DEA Appears Open to Tele-Script for Certain Controlled Substances

On August 7th, the Drug Enforcement Agency (DEA) issued a notice of meeting regarding telemedicine prescription of certain controlled substances (Schedule II only). The meeting(s) will be conducted as “listening sessions”, conducted Tuesday, September 12th, and Wednesday, September 13th from 9 a.m. to 5:30 p.m. at the DEA Headquarters (located at 700 Army Navy Drive, Arlington, VA). Participants must pre-register using this link, before or on August 21st. In-person requests will be granted via lottery and the sessions will be live-streamed. Similarly, those wishing to provide limited oral presentation, either in-person or via live-stream must also fill out the form. Again, these will be selected by DEA personnel based upon quality of summary of presentation. Presentations may be made by anyone with an interest in and expertise in the subject matter. The DEA has asked for feedback on the following questions:

• If telemedicine prescribing of schedule III–V medications were permitted in the absence of an in-person medical evaluation, what framework, including safeguards and data, with respect to telemedicine prescribing of schedule III–V medications do you recommend to help DEA ensure patient safety and prevent diversion of controlled substances?

• Should telemedicine prescribing of schedule II medications never be permitted in the absence of an in-person medical evaluation? Are there any circumstances in which telemedicine prescribing of schedule II medications should be permitted in the absence of an in-person medical evaluation? If it were permitted, what safeguards with respect to telemedicine prescribing of schedule II medications specifically would you recommend to help DEA ensure patient safety and prevent diversion of controlled substances?

• If practitioners are required to collect, maintain, and/or report telemedicine prescription data to DEA, what pieces of data should be included or excluded? What data is already reported to federal and state authorities, insurance companies, and other third parties?

• If pharmacies are required to collect, maintain, and/or report telemedicine prescription data to DEA, what pieces of data should be included or excluded? What data is already reported to federal and state authorities, insurance companies, and other third parties?

The listening sessions come as a direct result of the DEA receiving truly unprecedented responses to proposed rules published in March, in anticipation of the end of the COVID-19 public health emergency, and, thus, the DEA’s telemedicine waiver issued at the beginning of the COVID-19 pandemic. In all, the DEA received almost 40,000 comments across the proposed rules with much focus on the General Telemedicine proposed rule. We covered the content of those rules (and why they were a step backward as written) in March. In particular, we expressed concern over returning to pre-pandemic limitations on telemedicine when the pandemic-related waiver did not prove any spike in diversion and did, indeed, improve access to medication assisted substance use treatment for many patients. Along similar lines, because testosterone is considered a controlled substance, such a return at the height of bias-driven, state-based legislation limiting access to certain gender affirming care would have a disproportionately harmful impact among transgender men and undermine President Biden’s commitment to combat these hateful efforts.

The relationship between the DEA and harm reduction advocates has been long and fraught. Many harm reduction advocates criticize the role of law enforcement’s actions, particularly that law enforcement agency, working against best practices in public health, even those best practices recognized by federal public health agencies. For example, a couple of weeks ago, we highlighted the Substance Abuse Mental Health Administration’s document (currently open to public comment) aimed at formalizing certain policy positions, entitled Harm Reduction Framework. Nowhere in the “framework” is the conflict with law enforcement positions addressed.

Putting more pressure still on the DEA’s absolute refusal to meet its commitment from 2009 to introduce meaningful telemedicine rules (in response to passage of the Ryan Haight Online Pharmacy Consumer Protection Act) is the fact that the stimulant medication shortage is at its worst. Things are so bad the U.S Food and Drug Administration (FDA) and DEA issued a joint letter on August 1st to further detail actions being taken to address the shortage and consumer struggles. The problem with the letter is it is largely bypasses the responsibility the DEA has in the current situation. Leaning into a claim that manufacturers haven’t filled their annual quota limits in production and pointing fingers at an increase in legitimate prescription of stimulants to manage conditions like attention deficit hyperactivity disorder (ADHD), the letter fails to recognize that the DEA also places extraordinary limits and scrutiny on pharmacies dispensing stimulant medications. Known as “drug diversion”, the idea behind monitoring pharmacies has some merit when viewed under the lens that pharmacies have a responsibility to limit index events like those “pill mills” associated with the opioid epidemic. However, the DEA doesn’t take responsibility for pharmacy raids or strict enforcement against prescribing providers working to keep patients from turning to street supplies by providing legitimate prescriptions.

