(January 25, 2024): Although chelation therapy[1] has played an important role in mainstream medicine for many years,[2] it is still considered by many clinicians and regulators to fall within the category of "Complementary and Alternative Medicine." Proponents of chelation therapy in alternative medicine practices have supported its use in treating Alzheimer’s disease,[3] Parkinson’s disease, multiple sclerosis,[4] autism, and several other medical conditions.[5] One area in particular, cardiovascular disease, has generated considerable interest. Although many conventional medicine practitioners have expressed significant reservations regarding the use of chelation therapy in the treatment of heart disease, many alternative medicine proponents have supported the use chelation agents, such ethylenediaminetetraacetic acid (commonly known as "EDTA"), claiming benefits in treating heart disease.[6] Although chelation therapy has been studied and applied in the treatment of various medical conditions for more than 70 years, the benefits and drawbacks of this treatment regimen are still widely disputed. This article discusses the current reimbursement landscape with respect to chelation therapy and examines the current regulatory risks faced by healthcare providers when promoting chelation therapy.
I. Overview of Chelation Therapy
Chelation chemistry has a long and storied history. Its origins can be traced to the work of Alfred Werner, the father of modern biochemistry. In 1913, Werner received the Nobel Prize for his work which led to the development of chelation, and the process by which metals bind to organic molecules.[7] Chelation therapy was initially used to treat heavy metal poisoning for industrial and environmental exposures. It was first approved by the U.S. Food and Drug Administration (FDA) more than 50 years ago for the treatment of lead poisoning.[8] Since that time, the FDA has repeatedly found that chelation therapy has been inappropriately marketed for the treatment of various diseases and medical conditions. Although proponents of chelation therapy argue that it is a safe, effective way to remove toxic substances from an individual’s body, detractors of this treatment regimen can point to several safety concerns.
How Does Heavy Metal Toxicity Occur?
Chelation therapy is often touted as one way to remove heavy metals from the body. Unfortunately, there are an endless number of ways that an individual may become exposed to toxic levels of heavy metals and other toxins. One of the ways to be exposed to heavy metal toxicity is to work in the petroleum industry. Crude oil contains metals such as Cadmium (Cd), Lead (Pb), Manganese (Mn), Nickel (Ni), and Vanadium (V). Additionally, drilling fluids have been shown to contain additional metals like Chromium (Cr) and Zinc (Zn).[9], [10] Although containment efforts are being made by petroleum producers and refineries, heavy metals and other toxins are often present in the workplace. As these substances leach into the water table and are carried through the air, workers and their families are being exposed to these potentially deadly substances.
How Does Chelation Therapy Work?
Chelation therapy involves the use of compounds that are known to bond to certain substances such as heavy metals and / or other toxins. These compounds are known as "chelators" or "chelating agents". These chelating agents are typically administered subcutaneously (SQ), intramuscularly (IM), or intravenously. Oral administration of chelating agents is also possible but is felt to be less effective. Chelation therapy typically involves weekly intravenous infusion sessions of EDTA. Each infusion session lasts from 30 minutes to several hours. In general, the infused EDTA finds and sticks to heavy metals and minerals in the bloodstream. Once heavy metals are bound with chelating agents, they are naturally excreted from the body.
Can Chelation Therapy be Used to Treat Medical Conditions Other Than Heavy Metal Toxicity?
Simply put, chelation therapy is intended to help detoxify and / or remove harmful substances from an individual’s body. Alternative medicine proponents have long argued that chelation therapy may be beneficial in the treatment of a variety of medical conditions, ranging from heart disease to autism. It is important to note that these proponents aren’t necessarily wrong. For instance, proponents of treating heart disease with chelation therapy have argued that EDTA can "stick to — and remove — calcium found in deposits that clog arteries." [11] Even in the case of heart disease, mixed results have been found in studies conducted over the last 20 years. One of the most frequently cited studies, "The Trial to Assess Chelation Therapy" (TACT) found that:
"Chelation therapy for stable patients with a history of MI showed modest improvement in the reduction of non-fatal cardiovascular events but the results were not significant enough to recommend its routine use and further research may be warranted." [12]
To date, the FDA has not approved chelation therapy for use as a heart disease treatment or for any other medical condition other than heavy metal toxicity.
