Acetaminophen/Oxycodone Hydrochloride

This month, the U.S. Department of Health and Human Services (HHS) and the Substance Abuse and Mental Health Services Administration (SAMHSA) took steps to expand access to opioid use disorder treatment through its new final rule, which includes a provision that permanently allows for the initiation of treatment (methadone and buprenorphine) via telehealth. However, the final rule narrowly applies to only practitioners working in Opioid Treatment Programs (OTPs) and does not include other providers like primary care physicians and addiction medicine specialists. Telehealth advocates applaud HHS’ final rule but say further action needs to be taken by the Drug Enforcement Administration (DEA) to more broadly expand access to treatment via telehealth. While HHS and SAMHSA have jurisdiction over OTPs, the prescribing of controlled substances is under the DEA’s jurisdiction. OTPs are clinics licensed by a state’s health department and require federal accreditation to dispense medication-assisted treatment (MAT) services. The telehealth capabilities for OTPs began during the Covid-19 pandemic when it was more difficult to seek treatment in person. Under the final rule, practitioners in OTPs can start patients on methadone via an audio-visual telehealth appointment and start patients on buprenorphine via an audio-only telehealth appointment. The final rule doesn’t allow for an audio-only appointment for methadone because, compared to buprenorphine, it “holds a higher risk of sedation, especially if taken by someone who already is experiencing some drowsiness,” according to the SAMHSA. In addition to the telehealth changes, the final rule also allows patients to receive take-home doses of methadone and expands provider eligibility to allow nurse practitioners and physician assistants to order medications in OTPs. It also removed criteria that required patients to have a history of addiction for a full year before being eligible for treatment. “The easier we make it for people to access the treatments they need, the more lives we can save,” said HHS Deputy Secretary Andrea Palm in a statement. “With these announcements, we are dramatically expanding access to life-saving medications and continuing our efforts to meet people where they are in their recovery journeys.” What the final rule does not include is the virtual prescribing of a broader range of controlled substances in addition to buprenorphine, such as Adderall, Percocet and Xanax. The rule also does not apply to a broader range of providers, such as primary care providers, psychiatrists and virtual providers. The DEA released a proposed rule last year that would roll back Covid-19 flexibilities that allowed a range of practitioners to prescribe controlled substances virtually. However, after receiving a record number of comments, the agency has extended the flexibilities through December of this year. And now with HHS issuing this final rule on OTPs, some are hoping the DEA will expand who is eligible to provide care through telehealth and make these flexibilities permanent. While the final rule is “really important,” one telehealth advocate is left wanting more. “We hope that this forward-looking access to care that’s been achieved through this final rule will be something that is taken up by the DEA, working in conjunction with SAMHSA on this broader overarching policy that we still don’t have a permanent foundation for. … SAMHSA has applied lessons learned to ensure appropriate levels of access for those patients who will go to treatment centers,” said Kyle Zebley, senior vice president of public policy at the American Telemedicine Association, in an interview. He added that he hopes the DEA “exceeds” what SAMHSA has done when it comes to the virtual prescribing of controlled substances. One provider who is not affected by HHS’ rule and is awaiting direction from the DEA is Bicycle Health. The Boston-based telehealth company currently offers access to buprenorphine and treats patients across 32 states. Dr. Brian Clear, chief medical officer of the company, said “it’s about time” that the HHS final rule was passed, but noted that there are limitations. In March of 2021, there were just 1,816 OTPs in the U.S., according to Pew Charitable Trusts. That just barely scratches the surface of the need when it comes to opioid use disorder. Clear argued that HHS and SAMHSA’s rulemaking is based on evidence from primary care providers and programs like Bicycle Health that shows virtual prescribing of buprenorphine is safe and effective. Therefore, it would be “absurd” if the DEA decides providers like Bicycle Health can’t also prescribe treatment virtually. Another virtual opioid use disorder provider also cheered the final rule while echoing Clear and Zebley on its limitations. “There are significant ways in which this final rule can help expand access to OTP services, but challenges also remain for patients who want or need low-barrier access to medication-based treatment for SUD,” said Ben Maclean, general counsel at Portland, Oregon-based Boulder Care. What specifically should the DEA do to expand access? Zebley of the American Telemedicine Association said the agency should create a special registration process that allows medical professionals to register with the agency in order to virtually prescribe controlled substances. Congress mandated the DEA to create this process back in 2008, but the agency has yet to do so. Zebley said it’s “dangerous to make too many predictions” about whether the DEA will follow HHS’ footsteps. However, he noted that the virtual prescribing of controlled substances has now been allowed for four years. By the time the extension ends in December, it’ll be just shy of five years. “Why would we throw the door back up, gates back up, build that wall back up and leave a lot of vulnerable patients out in the cold? I do think it is a life or death circumstance for some,” he said. “Some Americans receiving care now will have their continuity of care severed and some Americans in the future will never have this opportunity to have that level of access to care that they need when and where they need it.”

