Hatch made the following statement regarding chiropractic (reported at 143 Cong. Rec. S6120-02, 6159 (daily ed. June 24, 1997)) during a debate on the Balanced Budget Act of 1997:

Chiropractic services are currently provided in the Medicare program; however, the coverage is extremely limited to treatment by means of manual manipulation of the spine. Moreover, current law requires chiropractors to obtain an x-ray before payment will be made even though Medicare will not pay chiropractors to take the x-ray.

I had initially planned to offer an amendment identical to the language in the House Ways and Means Committee that would remove the requirement for x-rays as a condition of coverage and payment of chiropractic services. I would note that this provision also had the support of the Administration and was included in their budget proposal as well.

• • • •

[A]lthough it was included in the Ways and Means bill as I previously mentioned, the Finance Committee spending parameters did not allow for its inclusion principally due to the cost estimate.

Accordingly, I offered an amendment proposing a two-year demonstration project to study the cost effectiveness of removing the x-ray requirement as well as allowing doctors of chiropractic to order and perform x-rays in both a fee for service and managed care setting. ... [T]he committee unanimously approved my amendment.

I was astonished to learn yesterday that, in fact, the CBO scored my amendment at $900 million.... [P]ending [review], the Committee had no choice but to drop my amendment.

I firmly believe that affording greater access to chiropractic services by beneficiaries will not only result in reduced Medicare expenditures but will also reduce the performance of needless surgery to correct back problems.

(Exhibit U, attached hereto.)

39. On August 5, 1997, Congress redefined coverage of chiropractic services under Medicare by amending 42 U.S.C. 1395x(r)(5) to eliminate the requirement that a subluxation being treated by a chiropractor must be "demonstrated by x-ray to exist" in order for it to be a covered service. The amendment is found in the Balanced Budget Act of 1997, Pub. L. 105-33, § 4000, 111 Stat. 270, 444 (1997) and reads:

Sec. 4513. No X-ray required for Chiropractic Services.

(a) In General - Section 1861(r)(5) (42 U.S.C. 1395x(r)(5)) is amended by striking "demonstrated by X-ray to exist". [Please note that the purpose of the manual manipulation was retained, i.e., "to correct a subluxation," a uniquely chiropractic service.]

• • • •

(c) Utilization Guidelines - The Secretary of Health and Human Services shall develop and implement utilization guidelines relating to the coverage of chiropractic services under part B of title XVIII of the Social Security Act in cases in which a subluxation has not been demonstrated by X-ray to exist.

(Exhibit V, attached hereto, emphasis added.)

40. Several times during 1997 and 1998, various individuals, including representatives of the ACA, made inquiry of HHS regarding the study of chiropractic services under HMO Medicare plans mandated by Congress. The ACA was variously told that, while some form of study had been performed, no report had ever been issued to Congress.

Count I - Administrative Procedure Act

41. Plaintiffs repeat the allegations of paragraphs 1-40.

42. The Secretary's failure to complete a study of the scope and method of delivery of chiropractic services under HMO Medicare plans and submit to Congress a report detailing the study violates Pub. L. 101-508, § 4204(f), 104 Stat. 1388, 112 as amended by Pub. L. No. 103-432, §157, 108 Stat. 4398, 4442 (1994).

43. Pursuant to 5 U.S.C. § 706(1), this Court should compel the Secretary to comply with Pub. L. 101-508, § 4204(f), 104 Stat. 1388, 112 as amended by Pub. L. No. 103-432, §157, 108 Stat. 4398, 4442 (1994) by completing the mandated study and submitting the required report to Congress forthwith.

Count II - Mandamus

44. Plaintiffs repeat the allegations of paragraphs 1-40.

45. The Secretary owed a duty to the plaintiffs to comply with Pub. L. 101-508, § 4204(f), 104 Stat. 1388, 112 as amended by Pub. L. No. 103-432, §157, 108 Stat. 4398, 4442 (1994).

46. Pursuant to 28 U.S.C. § 1361, this Court should compel the Secretary to comply with Pub. L. 101-508, § 4204(f), 104 Stat. 1388, 112 as amended by Pub. L. No. 103-432, §157, 108 Stat. 4398, 4442 (1994) by completing the mandated study and submitting the required report to Congress forthwith.

47. Plaintiffs have no other adequate remedy.

WHEREFORE, plaintiff ACA prays this Court for the following relief:

A. That the Court should compel the Secretary to comply with Pub. L. 101-508, § 4204(f), 104 Stat. 1388, 112 as amended by Pub. L. No. 103-432, §157, 108 Stat. 4398, 4442 (1994) by completing the mandated study and submitting the required report to Congress forthwith;

B. That, pursuant to its equitable jurisdiction, and pendente lite, and in the absence of submission of the study to Congress, the Court should order the Secretary of HHS to refrain from publishing any new regulations, rules, policy statements and/or guidelines, and to correct or rescind any extant regulations, rules, policy statements and/or guidelines which have as their intended purpose any effort to deny Medicare HMO patients the congressionally ordered chiropractic benefit of manual manipulation of the spine to correct a subluxation delivered by a licensed doctor of chiropractic, whether the denial is based (1) on a simple failure to provide the services; (2) on a requirement that a hostile, untrained competitive medical physician make the determination of the need for chiropractic services; or (3) on allowing any and all health care professionals to provide the uniquely chiropractic services.

C. That ACA be awarded its costs and expenses in this action;

D. That the ACA be awarded its attorneys' fees; and

E. That the Court grant ACA such other and further relief as it may deem just and proper.

Respectfully submitted,

 

Date: November 9, 1998

George P. McAndrews
Peter J. McAndrews
McAndrews, Held & Malloy, Ltd. 500 West Madison Street
34th Floor
Chicago, Illinois 60661
 

Thomas R. Daly
American Chiropractic Association
1701 Clarendon Blvd.
Arlington, Virginia 22209

Attorneys for Plaintiff,
American Chiropractic Association



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