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Between a Rock and a Hard Place: The Doctor's Dilemma and the Law

©Copyright 1999 by Emalee B. Murphy, J.D., USA
(Explore Issue: Volume 9, Number 6)

A survey reported in the October 25, 1999 issue of Archives of Internal Medicine (AIM) indicated a willingness by many doctors to lie to third party payers in order to obtain medically necessary care for patients. In fact, according to the survey, many doctors believe that this deception is the lesser of two evils if otherwise a patient would go without treatment. Of 169 internists asked, 57.7% would not object to the use of deception for a patient in need of a coronary artery bypass, although the percentage of doctors who said they would support a colleague's deception of a third party payer to secure coverage varied according to the procedure:

  • Coronary bypass survey (57.7%)
  • Arterial revascularization (56.2%)
  • Intravenous pain medication and nutrition (47.5%)
  • Mammography (34.8%)
  • Psychiatric Referral (32.1%)
  • Cosmetic Rhinoplasty (2.5%).

The same doctors chose as their primary professional responsibility practicing:

  • Within the rules/restrictions of third party payers
  • With strict adherence to those rules to the best of my ability (4.3%)
  • Within the rule/restriction of third party payers as long as those rules do not significantly compromise my patient's interest (8.7%)
  • In a way that equally balances my patient's interests with the rules/restrictions of third party payers (8.7%)
  • As my patient's advocate working within the rules/restriction of third party payers as long as those rules do not significantly compromise my patient's interests (74.5%)
  • As my patient's advocate without regarding the rules/restrictions of third party payers (3.7%).1

 


Two other studies confirmed the AIM results. Nearly half of the doctors polled in a recent Kaiser Family Foundation/Harvard University School of Public Health Survey admitted to exaggerating the severity of a patient's condition in the past two years. A third survey (by the AMA Institute for Ethics) found that 39% of physicians had used deception to obtain better medical coverage for their patients.

Physicians may be advocating a patient's right to medical coverage by these actions; however in doing so, they may be violating one or more laws.

In light of these survey reports, it is not surprising that law enforcement officials have turned their attention toward anti-fraud enforcement activity in the healthcare area. In a speech before the American Law Institute/American Bar Association in Washington, DC, James G. Sheehan, Assistant U.S. Attorney for the Eastern District of Pennsylvania, stated that law enforcement agents are paying attention to upcoding and diagnosis-related group (DRG) upcoding by physicians. According to Sheehan, the Justice Department intends to continue to investigate complaints of provider upcoding and will look at whether services are documented the level billed. In the case of patient DRG classifications (which list the type of conditions suffered by a patient for reimbursement purposes), the government will investigate outliers, that is, those providers who seem to report unusually large numbers of more expensive conditions. In addition, Sheehan mentioned other priorities, including potential fraud in the physician's role as patient advocate, including improper insurance billing for experimental devices and procedures, quality of care issues and monitoring and negotiation relating to compliance, voluntary disclosures and corporate integrity plans.

Sheehan's personal (not official) top nine health fraud issues are:

  1. The relationship between managed care plans and physicians.
  2. The physicians responsibility as an advocate for patients.
  3. Physician upcoding and physician billing for services provided by residents and others.
  4. Experimental device and procedure claims.
  5. Diagnosis related group upcoding.
  6. Third party billing companies.
  7. Prescription drug issues.
  8. Quality of care issues.
  9. Monitoring and negotiation relating to compliance, voluntary disclosure and corporate integrity plans.

Although federal efforts to eliminate insurance fraud, particularly Medicare fraud is not new, several new laws provide the government with additional ways of enforcing against healthcare fraud problems. For example, the Health Insurance Portability and Accountability Act provided additional funds to the government to use in its fight against fraud by nearly doubled the number of Office of Inspector General (OIG) auditors and investigators. It also expanded the Federal Bureau of Investigation's ability to investigate healthcare fraud. In addition, the law created the Medicare Integrity Program that permits the Department of Health and Human Services to enter into contracts with private entities to review and audit activities covered by Medicare. The law also allows the Office of Inspector General to keep part of the recovery realized from its activities and uses it to fund OIG activities, which makes enforcement in this area particularly attractive.