What Does it Mean to Say That a Particular Chelation Therapy Regimen is FDA Approved?
Before the FDA can approve a drug or biological product, the agency must review the scientific information and clinical findings to make sure that it is safe and effective for its "intended use." [13] For example, the intended use of utilizing chelating agents to address heavy metal toxicity is to help rid the body of heavy metals.
Once the FDA approves a drug, it means that the agency has found that (1) the drug is safe and effective for its intended use, and (2) the benefits of using the drug outweigh the risks as long as the drug is used as intended, according to its approved labeling.
What Chelation Therapy Agents Have Been Approved by the FDA?
When the FDA approves a drug for sale in the United States, the FDA includes a section in the drugs package insert titled "Indications for Use." Simply stated, this section lists the diseases or medical conditions for which the drug was approved by the FDA and designed to treat, prevent, cure or mitigate. The package insert also lists the drug’s target population, dosage, packaging, possible adverse reactions, and information regarding the administration of the drug.
Over the last 70 years, only a handful of chelation therapy agents have been approved for patient medical conditions by the FDA. A brief listing of these approvals, along with the drug’s generic name. is set out below. Please note, this listing may not include any subsequent approvals by the FDA for other indicated uses:
- 1953. EDTA was approved by the FDA in 1953[14] for lowering blood lead levels among both pediatric and adult patients with lead poisoning
- 1968. Deferoxamine[15] was first approved by the FDA for subcutaneous, intramuscular, or intravenous injections to treat acute iron intoxication and chronic iron overload due to transfusion-dependent anemia. Several generic forms of deferoxamine have been approved by the FDA.
- 1991. Succimer[16] was first approved by the FDA under its Orphan Drug Designation authority in 1991 for the treatment of lead poisoning in pediatric patients only.
- 2005. Deferasirox[17] was approved by the FDA in 2005. It is available as a tablet for oral suspension and is indicated for the treatment of chronic iron overload due to blood transfusions in patients ages 2 years and older.
- 2011. Deferiprone[18] is an iron chelator that was approved by the FDA in 2011 for the treatment of patients with transfusional overload due to thalassemia syndromes when another chelation therapy is inadequate. Deferiprone is available in tablet form.
- 2014. In a warning to consumers, the FDA recommended that consumers avoid all products offered over the counter (OTC) for chelation or detoxification. As the warning stated, in part:
"There are no FDA-approved OTC chelation products. FDA-approved chelating agents are available by prescription only and are approved for use in specific indications such as lead poisoning and iron overload."[19]
If a Chelation Therapy Regimen is FDA Approved, Will it be Covered by Medicare and Other Payors?
Great question. Unfortunately, FDA approval and payor coverage are separate determinations. Although all Medicare-covered drugs and biologics have been FDA approved, not all FDA approved drugs and biologics will qualify for coverage and payment by Medicare and / or other payors. Medicare’s coverage of chelation therapy services is discussed in more detail in the following section.
Can a Physician Prescribe Chelation Therapy for an Off-Label Use that is Not FDA Approved for a Particular Use?
While chelation therapy has been approved by the FDA for the treatment and removal of lead and other toxic heavy metals, many providers have applied this regimen in the treatment of various other medical conditions. As the FDA has noted:
"Why might an approved drug be used for an unapproved use?
From the FDA perspective, once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient.
You may be asking yourself why your healthcare provider would want to prescribe a drug to treat a disease or medical condition that the drug is not approved for. One reason is that there might not be an approved drug to treat your disease or medical condition. Another is that you may have tried all approved treatments without seeing any benefits. In situations like these, you and your healthcare provider may talk about using an approved drug for an unapproved use to treat your disease or medical condition." (Emphasis added).[20]
While the FDA may be open to the use of approved drugs in an "off-label" fashion, some physicians have run afoul of State Medical Board regulations and / or law enforcement when they have ordered chelation therapy for an off-label purpose. An overview of these concerns is provided in Section III below.
