|
|
Hot Topics
for the District of Columbia
Preamble 1. This Amended Complaint alleges that the Department of Health and Human Services ("HHS") acting through its Health Care Financing Administration ("HCFA") has failed to "take care that the laws be faithfully executed" (U.S. Constitution, Article II, Sec. 3) by failing to compel Medicare managed care organizations to provide the chiropractic service of manual manipulation of the spine to correct a subluxation – a Congressionally mandated Medicare service to which all senior citizens eligible for Medicare benefits are entitled. As a direct result of HCFA’s non-feasance and misfeasance, the mandated chiropractic service has been all but eliminated as a benefit for senior citizens in Medicare managed care organizations. 2. The plaintiff, the American Chiropractic Association, Inc. ("ACA"), brings this action, on behalf of its members, doctors of chiropractic, and their patients to force HHS and HCFA to ensure access to chiropractic care by Medicare patients enrolled in a managed care plan, such as a health maintenance organization ("HMO"), competitive medical plan ("CMP") or Medicare + Choice ("M+C") plan, 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 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 rescind any extant regulations, rules, policy statements and/or guidelines which, by purpose or effect, allow any Medicare HMO/CMP or M+C organization to deny to its Medicare enrollees the Congressionally mandated chiropractic benefit of manual manipulation of the spine to correct a subluxation delivered by a licensed doctor of chiropractic. Plaintiff asks this Court to order the Secretary of HHS to issue corrective regulations and policy statements that will ensure access by all Medicare HMO/CMP and M+C organization enrollees to chiropractors for manual manipulation of the spine to correct a subluxation. Finally, plaintiff asks this court to order the Secretary of HHS to cancel any contracts, and refrain from entering into any new contracts, with Medicare HMO/CMP or M+C organizations that do not provide to senior citizens meaningful access to the chiropractic benefit of manual manipulation of the spine to correct a subluxation delivered by a licensed doctor of chiropractic. 3. Chiropractors have long suffered from illegal, anti-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 a nationwide, 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:
***** 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]4. 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 latter 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 actions of HHS complained of here, and the bias demonstrated by HHS, is, on information and belief and historical fact, a result of medical doctors’ strong influence on, and dominating presence within this administrative body. Changes to the Medicare laws have created the need for modifications in HHS’s rules, regulations and policies governing Medicare HMO/CMP and, more recently, M+C plans. HHS has embarked on this rulemaking process without regard to the fact that current Medicare HMO/CMP 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 HMO/CMPs and M+C plans their rightful claim to chiropractic services delivered by licensed doctors of chiropractic.
5. 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. 6. 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. 7. 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. 8. Venue is proper in this judicial district pursuant to 28 U.S.C. § 1391(e) and 5 U.S.C. § 703. 9. 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." 10. 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. 11. Despite the AMA’s illegal efforts, chiropractic ultimately became licensed in all 50 states. 12. 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, and conspiring with, HHS (then the Department of Health, Education and Welfare ("HEW")). 13. 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. 14. 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:
1. 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:
2. As a result of the negative report of the study panel, Congress delayed including chiropractic care in Medicare for five more years. 3. 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:
4. At the time that chiropractors were added to the Medicare program, only chiropractors manually manipulated the spine to correct subluxations. Manual manipulation of the spine to correct a subluxation 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 by senior citizens unhindered by the illegal AMA inspired boycott. 5. 42 U.S.C. § 1395x(r)(5) uses the term "subluxation" in the context of adding chiropractors to the Medicare program. At the time 42 U.S.C. § 1395x(r)(5) was passed, the term "subluxation" as used by chiropractors was unique to chiropractic diagnosis and treatment. At that time, medical and osteopathic doctors did not recognize a chiropractic "subluxation." 6. The chiropractic term "subluxation" denotes both a science and a philosophy of diagnosis and treatment:
7. Medical physicians, osteopathic physicians and physical therapists in 1972 (and yet today) were not qualified by education and training to diagnose spinal subluxations or to perform manual manipulation of the spine to correct a subluxation. To a medical doctor, a spinal "subluxation" connoted a complete dislocation of the spine that is untreatable by manual manipulation. 8. Many states specifically prohibit non-chiropractors from performing chiropractic services. For example the laws of the State of Washington recite: 18.25.005. "Chiropractic" defined (1) Chiropractic is the practice of health care that deals with
the diagnosis or analysis and care or treatment of the vertebral
subluxation complex and its effects, (5) Nothing in this chapter prohibits or restricts any other practitioner of a "health profession" defined in RCW 18.120.020(4) from performing any functions or procedures the practitioner is licensed or permitted to perform, and the term "chiropractic" as defined in this chapter shall not prohibit a practitioner licensed under chapter 18.71 RCW from performing medical procedures, except such procedures shall not include the adjustment by hand of any articulation of the spine. 18.71.011. 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: (4) Uses on cards, books, papers, signs or other written or printed means of giving information to the public, in the conduct of any occupation or profession pertaining to the diagnosis or treatment of human disease or conditions the designation "doctor of medicine", "physician", "surgeon", "m.d." or any combination thereof unless such designation additionally contains the description of another branch of the healing arts for which a person has a license: PROVIDED HOWEVER, That a person licensed under this chapter shall not engage in the practice of chiropractic as defined in RCW 18.25.005. Kansas Attorney General Opinion No. 96-12 (February 20, 1996) states:
The laws of the State of Illinois state:
California Attorney General Opinion No. CV 75-282 (January 21, 1976) states:
9. 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 Medicare HMO/CMP and M+C organizations) to prevent any insurance payments for chiropractic services. For example, AMA staff met with Blue Shield to prevent insurance payments for chiropractic services:
10. In 1977, the Health Care Financing Administration ("HCFA") was established under HHS to administer the Medicare and Medicaid programs. 11. 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 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 may "self-refer" to chiropractors. Fee-for-service patients have had substantial success in obtaining reimbursement for those services. 12. In addition to the Medicare Part B system, in 1982 Congress established, pursuant to 42 U.S.C § 1395mm, a "managed care" Medicare HMO/CMP system. Under the Medicare HMO/CMP system, a Medicare patient may receive benefits through a private health insurance carrier’s Medicare HMO/CMP 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/CMP plan. 42 U.S.C. § 1395mm provides:
(2)
(ii) only those services covered under part B of this subchapter, for those members enrolled only under such part, which are available to individuals residing in the geographic area served by the organization, except that (I) the organization may provide such members with such additional health care services as the members may elect, at their option, to have covered, and (II) in the case of an organization with a risk-sharing contract, the organization may provide such members with such additional health care services as the Secretary may approve. The Secretary shall approve any such additional health care services which the organization proposes to offer to such members, unless the Secretary determines that including such additional services will substantially discourage enrollment by covered individuals with the organization. 13. Since the implementation of Medicare HMO/CMP plans, many Medicare patients have been denied access to chiropractic services by Medicare HMO/CMP organizations. Medicare HMO/CMP organizations, which are largely operated, owned 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/CMP organizations 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 (and well known to HCFA), largely biased against chiropractors, have been trained to boycott them and, in any event, have insufficient training to diagnose a spinal subluxation and/or determine when a patient is in need of chiropractic services. These actions are contrary to 42 U.S.C. §1395x(r). 14. As a result of the actions of Medicare HMO/CMP carriers and their gatekeepers, and paralleling the AMA’s conspiracy to contain and eliminate chiropractic, Medicare HMO/CMP patients were denied the Congressionally mandated chiropractic benefit of "manual manipulation of the spine (to correct a subluxation demonstrated by X-ray to exist)." 15. On October 2, 1990, Senator George Mitchell of Maine wrote to Louis Sullivan, then the acting Secretary of HHS:
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. 16. 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/CMP’s were providing chiropractic services to Medicare patients. This law, Pub. L. 101-508, § 4204(f), 104 Stat. 1388, 112 (1990) states:
(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. 17. On April 17, 1991, Senator Mitchell again wrote to HHS regarding the mandated study of chiropractic services under Medicare HMO/CMP 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. 18. 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)):
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. 19. The Secretary of HHS did not issue a report on chiropractic services to Congress on January 1, 1993. On information and belief, this failure to execute the law was part and parcel of HHS and HCFA’s alliance with medical physicians to continue the oppressive boycott of chiropractors. 20. 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)):
21. 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)):
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. 22. On September 16, 1994, plaintiff ACA wrote to HCFA regarding its concern over the improper limitation of coverage of chiropractic services by a particular Medicare HMO/CMP carrier acting under the constraints of a medical physician’s attitude toward chiropractic. While this Medicare HMO/CMP carrier, Kaiser Permanente of California, purported to offer "chiropractic services" to its Medicare HMO/CMP patients, the following statements were made in its marketing material:
23. On October 31, 1994, Congress reaffirmed its request to HHS for a report on the study of chiropractic services under HMO/CMP Medicare plans by amending Pub. L. 101-508, § 4204(f), 104 Stat. 1388, 112 (1990) to delete the requirement for a "final" 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:
(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. 24. On December 14, 1994, HHS and HCFA issued a policy letter (Operational Policy Letter #23) stating:
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. 25. 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)):
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. 26. As part of the Balanced Budget Act of 1997, Congress established Medicare Part C. Under Medicare Part C, existing Medicare HMO/CMPs will be phased out and replace by M+C managed care plans. The benefits to which a senior citizen is entitled under Medicare Part C are carried over from Medicare Part B:
(1) IN GENERAL.--Except as provided in section 1859(b)(3) for MSA plans, each Medicare+Choice plan shall provide to members enrolled under this part, through providers and other persons that meet the applicable requirements of this title and part A of title XI-- (A) those items and services (other than hospice care) for which benefits are available under parts A and B to individuals residing in the area served by the plan …. 27. 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:
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. 28. 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:
(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. 29. On May 14, 1998, HCFA issued a "solicitation of comments" for a document entitled Quality Improvement System for Managed Care ("QISMC"). QISMC provides that a chiropractor may provide manual manipulation of the spine to treat a subluxation, but that "the organization may instead provide this service through a physician or physical therapist." (Exhibit X, attached hereto, emphasis added.) This statement is directly contrary to law. 30. 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/CMP 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. On information and belief, no report was issued because the results would have confirmed HHS’s non-feasance and misfeasance. 31. On April 12, 1999, HHS submitted a report to Congress entitled "Chiropractic Services In Medicare Managed Care" (the "1999 HHS Report"). On information and belief, the 1999 HHS Report was hastily completed and submitted only as a result of the present lawsuit. A cover letter to the 1999 HHS Report states:
Section 4204(f) of OBRA 90 also directed the Secretary to include in this report "recommendations with respect to any legislative and regulatory changes that the Secretary determines are necessary to ensure access to [chiropractic] services." For the reasons outlined in the report, we are not recommending legislative or regulatory changes to ensure access for Medicare HMO and M+C organization enrollees to Medicare-covered chiropractic services. 32. The 1999 HHS Report did not, as required by 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)), report "the extent to which [Medicare HMO/CMPs] make available to enrollees … chiropractic services." The 1999 HHS Report only reports that all HMO/CMPs claim to provide manual manipulation of the spine to correct a subluxation and the percentage of HMO/CMPs that claim to supply the service through chiropractors, medical doctors, osteopaths, physical therapists or other practitioners. From the data supplied in the 1999 HHS Report, the only information regarding the "extent" of availability of chiropractic services is that the reporting HMO/CMP organizations claim to have made a "chiropractic service" available. The 1999 HHS Report includes absolutely no information regarding whether any patient actually received manual manipulation of the spine to correct a subluxation, the number of patients that received manual manipulation of the spine to correct a subluxation, the number of treatments, or the number of treatments received from any particular practitioner. 33. The 1999 HHS Report does, however, plainly demonstrate that 22% of the surveyed Medicare HMO/CMP organizations do not provide any access to manual manipulation of the spine to correct a subluxation by a licensed doctor of chiropractic. For the 78% that purportedly provide some access to chiropractors for manual manipulation of the spine to correct a subluxation, the 1999 HHS Report states that "the majority also use other practitioners [e.g., orthopedists, osteopaths, physical therapists] to provide services." The 1999 HHS Report provides no data regarding the extent to which chiropractors are being used to provide the service. However, the 1999 HHS Report does state that "none of the plans that utilized chiropractors included them on the staff, group or panel." Furthermore, the 1999 HHS Report recognized that "[d]ata from a study published in the April 1991 American Journal of Public Health indicates that ‘fewer that [sic] 1 percent of the visits [to a chiropractor] were referred from another health care provider.’" The obvious result of having no chiropractor on the Medicare provider organization’s staff, group or panel, in view of the anti-chiropractic and financial bias of other practitioners, is that the actual accessibility of chiropractors will be almost nonexistent. More recent studies by the government, also believed to be prompted by the present lawsuit, serve to prove the above conclusion. 34. A preliminary survey performed by the Inspector General of Medicare HMO/CMPs for the period 1995-1996 entitled "Chiropractic Services Covered by Medicare Managed Care Organizations" was submitted to HCFA on January 13, 1999 (the "OIG Survey"). (Exhibit Z, attached hereto.) The OIG Survey demonstrates that, although 6 to 7 percent of Americans use chiropractors on a regular basis and 4.15 percent of senior citizens, exercising fee-for-service privileges under Medicare, utilize doctors of chiropractic for chiropractic services, Medicare beneficiaries find the availability of chiropractic services reduced 67 percent merely by virtue of being in an HMO/CMP and 87 percent if the Medicare HMO/CMP has a medical or osteopathic physician referral requirement. The following graph was prepared from data in the OIG Survey. 35. The 1999 HHS Report and the OIG Survey, together, show that Medicare patients enrolled in Medicare HMO/CMP programs have been denied access to the Congressionally mandated chiropractic benefit of manual manipulation of the spine to correct a subluxation by a licensed doctor of chiropractic, and that the trend for future M+C managed care programs will be no different. Consequently, potentially tens of millions of tax dollars awarded by HCFA to the defaulting HMO/CMP organizations have been misspent, misappropriated or otherwise diverted from senior citizens in need of chiropractic services. 36. The reason that the chiropractic benefit has all but disappeared from Medicare HMO/CMPs is twofold. First, HHS and HCFA have issued regulations, rules, policy statements and/or guidelines (including Operational Policy Letter #23 and QISMC) that unlawfully allow Medicare HMO/CMP organizations to substitute untrained and unqualified medical physicians and legally disqualified physical therapists for chiropractors. Second, HHS and HCFA have allowed Medicare HMO/CMP organizations to operate with a medical doctor gatekeeper barrier between Medicare patients and chiropractors in spite of the fact that, well known to HHS and HCFA, an anti-chiropractic bias exists within the medical profession and it is generally accepted and recognized (even by HHS) that medical doctors rarely, if ever, refer patients to chiropractors. 