Investigators are also using the False Claims Act (FCA) which prohibits making false statements to government entities. For example, the Act authorizes the government to impose civil liability on any person or entity submitting a false or fraudulent claim for payment. Violators must repay three times the amount of damages suffered by the government, plus a mandatory civil penalty of at least $5,000 and no more than $10,000 per claim. Again, the FCA permits whistle blowers under the Act to bring suits on behalf of the government and to share in the damages recovered (False Claims Act Qui Tam lawsuits--whistle blower lawsuits). Criminal penalties may be imposed if the healthcare provider "knowingly and willingly" defrauded Medicare, Medicaid, or any other federal healthcare benefits program. Once a claim has been determined to have been submitted fraudulently, the government may imprison the offending individual for up to five years, impose a fine for up to $250,000 per claim and exclude the healthcare provider from participating in Medicare and Medicaid programs. The Health and Human Services Department has launched a campaign to encourage individuals covered by Medicare to analyze their physicians' bills and to report suspected instances of Medicare fraud to the government. Again, this is particularly attractive to individuals because if fraud is proven, one-third of the amount is returned to the reporting patient.

Patients under the care of complementary and alternative medicine practitioners are less likely to sue their physicians than are patients under more standard medical practices. According to a report in the Journal of the American Medical Association (November 11, 1998), during the years 1990 to 1996, the rate for chiropractic claims for medical malpractice was 2-3% versus 6-10% for traditional medicine providers. Nevertheless, doctors practicing CAM (Complementary and Alternative Medicine) should take the same precautions as traditional physicians to avoid claims of fraudulent billing practices, as well as malpractice complaints.

First, the physician must be able to show that the service being rendered to a patient is warranted given the patient's condition. For example, has the patient been thoroughly diagnosed and tested, and has that diagnosis and testing been documented in writing? Second, physicians should be able to check when a bill was actually sent and when a service was provided in order to eliminate issues of double billing and services not rendered. Every practice should have a compliance plan, including a training session for billing staff, to minimize potential coding errors and the possibility of upcoding. According to the AMA, the plan should name a person responsible for billing compliance and should include routine in-house checks to be sure that the patient records are complete and accurate and can provide the justification necessary to support claims payment.

To minimize the potential for medical malpractice claims, complementary and alternative medicine practitioners should obtain informed consent agreements from each patient. These agreements spell out the risks and inform the patients that the treatments provided are considered alternative. An informed consent agreement should include: the diagnosis, the test results, the nature and purpose of the treatment, the material risks of the treatment, the prognosis with and without treatment, any physician conflicts of interest, and any conventional methods of diagnosis and treatment a reasonable medical doctor would use.

Of course, this may not prevent state medical board disciplinary proceedings that are also based upon alleged departure from generally accepted medical standards. Unless a state has enacted statutes such as North Carolina's Medical Freedom Act of 1993, state medical boards may still discipline physicians when they disagree with the alternative physician's treatment protocols. Medical Freedom Act statutes also exist in Alaska, Washington, South Dakota, Oklahoma, New York and Oregon, and are intended to prohibit the medical board from revoking a doctor's license solely because the person practices a therapy that is experimental, non-traditional, or that departs from acceptable and prevailing medical practices.

Complementary and alternative medical doctors are also not immune from the general ethical questions confronting the medical profession as a whole. Even former Surgeon General Dr. C. Everett Koop has been forced to defend his relationship with a latex glove manufacturer. According to the New York Times and Reuter's Health Information, Dr. Koop signed a four-year $1,000,000 contract in 1994 with a latex glove manufacturer to act as a spokesperson for the company on health and nutrition. He did not disclose this relationship when he testified before Congress and OSHA in favor of latex gloves and downplayed the potential problems created by latex allergies. Disclosing physician links to drug, device, and supplement manufacturers is even more important if the physician sells these items to patients. The American Neutraceutical Association recently distributed the following set of guidelines to physicians who distribute neutraceuticals to their patients:2

