“. . . violated his oath to do no harm by administering unnecessary chemotherapy and other toxic medications to patients with serious diseases — including some of the most vulnerable victims imaginable — are almost beyond comprehension.”
The defendant is alleged to have “misdiagnosed” numerous patients, some of which were vulnerable individuals who were young, elderly or disabled. Four of the five counts of health care fraud in the indictment are alleged to arise out of the defendant’s “False Diagnosis of Rheumatoid Arthritis.” You may wonder, how does something like a false diagnosis happen? Unfortunately, diagnosing a patient with rheumatoid arthritis isn't as straight-forward as it may seem from reading the government's indictment. There isn’t a single test that can be run to determine whether a patient has this diagnosis. Instead, a physician has to take into consideration a patient’s symptoms, blood and diagnostic test results (none of which are definitive on their own), and a patient’s family and prior medical history. Taken collectively, a physician will typically use this information and apply industry-accepted diagnostic criteria. Regardless of how this case ends up being resolved, rheumatologists around the country should take note of the concerns that the government has raised. While this case currently dominates the headlines, it is important to keep in mind that this isn’t the first time that law enforcement has focused its attention on rheumatologists. Far from it. This article provides an overview of cases that have been brought against these specialty practices and will cover a number of steps that a rheumatologist can take to reduce his / her level of risk.
I. Overview of Administrative Adverse Actions and Rheumatology Audits Against Physicians and Rheumatology Practices:
Administrative adverse actions against rheumatologists can take a number of forms, including, but not limited to: licensure actions, exclusion actions, and administrative claims audits.
Texas Medical Board Disciplinary Actions
As illustrated in this first case, it is imperative that rheumatologists fully document their mental impressions and the reasoning behind diagnostic conclusions reached.
• Texas Physician Failed to Properly Document Objective Medical Evidence to Support a Rheumatology Diagnosis.
In this case, the Texas Medical Board (Board) entered into an Agreed Order with a physician alleged to have violated the standard of care in a number of cases. More specifically, the Board alleged that the physician provided treatment that was inappropriate and nontherapeutic. Additionally, the physician was alleged to have failed to perform adequate testing and document objective medical evidence to support his diagnosis for several patients. Under the Agreed Order, the Board required that the physician submit the medical records of all of his rheumatology patients to a Board-approved rheumatologist for monitoring purposes for a set period of time. The physician was also required to complete 24 hours of CME (four hours in medical record-keeping and 20 hours in rheumatology). How can you avoid committing these types of licensure violations? When documenting your medical decision-making process, Texas rheumatologists need to ensure that their medical records comply with both the applicable standard of care AND fully meet the documentation mandates outlined in the Texas Administrative Code, Title 22, Part 9, Chapter 165. Medical Records §§165.1-165.6. 
OIG Exclusion Actions.
As early as 1977, the Department of Health and Human Services (HHS) has been “excluding” individuals and entities from participation in Federal health benefits programs. The HHS, Office of Inspector General (OIG) assumed responsibility for taking these administrative actions in 1981. What is an exclusion? Simply put, if an individual is subjected to an adverse licensure action, is convicted of certain crimes, or has engaged in other specific enumerated conduct, he / she may be excluded from participation in Federal health benefits programs. It is important to keep in mind that an excluded party is not merely barred from participating in Medicare, Medicaid and other Federal health benefit programs. Excluded parties may not even work for an organization that participates in these government health benefit programs. There are two types of exclusion actions that are taken by the OIG. “Mandatory” exclusion actions must be imposed by the OIG if an individual or entity is convicted of certain crimes. In contrast, the OIG exercises the authority to impose or to waive certain exclusion actions that may be triggered by one or more other violations. These types of exclusion actions are “Permissive” in nature.