For the DEA to be a meaningful partner in combatting both illicit and harmful drug use and overdoses and help to address drug shortages, limiting harmful diversion, the agency needs to consider a dramatic shift from an “all drugs are bad, and the people who use them are bad” mindset. There needs to be a thoughtful “medium, wherein stakeholders other than law enforcement can engage in distinguishing best practices in supply chain security and harm reduction and readily identifying criminals taking advantage of patients seeking care by any means they can achieve it – including illegal and illicit channels.

Patient advocates outside of harm reduction and substance use disorder focuses and the industry stakeholders who serve these patients would do well to consider engagement in these and other opportunities to help re-shape and re-imagine the DEA’s role, ideas, and programs to better serve the public at large, better secure the supply chain and limit disruptions, and ensure patients can have ready, reliable, and modernized access to the care we need.

DEA Proposed Rules Risk Harming Access to Care

Since the beginning of the COVID-19 pandemic, the United States Drug Enforcement Administration (DEA) has held certain relaxed or waived rules regarding prescribing of controlled substances. On January 30th, President Biden announced his administration would end the public health emergency (PHE) declaration related to COVID-19 in May of 2023, after one, last renewal in February. Part of what’s being called an “unwinding” of the PHE includes returning to “normal” operations for executive entities like the DEA. But times have changed dramatically in terms of healthcare access since the beginning of the COVID-19 pandemic, most notably around the issue of telehealth. Thus, on February 24th, the DEA announced two proposed rules regarding permanent telehealth access and prescribing related to controlled substances.

The DEA’s controlled substances list is…controversial, to say the least. The five category list includes those which the agency has deemed to have the “potential for abuse or dependency” characterization. Schedule “V” (five) having a “low” potential for abuse relative to other levels and having sufficient medical value, resulting in quantity limits but, typically, not more than that in terms of regulatory impact. These medications include certain cough medicines and an anti-diarrheal medication, among others. Schedule “I” (one) substances as having been deemed to have “no” medicinal value, a high potential for abuse, and a lack of accepted safety for use even under medical supervision. These substances include marijuana, “ecstasy”, LSD, and peyote. In between these, you’ll find certain pain killers, treatment for attention deficit disorder (ADD), anabolic steroids, and medications used to treat opioid use disorder (OUD). The DEA’s proposed telehealth rules (here and here) would allow for a provider who has never conducted an in-person assessment of a patient to only prescribe up to a 30-day supply of schedule III-V non-narcotic medications and a 30-day supply of buprenorphine. In order to get a refill or maintain treatment, a patient would have to then arrange for an in-person assessment. For patients referred by a provider who has already conducted an in-person assessment in the last year or for providers who are directly prescribing the medication and have already had an in-person assessment in the last year, the limitations on telehealth would not apply.

Particularly, in the rules, the DEA argues medications used to treat OUD are at risk of diversion and misuse, despite evidence that misuse is relatively rare and declining and despite the fact that only about 11% of the population which could benefit from medication assisted treatment (MAT) have access, according to a report from the Substance Abuse and Mental Health Services Administration (SAMHSA). Reasons for limited access are slowly being addressed. Most notably, the “X-Waiver”, a program which limited which prescribers could offer buprenorphine and other MAT and how many patients they could treat. The “X-Waiver” requirements were repealed in Section 1262 of the Consolidated Appropriations Act of 2023 (otherwise known as the Omnibus). Another giant barrier to prescribing MAT is provider stigma. This stigma against people who use drugs (PWUD) often leads to patients having an exceptionally hard time finding a provider willing to help them, when they need it. Years of prescribing limits and the vagueness of the DEA requiring pharmacies to report “suspicious” orders (the DEA does not define what’s constitutes “suspicious”), has also left pharmacies, wholesalers, and distributors exceedingly cautious as not gaining the DEA’s ire. With these proposed rules, the biggest barrier to President Biden’s plan to expand access may be the bureaucracy he enabled as a Senator and Vice President (Politico details more here).