37. Plaintiffs repeat the allegations of paragraphs 1-50. 38. The Secretary’s failure to include in the 1999 HHS Report appropriate recommendations to Congress with respect to legislative and regulatory changes that the Secretary determines are necessary to ensure access to chiropractic services 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). 39. The Secretary’s failure to include in the 1999 HHS Report information regarding "the extent to which [Medicare HMO/CMPs] make available to enrollees … chiropractic services" 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). 40. 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). 41. Pursuant to 5 U.S.C. § 706(1) (Administrative Procedure Act) and 28 U.S.C. § 1361 (mandamus), 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 submitting to Congress forthwith a supplemental report that includes: (1) recommended legislative and regulatory changes that will ensure access to chiropractic services provided by licensed doctors of chiropractic and (2) meaningful data collected from Medicare HMO/CMP and M+C plans regarding whether any patient actually received manual manipulation of the spine to correct a subluxation, the number of patients that received manual manipulation of the spine to correct a subluxation, the number of treatments, and the number of treatments received broken down by practitioner. 42. Plaintiffs have no other adequate remedy. 43. Plaintiffs repeat the allegations of paragraphs 1-50. 44. The Medicare laws (including 42 U.S.C. §§ 1395k, 1395u, 1395x(q-s) and 1395mm) require that manual manipulation of the spine to correct a subluxation be available to all Medicare enrollees. 45. The Secretary owes a duty to the plaintiffs to comply with the Medicare laws (including 42 U.S.C. §§ 1395k, 1395u, 1395x(q-s) and 1395mm). 46. In passing 42 U.S.C. § 1395x(r) Congress intended that manual manipulation of the spine to correct a subluxation be provided by chiropractors. 47. A physical therapist is not a "physician" pursuant to 42 U.S.C. § 1395x. 48. Manual manipulation of the spine by a physical therapist is not a Medicare covered service and may not be substituted by a Medicare HMO/CMP or M+C organization for manual manipulation of the spine to correct a subluxation performed by a chiropractor. 49. HHS and HCFA have issued regulations, rules, policy statements and/or guidelines, including Operational Policy Letter #23 and QISMC, which, by purpose or effect, allow Medicare HMO/CMP and M+C organizations to substitute manual manipulation by a physical therapist for manual manipulation of the spine to correct a subluxation by a chiropractor. 50. Pursuant to 5 U.S.C. § 706 and 28 U.S.C. § 1361, this Court should compel the Secretary to rescind any and all regulations, rules, policy statements and/or guidelines, including Operational Policy Letter #23 and QISMC, which, by purpose or effect, allow Medicare HMO/CMP and M+C organizations to substitute manual manipulation of any kind by a physical therapist for manual manipulation of the spine to correct a subluxation by a chiropractor. 51. Pursuant to 5 U.S.C. § 706 and 28 U.S.C. § 1361, this Court should order the Secretary to issue corrective regulations, rules, policy statements and/or guidelines, which unambiguously state that all Medicare HMO/CMP and M+C organizations must offer manual manipulation of the spine to correct a subluxation through a licensed doctor of chiropractic and may not offer this chiropractic service through a physical therapist. 52. Pursuant to 5 U.S.C. § 706 and 28 U.S.C. § 1361, this Court should order the Secretary to cancel any existing contracts, and refrain from entering into any new contracts, with Medicare HMO/CMP and M+C organizations that do not offer manual manipulation of the spine to correct a subluxation through a licensed doctor of chiropractic and/or substitute physical therapists to offer this chiropractic service. 53. Plaintiffs have no other adequate remedy. 54. Plaintiffs repeat the allegations of paragraphs 1-50. 55. The Medicare laws (including 42 U.S.C. §§ 1395k, 1395u, 1395x(q-s) and 1395mm) require that manual manipulation of the spine to correct a subluxation be available to all Medicare enrollees. 56. The Secretary owes a duty to the plaintiffs to comply with the Medicare laws (including 42 U.S.C. §§ 1395k, 1395u, 1395x(q-s) and 1395mm). 57. In passing 42 U.S.C. § 1395x(r) Congress intended that manual manipulation of the spine to correct a subluxation be provided by chiropractors. 