As of April 2018, there are a total of 69,875 individuals and entities named in the List of Excluded Individuals and Entities (LEIE) maintained by the OIG. The LEIE is one of 40 various databases that are supposed to be checked every 30 days by providers in order to better ensure that no excluded parties have been hired. Of the 69,875 excluded individuals and entities currently on the LEIE, only five are specifically identified as physicians specializing in rheumatology. Nevertheless, it is difficult to fully assess the number of physicians on the list that provide rheumatology services because of the limitations in the specificity of OIG’s database. As we will see below, a number of the cases brought against rheumatologists for criminal conduct would undoubtedly require mandatory exclusion, in addition to any civil and criminal sanctions that may have been imposed.
C. Administrative Rheumatology Audits by ZPICs and UPICs.
As a participating provider in Medicare’s Part B program, rheumatologists and their practices are subject to prepayment audit by a number of federal, state and private payor audit entities. If your practice is placed on prepayment audit by a Medicare contractor, you may want to know how you ended up on the auditor’s radar. We have repeatedly heard of instances where a Medicare contractor has told the practice that their placement on prepayment review was the result of a “random audit.” Despite their assurances to the contrary, physicians should keep in mind that virtually NONE of the Medicare audits we have seen are truly random. The following Federal Register issuance included agency comments that confirm what we have all thought, CMS and its contractors do not conduct random repayment audits of health care providers. As CMS expressly set out in the Federal Register:
"Although section 934 of the MMA sets forth requirements for random prepayment review, our contractors currently do not perform random prepayment review. However, our contractors do perform non-random prepayment complex medical review. We are cognizant of the need for additional rulemaking should we wish our contractors to perform random review."
How is a rheumatology practice targeted for an audit? As the Centers for Medicare and Medicaid Services (CMS) has expressly noted in Chapter 2, Section 2.3 of the Medicare Program Integrity Manual (MPIM):
“Claims data is the primary source of information to target abuse activities.”
Utilizing this data, Medicare program integrity contractors employ predictive modeling and data mining to identify rheumatology care, treatment, coding and billing practices that would be considered “outliers” when compared to the utilization, coding and billing practices of their peers. In the first quarter of 2018, we have already seen evidence that law enforcement, government agencies and their contractors are continuing to rely on data mining for targeting purposes. How do your utilization, coding and billing practices compare to those of your peers? No idea? Now is the time to find out! Rheumatology audits are actively being conducted by Zone Program Integrity Contractors (ZPICs) and Uniform Program Integrity Contractors (UPICs) around the country.
Other sources of an audit include complaints by beneficiaries, overpayment data, referrals from other Medicare program integrity contractors, and reports published by OIG and Government Accounting Office (GAO) of specific improper coding and billing practices that they identified. Several of the specific issues identified in ZPIC and UPIC audits of rheumatology-related claims that we have defended have included:
- Failure to Document a Diagnosis of Arthritis. The alleged failure to document a diagnosis of arthritis has been cited as a basis for taking action in ZPIC and UPIC administrative audits, Texas Medical Board disciplinary actions, civil False Claims Act cases and criminal prosecutions of rheumatologists. As discussed in more detail in our discussion of rheumatology audits, this denial reason is subject to considerable dispute. Unfortunately, there isn’t a single “test” or “symptom” that can be relied on by a physician when diagnosing a patient with rheumatoid arthritis, ankylosing spondalytis or a host of other rheumatic diseases. Instead, a physician often relies on his / her professional experience and knowledge when diagnosing a patient with one of the conditions. This problem is further exacerbated by the fact that CMS and its contractors have not issued specific guidelines (in the form of National Coverage Determination (NCD) or Local Coverage Determination (LCD) guidance) that outlines precisely what the government expects to see in order for a diagnosis to be properly documented. Ultimately, a physician will need to show that the diagnosis has been based on accepted criteria such as “2010 American College of Rheumatology / European League Against Rheumatism Classification Criteria for Rheumatoid Arthritis.” 