  • Patient care must be exercised with the patient's best interest in mind and with sound medical judgment informed by meaningful and reliable scientific evidence; thus, scientific studies on dietary supplements should be independent, peer reviewed, and published, and controlled studies should support the recommendation of any product to a patient by a physician.
  • In making a recommendation to a patient, a physician must take into account the unique needs of the patient, including his or her precise health condition and the likelihood of success of one recommended modality of care over another.
  • A physician who recommends a particular brand or product when he or she has a financial relationship with its manufacturer, distributor, or marketer should disclose the details of the nature of that relationship with his or her patients. Complete disclosure should be verbal as well as visual through signs in the office and waiting room that acknowledge the relationship and the name of the manufacturer, distributor or marketer.
  • A physician should make every effort to ensure his or her patients do not feel obligated to purchase recommended products. To accomplish this, physicians should, at a minimum, identify the availability of alternative products associated with different manufacturers, distributors or marketers.
  • Physicians should carefully select companies that they represent that have in place Good Manufacturing Practices, independent scientific data that is controlled, peer reviewed and published to support their ingredients and structure/function claims and as much patient support literature as possible.
  • Physicians who choose to become involved with companies that distribute their products through network marketing programs should avoid the direct recruitment of their patients for participation in the network marketing or business opportunities available through these companies.

 

A further instance of required disclosure and transparency is FDA's recently published guideline on financial disclosure by clinical investigators. FDA's proposed Guidance would require that any marketing application for a drug or device disclose any equity interest by an investigator in the sponsor of a covered study, any equity interest in a publicly held company that exceeds $50,000 in value, and significant payments of other sorts (payments that have a cumulative monetary value of $25,000 or more) by the sponsor to the investigator or the investigator's institution. Not only payments made during the course of the study but for one-year following the study's completion, are subject to disclosure under FDA's Guidance document. The regulation underlying the Guidance is intended to address compensation that may be affected by the study outcome. However, other payments, such as bonuses or other incentives to investigators for recruiting subjects, do not, according to the FDA, meet the definition of compensation covered by the Guidance and, therefore, are not reportable under the rule.

Finally, complementary and alternative medical practitioners are, of course, also covered by the Anti-Kickback statutes which make it a criminal offense to knowingly and willfully offer pay, solicit, or receive any remuneration to induce the referral of services or products covered by a federal health program. Unless an arrangement fits within the so-called safe harbor regulations, referring patients to health-related goods or services in which the physician or any member of the physician's family has a financial interest, is prohibited. These include: clinical laboratory, physical therapy, occupational therapy, radiology, radiation therapy, services and supplies, durable medical equipment, parenteral and enteral nutrients, equipment and supplies, prosthetics, orthotics and prosthetic devices, home health services, outpatient, prescription drugs, and inpatient and outpatient hospital services. The financial arrangements that trigger the stature may either be physician or physician family ownership or investment interest in the health service entity or a compensation arrangement between a physician or his family and an entity. Certain exceptions are provided for group practices and for compensation that meets certain bona fide fair market value standards. While the Anti-Kickback statute provides for criminal sanctions, the self-referral prohibitions added to the statute by the so-called Stark Amendments, carry civil penalties for improper referrals.

In conclusion, life is full of legal pitfalls today. A heightened enforcement posture by both federal and state agencies makes it important to know the laws and especially one's rights under the laws. As in most things, the best defense is a combination of (1) awareness--know the law and regulations, (2) planning--have a procedure in place to eliminate potential liabilities, and (3) documentation--if it is not written, it does not exist. *

About the Author

Emalee Murphy, whose experience in FDA-regulated industries spans over 20 years, provides regulatory and enforcement counseling for clients in the drug (prescription and OTC), medical device, dietary supplement, cosmetic, food, and food additive industries, with particular emphasis on market entry issues and strategies for new products and new companies. She is experienced in FDA import and export issues and provides assistance to companies involved in FDA compliance, import detention, and enforcement matters. Ms. Murphy is a member of the Food and Drug Department of McKenna & Cuneo, LLP and practices in the firm's Washington, DC office. She has written and spoken on a variety of FDA related issues, most recently on the international aspects of dietary supplement regulation.

References

  1. Victor G. Freeman, M.D., et al. "Lying for Patients: Physician Deception of Third Party Payers," Archives of Internal Medicine, October 25, 1999.
  2. Rieder, MJ, Physician's Financial News, 17(8): 1, 34,36; 1999.

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