Additionally, some states are attempting to ban access to gender-affirming care; not just for minors but for anyone accessing public payer programs and even attempting to forbid private, commercial plans from offering gender affirming care. While these would not necessarily impact access to care for transgender women seeking out-of-state telehealth, it would adversely affect transgender men because testosterone is a schedule III controlled substance. Thus, under these rules, transgender men would have to have in-person assessment with a provider in order to begin or continue accessing prescribed testosterone replacement therapy. Where this is a bit of a “come uppins” moment for President Biden is in his historical record of championing the Anabolic Steroid Control Act of 2004, making testosterone and anything related to it a controlled substance. The law rose to a certain popularity because of major sports leagues in the United States insufficiently addressing steroid use among professional athletes. The world has changed greatly since then and most, if not all, of those entities have adopted tight controls and regular screenings of athletes (which do need some update to appropriately reflect the endocrinological variety the human species offers). A carve out in the law would allow for the DEA to exempt medications which “does not present any significant potential for abuse.”

Chronic pain patients, disability advocates, harm reduction advocates, and advocates for access to gender-affirming care are sufficiently outraged to see their life-saving care being ripped from the ease of telemedicine. Leo Beletsky, a law professor at Northwestern University said, “The fallout is going to be measured in lives lost.” Dr. Brian Hurley, the president-elect of the American Society of Addiction Medicine said, “I would posit that untreated opioid use disorder is a bigger threat to public safety currently than the risk of diversion.” “forcing people with disabilities who are immunocompromised or high-risk to choose between potential COVID exposure and forgoing vital medications is ableist and dangerous,” said Madeline T. Morcelle of the National Health Law Program. Adult ADHD patients are already fighting a shortage on their medications and providers who will prescribe them. And with the rural health care crisis limiting access to providers for queer people, disabled people, and PWUD, this rule will strip them of the only time they’ve seen their access to care expand in decades.

A bi-partisan, bi-cameral group of legislators have written a letter to the DEA cautioning against these rules and Senators Warren (D-MA) and Ed Markey (D-MA) have also written a letter to the U.S. Department of Justice, U.S. Department of Health and Human Services, and the DEA about de-scheduling testosterone. Neither letter has been answered yet. Orion Rummler of 19th News recently asked for an update and will be following up on the status of a response from the Biden Administration and executive agencies.

With these massive concerns on finding and accessing care, patients may well turn to the black market or grey market to self-manage the life-saving medications they need. This not only defeats the purpose of the DEA’s rules in attempting to prevent diverse by artificially creating a market for illicit trade, it exposes patients to risks of infections, counterfeit medications, and other safety hazards.

Patients should not have to risk their lives and even incarceration in order to access life-saving medications they have readily enjoyed over the last three years. The DEA should engage providers, advocates, and patients more than any other stakeholder from law enforcement to approach promulgation of these rules in a way that aligns with public health instead of carelessly chasing after ways to limit access to life-saving medications.

The proposed rules aim to come into effect in November. The public comment period ends on March 31, 2023. We encourage our partners, including those not directly involved in issues of substance use or production of controlled substances, to comment in support of adjustments to the proposed rules that would maintain telehealth access to care, meet the stated public health goals of the Biden Administration, and, most directly, maintain access to the life-saving medications patients depend upon. The public may submit comments here and here.

Nevada Adds New Syringe Exchange Vending Machines, Building on Success

Just before the holiday, the Southern Nevada Health District (SNHD) announced it would be showcasing a newly added harm reduction vending machine to the located at the main SNHD health center on Decatur Boulevard in Las Vegas. In a year where other some jurisdictions are seeing local and state legislators push back against harm reduction programs of all sorts, the Las Vegas health entity has chosen to invest in successes already achieved and expand their vending machine program.

In 2017, Nevada became the first state in the country to offer syringe exchange services via vending machine, after the legislature passed a harm reduction measure allowing the state to fund these efforts, known as HB 410. Nevada’s syringe change program is operated by Trac-B Exchange out of a store front and the entity was one of three in which the program launched as a pilot. Sometimes called “public health” vending machines when numerous types of self-administered care supplies are offered, kits in the machine include syringes, tourniquets, a disposal container, first aid supplies, safe sex supplies, naloxone (the opioid overdose reversal medication), pregnancy tests, and hygiene kits. Health officials also highlighted how these kits might be used for “street” hormone replacement therapy, or when a transgender person is not engaged in traditional care but is still acquiring hormone medications (commentary also addressed bodybuilders for similar activities). The machines do not require cash to operate, rather a person seeking to use the machine is required to fill out a form and will receive a code and card. Identifying information is not required to receive access to the vending machines. Advocates and program operators have cited how the machines save public dollars by reducing the labor burden and keeping more people engaged in care.

