Legal Aspects of Building an Age Management Practice

This home-study segment covers selected aspects of practice, unique to age management medicine (AMM). The material assumes you have an understanding of legal requirements for traditional medical practice—and will seek legal counsel, regarding any issues concerning individual practices and legal issues specific to them.

For the purpose of our discussion, let’s first establish a definition for AMM: It is a proactive, preventative approach to healthcare for an aging population, which is focused on preservation of optimum human function and quality of life, making every effort to modulate the process of aging prior to the onset of degenerative aging.

The basic tenets of AMM are patient evaluation through extensive medical history, lifestyle assessment, physical examination and laboratory evaluation to establish personalized proactive treatment plans. These proactive programs consist of proper diet, exercise, stress management and appropriate medical interventions.

Unique aspects of the specialty exists:

AMM is proactive—patients are not necessarily “sick”
AMM has a greater use of dietary supplements and alternative medicines than a traditional reactive practice
AMM seeks balanced hormones, using estrogens, androgens and human growth hormone (“hGH” or “somatatropin”), when GHD has been established

Laws Governing hGH (Somatatropin)

Strict regulations mandate how hGH can be prescribed, manufactured, distributed and sold. Therefore, it is critical for physicians to acknowledge, understand and adhere to these laws.

Food Drug and Cosmetic Act

(FDCA) sanctions the FDA, giving it broad authority to oversee the efficacy and safety of drugs. Two broad categories of offenses exist under the FDCA:

(i) Adulteration and (ii) Misbranding 21 U.S.C. §331

Normally, the FDA does not oversee physicians or the practice of medicine. However, since hGH is highly regulated by the FDA and the Drug Enforcement Administration (DEA), the FDA has been scrutinizing and investigating physicians for acts related to hGH.

Legal Context of Growth Hormone Laws

With a unique status under the FDCA, hGH is the only drug having off-label distribution expressly forbidden. In fact, off-label distribution is a federal felony. And it is the only noncontrolled substance for which the DEA has been granted jurisdiction. DOJ hGH/Steroids Statutory Overview

FDCA: Definition & Prohibited Distribution of hGH

As used in the FDCA, “the term ‘human growth hormone’ means somatrem, somatropin, or an analogue of either of them.”

21 U.S.C. §333(e)(4)

The following prohibitions state distribution parameters:

[W]hoever knowingly distributes, or possesses with intent to distribute, human growth hormone for any use in humans other than the treatment of a disease or other recognized medical condition, where such use has been authorized by the Secretary of Health and Human Services under section 505 and pursuant to the order of a physician, is guilty of an offense punishable by not more than 5 years in prison. 21 U.S.C. §333(e)(1)

Whoever commits any offense set forth in paragraph (1) [illegal distribution of human growth hormone] and such offense involves an individual under 18 years of age is punishable by not more than 10 years imprisonment, such fines as are authorized by title 18, United States Code, or both. 21 U.S.C. §333(e)(2)

It should be noted that hGH is the only noncontrolled substance, which expressly warrants the same penalties as violation of the Federal Controlled Substances Act:

Illegal distribution of hGH is considered a felony violation of the Federal Controlled Substances Act for the purposes of forfeiture. 21 U.S.C. §333(e)(3)

Also, hGH is the only noncontrolled substance over which the DEA has jurisdiction: The Drug Enforcement Administration is authorized to investigate offenses punishable by this subsection. 21 U.S.C. §333(e)(4)& (5)

Prohibited hGH Distribution: Elements of an Offense

Under 21 U.S.C. §333, the elements of the criminal offense are stated as . .

Knowingly
Distributes (or possesses with intent to distribute)
For any use other than
The treatment of a disease or other recognized medical condition, where such use has been authorized by the Secretary of Health and Human Services under section 505 (i.e., and indicated use) and
Pursuant to the order of a physician

An examination of each element gives further insight as to what each part embodies.

