False promises rebuked by FDA, no tea or vitamin can cure cancer

Bogus cancer “treatments” being marketing and sold without FDA approval were the target of 14 warning letters and four online advisory letters, according to a press release and consumer update from the agency. The 65-plus products listed by the agency include pills, tablets, creams, syrups, sprays, oils, salves, teas, and medical devices, claiming to cure cancer in humans and pets, and have been found illegally for sale online, in retail stores, at flea markets and swap meets, and even at trade shows.

The FDA called these illegal products a “cruel deception,” and urged consumers to stay away from products that have not passed the agency’s review process, designed to ensure the safety and effectiveness of treatments. It listed the following phases or concepts as warning signs that the advertised product was unlikely to be approved by the agency:

  • treats all forms of cancer;
  • miraculously kills cancer cells and tumors;
  • shrinks malignant tumors;
  • selectively kills cancer cells;
  • more effective than chemotherapy;
  • attacks cancer cells, leaving healthy cells intact; or
  • cures cancer.

Additionally, many of the products that were the subject of the warnings were advertised as “natural” or “non-toxic.”

The warning and advisory letters ask the recipient companies to provide written responses to the violations covered in the letters; if the companies fail to respond and make adequate corrections, they could be subject to further actions including criminal prosecution. According to the FDA, the best scenario for consumers who have purchased or used these products is ineffectiveness. It is possible, however, that these products could interfere with proven, beneficial treatments, or even cause direct harm.

8 years of illegal kickbacks costs Hospice Plus $12M

A group of hospices owned by Curo Health Services and operating under the Hospice Plus brand agreed to pay over $12 million to resolve allegations that they paid kickbacks in exchange for patient referrals in violation of the False Claims Act (31 U.S.C. §3729). The scheme came to light after several whistleblowers filed qui tam lawsuits on behalf of the United States, consolidated as U.S. ex rel. Capshaw v. White. The United States had previously partially intervened in the lawsuit against the corporate defendants for purpose of settlement; the suit remains pending against two former Curo executives, and the United States requested permission to intervene in the remainder.

Kickbacks were allegedly paid to (1) American Physician Housecalls, a physician house call company in the form of sham loans, free equity interest in another entity, stock dividends, and free rental space; and (2) to medical providers, including doctors and nurses, in the form of cash, gift cards, and other valuable items. According to the consolidated whistleblower complaints, the house call company allegedly received kickbacks from 2007 through 2012, while providers allegedly received payments from 2007 through 2014.

The involved hospices primarily operate in and around Dallas, Texas, and were first known as Hospice Plus, Goodwin Hospice, and Phoenix Hospice. The three companies were purchased by Curo Health Services in 2010 and consolidated under the Hospice Plus brand.

OMHA trying to speed claims appeals process

The Medicare appeals backlog, which at its pinnacle had more than 650,000 claims waiting for adjudication before an administrative law judge (ALJ), is shrinking, according to Office of Medicare Hearings and Appeals (OMHA) chief ALJ Nancy Griswold. Griswold told attendees at the Health Care Compliance Association’s (HCCA) Compliance Institute that OMHA is pursuing a number of initiatives to reduce the backlog and speed claim resolution. Joined by Andrew B. Wachler of Wachler & Associates, Griswold discussed policy and regulatory changes to the appeals process, and Wachler shared best practices.

OMHA is doing a demonstration project using voluntary formal telephone discussions with durable medical equipment (DME) suppliers in Medicare Administrative Contractor (MAC) Jurisdictions C & D. These discussions give the supplier an opportunity to present facts and additional documentation to support resolution of the appeal. According to Griswold, over 5,000 appeals have favorably resolved through the demonstration project, while more than 16,000 have been remanded to reopen or resolve the claim favorably. The agency is also working on settlement conference facilitation (resolving more than 10,000 appeals since June 2014), adjudication through statistical sampling, and use of a senior attorney on the record.

Griswold also discussed OMHA’s plans for the Electronic Case Adjudication Processing Environment (ECAPE). Release 1, which consists of a public portal for case intake and appellants, is scheduled for Spring 2017, with additional releases planned through Summer 2018.

Wachler explained that preparation is key for attorneys representing clients in appeals before OMHA, and explained that best practices include prominently listing the Medicare Appeal Number, ensuring that all information submitted is accurate and consistent, documenting proof of service, submitting only one request per Medicare Appeal Number, and keeping track of all due dates. He also recommended that attorneys wait until an ALJ is assigned to the case before attaching evidentiary submissions or additional filings; rather than submitting that information to OMHA Central Operations, Wachler says it can be directly submitted to the ALJ.

23andme approved to market 10 genetic risk tests, FDA simplifies pathway for more

For the first time, the FDA gave DNA-testing company 23andMe authorization to market direct-to-consumer (DTC) genetic health risk (GHR) tests that provide information on an individual’s genetic predisposition to certain medical diseases or conditions. However, in announcing the approval, the FDA cautioned consumers to remember that GHR tests cannot predict the likelihood of developing a disease or condition, which depends on many factors beyond genetics.

23andMe’s GHR tests work by testing a saliva sample, isolating DNA from that sample, and testing it against 50,000 genetic variants. Certain variants are associated with an increased risk for developing certain genetic conditions. The GHR tests approved by the FDA are associated with:

The 23andMe GHR tests were reviewed by the FDA through the de novo premarket review pathway, but in the future, the agency will exempt 23andMe from premarket review for additional related GHR tests, while other companies will also have the opportunity for an exemption after their first GHR tests receive premarket approval. However, this exemption does not apply to GHR tests that function as diagnostic tests, which are often used as the sole basis for major treatment decisions.

In 2013, the FDA issued a warning letter to 23andMe requiring the company to immediately halt marketing for their DNA testing kits until it secured FDA premarket approval. At that time, the FDA noted that 23andMe failed to complete studies that could validate the effectiveness of the DNA test kits and failed to provide additional information requested by the agency (see Citing Risks of Illness, Injury, or Death, FDA Orders 23andMe, Inc. to Stop Marketing DNA Test Kits, December 5, 2013). For this new approval, 23andMe submitted supporting data from peer-reviewed, scientific literature that demonstrated a link between specific genetic variants and each of the 10 health conditions. The FDA also reviewed studies, which demonstrated that 23andMe GHR tests correctly and consistently identified variants associated with the 10 indicated conditions or diseases from a saliva sample.

Risks associated with use of the 23andMe GHR tests include false findings, both false positives indicating incorrectly that an individual has a certain genetic variant, and false negatives indicating incorrectly that he or she does not have a certain genetic variant.