In 2017, Las Vegas had at least 5,800 active injection-drug users and program staff have cited the success of the pilot as to part of why the newest vending machine was added. With nearly ten percent of Nevada’s new HIV diagnoses being attributed to illicit syringe use and the well-studied benefits to reducing Hepatitis C transmissions, SNHD’s newest addition seeks to engage a broader range of the public as the kits offered are more expansive in meeting care needs. Since the 2017 pilot launch in Nevada, other jurisdictions have considered beginning their own programs (not without opposition). Ohio, for example, launched a vending project in early 2021 (in part to reduce the risks associated with in-person care during a wave of high COVID-19 transmission), making it the second state to offer this type of access program. Those machines included “smoking” kits and their safe consumption kits also include fentanyl testing strips as options. Since the launch, more than 1300 items have been dispensed and almost 600 overdoses have been reversed in the community the vending machine serves.

Research released in June of 2022 found the anonymous nature of the vending machine programs was critical for many people using them. Researchers established a baseline of foot traffic for the machines by setting up a camera (which would identify consumers), afterwards setting up near the machine to offer services and information. While some consumers engaged with peers they recognized, many chose not to and the researchers had good indication at least a few potential consumers avoided the machine they might otherwise use because of the researchers’ presence. In an interview as part of the study, one person admitted to avoiding getting supplies they needed because of police presence near the vending machine. This presents a difficult-to-balance issue in working to ensure people using the machines are actively linked to care they need. Potential solutions include offering a QR code on the machine, reliance on drug using and former drug using peers to staff tables, information inserts in each kit, and possibly having a table staffed at regularly posted times so that consumers could chose to engage when and how they’d like. However, the issue of police presence as a deterrent to seeking care will remain a barrier and has been problematic for other syringe exchange programs across the country. Because law enforcement activity appears to be a significant barrier to engaging in harm reduction services, specifically syringe exchange programs or in reporting overdoses (the limitations of Good Samaritan laws vary by state, often with carve outs for drug users reporting a need for help for a friend), legislatures could address the conflict by passing laws which carve out certain enforcement, but prosecutors and police department leadership need to “buy-in” as well. Reducing uniformed patrol around these areas or committing to not prosecute people seeking harm reduction services and products via vending machines would go a long way to reducing law enforcement engagement with patient populations, increasing trust with affected communities (with both law enforcement and care provider entities), and increasing engagement with these critically necessary, life-saving programs.

Despite All Evidence in Support of Harm Reduction, Stigma Drives Public Attitudes

Earlier this year, a false claim spurred outrage from commentators and politicians regarding federal grant dollars for harm reduction programs across the country. Shortly after, in April 2022, the U.S. Department of Justice (DOJ) issued guidance on how the Americans with Disability Act (ADA) provides protections for people with opioid use disorder (OUD), which may also apply broadly to people with substance use disorder (SUD). From local and national advocates to actions from the Biden Administration, as a nation, the United States is facing the greatest change in drug policy since the Nixon Administration introduced a national policy officer (“drug czar”) on the issue. Forty years after Nancy Reagan’s “Just say no” campaign and the abject failure of the D.A.R.E. (drug abuse resistance education) program, the United States’ “War on Drugs” has only succeeded in criminalizing a health status with, up until relatively recent history, with broad bipartisan support. The effort to combat the stigma sewn into the fabric of our social attitudes towards drug use and misuse is coming to a fever pitch.