Knowingly—the mens rea (guilty mind) or criminal intent. The term "knowingly" or "knew" means a person with respect to information has actual knowledge of the information, or acts in deliberate ignorance or reckless disregard of the truth or falsity of the information. 21 U.S.C. 321(bb)

Distributes (or possesses with intent to distribute)—no definition of “distribute” exists in the statute, but FDA regulations define “distribute” as a means to sell, offer to sell, deliver, or offer to deliver a drug to a recipient, except that the term “distribute” does not include, per 21 U.S.C. § 203.3(h):

Delivering or offering to deliver a drug by a common carrier in the usual course of business as a common carrier; or
Providing of a drug sample to a patient by:
(i) A practitioner licensed to prescribe such drug;
(ii) A health care professional acting at the direction and under the supervision of such a practitioner; or
(iii) The pharmacy of a hospital or of another health care entity that is acting at the direction of such a practitioner and that received such sample in accordance with the act and regulations

For any use other than—the treatment of a disease or other recognized medical condition, where such use has been authorized by the Secretary of Health and Human Services under section 505 (i.e. an indicated use) and pursuant to the order of a physician. The FDA appears to interpret this element to mean no off-label use.

Department of Justice: Prohibited hGH Distribution

The Department of Justice (DOJ) has practical considerations for prosecution.

Since section 333(f)(1) allows physicians to distribute hGH in connection with either (1) “treatment of a disease” or (2) “other recognized medical condition,” which has been authorized by the Secretary of Human Services, additional evidence is necessary to prove that a physician is a drug dealer. Obtaining such evidence can be difficult. Consideration should be given to attempting “controlled buys” using undercover agents or informants.

The DOJ “Practical Considerations” . . .

Often, both search warrants and grand jury subpoenas for the physician’s medical files will be utilized. Of course, in so doing, care must be given to protect the bona fide privacy interests of any legitimate patients the physician might have.

According to the DOJ Civil Resource Manual for Human Growth Hormone and/Steroids there are unanswered questions:

Can the writing of a prescription for hGH be considered distributing?
Considering that §333(e)(1) requires distribution for only FDA approved uses and “pursuant to the order of a physician,” how would this latter phrase be considered when prosecuting a physician who would be the one writing the order?

And with regards to the FDCA and prohibited hGH distribution, this question is unanswered: Can the writing of a prescription for hGH for an off-label use be considered aiding, abetting, conspiring or otherwise assisting with the unlawful distribution of hGH?

FDA Communication About hGH

The following excerpts are from a memo by Mark W. Askine—Regulatory Operations Officer—sent to California Pharmacists Association on August 11, 2005. Mr. Askine worked in the Division of New Drugs and Labeling Compliance, Office of Compliance Center for Drug Evaluation and Research, FDA.

FDA is aware that hGH is increasingly being used by individuals for anti-aging or athletic purposes. Although it appears that many individuals are obtaining hGH for these purposes without help from physicians or other healthcare providers, others obtain hGH prescriptions, or the drug itself, directly from doctors. Some physicians operate or are associated with anti-aging clinics that provide hGH products and heavily promote use of hGH for this purpose.

FDA has a long-standing policy generally not to interfere with the practice of medicine, which includes a physician’s prescription of an FDA-approved drug for an off-label use. However, specific laws apply to hGH . . . Under section 303(e) of the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. § 333(e)), it is a crime to knowingly distribute, or possess with intent to distribute, human growth hormone “for any use in humans other than the treatment of a disease or other recognized medical condition where such use has been authorized [under a new drug application approved by the FDA] and pursuant to the order of a physician.”

This hGH provision . . . does not differentiate between physicians and non-physicians, or between pharmacists and non-pharmacists. Violation of the law is punishable by up to five years in prison, or ten years if the offense involves a minor, and fines (up to $250,000 for an individual or $500,000 for an organization, or twice the gross gain or loss from the offense).

FDA Warning Letter to Genentech

On August 25, 2003, the FDA sent a warning letter to Genentech, Inc. for circulating promotional material, which stated indications for hGH, but failed to mention the risks of somatropin. Although the letter did not accuse Genentech of using hGH for off-label purposes, the FDA opined on the indicated use and diagnostic criteria.