58. Medical doctors and osteopaths are generally not educated or trained to perform manual manipulation of the spine to correct a subluxation. 59. Medical doctors and/or osteopaths are specifically precluded by the laws of a number of states from performing chiropractic services such as manual manipulation of the spine to correct a subluxation. 60. HHS and HCFA have issued regulations, rules, policy statements and/or guidelines, including Operational Policy Letter #23 and QISMC, which, by purpose or effect, allow Medicare HMO/CMP and M+C organizations to substitute manual manipulation by medical doctors and/or osteopaths for manual manipulation of the spine to correct a subluxation by a chiropractor. 61. Pursuant to 5 U.S.C. § 706 and 28 U.S.C. § 1361, this Court should compel the Secretary to rescind any and all regulations, rules, policy statements and/or guidelines, including Operational Policy Letter #23 and QISMC, which, by purpose or effect, allow Medicare HMO/CMP and M+C organizations to substitute manual manipulation of any kind by a medical doctor or osteopath for manual manipulation of the spine to correct a subluxation by a chiropractor. 62. Pursuant to 5 U.S.C. § 706 and 28 U.S.C. § 1361, this Court should order the Secretary to issue corrective regulations, rules, policy statements and/or guidelines, which unambiguously state that all Medicare HMO/CMP and M+C organizations must offer manual manipulation of the spine to correct a subluxation through a licensed doctor of chiropractic and may not offer this chiropractic service through a medical doctor or osteopath. 63. Pursuant to 5 U.S.C. § 706 and 28 U.S.C. § 1361, this Court should order the Secretary to cancel any existing contracts, and refrain from entering into any new contracts, with Medicare HMO/CMP and M+C organizations that do not offer manual manipulation of the spine to correct a subluxation through a licensed doctor of chiropractic and/or that substitute medical doctors or osteopaths to offer this chiropractic service. 64. Plaintiffs have no other adequate remedy. 65. Plaintiffs repeat the allegations of paragraphs 1-50. 66. The Medicare laws (including 42 U.S.C. §§ 1395k, 1395u, 1395x(q-s) and 1395mm) require that manual manipulation of the spine to correct a subluxation be available to all Medicare enrollees. 67. The Secretary owes a duty to the plaintiffs to comply with the Medicare laws (including 42 U.S.C. §§ 1395k, 1395u, 1395x(q-s) and 1395mm). 68. In passing 42 U.S.C. § 1395x(r) Congress intended that manual manipulation of the spine to correct a subluxation be provided by chiropractors. 69. Medical doctors, osteopaths, physical therapists and other non-chiropractors are generally not educated or trained to properly diagnose a subluxation and determine when manual manipulation of the spine to correct a subluxation is necessary and desirable. 70. Non-chiropractors are specifically precluded by the laws of a number of states from performing chiropractic services such as manual manipulation of the spine to correct a subluxation. 71. Medical doctor organizations have been found guilty of a nationwide, illegal conspiracy to contain and eliminate the chiropractic profession, through, inter alia, a prohibition on referrals to chiropractors, and many medical doctors, osteopaths, physical therapists and other non-chiropractors continue to hold strong anti-chiropractic biases. 72. Medical doctors, osteopaths, physical therapists and other non-chiropractors rarely, if ever, will diagnose a subluxation or make a referral to a chiropractor due to their lack of education and training, and inherent anti-chiropractic biases. HHS and HCFA are well aware of this fact. 73. A requirement that manual manipulation of the spine to correct a subluxation may only be provided by a chiropractor upon referral by a medical doctor, osteopath, physical, therapist or other non-chiropractor is contrary to the Medicare laws (including 42 U.S.C. §§ 1395k, 1395u, 1395x(q-s) and 1395mm). 74. Pursuant to 5 U.S.C. § 706 and 28 U.S.C. § 1361, this Court should compel the Secretary to rescind any and all regulations, rules, policy statements and/or guidelines, including Operational Policy Letter #23 and QISMC, which, by purpose or effect, allow Medicare HMO/CMP and M+C organizations to require a referral by a medical doctor, osteopath, physical therapist or other non-chiropractor for manual manipulation of the spine to correct a subluxation by a chiropractor. 