Scrolling through my own social media, I can across Representative Malinda Brumfield White’s post regarding a methadone clinic opening in Bogalusa – expressing “concern” for the location. The comments were rife with assumptions as to what the clinic might “mean” for the area and opposition to its location. The animus voiced is the exact type of animus an industrious litigator might cite to prove the attitudes DOJ cited as discriminatory and might spur actions which could violate the ADA. This clinic didn’t pop up out of nowhere, Louisiana’s legislature ordered a needs assessment on the impacts of the opioid crisis in 2018 after the Governor Bobby Jindal ushered in closing of most of the clinics in the state. Subsequently, the state’s health department identified a need to establish at least 10 new harm reduction service providers, focusing on addiction treatment centers (specifically, medication assisted treatment). A request for proposals (RFP) was issued in late 2021 and signed with Behavioral Health Group (BHG) shortly thereafter. But it’s just now that the local electeds are making noise about the clinic – as the operation is getting set to open.

Meanwhile, in California, Governor Gavin Newsom is rumored to be thinking about vetoing SB57, a piece of well-supported state legislation that would allow for pilot project locations for safe consumption sites. The project would be the largest yet seen, after New York allowed for a similar project last year, and is facing tough opposition even after the bill passed out of the state’s legislature, with a concerted campaign urging Governor Newsome to veto the bill. New York expanded their project this year thanks in large part due to the success of reversing hundreds of overdoses already.

Vermont’s Governor has already vetoed a similar bill. Though, that veto also axed additional funding for multiple modalities of harm reduction, including ones already existing in Vermont, Governor Phil Scott specifically cited the safe consumption sites projects as “counterintuitive” – a statement rooted in stigma (his assertation that data did not exist to support the project is false – see previous links on New York’s success). A bill in Kentucky to initiate a pilot project didn’t even get a committee hearing this year. And Rhode Island is finally finding a way to fund safe consumption sites – by using the state’s opioid settlement dollars. Rhode Island had already passed a law allowing study of safe consumptions sites, the legislation just did not include any funding to do so and those entities interested in opening sites were hard strapped to find enough private funding to open.

In other states, advocates are playing slower “games”, taking time to further educate their legislatures and communities. In North Carolina, experts took time to both debunk the claim the Biden Administration was pushing on smoking pipes but also how those same tools would be an improvement in harm reduction offerings already existing in the state. In Massachusetts, elected representatives are supportive of safe consumption sites but elected law enforcement isn’t. Those same elected law enforcement officials are peddling stigmatizing ideas with ominous sound bites like “let’s ask people in neighborhoods where they already exist and see if they feel it’s safer.” When there’s no one there to challenge these ideas, or journalists’ follow up questions aren’t answered, the dark clouds gather around pious suburbanites as if their own families aren’t one or two degrees of separation from experiencing the damaging impacts of an unabated overdose crisis.

Decades old attitudes which moralize a health condition as a personal failing and threat to our families hasn’t worked. Indeed, overdose deaths and non-fatal morbidities are on the rise…again. Despite having the tools, decades of behavioral intervention study, and a desperate need to address this issue, we keep seeing the same approached used over and over again – stigmatize, criminalize, and isolate. Our elected officials have an obligation to both educate themselves and advocate for more effective policy. The families affected by the opioid crisis, substance use disorder, Hepatitis C, and HIV are the voters and constituents these representatives are tasked to…represent. As advocates trudge on in sharing stories, we must leverage what we know to be true. This is indeed a moral fight – it is immoral and unethical to allow people to die with a callousness of disinterest, even triumph as if those deaths are somehow “deserved”. While our lawmakers are returning home as the federal legislative session comes to a brief break, they must also take this moment to lead their constituents in making the moral choice and support comprehensive harm reduction policies and programs.

Treatment Restrictions Hampering Hep C Harm Reduction Efforts

In January, Harvard’s Center for Health Law and Policy Innovation (CHLPI) and the National Viral Hepatitis Roundtable (NVHR) issued their 7th update to the Hepatitis C: State of Medicaid Access report. Originally published in 2017, the report seeks to evaluate and document the nuances of Hepatitis C treatment access in state Medicaid programs and was borne out of the payer originated barriers instituted after curative direct acting agents (DAAs) came to market as concerns over cost rose, especially in light of the fact that a patient being cured does not mean they cannot be re-infected and the most at-risk population for contracting HCV are drug users. The combination of moralized policy making and fiscal fears set the stage for Medicaid to offer curative HCV treatments as a “yes, but…” situation.

