With Increase in Fraud, Physicians Face Stricter Regulations
The Attorney General’s investigation into opioid prescription fraud and abuse will increase scrutiny on throughout the health care industry. With pain management in the spotlight, Janice Jacobs offers advice on how providers can ensure they are in compliance with the strict regulations and documentation requirements that will soon be put in place.
On July 13, 2017, the largest crackdown in U.S. history occurred when 412 people, including doctors, nurses and pharmacists, were charged with defrauding federally funded health programs of $1.3 billion. Among those included: a Florida treatment center enticed patients with airline tickets, cash and gift cards; and a Houston physician wrote hydrocodone prescriptions in exchange for $300 cash per visit. These examples are clear instances of blatant and reckless abuse, and Attorney General Jeff Sessions stated that “federal investigators believe that there are a lot more cases that need to be brought.” This will place increased scrutiny on all pain management practices and other providers who prescribe opioids to manage chronic and severe pain in patients.
Opioids were first used in the United States as a comfort measure for terminally ill patients, with the philosophy that dying patients should not suffer with severe pain in their final days. In the mid-1980s, members of the American Society for Pain argued that treatment for pain should not be limited to terminally ill patients and that no patient should have to suffer with pain when relief is available. Opioids were touted as a safe and humane alternative to surgery or to no treatment at all, provided the patient had no history of drug abuse.
The intended use of opioids is to relieve short-term acute pain, such as post-operative pain, in which case the benefit typically outweighs the risk. Opioids include morphine, methadone, buprenorphine, hydrocodone, and oxycodone. Heroin is also an opioid and is illegal. Opioid drugs sold under brand names include OxyContin®, Percocet®, Vicodin®, Percodan®, Tylox®, and Demerol®.
As more patients sought relief from long-term chronic pain, pain management became more challenging for providers due to the highly addictive nature of opioid treatment. Long-term use of opioids has various negative effects in addition to dependence, including kidney, liver and heart damage, as well as long-term effects on brain function. Long-term use must be carefully monitored to mitigate risk. For some patients, relief of pain is worth the risk of some side effects for them to maintain a reasonable quality of life.
A prescribing physician must determine the lowest dose possible to effectively relieve pain for the shortest duration while considering alternative therapies to supplement treatment, such as physical therapy, nerve blocks and trigger-point injections. Pain management physicians face the continuous and complex challenge of treating pain without creating addiction. With so many individuals suffering from addiction, a physician must carefully assess new patients to determine the legitimacy of a complaint and whether the patient would be accepted into a treatment program. Once accepted, patients must be carefully monitored via lab panels to ensure that they follow treatment protocol and do not abuse prescriptions.
Physicians also have to consider a patient’s other medications and associated drug interactions, as well as how to wean patients off opioid therapy as part of long-term treatment programs. Alternative medications, such as Suboxone, may be required to gradually reduce dependence on opioids and may carry their own side effects and risk factors. Additional medication may be required for lesser side effects like nausea and constipation, creating a ripple effect not only for patients, but also for insurers and society as a whole. A recent Time magazine article indicated that $1.9 billion was spent on opioid-induced constipation drugs alone in 2014. 
It is safe to assume that the Office of the Inspector General (OIG) will enhance its scrutiny of pain management professionals and other providers writing opioid prescriptions. The goal is to identify and prosecute serious offenders that intend to defraud federally funded programs. Unfortunately, conscientious providers will find themselves in the middle of this scrutiny and will face stricter regulations and documentation requirements.
Pain management practices should review evaluation and management (E/M) requirements and perform internal audits to ensure their documentation and coding supports the E/M levels of service billed. Frequently, pain management physicians misinterpret the rules for the risk component of medical decision-making and automatically assess the E/M level at the highest possible risk score in an effort to capture the physician’s own risk rather than the risk to the patient. This common error in the pain management specialty will result in higher-than-appropriate E/M levels billed to payers, which may result in a practice being flagged as an outlier by the OIG.
Clear and accurate documentation of medical necessity to support the use of opioids for pain management will also be critical. Documented plans of care (POC) outlining the course of treatment are necessary to support ongoing pain management. Physicians may soon be required to show documentation of progress or relief of symptoms to justify continued use of such medications. Lab studies performed in the office to detect overuse and abuse of prescription medication will be critical pieces of documentation to support POC oversight.
All providers submitting claims to federally funded payers should review their existing compliance programs, identify gaps and make necessary modifications to align existing programs with the OIG’s compliance program guidance. In the past, existence of a compliance program weighed favorably when the OIG was determining exclusion from participation in the Medicare program due to violation(s) of the Federal False Claims Act. But in April 2016, the OIG updated its criteria for exclusion determination to state that the presence of a compliance program will have no bearing on the OIG’s assessment of risk in determining exclusion. The new criteria further states, “The absence of a compliance program that incorporates the U.S. Sentencing Commission Guidelines Manual’s seven elements of an effective compliance program indicates higher risk.”
An additional layer of responsibility for providers stemmed from issuance of the Yates Memo in 2015 that imposes individual accountability and liability for corporate wrongdoing. In light of the unprecedented enforcement of fraud and abuse regarding the opioid epidemic, providers must be diligent in operationalizing proactive measures to mitigate the risk of healthcare fraud to its lowest possible level.
The views and opinions expressed in this article are those of the author and do not necessarily reflect the opinions, position, or policy of Berkeley Research Group, LLC or its other employees and affiliates.
 Haley Sweetland Edwards, “The Drug Cascade,” Time magazine (July 3, 2017), available at: http://time.com/4828108/the-drug-cascade/
 OIG, Criteria for implementing section 1128(b)(7) exclusion authority (April 18, 2016), available at: https://oig.hhs.gov/exclusions/files/1128b7exclusion-criteria.pdf
 U.S. Department of Justice, Individual Accountability for Corporate Wrongdoing, memo (September 9, 2015), available at: https://www.justice.gov/archives/dag/file/769036/download