Genetic tests are valuable because they can provide important information to patients and their medical providers regarding diagnoses, treatment, and disease prevention. However, the rapid growth in the number of tests ordered, especially in light of the telemedicine expansion during the pandemic, has invited well-earned scrutiny to the industry.
Make no mistake: genetic testing is heavily regulated (and enforced). The Federal Anti-Kickback Statute, Eliminating Kickbacks in Recovery Act, and Commercial Insurance Fraud Law have all been used to prosecute unscrupulous marketers, call centers, and telemedicine providers in the last few months. Kickbacks in exchange for genetic specimens are just as illegal as kickbacks for patients. Three months ago, a Florida man was sentenced to 10 years in prison for conspiracy to commit health care fraud. His actions resulted in the submission of approximately $3.3 million in fraudulent claims to Medicare for genetic testing.
The transition from paper medical records to electronic medical records has brought with it many conveniences and some unintended consequences. One example of an unintended consequence is cloning in the medical record. Cloning is copying and pasting previously recorded information from a prior patient note into a new patient note.
Providing quality medical care is only one part of the job. Appropriately documenting that care in order to be paid for your efforts is another. And while medical professionals are trained at length to provide care, hardly any are aware of the potential pitfalls associated with improper documentation.
In late 2015, CMS advised that cloning “is a problem in health care institutions that is not broadly addressed.” CMS specified that cloning records may indicate fraud, waste and abuse in inquiries and audits and that each part of a “medical record must contain documentation showing the differences and the needs of the patient for each visit or encounter.”
In CMS’ latest “MLN Connects” newsletter, the agency discusses the Comprehensive Error Rate Testing (CERT) program and the top five documentation errors committed by providers. Providers should pay close attention when CMS releases these types of notices. If selected for CERT review, providers are subject to potential action such as post-payment denials, payment adjustments, or other actions depending on the results of the review. Therefore, providers should ensure they fully understand Medicare’s documentation requirements and how to meet these demands.
A recent whistleblower action (by UnitedHealthcare Medical Director, Tina Groat) against Boston Heart (laboratory) was brought under the federal False Claims Act and deals with medical necessity issues. As part of the analysis, the Court reviewed whether a laboratory [or supplier like DME] must determine the medical necessity of the ordering physician. Boston Heart contended that a doctor, not a laboratory, determines the medical necessity of a test. Boston Heart argued that when a laboratory bills Medicare for testing ordered by a physician, it must only maintain documentation it receives from the ordering physician and ensure that the information that it submitted with the claim accurately reflects the information it received from the ordering physician. It noted that the CMS-1500 form certification does not require that the billing lab to make the medical necessity determination. The lab certifies that the services are medically necessary by relying on the clinical determination of the treating physician.
In the healthcare business, giving a patient a break on a health insurance copay is often viewed as suspicious. The reasoning for the suspicion is that the financial incentive may give one provider a competitive advantage over another, or persuade a patient to seek services that might not be medically necessary. Moreover, any person who interferes with a patient’s obligations under his/her health insurance contract may be viewed as tortuously interfering with that contract. However, in an advisory opinion issued on December 28, 2016, the OIG opined that, in certain instances, a non-profit, tax-exempt, charitable organization could provide financial assistance with an individual’s co-payment, health insurance premiums and insurance deductibles when a patient exhibits a financial need.
The party requesting the advisory opinion was a non-profit, tax-exempt, charitable organization that did not provide any healthcare services and served one specified disease. The non-profit, tax-exempt, charitable organization is governed by an independent board of directors with no direct or indirect link to any donor. Donors to the non-profit, tax-exempt, charitable organization may be referral sources or persons in a position to financially gain from increased usage of their services, but may not earmark funds and or have any control over where their donation is directed.