II. Medicare Coverage of Chelation Therapy Services
Medicare’s coverage of chelation therapy services has been a moving target for more than 20 years. At one point, many of the Medicare Administrative Contractors (MACs) had issued Local Coverage Determination (LCD) guidance covering the provision, coding, and billing of reasonable and necessary chelation therapy services. As of today, we have not been able to locate a single LCD or MAC Article that is currently effective. Moreover, CMS’s website listing of retired LCDs and Articles related to chelation therapy is incomplete.[21] A partial list of the retired LCDs and Articles covering the provision of chelation therapy services is provided below.
Partial List of Retired LCDs and Articles Covering Chelation Therapy
| LCD / Article Number | Purpose of LCD / Article | Active or Retired |
|---|---|---|
| LCD L29098 First Coast Service Options, Inc. |
Chelation Therapy
For the removal of heavy metals from the body as a treatment for heavy metal poisoning or intoxication. |
Retired
LCD L29098: 09/30/15 |
| LCD L33809 First Coast Service Options, Inc. |
Chelation Therapy
For the removal of heavy metals from the body as a treatment for heavy metal poisoning or intoxication. |
Retired
LCD L33809: 08/11/17 |
| LCD L29113 First Coast Service Options, Inc. |
Chelation Therapy
For the removal of heavy metals from the body as a treatment for heavy metal poisoning or intoxication. |
Retired
Retirement Date is Unavailable on CMS Website |
| LCD L26766 TrailBlazer Health Enterprises, Inc. |
Chelation Therapy
Indications. Chelation therapy is the application of chelation techniques for the therapeutic effects of removing unwanted metal ions from the body. Treatment consists of the intravenous administration of chelating agents to promote excretion of the offending metal. Chelation therapy is a service eligible for payment only when performed for the treatment of heavy metal poisoning or secondary hemochromatosis. Chelation therapy performed for any condition other than this will be denied as not medically necessary. |
Retired
Retirement Date is Unavailable on CMS Website |
| LCD L32692 Novitas Solutions, Inc. |
Chelation Therapy
Indications. Chelation therapy is the application of chelation techniques for the therapeutic effects of removing unwanted metal ions from the body. Treatment consists of the intravenous administration of chelating agents to promote excretion of the offending metal. Chelation therapy is a service eligible for payment only when performed for the treatment of heavy metal poisoning or secondary hemochromatosis. Chelation therapy performed for any condition other than this will be denied as not medically necessary. |
Retired
LCD L32692 |
| Article A23306 TrailBlazer Health Enterprises, Inc. |
Chelation Therapy
Reasons for Denial. Chelation endarterectomy is a form of treatment used for the removal of plaque or calcium in the treatment or the prevention of atherosclerosis and is considered by Medicare to be investigational (NDC 20.21 and 20.22). |
Retired
Retirement Date is Unavailable on CMS Website |
What is a "Retired" LCD?
In terms of payment and coverage, when a MAC "retires" an LCD, only those services performed when the LCD was active can be denied by the payor based on the requirements set out in the LCD. In the absence of an applicable LCD or NCD, providers should keep in mind that a payor or program integrity contractor will still audit claims previously covered by an LCD. As one payor noted, "Coverage guidelines revert to whatever national guidelines exist for coverage and medical necessity determinations." [22]
If an LCD is Retired, Should You Give the Guidance Any Weight?