- Failure to Properly Document the Evaluation and Management (E/M) Level of the Visit. Despite the fact that specific guidance (1995 and 1997 E/M Guidance) on how Medicare E/M claims are supposed to be documented, coded and billed, many physicians still apply the less-specific, incorrect guidance set out in the AMA’s CPT Codebook. When audited, Medicare program integrity contractors have often downcoded (or in some case, denied in their entirety) E/M claims. (Although the AMA CPT Codebook is applicable when billing E/M services to private payors, the 1995 and 1997 E/M Guidance first issued by HCFA should be used as the proper measuring tool for Medicare claims).
- Failure to Fully Document a Patient’s Condition. ZPICs and UPICs are regularly denying claims on the basis that a physician’s physical examination of the patient does not document the specific joints where swelling has been identified, the extent a patient’s range of motion has been impacted, the level of pain cited by a patient, and the duration of the patient’s painful condition.
- Failure to Document the Medical Necessity of Biologics Used in Infusions. Not surprisingly, in large part due to its high cost, the medical necessity of infusions has been a favorite target of Medicare program integrity contractors and federal / state prosecutors. Auditors often point out the fact that a physician has failed to document less invasive (and less expensive) treatment options that had been tried and failed to provide relief.
If a rheumatology practice is placed on prepayment review, it can be financially devastating for the organization. Once put in place, it can take months to satisfy the Medicare contractor that it should be lifted. Adding insult to injury, after a practice is placed on prepayment review, it is fairly common for a ZPIC or UPIC to then initiate a postpayment audit of the practice’s rheumatology claims. While postpayment audits are not new, the number of these audits appears to be increasing. Moreover, ZPICs and UPICs are frequently pulling a relatively small sample of 30 – 60 claims and then are extrapolating the alleged damaged based on the error rate that has been identified in the sample. In such case, we almost always work our own statistical experts to challenge the validity of the statistical sampling process and the resulting extrapolation of damages. Due to the high costs of biologics, it is fairly common for ZPICs and UPICs to seek alleged overpayments of millions of dollars.
II. Overview of Civil and Criminal Fraud Cases Brought Against Physicians for Rheumatology-Related Care and Treatment Services:
Rhode Island Remicade® Infusion Fraud Case.
In this Rhode Island case, a physician was indicted by a Federal Grand Jury for health care fraud, illegal distribution of controlled substances, and money laundering. The 152-count indictment also sought the forfeiture of about $5.9 million, alleged to be the proceeds of the physician’s criminal activity. Over a four-year period, the physician was alleged to have personally treated more than 4,800 patients. A significant portion of the physician’s practice was the administration of infusion therapy to treat the symptoms of such diseases as rheumatoid arthritis, various blood disorders, and certain cancers. Among the many counts set out in the indictment, the physician is alleged to have administered Remicade® without substantiating that a number of patients had been properly diagnosed as having rheumatoid arthritis. Notably, he also reportedly failed to treat patients with necessary ancillary drugs and failed to test patients for certain risks associated with Remicade®, such as tuberculosis. Finally, the physician is also alleged to have recorded dosages of Remicade® that greatly exceeded the recommended maximum dosages. Before he could be arrested, the physician fled the country and is a fugitive on the OIG’s “Most Wanted List” today. He is thought to have fled to Lebanon.
Virginia Remicade® Infusion Fraud Case.