Recently, a Florida-based physician practice specializing in pain management was ordered to pay the Federal Government $7.4 after it was determined that the group’s physicians were ordering medically unnecessary drug screens and billing Medicare for those tests. Federal prosecutors contended that the group’s physicians had appropriately ordered initial drug screens on many patients, but had inappropriately ordered more extensive (and more expensive) follow up tests nearly 100% of the time. Moreover, patient medical records did not reflect the need for more extensive testing.
ASAM and announced a collaborative effort with Brandeis University to test and validate three ASAM performance measures for addictions treatment. ASAM hopes that this project will provide measure testing of performance measures that will be accepted and adopted in the treatment of patients with addiction.
Three measures will be tested using two years of de-identified Cigna claims data for substance abuse. The measures to be tested in the study will be: use of pharmacotherapy for individuals with alcohol use disorders; pharmacotherapy for individuals with opioid use disorders and follow-up after withdrawal. This is expected to be a six month project.
Addiction treatment providers continue to react to an assault by payers to run them “out of town.” The first round of attacks (in the Fall of 2014) focused on the practice of copay and deductible write offs. The phrase cooked up by lawyers for Cigna, “fee forgiveness,” wound its way into the courts system in Texas in a case (Cigna v. Humble Surgical Hospital, Civ. Action No. 4:13-CV-3291, U.S. Dist. Ct., S.D. Tex., Houston Division) against a surgery center, where Cigna argued that the practice of a physician owned hospital in waiving “patient responsibility” relieved the insurer from paying ANYTHING for services needed by patients and provided to them. Though the case did not involve addiction treatment providers, it gave addiction treatment lawyers a look into what was going to come. The same argument made in the Texas case was the initial attack by Cigna in a broad attack of the addiction treatment industry, especially in Florida.
As addiction treatment providers fielded Cigna’s “fee forgiveness” attack in the context of “audits,” providers held firm to the belief that justice would prevail and that they would soon restore a growing need for cash flow. “If we just show them that we’re doing the right thing,” providers thought, “surely they will loosen up the purse strings.” After all, this was a patient population in terrific need of help, with certain [untested] protection by federal law (the Mental Health Parity Act).
Commercial plans continue their audit activity in 2016 demanding many changes and adjustments yet giving little in return. The 2015 audits have not been completed for the majority of substance abuse providers in South Florida, yet the commercial plans have arbitrarily stopped paying new claims even though it takes them at least 6 months to complete a post payment audit. If and when a provider finally gets an audit result, payors are imposing requirements that just are impossible to meet.
Payors do not appear to be paying attention to the public health crisis of substance abuse addiction and the ever growing need for treatment. The assumption is being made by the payors that all providers in this space are over utilizing services and engaged in fraudulent practices, despite the reality that many providers are doing just the contrary.
There is nothing readily understood about the term medical necessity. In healthcare it is the “overarching criterion for payment”. There is no payment for services or supplies if there is no medical necessity to support it. Today, every provider at some time is faced with a denial because of lack of medical necessity. Physician providers will usually hear that payors do not get in the way of the physician-patient relationship. Payors typically state that they never tell a physician how to practice medicine and a denial based on lack of medical necessity is for purposes of payment only. However, what provider, on a routine basis, will continue to order care and services which medically unacceptable and not supported for payment purposes?
The definition of medical necessity varies from one commercial plan to another. Federal law such as Medicare has its definition and so does state law under programs such as Medicaid. Various medical associations such as the AMA also define medical necessity.
Generally, medical necessity refers to services or supplies which are required for the treatment of an illness, injury, diseased condition or impairment and which is consistent with a patient’s diagnosis or symptoms and are in accordance with generally accepted standards of medical practice. Services or supplies must not be ordered only as a convenience to the patient or provider. Of course care and services which are investigational or unproven are not considered medically necessary.
Health law is the federal, state, and local law, rules, regulations and other jurisprudence among providers, payers and vendors to the healthcare industry and its patient and delivery of health care services; all with an emphasis on operations, regulatory and transactional legal issues.