Medicaid coverage of treatment came with layers of restrictions on patients and providers alike. From more common utilization management practices, like prior authorizations, to restrictions in who can access treatments (sobriety and fibrosis requirements) and requiring patients to visit a specialist in order to receive coverage (when a primary care physician should be able to manage the necessary care), barriers abound. Harm reduction advocates rightly pointed out refusing treatment coverage worked against best practices in interrupting HCV chains of transmission. Indeed, the American Association for the Study of Liver Diseases has strongly discouraged sobriety requirements because doing so artificially inserts barriers to care and harms public health efforts to eliminate HCV, stating:

… there are no data to support the utility of pretreatment screening for illicit drug or alcohol use in identifying a population more likely to successfully complete HCV therapy. These requirements should be abandoned because they create barriers to treatment, add unnecessary cost and effort, miss an opportunity to decrease HCV transmission, and potentially exclude populations that are likely to obtain substantial benefit from therapy. Instead, scaling up HCV treatment in PWID is necessary to positively impact the HCV epidemic in the US and globally.

The pushback against the moralized argument, which frames drug users as “unworthy” of receiving potentially life-saving care, is that people who use drugs are still patients and we don’t get to tell patients how to prioritize their care based on a payer or provider’s biases. Just as providing gender affirming care results in improved health outcomes in transgender people living with HIV, providing people who use drugs with the medical care they need to cure HCV improve the behavioral health factors that contributed to drug use in the first place.

CHLPI and NVHR’s work has contributed to awareness of these policy issues, with the updated report being used as an effective tool in advocacy for removing these unethical restrictions on accessing HCV treatments. Since the 2017 report, 33 states have eliminated or reduced their fibrosis requirements, 29 states have eliminated or significantly relaxed their sobriety requirements, and 28 states have reduced their qualifying prescriber requirements.

Similar qualitative evaluation of other “harm reduction” policies, should be done to consider how these policies may potentially work against the goals of why they were instituted in the first place; including but not limited to Good Samaritan laws (where carve outs for those reporting over doses may result in the reporter being charged with a crime, rather than protected for seeking help) and “lock-in” laws and policies (where a patient may not be allowed to seek a different pharmacy or provider). In each of the two examples, people who use drugs are discouraged from engaging with public service personnel by disempowerment and threat of criminalization, risking either losing a patient in care or losing a life.

The mark of quality policy making, much like the mark of good science, is being willing and able to consider changing things when the facts of a given situation change or the available information changes. If we are to meaningfully invest in harm reduction policies at the intersection of drug use and HCV, we have to get a handle on what’s working and what’s not. And we have to learn not to repeat our mistakes in the coverage restrictions finally falling out of favor.

Biden’s State of the Union: Bold Promises on Public Health

On March 1st, President Biden delivered his first State of the Union Address to both chambers of Congress and the American people at large. Amid a slew of foreign and domestic policy proclamations, particular attention should be afforded to the statements and commitments made about addressing the COVID-19 pandemic and public health, more broadly. Championing the landmark legislation that was the American Rescue Plan, the President laid out how the legislation’s programming reduced food pantry lines, increased employment, and how expansion of the Affordable Care Act’s subsidies resulted in lower insurance premiums for many Americans. In addressing the COVID-19 pandemic, Biden also recognized a sobering outcome that will shake the nation: within the next few weeks, the United States’ official COVID death toll will surpass one million people. Though the President misstated the moment in that those empty seats at dinner tables will be more than a million; on average each COVID death has impacted 9 other people, including orphaning children across the country. Biden then shifted the address, citing the Centers for Disease Control and Prevention’s recent announcement of adjust masking guidelines and metrics of risk, trying to signal a much-needed political win in the fight against COVID. However, immediately following these statements, the President also focused on providing the country with another round of free at-home COVID-19 tests and implementing a tactic already well-known in the HIV space: test-to-treat, with added bonus of the program following the COVID vaccine model and having no out-of-pocket expense for patients.