In this case, the Federal Bureau of Investigation (FBI) first began investigating a Virginia-based physician after receiving a report from a former patient that the physician had been overprescribing controlled substances. Essentially, the former patient claimed that the physician prescribed the patient "whatever drugs she wanted" without performing a physical exam or medical tests. As a result of the FBI’s investigation, the physician was indicted for the illegal distribution and for conspiring to distribute controlled substances. In the course of the investigation, the FBI interviewed two of the physician’s former employees. In doing so, the FBI learned that the physician was also allegedly engaged in fraudulent conduct involving Remicade®. After analyzing the physician’s billing practices, purchasing records and bank records, the government concluded that the physician had engaged in a number of fraudulent practices involving the billing of Remicade®. The government’s concerns in this regard were later confirmed when the physician’s former assistant pleaded guilty to conspiring to distribute controlled substances. The physician’s former assistant later testified at trial that the following four main fraudulent schemes were employed by the physician. First, the physician was alleged to have billed for more Remicade® than the patients actually received. Second, the physician billed for Remicade® infusions when the patients received a less expensive steroid medication. Third, the physician supposedly billed for Remicade® infusions when the patients did not receive any infusions. And, finally, the physician is alleged to have billed for Remicade paid for by other patients’ health care benefit programs. Before the physician could be arrested, he fled the jurisdiction and is thought to have gone to Turkey.
Kentucky Remicade® Infusion Fraud Case.
In a case out of the Western District of Kentucky, a Louisville physician and his practice were alleged to have falsely billed the Medicare program for infusions of infliximab, a drug used in the treatment of patients with rheumatoid arthritis. The specific allegations were that the physician and practice were “splitting” vials of infliximab across the infusions of multiple patients but billed the Medicare program as if a whole vial were used for each Medicare beneficiary. It was further alleged that this improper conduct took place over a period of three years. A former employee of the practice filed a whistleblower case against the physician and his practice under the civil False Claims Act. The case was later settled for $349,860.00. The defendants also had to pay for the whistleblower’s attorney’s fees.
Oklahoma Remicade® Infusion Fraud Case.
In a case that was initially filed by a whistleblower under the civil False Claims Act, an Oklahoma physician in the Western District of Oklahoma was also later criminally charged with Medicare fraud. Through its investigation, the government claims that over a period of approximately 28 months, the practice billed Medicare for the infusion of 112,110 milligrams of Remicade.® However, it was alleged that during this period the practice had only ordered approximately 49,600 milligrams from its suppliers. The government further alleged that the physician had falsified patient records and caused his staff to submit false claims to Medicare for payment. The physician was sentenced to 33 months in prison and surrendered his state medical license. A $1.5 million civil consent judgement was entered in the case. The defendant was also ordered to pay $473,881.55 in restitution to Medicare and $69,685.26 in restitution to BlueCross BlueShield of Oklahoma.
Texas Allergy / Arthritis / Pain Management Clinic Alleged to be a Pill Mill.
Law enforcement investigators have found that a significant number of rheumatology patients are being treated multidisciplinary practices. In this case, a husband and wife (both physicians) ran a number of Texas clinics that provided care allergy, arthritis and pain management patients. Government investigators carefully tracked the number of patients being seen by the physicians, noting that they went from seeing 50-60 patients per day to 279 patients per day over a seven-year period. Additionally, through data-mining and the intra-agency sharing of information, law enforcement also noted that one of the physicians allegedly prescribed 615,671 tablets of hydrocodone (Vicodan®), 66,000 tablets of alprazolam (Xanax®), and 26,000 tablets of diazepam (Valium®) over a nine-month period. In fact, one patient received 92 hydrocodone prescriptions, totaling 8,040 tablets over an eight-month period. After conducting search warrants of the couple’s two clinics, residence and safe deposit boxes, investigators found $700,000 at the residence and $816,000 in the safe deposit boxes (allegedly only accessible by one of the physicians). In addition to the improper prescription of controlled substances outside the scope of professional practice and not for a legitimate medical purpose, the couple was also alleged to have billed Medicare and Medicaid for a number of fraudulent interventional procedures. Investigators alleged that the physicians would inject patients with a lidocaine / steroid combination that would provide patients with a temporary relief of various joint and muscle pain. Despite the fact that these injections were superficial, the procedures were falsely billed to insurance companies as facet joint injections, paravertebral injections, sacroiliac nerve injections, sciatic nerve injections and various nerve block injections. Nearly every patient was prescribed one or more controlled substances and put on a regimen of shots every two weeks. Initially, patients were required to sign the medical progress and procedure notes in their patient chart to prove they were at the clinic and received the shots. This subsequently changed and the physician had certain patients sign blank procedure/progress notes and then used those forms to generate a superbill in order to bill the insurance companies for injection procedures on days when the patient was not in the clinic.