Assuming that a payor has not decided that the services under a retired LCD no longer qualify for coverage, a provider may still argue that the services were medically necessary and qualify for coverage and payment. While a payor is not supposed to deny a claim based on the requirements in a retired LCD, in most instances, it is to the provider’s benefit to consider the guidance set out in a retired LCD. As Noridian has noted:
". . . Most LCDs are not retired because they are incorrect. The guidance in the retired LCD may be helpful in assessing medical necessity. Where providers have adjusted their billing and coding practices to correspond to the guidance in LCDs, they will want to be very careful in departing from these practices just because the LCD is retired." [23] .(Emphasis added)
List of Current NCDs Related to Chelation Therapy Services.
In contrast to LCDs, which are issued by MACs, a "National Coverage Determination" (NCD) is issued by CMS. The process for opening, deciding, and reconsidering NCDs was most recently updated in 2013.[24] As of today, two active NCDs address the use of chelation therapy in the treatment of atherosclerosis. Both NCDs have concluded that EDTA chelation therapy for the treatment or prevention of atherosclerosis is not covered.
| NCD Number | Purpose of NCD | Active or Retired |
|---|---|---|
| Publication No.: 100-3
Manual Sec. No.: NCD 20.21 |
Chelation Therapy for Treatment of Atherosclerosis
The application of chelation therapy using EDTA for the treatment and prevention of atherosclerosis is controversial. EDTA chelation therapy for the treatment or prevention of atherosclerosis is not covered. |
Effective Between:
01/01/66 --This is a longstanding national coverage determination. The effective date of this latest version has not been posted. |
| Publication No.: 100-3
Manual Sec. No.: NCD 20.22.[25] |
Ethylenediamine-Tetra-Acetic (EDTA) Chelation Therapy for Treatment of Atherosclerosis
The use of EDTA as a chelating agent to treat atherosclerosis, arteriosclerosis, calcinosis, or similar generalized condition not listed by the FDA as an approved use is not covered. Any such use of EDTA is considered experimental. |
Effective Between: 01/01/66 --
This is a longstanding national coverage determination. The effective date of this latest version has not been posted. |
III. Enforcement Efforts Involving Chelation Therapy
Regardless of whether you believe that chelation therapy is beneficial or not, healthcare providers must keep in mind that this treatment regimen remains controversial and has consistently drawn the attention of federal and state law enforcement, state licensure boards, and governmental / private payors. Examples of some of the actions taken against chelation therapy providers are discussed below.
State Medical Board Disciplinary Actions
Connecticut. In a Connecticut case, a physician alleged to have used EDTA chelation therapy in the treatment of multiple patients. The physician was also alleged to have treated a patient using Dimercapto Propane Sulphonic Acid (DMPS) as a chelating agent. Upon review, the Connecticut Medical Examining Board (Board) alleged that with respect to the use of EDTA chelation therapy, the physician violated the applicable standard of care in that the physician: (1) used it for conditions for which it was not indicated, (2) used it for diagnoses based on faulty test methodology, (3) used it based on incomplete and / or inaccurate informed consent. With respect to the physician’s use of DMPS, the Board noted that neither the FDA nor the Connecticut Department of Consumer Protection had approved the use of DMPS for any purpose. Based on these allegations, the Board concluded that it had grounds to pursue disciplinary action. This Connecticut case highlights the risks of ordering EDTA for use in an off-label fashion. It also points out the risks of using a drug that has not been approved for any purpose by the FDA (in this case, DMPS).
Texas. In a Texas case, a physician was alleged to have used EDTA chelation therapy in an off-label fashion. While critics may have disagreed with the physician’s use of EDTA chelation therapy in this way, the Texas Medical Board (Board) focused its attention on an advertisement placed by the physician in a Texas newspaper which allegedly touted the benefits of chelation therapy in the treatment of a medical condition that had not been approved by the FDA for this particular use. The Board alleged that the advertisement was misleading. From a review of disciplinary actions taken around the country, this is a recurring issue. This case and others like it highlight the risks of advertising that you provide chelation therapy in the treatment of a medical condition that has not been approved for this particular purpose by the FDA.
