Magazine Article | May 27, 2015

Opioid Epidemic Draws Congressional Scrutiny

Source: Life Science Leader

By John McManus, president and founder, The McManus Group

The opioid abuse epidemic, which started in the South and Appalachia, has spread nationwide and is now receiving heightened attention from policymakers. Opioids, which have been used for hundreds of years to relieve pain, have addictive properties with high risk for abuse and are often connected with unintentional overdose and polypharmacy with the elderly. More than 16,000 people die in the U.S. each year from overdoses of pain relievers — more deaths than any other drug, according to the Pew Charitable Trusts.

Policymakers are grappling with balancing two competing goals of restricting clearly abusive consumption of opioids by many addicts with appropriate access for patients who truly need them to treat severe and chronic pain.

In addition, consumption of “synthetic” opioids — drugs meant to deter overdoses or utilization of methadone restricted to a clinic setting — has been a deliberate public policy since enactment of the Drug Addiction Treatment Act 15 years ago.

According to the Substance Abuse and Mental Health Services Administration (SAMHSA), which is tasked with leading the country’s public health response to opioid and heroin addiction, nearly 1.5 million addicts were “treated” with synthetic opioids in 2012 — a five-fold increase in the last 10 years. At a recent Energy & Commerce Committee Oversight and Investigations Subcommittee hearing, Chairman Tim Murphy (R-PA) said, “I do not call this ‘treatment.’ It is addiction maintenance.”

Even the Medicare program is experiencing the opioid phenomenon. A recent Medicare Payment Advisory Committee’s examination of the issue found more than one-third of Medicare beneficiaries — 12.3 million — filled at least one opioid prescription. The top 500,000 Medicare opioid utilizers filled at least 23 prescriptions and accounted for 70 percent of the total $1.9 billion spent on opioids in Medicare in 2012. Almost two-thirds of the Medicare beneficiaries who utilized opioids qualified through their disability status.

Opioid addiction can have tragic clinical and human consequences, especially with pregnant addicts, as newborn babies become addicted while in the womb. Newborns exposed to opioids in utero may be born prematurely with low birth weight, have feeding difficulties, irritability, and seizures, and experience significantly longer hospital stays. Withdrawal symptoms, referred to as “neonatal abstinence syndrome,” develop shortly after birth. Symptoms include loud, high-pitched crying, sweating, tremors, and gastrointestinal and respiratory difficulties.

“A recent Medicare Payment Advisory Committee’s examination of the issue found more than one-third of Medicare beneficiaries — 12.3 million — filled at least one opioid prescription.”

A February 2015 Government Accountability Office (GAO) report on prenatal drug use and newborn health found that the government needs a better coordinated approach to this growing problem. The GAO commented that within Health and Human Services, there are nine agencies that address prenatal opioid use, but HHS “lacks a focal point to lead planning and coordination of efforts related specifically to opioid use or neonatal abstinence syndrome across the department … which limits the effectiveness of federal efforts to reduce prenatal opioid use among pregnant women. Additionally, there is a risk that federal efforts may be duplicated, overlapping, or fragmented.”

Local leaders at the front line of the epidemic are not waiting for the federal bureaucracy to coordinate a plan. Dr. Stefan Maxwell, of the MEDNAX Medical Group and chair of the West Virginia Perinatal Partnership, commented, “Pregnancy offers a unique opportunity for treating substance abuse because women are typically highly motivated to modify their behavior and deliver a healthy baby.” In 2012 the Partnership embarked on a Drug Free Moms and Kids project to provide a comprehensive effort to screen all women in eight hospitals at their first pregnancy to identify those who use drugs and provide treatment to wean them off drugs. Preliminary results are promising — in one pilot site, those testing positive dropped from 19 percent to 8 percent in the first two years.

Congress is now focusing on the issue. The Energy and Commerce Committee has held a series of hearings to examine the problem and develop solutions. While consensus has not yet been achieved with stakeholders, legislation is now being advanced to address the problem.

Patients addicted to painkillers often get numerous physicians to surreptitiously prescribe opioids, making it difficult for a physician to know whether the patient is taking too much pain medication. The Ways and Means Committee included a provision in its fraud and abuse bill that would have replicated in Medicare the drug management protocols already under way in many state Medicaid programs, which require the patient to receive opioids from only one doctor and fill them at a single pharmacy.

While that provision was dropped from the landmark Medicare Access and CHIP Reauthorization Act that repealed the Medicare sustainable growth formula, the Energy & Commerce Committee has picked up the concept in its 21st Century Cures legislation, a bill that represents more than a year’s worth of work by the Committee. But rather than restrict the patient to a single physician prescriber, the Energy and Commerce Committee bill would restrict the patient to a single pharmacy.

As might be expected, the single prescriber proposal has faced opposition from the American Medical Association and other physician groups, and the single pharmacy provision has generated opposition from some pharmacy groups, including the National Community Pharmacists Association.

A more fundamental problem is that the solutions themselves often beget different, more serious problems. For example, the National Association of Pharmacy Board’s InterConnect program facilitates the transfer of prescription monitoring program (PMP) data across state lines to authorized users, and 28 states are now participating. It allows participating state PMPs across the United States to be linked, providing a more effective means of combating drug diversion and drug abuse nationwide. This has made abusing prescription opioids more difficult.

However, this program, as well as a reformulation of OxyCotin to make it harder to abuse, may have caused heroin use to spike dramatically. Theodore Cicero, a psychiatry professor at Washington University said, “Much of the heroin use you’re seeing now is due in large part to making prescription opioids a lot less accessible.’’ The increased use of heroin and other opioids has also facilitated new outbreaks of HIV and Hepatitis C infections among this population, as addicts share dirty needles.

The Centers for Disease Control reported that a “severe outbreak” of HIV infections has soared in rural Indiana among users of a prescription opioid called Opana, which must be injected multiple times a day. More than 142 people were infected in Scott and Jackson counties, which have a population of only several thousand people, prompting the state to declare a state of emergency for that area. Conservative Governor Mike Pence (R-IN) also signed an executive order providing needle exchanges, which studies show reduce new infections.

Similarly, the Affordable Care Act, which requires Medicare patient satisfaction surveys to help rank hospitals in the Value-Based Purchasing program, could be contributing to prescription opioid drug abuse phenomena. In 2014, Senators Chuck Grassley (R-IA) and Dianne Feinstein (D-CA) wrote to the Centers for Medicare and Medicaid Services (CMS) “There is growing anecdotal evidence that these surveys may be having the unintended effect of encouraging practitioners to prescribe [opioid pain relievers] unnecessarily and improperly,” in order to solicit higher patient satisfaction surveys. Anna Lembke, MD, a professor of Psychiatry at Stanford University, testified at Energy and Commerce, “Many doctors are afraid that patients will sue them or complain about them if they don’t prescribe opioids, even when the doctor knows the opioid is harming the patient … Congress can push back against the opioid epidemic by requiring a revision of heath care quality measures to reduce over-prescribing.”

Obviously, no single solution will solve this complex problem. Multi-pronged approaches that are being tested in communities should be examined for propagation across the country. This will require bringing all stakeholders to the table and constantly monitoring what works and what may be producing unfortunate side effects.