Nutropin and Nutropin AQ are also approved for the replacement of endogenous GH in adult patients with GH deficiency who meet two criteria:

Biochemical diagnosis of adult GH deficiency by means of a subnormal response to a standard growth hormone stimulation test (peak GH < 5 µg/L); and,
Adult-onset patients who have adult GH deficiency either alone or with multiple hormone deficiencies (hypopituitarism) as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma or childhood-onset patients who were GH deficient during childhood, confirmed as an adult before replacement therapy with Nutropin is started.

Manufacturer’s Prescribing Information: Indicated Uses for Adults

Humatrope (Lilly)

Adult Patients—Humatrope is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria:

Adult Onset: Patients who have growth hormone deficiency either alone or with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation, therapy or trauma.
Childhood Onset: Patients who were growth hormone-deficient during childhood who have growth hormone deficiency confirmed as an adult before replacement therapy with Humatrope is started.

Nutropin (Genentech)

Adult Patients—Nutropin® [somatropin (rDNA origin) for injection] is indicated for the replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria:

Adult Onset: Patients who have adult growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or
Childhood Onset: Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.

In general, confirmation of the diagnosis of adult growth hormone deficiency in both groups usually requires an appropriate growth hormone stimulation test. However, confirmatory growth hormone stimulation testing may not be required in patients with congenital/genetic growth hormone deficiency or multiple pituitary hormone deficiencies due to organic disease.

Saizen (Serono)

Adult Patients—Saizen is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria:

Adult Onset: Patients who have growth hormone deficiency either alone, or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or
Childhood Onset: Patients who were growth hormone deficient during childhood who have growth hormone deficiency confirmed as an adult before replacement therapy with Saizen is started. In both of these patient populations, growth hormone deficiency should be confirmed by an appropriate growth hormone stimulation test.

FDA Enforcement Actions

The FDA enforces its aggressive initiative to “improve the health of consumers by providing them with scientifically accurate, FDA-approved information about the health effects of foods and dietary supplements” as well as expose “false health claims that mislead Americans, endanger their health” fighting against “false and misleading health claims on all regulated products.”

Cases in point . . .

A physician in Reno, Nevada, indicted for allegedly selling hGH. Below are the allegations against him:

The physician sold “Bio-tropin” to an FDA agent who said he previously had a tumor removed from his lung and that he did not feel like he was 25 years old any more

Bio-tropin was labeled in English and Hebrew
The advertisement listed hGH as part of treatment to reverse the effects of aging

Indictment in United States v. Forsythe (number 03:06:CR147-BES-VPC) U.S. Dist. Court for Nevada

DOJ Press Release from U.S. Attorney, District of Nevada

Read the DOJ Press Release from U.S. Attorney, District of Nevada.

The owner of Genapharm, Inc. pled guilty to criminal charges for counterfeiting hGH and for selling drugs directly to consumers including counterfeit Nutropin AQ.

On February 18, 2004, the FDA issued a warning letter to Tony Stires at Global Internet Alliance for selling “T-10 hGH” for anti-aging. The alleged anti-aging claims in the letter included . . .

hGH restores muscle mass
hGH decreases body fat
hGH increases sexual function
hGH thickens the skin, reducing wrinkles
hGH restores lost hair
hGH improves cholesterol profile
hGH improves vision
hGH improves memory; and
hGH elevates mood and improves sleep

The FDA also issued a warning letter to Cocoon Nutrition for selling “GH-Liquid Spray Growth-600 ng (growth hormone)” over the Internet.

Also, the FDA issued a warning to “AffordableHGH.com” for selling hGH and making statements that “fountain of youth flows from needle” and “human growth hormone therapy is one of the most promising anti-aging treatments.”

Focus of FDA Investigations

Rising political pressures resulting from scandals in sports have led to more investigations for hGH. The factors appearing to be relevant for FDA prosecutions:

The person prosecuted sells or assists in selling hGH
Most patients who ask for hGH obtain a prescription or the drug directly
There is little if any documentation of exams, labs and other medical records
hGH is sold without a prescription
Clear wrongdoing that makes it easy to obtain a conviction from a jury

Only FDA Approved hGH Products Should be Prescribed

Although physicians do not generally dispense drugs, they play a role in making sure the proper products are dispensed. If physicians sell hGH—which is an ill-advised and risky practice—they should only sell FDA approved products.