75. Pursuant to 5 U.S.C. § 706 and 28 U.S.C. § 1361, this Court should order the Secretary to issue corrective regulations, rules, policy statements and/or guidelines, which unambiguously state that all Medicare HMO/CMP and M+C organizations must either allow self-referrals for manual manipulation of the spine to correct a subluxation by a licensed doctor of chiropractic, or must include one or more licensed doctors of chiropractic on the staff, group or panel of the Medicare+Choice organization to operate as the chiropractic gatekeeper(s). 76. Pursuant to 5 U.S.C. § 706 and 28 U.S.C. § 1361, this Court should order the Secretary to cancel any existing contracts, and refrain from entering into any new contracts, with Medicare HMO/CMP and M+C organizations that do not allow self-referrals for manual manipulation of the spine to correct a subluxation by a licensed doctor of chiropractic, or do not include one or more licensed doctors of chiropractic on the staff, group or panel of the HMO/CMP or M+C organization to operate as the chiropractic gatekeepers. 77. Plaintiffs have no other adequate remedy. 78. Plaintiffs repeat the allegations of paragraphs 1-50. 79. Medicare pays Medicare HMO/CMP organizations a monthly predetermined capitated payment for each enrollee for the provision of all Medicare-covered services to the enrollees. 80. Medicare has or will pay M+C organizations a monthly predetermined capitated payment for each enrollee for the provision of all Medicare-covered services to the enrollees. 81. On information and belief, the capitated payments referred to in paragraphs 93 and 94 had to, by law, encompass payments for manual manipulation of the spine to correct a subluxation. 82. The capitated payments for manual manipulation of the spine to correct a subluxation have been misspent, diverted or otherwise misappropriated in that HCFA has refused to and failed to see that its contracting managed care organizations properly accounted for that portion of the capitation grants intended for senior citizen enrollees requiring manual manipulation of the spine to correct a subluxation. 83. HHS and HCFA should be ordered to calculate the amount of the default in the capitation grants and either (1) assess the plans for the misappropriation, default or diversion and designate the same solely for the chiropractic service or (2) withhold the past misappropriated amount from future payments and designate the whole solely for the chiropractic service with appropriate oversight by HCFA. 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 submitting to Congress forthwith a supplemental report that includes: (1) recommended legislative and regulatory changes (including punitive sanctions for non-compliance) that will ensure access to chiropractic services provided by licensed doctors of chiropractic and (2) meaningful data collected from Medicare HMO/CMP and M+C plans regarding whether any patient actually received manual manipulation of the spine to correct a subluxation, the number of patients that received manual manipulation of the spine to correct a subluxation, the number of treatments, and the number of treatments received broken down by practitioner; B. That, pursuant to its equitable jurisdiction, and pendente lite, and in the absence of submission of the above requested supplemental report 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/CMP 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 the Court should compel the Secretary to:
F.That the Court compel the Secretary to report to the Court forthwith on compliance with the requested Orders; G.That ACA be awarded its costs and expenses in this action; H. That the ACA be awarded its attorneys’ fees; and I. That the Court grant ACA such other and further relief as it may deem just and proper. Respectfully submitted, Date: May 18, 1999 ____________________________________ Robert K. Richardson, D.C. Bar No. 287870 Odin, Feldman & Pittleman, P.C. 9302 Lee Highway, Suite 1100 Fairfax, Virginia 22031 (703) 218-2126
____________________________________ George P. McAndrews Peter J. McAndrews McAndrews, Held & Malloy, Ltd. 500 West Madison Street, 34th Floor Chicago, Illinois 60661 (312) 707-8889
____________________________________ Thomas R. Daly American Chiropractic Association 1701 Clarendon Blvd. Arlington, Virginia 22209 (703) 812-0209
Attorneys for Plaintiff, American Chiropractic Association CERTIFICATE OF SERVICE I hereby certify that a true and accurate copy of the foregoing AMENDED COMPLAINT and exhibits was sent by certified mail to: Donna Shalala Secretary of the Department of Health and Human Services 615-F Hubert Humphrey Bldg. 200 Independence Avenue N.W. Washington, D.C. 20201 Janet L Reno Attorney General of the United States Department of Justice Room 5111 10th and Constitution Avenue N.W. Washington, D.C. 20530 Wilma A. Lewis U.S. Attorney for the District of Columbia 555 Fourth Street N.W. Washington, D.C. 20001 on this 18th day of May, 1999.
______________________________________ |
|
| ||
 | ||||||