New Jersey Rheumatologist Convicted of Investigational Research Fraud.
A New Jersey rheumatologist was sentenced to four years in prison after pleading guilty to the falsification of clinical data. The physician had been paid $1.86 million by drug companies to provide investigational new drug research nonsteroidal anti-inflammatory drugs (NSAIDS). The physician failed to conduct the research as agreed. Instead, he fabricated lists of patients supposedly participating in the study. He then is alleged to have falsified urine, stool and blood studies and forged the signatures of other clinicians. The rheumatologist also failed to report the deaths of two patients supposedly included in the “study.” Notably, the deaths were not related to the drugs being studied because they were never really in the study.
Ohio Rheumatologist Convicted of “Misbranding.”
In this case, an Ohio rheumatologist pleaded guilty to importing medications that had not been approved by the Federal Drug Administration (FDA). The physician admitted causing the shipment of misbranded drugs, which is a misdemeanor violation of the Food, Drug and Cosmetic Act. As a misdemeanor violation, the physician faces a statutory maximum of up to one year in prison and fines up to $100,000.
Kentucky Rheumatologist Convicted of “Misbranding.”
In this case, a Kentucky physician pleaded guilty to a misdemeanor criminal charge of treating patients with misbranded medications. He was later sentenced to a term of one-year probation and was ordered to pay $176,915.55 in restitution. The physician admitted to purchasing Rituxan®, Actemra®, Remicaid®, Aclasta®, Prolia®, and Synvisc® from foreign drug distributors based in the United Kingdom. The drugs originated outside the United States and were never approved by the FDA for introduction into the United States. These misbranded medications were then administered to patients under the physician’s supervision. Additionally, under a separate civil agreement, the physician agreed to pay $338,493.30 to settle certain claims brought against him by the OIG.
III. Steps You Can Take to Reduce Your Level of Risk:
Fully Document Your Basis for Concluding that a Patient has a Specific Diagnosis.
As the administrative, civil and criminal cases above reflect, it is imperative that physicians providing rheumatology care and treatment services take a critical look at their documentation practices. More than likely, there are a number of additional steps you can take to fully document the process you went through when diagnosing a patient with rheumatoid arthritis, ankylosing spondalytis or another rheumatic disease. Moreover, you need to tie your evaluation to the applicable standard of care and industry recognized protocols for diagnosing the patient’s condition. Have you fully documented a patient’s medical, family and present history? Have you noted the results of your hands-on evaluation of the patient’s joints, range of motion, etc.? Have you documented all of the prior treatment approaches that were tried and failed to address the patient’s painful condition? Have you ordered and documented the results of specific blood tests that should be considered in the course of reaching a diagnosis? Have radiology test results been included your decision-making process?
Just to be clear, despite the fact that the government often heavily relies on "Industry Standards of Care" when assessing a provider's case, it is important to keep in mind that diagnostic algorithms (such as those published by the American College of Rheumatology) are only part of the answer. As Jeffrey A. M.D., a Visiting Fellow at the Goldwater Institute and a Senior Fellow at the Cato Institute has noted:
"[P]racticing under the yoke of the algorithm discourages critical thinking. There is a tendency to surrender to the algorithm. This jeopardizes good patient care and can impact outcomes. There are times when a patient’s presentation and response to treatment do not follow the algorithm—their DNA did not get the memo about the guidelines. A physician must think “outside the box” to help that patient—an attribute that is discouraged and becomes a lost skill under the algorithmic regime."
Your Infusion of Costly Biologics Will Undoubtedly be Audited at Some Point.