The Orange Book

The only lawful US products are listed in the Orange Book—Food And Drug Administration Center for Drug Evaluation and Research Approved Drug Products with Therapeutic Equivalents. The Orange Book lists the name of the “applicant” that filed the new drug application, not necessarily the company selling the product. There may be a difference between the names on this chart and the entity marketing the products.

Nutropin (Genenteh)
Humatrope (Lily)
Norditropin (Novo Nordisk)
Genotropin (Pharmacia Upjohn)
Omnitrope (Sandoz)
Tev-Tropin (Ferring/Teva)
Serostim (Serono)
Saizen (Serono)
Zorbtive (Serono)

There are no generic forms of hGH are available.

“A” products in the Orange Book are those for which actual or potential bioequivalence problems have been resolved with adequate in vivo and/or in vitro evidence supporting bioequivalence
“B” products in the Orange Book are those the FDA considers not to be therapeutically equivalent to other pharmaceutically equivalent products

The hGH products listed in the Orange Book are all “B” drugs, which means the FDA considers them not to be therapeutically equivalent to other pharmaceutically equivalent products. State laws only permit substitution of drugs listed as “A” drugs in the Orange Book.

NOTE: Write prescriptions “Dispense as Written” to ensure no substitution of “generic.”

Know The Risks: Prescribing hGH from Unregistered Facility

If a physician has reason to believe an hGH product dispensed by a pharmacy comes from an unregistered facility, the physician faces additional legal risk, including potential malpractice risk if the product is contaminated.

Even if a physician monitors hGH levels and finds them to be acceptable, a product from an unregistered manufacturer may contain undetected contaminants. The fact is hGH is one of the most frequently compounds seized by customs—hGH products from China and Australia have been seized and placed on the FDA/customs import detention list because they are unapproved drugs.

The risks are clear and far-reaching . . .

Potential AMA Code of Ethics violation
AMA Code of Medical Ethics states that a physician places the safety and interests of patients above all other interests. AMA Code of Medical Ethics (1998 AMA Doc. #1, p.5 §8.03)

A physician has a duty to obtain informed consent and a duty to warn about risks associated with medication or treatments. AMA Code of Ethics §8.08

A physician should not refer a patient unless the physician is confident the services provide will be performed competently and in accordance with scientific and legal standards. AMA Code of Ethics at §3.04
AMA Code of Ethics considerations
If a physician is prescribing hGH from pharmacies that do not dispense FDA approved products, the physician could violate the Code of Ethics unless the patient is warned that (1) the product may come from foreign countries and (2) may not be manufactured in accordance with FDA standards.
Violation of AMA Code of Ethics could lead to (1) additional evidence of negligence in a malpractice claim arising from contaminated hGH; (2) grounds for disciplinary action by state licensing board.

Compliance: Steps to take

Do not prescribe for anti-aging or for any other off-label use
Do not sell hGH—let patients buy hGH from a licensed pharmacy
Prescribe hGH that is FDA approved
Conduct thorough history and physical examination and order appropriate lab tests
Document all signs, symptoms, and test results that form the clinical basis for the diagnosis of GHD
Conduct thorough follow up
Do not prescribe to athletes

Prescribing Testosterone: Controlled Substances Acts

Both state and federal laws apply and must be followed. Individuals who prescribe or dispenses controlled substances must have two registrations.

A federal registration issued by the DEA: Recent change to DEA regulations requires physicians who prescribe from offices in more than one state to obtain separate DEA registrations for each state.

A state registration or license: The state license might simply be a license to practice medicine or separate state controlled substances license.

Federal Law: Prescribing Testosterone

The 1990 Anabolic Steroids Control Act classified anabolic steroids as Schedule III. Then in 2004, Congress amended the Act in light of the ongoing issues surrounding professional athletes. The 2004 Act directed the United States Sentencing Commission to reevaluate the criminal sentencing guidelines for illegal use of anabolic steroids.