Montana. In this case, the Montana Board of Medical Examiners (Board) initiated an investigation of a physician’s use of EDTA chelation therapy in the care of multiple patients. The Board found that there was no demonstrated medical history in the patients treated that would support a diagnosis of heavy metal toxicity. The Board also pointed out that there was no medical basis to support the use of EDTA chelation therapy when treating patients for atherosclerotic heart disease. The Board found that treating patients with EDTA chelation therapy who do not have a proper diagnosis of heavy metal toxicity fell below the standard of care required by the State of Montana. Once again, this case illustrates the need to properly document medical necessity. It also reflects the fact that at least this Board has no tolerance for using chelation therapy in an unapproved fashion (for the treatment of heart disease).
UPIC Audits of Chelation Therapy Services
Unified Program Integrity Contractors (UPICs)[26] are the primary program integrity contractors working on behalf of CMS to ferret out instances of fraud and suspected fraud in the Medicare and Medicaid programs. Unfortunately, even if a healthcare provider is using EDTA chelation therapy for an FDA approved and indicated use, there are many ways a UPIC audit of your chelation therapy claims may result still in an unfavorable finding. First and foremost, auditors will look for evidence that the chelation therapy services were medically necessary and appropriate. Your documentation and verification that the patient suffers from a covered condition is essential. UPIC auditors will also carefully examine the place of service and the qualifications of individuals tasked with infusing the chelating agents. Finally, the auditors will want to know whether you obtained the chelation agents from a qualified compounding pharmacy or whether these chelation agents were bought pre-mixed from a pharmaceutical company. The source of these chelation agents, along with the price you paid for them impacts the reimbursement you can expect. HCPCS codes used in the billing of chelation therapy include the following:
| HCPCS Coding: | |
|---|---|
| J0470 | Injection, dimercaprol, per 100 mg |
| J0600 | Injection, edetate calcium disodium, upto 1000 mg |
| J0895 | Injection, deferoxamine mesylate, 500 mg |
| J3520 | Edetate disodium, per 150 mg (Endrate, EDTA) |
| M0300 | IV Chelation Therapy (chemical endarterectomy) |
Please note that the above HCPCS codes for J0470, J0600, J0895, and J3520 represent the manufactured version of these drugs and do not apply when the chelation agent used by a provider is prepared by a compounding pharmacy.[27] When a chelation agent is compounded, CMS and the MACs generally require providers to use a "Not Otherwise Classified" HCPCS code, which is usually reimbursed based on invoice pricing. We have worked with several providers that have been audited based on the use of J0600 for compounded edetate calcium disodium. Both Medicare contractors and private insurers have focused on this coding issue primarily because the pricing for the manufactured version of this drug is often ten times or more higher than compounded versions. Care should be exercised in selecting the appropriate HCPCS code for billing chelation agents.
False Claims Act Liability.[28]
Georgia. In this case, the government alleged that a Georgia-based internal medicine physician and his practice administered EDTA to address a wide range of conditions, including atherosclerosis, high blood pressure, headaches, GI ailments, fatigue, and other generalized symptoms. As the government alleged, chelation therapy using EDTA is only recognized as a treatment for lead poisoning and lead encephalopathy. The government alleged that the defendant falsely claimed that his patients suffered from heavy metal poisoning, when in fact, the patients lacked lead-related conditions. The government further claimed that the physician owner and his practice unlawfully received approximately $1.1 million in reimbursement from Medicare. When the case proceeded to trial, the jury found that the defendants were guilty of submitting more than 4.000 false claims to Medicare. The jury awarded $1.1 million in damages to the government. Under the law, the presiding Judge was required to award treble damages PLUS penalties for each of the false claims submitted to the government for payment. Ultimately, the Court ordered that defendants pay more than $27 million in damages and penalties.
Georgia. As of the writing of this article, this False Claims Act case is ongoing. The government’s Complaint in this case alleges that a Georgia physician provided medically unnecessary chelation therapy, intravenously administering the chelation drug edetate calcium disodium (EDTA) to Medicare beneficiaries who were not suffering from lead poisoning. The government’s position is that ". . . [c]helation therapy is a rarely used treatment that is generally only indicated for individuals suffering from lead poisoning and other forms of heavy metal poisoning."
