If you have the 2-4 hours to spare, you can pick up a lot of good information in a congressional hearing - legislation coming down the pipeline, general congressional sentiment on any given issue, and where the lobbyist money is going. However, most of us don’t have those 2-4 hours to spare, and the recaps you’d read today are either very dry, or politically driven. I’d like to create a succinct, apolitical alternative here. Feel free to subscribe below if of interest!
APRIL 5, 2022
"Communities in Need: Legislation to Support Mental Health and Well-Being", or
MENTAL HEALTH CONCERNS UNITE MEMBERS ACROSS THE AISLE
Relevant for: Mental Health, Medicaid, Staffing
This hearing was a sub-committee hearing on 12 different bi-partisan bills focused on mental health. Many of these bills were reauthorizations of existing programs, but there were a few net new considered - including striking down the 1 year requirement of opioid usage before accessing opioid recovery centers, the development of housing for those suffering Substance Use Disorder (SUD), and increasing reimbursement amounts for pediatric behavior health visits. The first panel of witnesses included representatives from the Substance Abuse and Mental Health Services Association (SAMHSA) and the Health Resources & Services Administration (HRSA). The second panel included members from the American Psychiatric Associations, the American Pediatric Association, and a few directors from different state mental health departments.
Mental health staffing is the number one issue for SAMHSA and HRSA.
Like many other parts of healthcare, mental health staffing is a major crisis that the subcommittee clearly recognizes, and much of the discussion surrounded how to improve dismal psychiatrist/patient ratios, especially in rural areas and in pediatric settings. SAMHSA and HRSA discussed some of their plans to address this, including incentivizing BH specialists to practice in underserved areas (free tuition) and integrating primary care with behavioral health.
Other Takeaways:
Removing the IMD exclusion seems to be a partisan position, and I’m not sure why. Allowing Medicaid to reimburse 17+ bed institutions for long term BH care for Medicaid seems reasonable, especially if there are no other options in certain areas.
The new 988 suicide hot line is ready for an all-state roll out in July. This is a no-brainer, as anyone familiar with survey drop-off rates can tell you. Moving from 10 to 3 digits will certainly increase engagement - here’s to hoping the roll out goes smoothly.
Enforcing mental health parity laws will continue to be difficult.With already limited HHS compliance resources going towards bills like the No Surprises Act, it’s hard to imagine when Big Insurance will get their comeuppance for these BH violations.
Will the Committee eventually target mental health start-ups for shoring up therapist and counselor resources? Given how crowded the space is right now, I wouldn’t be surprised if the Committee turns its eyes there if staffing issues don’t improve.
Disparate interest groups all agreeing this much makes me nervous. Is the amount of funding too little to matter? Is the mental health awareness momentum just that strong? Do I have deeply entrenched personal issues?
“FDA User Fee Agreements: Advancing Medical Product Regulation and Innovation for the Benefit of Patients (Panel 1)” or,
FDA REQUESTS TO DOUBLE USER FEES IN POST-COVID REBOOT
Relevant for: drug development, clinical trials, women and minority health, cyber security
This was one of two hearings scheduled to focus on the reauthorization of user fee agreements. User fee agreements are fees collected from biopharma, med device, generics, and bio-similar companies to fund the FDA approval process for new devices and drugs. This is in addition to the standard appropriation budget of the FDA as determined by Congress each year. This re-authorization is the 7th for the Prescription Drug User Fee Act since its inception in the early 90s, though it is an earlier iteration for the other “UFAs” which came into effect at different times since that initial program.
If the FDA isn’t penalized for missing targets - what’s the point of Congressional accountability?
Ranking member Senator Burr (R-NC) really drove home the biggest takeaway here - this reauthorization is a 100% increase in user fee agreement budget across the various UFA agreements, despite the FDA’s consistent failure to meet its KPIS. For example, the FDA missed 7 out of 15 product development meeting goals, in addition to 12 out of 14 general stakeholder meeting goals. Given the unique funding structure here (industry pays), FDA has significantly less accountability to Congress than other agencies (since it takes up less of the overall budget they have to approve). FDA already has a looser leash - what’s the point of these accountability metrics if there’s no accountability?