Looking for a new doctor? That’s as easy as looking for a new restaurant. Search on Yelp, Google Reviews, US News and World Report, or a dozen other online sites and you’ll find patient satisfaction scores for hundreds of thousands of doctors, rated as diners might review a chocolate souffle. These satisfaction reviews will tell you if the doctor is pleasant, reassuring, or funny. They will tell you if the staff is polite, if there are long wait times, and if there is adequate parking. Overall, they will tell you if patients are happier when they leave the office than when they came in. But there’s one big problem: patient satisfaction scores tell you nothing about whether a doctor is good at curing people. In fact, patient satisfaction scores can lead to unnecessary healthcare costs, unnecessary injuries, and in some cases, the preventable deaths of patients. Patient satisfaction scores play a major role in helping doctors attract patients and they incentivize doctors to keep patients happy. Afraid of receiving negative ratings, some physicians are intimidated into granting patient requests for tests, medications, or procedures that are expensive, unnecessary and sometimes even dangerous. Like all medical procedures, unnecessary ones can harm patients or even lead to deaths. In fact, one massive study of patients who provided satisfaction scores found that patients who were most satisfied with their doctors had higher mortality rates than dissatisfied patients. In 2012, researchers at the University of California at Davis, using data from nearly 52,000 adults, found that the most satisfied patients also spent the most on healthcare and prescription drugs. They were 12% more likely to be admitted to the hospital and accounted for 9% more in total health care costs. Strikingly, they were also the ones more likely to die. The study researchers suggested that the most satisfied patients have a higher mortality rate because they receive more discretionary services–interventions that carry a risk of adverse effects. As an orthopedic surgeon who has treated thousands of patients, I have seen the tyranny of patient satisfaction ratings at work. Say a patient demands a powerful opioid like Percocet, a highly addictive pain killer. You, as their doctor, know they should take a less powerful, non-addictive pain killer. You also suspect that the patient is an opioid addict. The right thing to do is to say no. But you also know that if you deny this patient, he can easily post terribly derogatory reviews online. Potential new patients will see those reviews and stay away. Your kids will see it and think their dad is a bad doctor. Medical peers will see it and wonder what is going on. The easiest thing to do is the wrong thing to do: write a prescription for Percocet and send the patient on his way. Don’t take my word for it. One state medical society survey of 155 respondents found that more than half had ordered inappropriate tests and prescribed inappropriate antibiotic or opioid pain medication as a result of patient satisfaction scores. A third had unnecessarily admitted a patient into hospital and almost half of respondents believed they had provided inappropriate patient care in deference to patient satisfaction ratings. In addition to focusing doctors on patient catering over patient care, subjective reviews fail to gather objective data that indicates how much improvement (or worsening) a given doctor has been able to help prior patients with similar conditions achieve. Take for example, a 5-star review from a patient who achieves 50% improvement in their symptoms after being treated by a doctor with a great bedside manner and a beautiful office. Conversely, a patient who achieves 100% improvement from a doctor with a poor bedside manner (or timeliness, parking, staff, office lighting, etc..) is likely to give them a poor review. What we really want is a way to differentiate which doctor is most likely to give us the best result. Is knowing that information even possible? Luckily, it is. Patient Reported Outcome Measures (PROMs) can provide objective data on the effectiveness of providers, as patients report their symptoms, functional status, and quality of life using science, not subjective opinions. PROMs are standardized and validated questionnaires that gather critical data on patient improvement. They are developed through extensive research and validation processes to ensure their reliability, validity, and relevance. They are the same questionnaires used in FDA studies and clinical trials. PROMs scores should be the gold standard for how patients find their doctors, not viewing subjective online reviews of doctors’ ability to satisfy their patients. For example, Newsweek and Statista recently developed a PROMs implementation survey to determine the current state of PROMs implementation in hospitals. The results of this survey were incorporated into the 2023 editions of Newsweek’s World’s Best Specialized Hospitals and World’s Best Hospitals rankings. But PROMs are generally not available to the public and gathering PROMs data requires extra work by physicians and their staffs. Nonetheless, if PROMs data were available, they would reduce healthcare costs, eliminate some unnecessary procedures, and even prevent avoidable deaths. A major step would be for the Centers for Medicare and Medicaid Services, which administers Medicare coverage for 60 million Americans, to begin meaningfully incentivizing physicians and other providers to collect PROMs data on their practices and make that data available to the public. Once government has begun a push for PROMs, the private sector is likely to follow suit, providing an alternative source of information that truly reveals who is practicing medicine well and who is not. It is time for the healthcare industry to put an end to the tyranny of subjective patient satisfaction ratings. It is more than an issue of being fair to doctors. It is a matter of doctors first doing no harm.