Subsequently, the Steroids Working Group of the United States Sentencing Commission issued the 2006 Steroids Report, which provides details of the law governing steroids

Anabolic steroids, including testosterone and some 50 related compounds, are classified as Schedule III controlled substances. 21 USC § 802

DEA regulations mandate that controlled substances be issued for a “legitimate medical purpose.” 21 CFR § 1306.04

Additionally, if a prescription is not for a legitimate medical purpose, the prescriber is subject to the criminal penalties under the Controlled Substances Act.

The key question for prescribers is: What does “legitimate medical purpose” mean? Courts interpret the meaning of “legitimate medical purpose in this way: When

a law and implementing regulations do not specifically define terms, they should be given their “ordinary meaning.” e.g., Asgrow Seed Co. v. Winterboer, 513 U.S. 179, 187 (1995)

The US Supreme Court unanimously held that physicians violate the Controlled Substances Act “when their activities fall outside the usual course of professional practice.” United States v. Moore, 423 U.S. 122 (1975)

A recent US Supreme Court decision indicates a state standard applies to determining whether a CS prescription is for a legitimate medical purpose.

Gonzales v. Oregon. The Bush administration asserted that Oregon’s Death with Dignity Act violated the federal CSA because using drugs to end life cannot be a legitimate medical purpose.

In Gonzales v. Oregon, the Court concluded the CSA does not allow the

Attorney General to prohibit doctors from prescribing regulated drugs for use in physician-assisted suicide under state law permitting the procedure.

In a 2004 case, the Supreme Court reiterated the fact that the regulating the practice of medicine is left to the states. “The statute and our case law amply support the conclusion that Congress regulates medical practice insofar as it bars doctors form using their prescription-writing powers as a means to engage in illicit drug dealing and trafficking as conventionally understood. Beyond this, however, the [CSA] statute manifests no intent to regulate the practice of medicine generally.” Gonzales v. Raich

State Law: Prescribing Testosterone

Some states regulate anabolic steroids more strictly than the federal CSA. Physicians must consult with legal counsel who understands the interplay between federal and state laws and who understands where laws regulating steroids and hGH can be found.

Here are some examples:

Utah law states that a license can be sanctioned by prescribing “anabolic steroids for the purpose of manipulating human hormonal structure so as to (A) increase muscle mass, strength or weight without medical necessity and without a written prescription by any practitioner in the course of professional practice; or (B) improve performance in any form of human exercise, sport or game.” Utah Code Ann. § 58-37-6(4) (a)(viii)

Oklahoma law states: “A valid medical purpose for the use of anabolic steroids or human growth hormones shall not include bodybuilding, muscle enhancement or increasing muscle bulk or strength of a person who is in good health . . .”

Violation of this section is a felony punishable by three years imprisonment in the State Penitentiary. 63 Okl. St. § 2-312.1

Compliance: Steps to Laws Governing Testosterone

Here are the prime points of focus:

Obtain all state and federal licenses and registration and keep them current
Know the red flags: In an AMM practice, where patients are likely to be middle aged or older, prescribing testosterone for young individuals will raise a red flag
DO NOT PRESCRIBE TESTOSTERONE FOR ATHLETES
Conduct a thorough physical and tests and prescribe testosterone only for individuals who manifest clinical signs and symptoms of deficiency

Federal Trade Commission Act: Concerns About Promotions to the Elderly

The directive of the Federal Trade Commission (FTS) is to prevent unfair competition and to protect consumers from unfair or deceptive acts or practices. The FTC has authority to protect consumers by enforcement authority under some 40 statutes. Statutes Enforced by FTC

The Federal Trade Commission Act created the FTC in 1914 and is the primary source of the FTC’s authority. FTC Act at the FTC website 15 U.S.C. §§ 41-45

The FTC has used its authority to take legal action against some who have claimed certain products would stop or reverse the aging process, cause weight loss, increase muscle, regrow hair and remove wrinkles.