The program ideals outlined in the days that followed found some confusion, need for clarity, and even some professional association bickering. Public health professionals who have long advocated for more robust responses to the pandemic took to news outlets to vent their frustrations and the American Medical Association drew derision on social media for their statement discouraging pharmacists prescription and provision of COVID antivirals. Pharmacists have long been a target for HIV advocates, especially in terms of increasing pre-exposure prophylaxis (PrEP) access and decreasing test to treat initiation delays. Wouldn’t it be nice if this COVID program provided a model outside of vaccination in which pharmacists could also serve a more robust role in facilitating seamless treatment and prevention? The meaningful hiccups the administration and advocates should keep a close eye on in this regard is the labor shortage of pharmacists, closing of more rural locations for chain pharmacies, and any developments around anti-competitive practices of pharmacy benefit managers (PBMs) associated with pharmacies. Consequences of these will extend beyond immediate COVID programming and ideal HIV programming.

The President also made statements referring to medication costs and price controls and needing to make sure more Americans could afford their care. However, details were lacking and if any recent effort is indicative, singularly focusing on manufacturer list prices won’t address patient costs or get much anywhere. Buyer beware, some proposals in the apparently sunk Build Back better legislation would also cut provider compensation in public payer programs, a dire consequence as the nation struggles with health care staffing shortages. Those shortages should be noted in detail because the American Rescue Plan provided funding meant to supplement the financial demands of staffing a pandemic and there’s good reason to suspect administrators, rather than providers, enjoyed the fruits of that labor. Further, most Americans experience their out-of-pocket costs of care due to the benefit design of their insurer (and PBM), not the manufacturer list price. Indeed, the Biden Administration appears to eb as insurer friendly as the Obama admin. To impact the costs facing patients more meaningfully at the pharmacy counter and other burdens in accessing medication, the Biden administration should focus more on developing patient protections via the regulatory process, limiting the aggressive utilization management (or deny-first coverage) policies, increasing formulary restrictions, and discriminatory plan design. Some of the tools for doing so already exist, but the federal government has yet to curb the tactics of payers in avoiding their responsibilities under the ACA’s medical-loss-ratio rules or ensure payers are not inappropriately applying cost-sharing for qualifying preventative medications and services.

The President also became the first to mention “harm reduction” in a State of the Union Address. Urging Congress to pass the Mainstreaming Addiction Treatment Act (MAT Act), President Biden is seeking to fulfill his commitments to address the opioid epidemic and move toward modernizing domestic drug policy. In a sign of acknowledgment of the scope and size of substance use epidemic in the country, Biden endorsed recovery programs and recognized the more than 23 million people struggling with addiction in the country. Immediately following the MAT Act mention, the President moved on to address of a lesser defined but equally important need in encouraging commitment to a robust set of policy ideals aimed at meeting the mental health needs of the country.

All these good things can easily be outweighed by what wasn’t mentioned. President Biden did not mention any interest in extending another round of stimulus payments, despite the program resulting in one of the largest reductions in poverty in US history. And while there was focus on rebuilding the nation’s health care staffing, no mention was afforded to rebuilding the nation’s public health infrastructure. Meanwhile, we’ve known for quite some time poverty as a notable association with HIV and decreasing poverty also decreases HIV risks and prevalence, data remains in the decline with regard to HIV and STI screenings, Hepatitis C rates are still on the rise, and inconsistencies in PrEP usage during the height of initial COVID waves likely foretells a more diverse at-risk community. Even the government’s own HIV.gov webpage dedicated to the State of the Union fails to mention any HIV or HCV specific programming efforts associated with the address.

While there’s much to celebrate about the President’s COVID goals, advocates should be cautious about projecting those goals onto other public health efforts. Afterall, COVID proved we could provide more up to date reporting than the 2 year delays we typically see in HIV and HCV surveillance, but we haven’t. COVID-related telemedicine expansion was welcomed by patients across the nation but Congress is poised to claw back those gains. For many of us, while the state of the union is improving coming out of the Omicron wave of the COVID-19 pandemic, much work remains. Including reminding this administration that it is empowered to protect patients, access to and affordability of care, an obligation to invest in public health programs beyond COVID and has committed to advancing efforts to End the HIV Epidemic.

What a Narrowly Divided Senate Means for Health Policy

On January 5th, Reverend Raphael Warnock and Jon Ossoff defeated Senators Kelly Loeffler and David Perdue in the Georgia Senate run-off elections, respectively. Democrats narrowly winning both Georgia Senate seats also means Democrats have narrowly won the Senate, dividing seats 50-50 between members who caucus with Democrats and Republicans with Vice President-elect Harris empowered to cast any tie-breaking votes and handing the incoming Biden administration a unified government.