Criminal Liability Related to Chelation Therapy
Colorado. In this case, a Colorado chiropractor was indicted by a federal grand jury for allegedly submitting false claims to Medicare. One of the allegations asserted by the government was that the chiropractor instructed staff to describe chelation therapy services performed as intravenous therapy, not as chelation therapy. Employees were also instructed to go through old charts and re-bill insurance using the intravenous therapy codes. For the medical issues involved, chelation therapy was not covered by Medicare. Nevertheless, the chiropractor submitted bills to Medicare indicating that that the clinic had performed a form of intravenous therapy which was covered by Medicare. After a four-week jury trial, the chiropractor was convicted of multiple counts of wire fraud, mail fraud criminal false claims, and money laundering. The chiropractor was sentenced to 5 years on the fraud convictions and 6 years on the money laundering convictions, with the sentences to run concurrently.
IV. Conclusion
As our level of knowledge advances and more evidence regarding the benefits (and possible risks) of chelation therapy becomes available, the usage of this treatment regimen may change. In the meantime, healthcare providers should exercise caution when ordering, providing, documenting, coding, and billing payors for chelation therapy services. Providers should also review the position taken by their State Medical Board with respect to the use of chelation therapy in the treatment of FDA approved AND unapproved, off-label uses. Additionally, providers should exercise caution when coding and billing chelation therapy services to governmental and private payors. It is essential that you verify coverage (if any), and the proper coding and billing requirements before you proceed. These requirements can vary widely from payor to payor. Finally, health care providers should keep in mind that in today’s regulatory environment, it isn’t uncommon for a UPIC audit or a False Claims Act settlement to trigger a number of collateral adverse actions.[29]
Liles Parker attorneys have worked on a wide variety of chelation therapy cases, including administrative audits, State Medical Board investigations, and federal criminal prosecutions. For a free consultation regarding your chelation therapy case, please give us a call: 1 (800) 475-1906.
Liles Parker attorneys have considerable experience in representing providers in chelation therapy audits and investigations. Anyone seeking further assistance in this area should contact Ashley Morgan at 800-475-1906.
- [1] "Chelation therapy" involves compounds that are known to bond to certain substances, such as heavy metals. These compounds are known as "chelators." This therapy can then be used to help remove heavy metals from the body. Chelating agents can bind to metal ions, forming a complex that can be excreted from the body. Common chelating agents used include ethylenediaminetetraacetic acid (EDTA), dimercaptosuccinic acid (DMSA), and dimercaprol (BAL). EDTA binds to metals like lead, mercury, and cadmium as an intravenous drug, easing their excretion through the urine. Another group of chelating agents, known as "metal protein attenuating compounds" (MPACs) is currently being reviewed for the treatment of Alzheimer’s disease.
- [2] Joel A. Vilensky, Kent Redman, "British Anti-Lewisite (dimercaprol): An Amazing History." Annals of Emergency Medicine, Volume 41, Issue 3, 2003. Pages 378-383. During World War II, British chemists started using Dimercaprol as a heavy metal chelating agent in the treatment of arsenic poisoning resulting from the use of gas in chemical warfare. These chemists subsequently learned that ethylenediaminetetraacetic acid (EDTA), also called edetic acid, was effective in treating lead poisoning.
- [3] Fulgenzi A, Vietti D, Ferrero ME. "EDTA Chelation Therapy in the Treatment of doi:10.3390/biomedicines8080269Neurodegenerative Diseases: An Update." Biomedicines. 2020; 8(8):269.
- [4] Ibid.
- [5] James S, Stevenson SW, Silove N, Williams K. "Chelation for autism spectrum disorder (ASD)." Cochrane Database Syst Rev. 2015;5(5).