A claim or practice is deceptive if:

(i) it is likely to mislead consumers acting reasonably under the circumstances; and

(ii) is material, that is, likely to affect consumers’ conduct or decisions with respect to the product.

A practice is unfair if the injury to consumers it causes or is likely to cause:

(i) is substantial;

(ii) is not outweighed by countervailing benefits to consumers or to competition; and is not reasonably avoidable by consumers themselves. 15 U.S.C § 45(a)

The US Government has conducted several studies to evaluate “anti-aging” products and medical practices. In 2001, the GAO issued a Report to the Chairman, Special Committee on Aging, U.S. Senate: Health Products for Seniors: “Anti-Aging” Products Pose Potential for Physical and Economic Harm

Federal Concerns: “Anti-Aging” Products & Practices

Practitioners engaged in AMM should read the GAO Report to understand what products and practices the government is concerned about.

See also Reisman, N.R., Legal Issues Associated with Current and Future Practice of Anti-Aging Medicine, Journal of Gerontology, vol 59A, 7, 674-681(expressing concern about fraud and FTC prosecution in age management practice).

The GAO report listed “Herbal and Specialty Supplements” with known adverse effects and contraindications. The examples include the following, among many others:

DHEA
Kava Kava
Ginkgo biloba

The GAO Report listed FDA actions against entities marketing products. Some examples include . . .

· Cholestin (“red yeast rice”) imported by Pharmanex and determined to be illegal new drug and not a dietary supplement

· Various products distributed Hillestad^® Pharmaceuticals (e.g., ginkgo biloba and St. John’s wort) contained unlawful disease claims; court ordered company to change the claims in catalogues and on the website

The GAO Report listed FTC actions against companies with illegal advertising. For example . . .

· Action against Maxcell Bioscience, Inc. for making anti-aging claims for “Longevity Signal Formula with DHEA” and for “Anabolic/Catabolic Test;” company was ordered to stop making claims and to pay consumers $150,000

FTC & FDA: Concurrent Jurisdiction

Often the FDA and FTC have overlapping jurisdiction. The FTC investigates drug advertising and dietary supplements.

FTC: FTC Targets Bogus Anti-Aging Claims for Pills and Sprays Promising Human Growth Hormone Benefits ($20 Million Fine).

Two Florida businesses have agreed to a federal court order requiring them to pay up to $20 million in consumer redress—the largest monetary judgment ever obtained in an FTC health fraud case—to settle charges that they deceptively claimed that their pills and sprays would increase consumers’ human growth hormone (hGH) levels and provide anti-aging benefits, including weight loss and increased cognitive function. In addition, the Commission has issued warning letters to more than 90 Internet marketers making similar claims. FTC Press Release June 9, 2005

FTC Press release, January 4, 2007.

“FTC Recovers $25 Million to Settle Allegations of deceptive Marketing for Xenadrine EFX, CortiSlim, TrimSpa, and One-A-Day WeightSmart.”

The FTC’s complaint alleged defendants made false or unsubstantiated claims for rapid and substantial weight loss. The complaint alleged that one study, however, subjects taking product lost an average of only 1.5 pounds over 10 weeks, while a placebo control group lost an average of 2.5 pounds.

State Consumer Protection Laws

Each state has an unfair trade practice act or consumer protection act similar to the FTC Act. These laws, like the FTC Act, are intended to prevent false or misleading claims.

Here are some examples of state claims for unfair trade practices:

· Plaintiff stated a valid claim for deceptive trade practice by alleging in vitro fertilization advertisements contained misrepresentations about success rates. Karlin v. IVF America, 690 N.Y.S.2d 495, 712 N.E.2d 662 (1999)

· Plaintiff stated a claim under consumer protection act when pharmacy advertised a drug interaction detection system that did not catch an error. Arbor Drugs, Inc., 544 N.W.2d 727 (Ct. App. Mich. 1996)

The next potential step: In these types of scenarios, one can imagine a creative attorney crafting a claim for unfair trade practices when a patient doesn’t feel younger after receiving treatment from an AMM clinic.