Is a rheumatology audit in your future? If your practice or clinic administers infusions, your claims will be audited by one or more Medicare program integrity contractors. With this in mind, you need to carefully document the medical necessity of this treatment option. Moreover, keep in mind that CMS and its MACs have issued NCDs, LCDs and other specific guidance governing the utilization of Remicade, Enbrel, and a number of other costly drugs. When is the last time you have reviewed this guidance?
Develop, Implement and Comply with the Provisions Set Out in an Effective Compliance Program.
The government doesn’t expect you to be perfect. Nevertheless, you do expect you to try your best to follow applicable rules and regulations governing the billing of claims to the Medicare program. If you implement an effective Compliance Program and diligently work to comply with its requirements, you will significantly reduce your level of claims risks. Remember, self-audits aren’t just encouraged, they are required by law under the Affordable Care Act and are especially important if your practice wants to be viewed as a good corporate citizen. Through periodic auditing and monitoring your practice’s activities you can better avoid:
- The submission of false and fraudulent claims;
- Engaging in overbilling;
- Improperly using a provider’s number to bill for claims that were provided by a different individual;
- The improper solicitation of referrals;
- Engaging in medical identity theft;
- The improper billing for services by unlicensed individuals;
- The improper administration of infusion by unsupervised staff; and
- The employment of excluded individuals.
Avoid Engaging in Business Practices that Could Constitute (or be Misinterpreted to be) Kickbacks / Disguised Kickbacks and / or Bribes.
It isn’t sufficient to only focus on your documentation, medical necessity, coverage, coding and billing practices. If you or your practice is ever investigated, federal and state prosecutors will systematically evaluate each and every one of your business arrangements. Simply put, where do your referrals come from and where do you send referrals. These business relationships will be exhaustively examined by the government. Some of the risk areas identified have included:
- Be especially careful before your practice or clinic enters into any business arrangement with a compounding pharmacy.
- A continuing concern of the government involves lease arrangements with actual and / or potential referral sources.
- Situations where a physician serves as a medical director to a hospice, home health agency, or nursing home to whom you make patient referrals.
- Serving as a consultant or speaker to a pharmaceutical manufacturer, compounding pharmacy or durable medical equipment supplier whose products you prescribe.
- Participating in a sham loan arrangement with an entity to whom you make referrals or whose products you prescribe, order or recommend.
- Acquiring or having a financial interest in an entity to whom you send referrals (especially if the referral is for Designated Health Services which could implicate Stark).
- Accepting cash, gifts or other Items of value from a patient or other individual in exchange for a prescription for opioids or other controlled substances.
- Accepting or soliciting any type of remuneration (something of value), such as a gift card, sporting event tickets or liquor, from a pharmaceutical representative, compounding pharmacy or DME supplier whose products you order or prescribe (or could order or prescribe).
Prior to entering into a business arrangement, we strongly recommend that you contact an experienced health lawyer so that an assessment of the risks can be conducted and an evaluation of whether the arrangement may violate the False Claims Act, the Anti-Kickback Statute or Stark.
Keep in Mind that the Government is Actively Pursing Individuals for Their Role in the Commission of White Collar Fraud.
While culpable individual defendants have regularly been prosecuted, over the past decade, most DOJ prosecutors have focused on seeking large financial fines and penalties from corporations. For example, how many individuals can you think of that went to jail when the banking sector almost collapsed? On September 9, 2015, Deputy Attorney General Sally Quillian Yates issued a Memorandum entitled “Individual Accountability for Corporate Wrongdoing” (Yates Memo). This historic document instructs DOJ prosecutors to stop resolving corporate cases that release individuals from personal liability, absent extraordinary circumstances. Throughout the rest of 2018, we expect to see an increase in parallel proceedings and prosecutions of physicians, managers, coders, billers and other non-clinical staff who are alleged to have violated the law. Your personal conduct, and your efforts to comply with applicable rules and regulations will be assessed by DOJ if there is ever a problem.