Other Takeaways:
The FDA needs to do better at engaging external stakeholders in a timely manner. I can’t imagine how frustrating a late denial letter with no explanation, especially for smaller companies. If FDA gets it full fee increase, this should be priority one for the org.
Curbing Big Pharma’s efforts to stymy cheaper generic development will be difficult due to existing regulatory complexity. The risk is that Congress manages to pass some fix after years of effort, and then a workaround is discovered and exploited. Frustrating.
Should the FDA cover supplements and skin care products? Obviously, nobody wants hazardous materials on the market. But if the FDA can’t evaluate its current pipeline with any speed, how could they possibly justify a scope extension?
It’s unclear how much focus gender and racial diversity will get in future clinical trials. Several committee members did comment on this as a goal of the Administration, but the lack of real discussion leaves me to wonder.
Both the FDA and industry pledge to do more uncured rare diseases. Several committee members hinted that this might mean opening up new approval pathways, and pushing for different testing methodologies. especially when determining the right surrogate endpoints to measure new drug efficacy is highly complex?
APRIL 26, 2022
“Next Steps: Examining Plans for the Continuation of the Department of Veterans Affairs Electronic Health Record Modernization Program” or….
CERNER AND THE EHRM OFFICE PLAY DEFENSE WITH SOME VERY ANGRY CONGRESS MEMBERS
Relevant to: EHRs, government contracts, VA, project management
This was a hearing on the progress of EHR Modernization contract between Cerner and the VHA, now in year 4 of 10. A little background: Cerner initially contracted with DOD for their EHR modernization efforts across the country - which went well, all things considered. Cerner was then awarded a $10B, 10 year contract with the VHA to replace their 40 year old legacy EHR Vista in a similar effort. The Cerner-VA implementation across pilot locations has been rough, to say the least, eventually leading to a total ouster of current EHR modernization leadership. Unfortunately, the new leadership has not been able to quite turnaround the project in the 4 months since their installment - the OIG report released the weekend prior was, to paraphrase Rep Newhouse, one of the most scathing reports the OIG has ever put out.
Cerner/VA EHR Modernization is a case study on how to not manage a project management.
At the highest level, Cerner’s EHR products were not built for the VA’s unique clinical workflows, especially around medication management. This is just a fact, not a damnation in it of itself - there are 2, maybe 3 EHR companies that could handle this type of project at all, and none of them have VA-specific capabilities. The problem is that neither Cerner nor the VA thought through this BEFORE signing a $10B contract. Even the potential for this contingency wasn’t contracted for - VA has to negotiate modifications in schedule and budget for this contract for Cerner to put these new capabilities on their product roadmap - features the company estimates completion within next 1-3 years.
Other Takeaways:
The committee did an excellent job framing their questions, given highly technical, highly niche subject matter. In light of the infamous “we sell ads, Senator” hearing, it’s nice to see a Committee that can handle niche, technical subject matters.
The EHR Modernization (EHRM) Office is hell bent on scaling to larger VA sites, despite material failures of pilot sites. I’m unclear as to why the EHRM department is so fervent to push this. I don’t buy “more launches = more lessons learned” as the reason.
A systemic problem for all EHR installations? It’s hard to say whether the issues here are uniquely bad, or indicative of EHRs writ large. EHR installations were never a cake walk, and almost none of these intense projects get Congressional oversight.
Cerner’s spokespeople sound like big health systems at innovation conferences. The Cerner reps eloquently espoused the EHR giant’s merits and successes. As Rep. Rosedale bluntly points out - the words don’t match the actions here, not even close.
The Cerner-VA integration will continue painfully, but the path forward is unclear. The Committee and the OIG want pilot fixes before new roll outs. However, the Office of EHR Modernization has the authority to continue on, barring a new vote or lawsuit.
“Hearing on The Fiscal Year 2023 HHS Budget” or….
SEC. BECERRA’S BUDGET APPLAUDED BY DEMOCRATS, LAMBASTED BY REPUBLICANS OVER KEY ISSUES
Relevant for: Mental Health, COVID, Prescription Payment, Life Sciences R&D, Health Equity
The House hearing on the 2023 Budget for HHS was essentially a 3.5 hour interview of current Secretary Xavier Becerra. Committee questions were focused less on numbers within the budget, and more about the policy choices underlying the numbers. Throughout the hearing Mr. Xavier Becerra was unsurprisingly non-committal with most responses - as should be expected with such a highly visible position in the President’s Cabinet. Equally unsurprising was the level of partisanship in relation to other hearings - Climate change, COVID mandates, and border control all came up at various times from both sides of the aisle.