Federal Concerns: “Anti-Aging” Products & Practices

There are practice implications you need to be cognizant of, such as making sure any products prescribed, sold or recommended are from reliable companies that comply with all laws. For dietary supplements, make sure products are not making therapeutic claims. Also, be certain the dietary supplement actually contains the active ingredient.

To avoid claims of deception, understand the distinction between disease claims and permitted structure function claims. FDA Guidance– Substantiation for Dietary Supplement Claims

Realize that liability risk increases substantially if products not complying with federal and state laws are prescribed. Prevent harm to patients from useless or harmful products.

Risks: Profiting from Labs & Drugs

Read the AMA Principles of Medical Ethics § 8.09:

“Under no circumstances may physicians place their own financial interests above the welfare of their patients. . . . For a physician unnecessarily to . . . prescribe a drug . . . for the physician’s financial benefit is unethical.”

Violations of ethical standards can lead to disciplinary actions by medical licensing boards or civil penalties. In Utah, it is considered unprofessional conduct to violate “any generally accepted professional or ethical standard applicable to an occupation or profession.” Utah Code Ann. § 58-1-501(2)(b)

New York defines professional misconduct as:

“Exercising undue influence on the patient, including the promotion of the sale of services, goods, appliances, or drugs in such manner as to exploit the patient for the financial gain of the licensee or of a third party.” N.Y. Art. 131-A § 6530(17)

The central theme of these types of laws and the AMA Ethics Code is that exploiting the physician-patient relationship for personal gain is frowned upon. Physicians profiting directly from prescriptions or lab work comes too close to this type of behavior and should avoid such behavior.

It is ill advised for physicians engaged in AMM practices to increase profits by marking up prescriptions or laboratory work. If a physician earns extra money by prescribing and/or dispensing certain drugs, the physician has an incentive to place his or her financial interests above the patient’s welfare. At the least, this arrangement creates the appearance of impropriety.

Addressing Medicare

Typically, AMM practices do not accept insurance or Medicare since many AMM services are not covered. The fact is coverage determinations can be tricky, uncertain and time consuming.

The quandary: How does a physician deal with Medicare patients when the physician accepts Medicare? Medicare does not cover many AMM services; therefore, a physician would bill the patient for such non-covered services.

Many tests and labs are covered by Medicare. These labs might not be covered, if the reason for the labs is related to AMM.

For covered services, a physician must bill Medicare and only collect the applicable co-payment from the patient.

A physician may opt out of Medicare and may then charge the patient for services that would otherwise be covered. By opting out, the physician cannot bill for any Medicare beneficiaries (other than limited circumstances).

For services not covered by Medicare, a physician can provide the services and charge the patient. Program Memorandum (Carriers) HCFA Pub. 60B, Transmittal No. B-97, January 1, 1998

A problem arises when it is unclear whether a service is covered.

If a physician submits a bill for labs that are not covered (because they are for non-covered age management services), there is a risk the bill constitutes a false claim and could trigger a claim under the federal False Claims Act. 31 U.S.C. §3729 et seq

Under the False Claims Act, a provider may have to pay a penalty of $5,500 to $11,000 per claim plus triple damages—the results can be catastrophic. One solution might be for physicians to practice for two clinics. One clinic would accept Medicare and would be able to bill Medicare for covered services, such as treatment of specific diseases. Meanwhile, the other—the AMM clinic—would not accept Medicare (i.e. the clinic and providers who work there would opt out of Medicare).

If a physician chooses the dual clinic option, it’s essential to obtain advice of counsel, regarding the following:

· Must have 2 different tax IDs

· Must be separate legal entity

· Must understand tax consequences

· Must understand CMS’s position to make sure the dual clinic approach is proper under its current interpretation of the law

Other Legal Considerations

Numerous additional elements must be examined, such as risks from failed patient expectations; fraud (misrepresenting results of physical exams and labs to pressure patients into additional therapy); product liability based on selling drugs or endorsing a particular product; agency issues (negligence or claims based on employees and related workers), etc

Reisman, N.R., Legal Issues Associated with Current and Future Practice of Anti-Aging Medicine, Journal of Gerontology, 2004, vol 59A, 7, 674-681