- [6] Lamas GA. Cardiology Patient Page. "Chelation Therapy: A New Look at an Old Treatment for Heart Disease, Particularly in Diabetics." Circulation. 2015 May 26;131(21).
- [7] See "Alfred Werner - Nobel Prize for Chemistry 1913". University of Zurich.
- [8] Wax PM. "Current Use of Chelation in American Health Care." J Med Toxicol. 2013 Dec;9(4):303-7.
- [9] Lord C. J. "Determination of Trace Metals in Crude Oil by Inductively Coupled Plasma Mass Spectrometry with Microemulsion Sample Introduction." Anal. Chem. 1991, 63, 1594–1599.
- [10] Ajayi T. R.; Torto N.; Tchokossa P.; Akinlua A. "Natural Radioactivity and Trace Metals in Crude Oils: Implication for Health." Environ. Geochem. Health 2009, 31, 61–69.
- [11] Tucson Medical Center website article titled "Chelation therapy for heart disease: Does it work? Can chelation therapy treat heart disease?" (June 13, 2023).
- [12] For a summary of the study findings, please see the National Heart, Lung and Boold Institute’s website.
- [13] See 21 C.F.R. 801.4.
"The words intended uses or words of similar import in §§ 801.5, 801.119, 801.122, and 1100.5 of this chapter refer to the objective intent of the persons legally responsible for the labeling of an article (or their representatives). The intent may be shown by such persons' expressions, the design or composition of the article, or by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. Objective intent may be shown, for example, by circumstances in which the article is, with the knowledge of such persons or their representatives, offered or used for a purpose for which it is neither labeled nor advertised; provided, however, that a firm would not be regarded as intending an unapproved new use for a device approved, cleared, granted marketing authorization, or exempted from premarket notification based solely on that firm's knowledge that such device was being prescribed or used by health care providers for such use. The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he or she received the article, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses." (Emphasis added).
- [14] PubChem, National Library of Medicine, Compound Summary. Edetate Calcium Disodium.
- [15] Deferoxamine was first approved by the FDA iron chelation in 1968, See "Office Director Memo." Center for Drug Evaluation and Research. Application Number: 021825Orig1s00. Reference IF: 3029235
- [16] The Orphan Drug Designation History and Approval of Succimer by the FDA is currently only available through a search of web archived materials.
- [17] Deferasirox was first approved by the FDA in 2005.
- [18] Deferiprone was initially approved for use in the United States by the FDA in 2011.
- [19] FDA Warning titled "FDA warns consumers about potential health risks from using Thorne Research’s Captomer products." (June 12, 2014).
- [20] See FDA’s article titled "Understanding Unapproved Use of Approved Drugs "Off Label." (Last updated 02/05/2018).
- [21] CMS database of Retired LCDs and Retired Articles. (Data as of January 14, 2024).
- [22] National Government Services (NGS), "NGS Medicare University Virtual Conference." (2021).
- [23] Noridian Healthcare Solutions. "LCD Retirement Clarification." (Last updated: November 3, 2022).
- [24] See 78 FR 48164-69. (August 7, 2013).
- [25] National Coverage Determination (NCD) titled "Chelation Therapy for Treatment of Atherosclerosis." Publication Number: 100-3. Manual Sec. 20.21. Also see Manual Sec. 20.22.
- [26] For additional information regarding the UPIC audit process, please see Liles Parker’s article titled "A UPIC is Serious Business – Is Your Office Prepared?"
- [27] Medicare Claims Manual, Chapter 17, Drugs and Biologicals, Section 20.1.2, stating that:
"Pricing for compounded drugs is performed by the local contractor. Beginning in July 2015, claims for compounded drugs shall be submitted using a compounded drug, not otherwise classified (NOC) HCPCS code."
- [28] For an overview of the False Claims Act, see our article titled "False Claims Act Matters and Cases – Overview."
- [29] For an overview of potential collateral adverse actions a provider may face, see our article titled "Providers Should Ensure that they Are Fully Aware of the Collateral Consequences that May Occur When Settling with the Government."