-  The American College of Rheumatology has prepared decision trees that can be used to diagnose (or rule out) certain type of rheumatic disease. For example, the algorithm used to determine if a patient is suffering from rheumatoid arthritis is set out at the following link: https://www.rheumatology.org/Portals/0/Files/2010%20RA%20Classification%20Tree_Tree%20Format%202010.pdf
-  http://www.tmb.state.tx.us/idl/3E399486-3B51-843A-AAD2-E67B31810FB0
-  https://oig.hhs.gov/faqs/exclusions-faq.asp
-  Such as a licensure suspension or revocation.
-  For instance, under Section 220.127.116.11 of the Medicare Program Integrity Manual, if a provider is placed on prepayment review for an extended period of time and has not corrected their pattern or practice after receiving educational/warning letters, Zone Program Integrity Contractors (ZPICs) and Uniform Program Integrity Contractors (UPICs) are directed by the Centers for Medicare and Medicaid Services (CMS) to refer the provider to the OIG for possible “exclusion” action.
-  For additional information on exclusions, and your obligation to check Federal and State databases every 30 days, see the articles published on the Exclusion Screening website. www.exclusionscreening.com
-  Please note, there is one narrow exception to this basic rule that I am aware of. When a Comprehensive Error Rate Testing (CERT) audit is conducted, the CERT auditor is essentially auditing a specific previously-paid type of claim to determine whether a Medicare Administrative Contractor (MAC) was correct in allowing the claim to be paid. To accomplish this, the CERT auditor pulls a sample of specific paid services submitted for payment in a MAC region. Providers with claims in the sample universe are then randomly pulled by the CERT auditor.
-  https://www.aafp.org/afp/2011/1201/p1245.html#afp20111201p1245-t1
-  FBI Press Release, SDTX, June 24, 2009, “Husband and Wife Charged with Operating a Pill Mill,” https://archives.fbi.gov/archives/houston/press-releases/2009/ho062409.htm
- U.S. Attorney’s Office, Southern District of Texas, Press Release. June 3, 2013.
-  https://pink.pharmaintelligence.informa.com/PS015210/NSAID-INVESTIGATOR-ORDERED-TO-REPAY-DRUG-FIRMS--186-MIL
-  Section 502 of the Federal Food, Drug and Cosmetic Act (FFDCA) contains provisions on misbranding including some that relate to false or misleading labeling. A device’s labeling misbrands the product if:
- Its labeling is false or misleading in any particular;
- It is in package form and its label fails to contain the name and place of business of the manufacturer, packer, or distributor and an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count;
- Any required wording is not prominently displayed as compared with other wording on the device, or is not clearly stated;
- Its label does not bear adequate directions for use including warnings against use in certain pathological conditions or by children where its use may be dangerous in health or against unsafe dosage, or methods, or duration of administration or application;
- It is dangerous to health when used in the dosage or manner or with the frequency or duration prescribed, recommended or suggested in the labeling; or
- It does not comply with the color additives provisions listed under Section 706 of the FFDCA;
- The device's established name (if it has one), its name in an official compendium, or any common or usual name is not prominently printed in type at least half as large as that used for any proprietary name;
- The establishment is not registered with FDA as required by Section 510 of the FFDCA and has not listed the device as required by Section 510(j) of the FFDCA or obtained applicable premarket notification clearance as required by Section 510(k) of the FFDCA;
- The device is subject to a performance standard and it does not bear the labeling prescribed in that standard;
- There is a failure or refusal to comply with any requirement related to notification and other remedies prescribed under Section 518 of the FFDCA, if there is a failure to furnish any materials or information required by, or requested by the Secretary pursuant to, Section 519 of the FFDCA, or if there is a failure to furnish materials or information relating to reports and records required by Section 522 of the FFDCA; or
- There is any representation that creates an impression of official approval because of the possession by the firm of an FDA registration number.