While those with lofty ambitions on policy and legislative issues are cheering, there’s good reason to consider the need for moderating what can be expected from the 117th Congress: Democrats aren’t always on agreement on major issues like direct payment amounts as part of COVID relief or Medicare For All. The Biden administration will likely need to rely heavily on the regulatory powers allowed to federal agencies – which makes the prospective appointment of Xavier Becerra to lead Health and Human Services make more sense than it perhaps did on the surface. After all, who appoints an attorney to lead a health care agency?

The Trump administration made dramatic regulatory moves with regard to health care, targeting non-discrimination rules in health care, the Affordable Care Act including attempting to get the legislation declared unconstitutional by the Supreme Court, drug pricing, and championed legislative changes eliminating individual mandate penalty. While a judge has already temporarily blocked Trumps’ effort to tie drug prices to that of other nations’ prices and the Supreme Court has given the green light to recently-revived Food and Drug Administration rules on abortion pill access, these issues are regulatory in nature. The Biden administration could simply choose not to defend these moves in court change these regulations. While state push back is likely, a lack of Congressional challenge against these moves may help smooth the way for institutional changes.

It’s largely expected that among Biden’s first moves regarding health care will include expanding COVID relief measures and vaccine distribution plans, rescind the Mexico City policy (also known as the “Global Gag Rule”), “expand[ing] access to high-quality health care for Lesbian, Gay, Biden, Transgender, and Queer+ individuals” (or moving quickly to rescind the “Provider Conscience” rule), and reversing the 23% rate cut to 340B entities. With the help of a unified House and Senate, among Biden’s first accomplishments may be a legislative “fix” to the Affordable Care Act challenge awaiting ruling from the Supreme Court. Other campaign promises from Biden include seeking legislation to end HIV criminalization and increasing research into harm reduction models, expanding syringe services programs, and substance treatment funding – an issue Biden has evolved on and largely due to bearing witness and supporting his son through.

Other moves to watch for:

Strengthening the Affordable Care Act:
                - A regulatory move recalculating and increasing subsidies for Marketplace plans
                - Restoring Marketplace Navigator funding
                - Returning the open enrollment period to 90 days
                - Rescinding a proposed rule on 1332 waivers allowing states to opt-out of the Marketplace
                - Changes to regulations regarding short-term policies and association health plans (including reduced allowable coverage periods and requiring coverage of pre-existing conditions, including pregnancies, HIV, HCV, and transgender identity among others)
                - Reduce documentation burden for subsidies and Special Enrollment Periods
                - Expand the definition of qualifying life events and rules regarding special enrollment periods
                - Enforce mental health and substance abuse coverage parity
Strengthening Medicaid:
                - Rescind, reject, and stop defending 1115 waivers seeking work requirements
                - Encourage 1115 waivers to include the impacts of increasing coverage
                - Revise increased eligibility verification for Medicaid
                - Encourage policies regarding presumptive eligibility outside of hospitalization and emergency situations
                - Review and revise reimbursement schedules for Rural Hospitals
LGBTQ Health Equity:
                - Issue guidance and seek funding to address mental health services and support staff in schools
                - Reinstitute and/or strengthen Obama era guidance regarding transgender students and Title IX protections
                - Revise and strengthen Affordable Care Act, Section 1557 non-discrimination rules protecting women, Lesbian, Gay, Bisexual, Transgender, and Queer people, and people living with pre-existing conditions like HIV or HCV (in which the Trump administration would allow payers and providers to refuse care
                - Rescind the Trump era ban on transgender people serving in the military
                - Reverse or rescind Trump era “religious conscience” applying to civil rights laws – use regulatory power to include Lesbian, Gay, Bisexual, Transgender, and Queer people in civil rights protections in health, housing, and labor
                - Expanding data collection policies to include sexual and gender identities

While some may view the heads of regulation making agencies as “unelected officials”, in many ways, who we elect to be the executive is very much choosing who leads the agencies that impact our lives on a daily basis. There is much work to do for the Biden administration on the regulatory front and unified, carefully crafted legislation speaking to these issues may well help cement these changes beyond political party ping pong.