Who has authority to do what?
If anything, this hearing emphasized how much of a role process and delegated authority effect the implementation of policy, for better or worse. The question of authority was a convenient “punt” option for Sec. Beccerra - Many questions of the committee were answered with some iteration of “Congress would need to give statutory authority to HHS to do X”, or “X is currently under the purview of Department Y, not the HHS.” That said, I doubt the committee members genuinely didn’t know he before asking. I’d wager that these questions were asked mostly for performance to highlight key partisan policy points. After all, the HHS is a highly visible political cabinet - substantive views and policy are not being changed by perfect logic or discovered facts in a budget hearing.
Other Takeaways
The Committee pushes Medicare’s authority to negotiate drug prices. I don’t know when it will happen, but if this hearing was anything to go off of, even well heeled pharma lobbyists won’t be able to stop this from becoming law eventually.
I wouldn’t hold my breath for PBM reform. Almost by design, the PBM business model seems too complicated to build true public support for reform. A few Committee members tackled the rebate model, but I just don’t see the path forward right now.
The handling of Title 42 is clearly motivated by immigration politics on both sides. The Republicans can’t use Title 42 to push immigration policies. But Democrats need to be consistent - if large migrant groups don’t pose COVID risks, then how do children?
Establishing a Climate Change Office in the HHS is a mistake. What is the goal here? This will only decrease trust in our health institutions. Climate change is the world’s number one problem, but those resources would be more effective within the EPA.
ARPA-H is exciting until you think about the redundancies. An organization dedicated to accelerating biomedical innovation with public-private partnership sounds amazing, but how different is this from the many NIH departments focused on this already?
”FDA User Fee Agreements: Advancing Medical Product Regulation and Innovation for the Benefit of Patients (Panel 2)”, or
FDA REGULATORS UNDER INTENSE SCRUTINY FOR BUDGET INCREASE
Relevant for: drug development, clinical trials, women and minority health, cyber security
This was the second of two hearings surround User Fee Agreement reauthorizations. I would characterize the first hearing as a light-hearted informational interview between members of congress and representatives of industry. There is a notable change in tone with this second hearing, as FDA representatives are put on the proverbial stand to answer for their request for a doubling of User Free Agreements (UFA). Impressively, FDA representatives Dr. Cavazzoni and Dr. Shuren were able to tow a fine line throughout the hearing - standing up for their respective department decisions while being careful not to directly refute the underlying premise of committee member questions.
The massive influence of the corporate lobbyist was on full display.
The industry has a lot of money riding on the content of these UFA reauthorizations - if I was a large pharmaceutical company, I’d be stupid not to be hiring as much lobbying power as possible. Still, it’s a bit grating to hear committee members voice questions clearly designed, or strongly influenced by, well paid trade lobbyists. The FDA reps noticed this too, at times, asking “who would that *insert relevant provision* really benefit?” That said, most of the lobbyist-inspired questions did need to be addressed. It’s just unfortunate when you think about the relative number and power of advocacy lobbyists representing patients in comparison.
Other Takeaways
The Catalyst court decision will hurt orphan drug research efforts. The FDA can now award exclusivity for an entire condition by treating one indication. Naturally, companies will spend less R&D on harder-to-treat indications, like pediatrics.
The committee sees the CMS coverage decision on Aduhelm as an attack on the FDA. While the FDA doesn’t see this having a chilling effect on Alzheimer’s R&D today, I could see this becoming an ongoing issue with a few more controversial approvals.
Cyber security is a growing concern for the committee. This was not a focal point today, but I think we’ll see this issue grow in importance and emphasis, especially as our geo-political relationship with China and other actors continue to fray.
The FDA faces no consequences for missing targets. The FDA made compelling arguments (COVID…) for its KPI failures. However, these metrics are totally meaningless if there’s no “stick” for poor performance.
Will the FDA consider more data collaborations with its European counterparts? They’ve had the authority to do so since 1997, but have only used it during the COVID pandemic. I’m skeptical, but I wouldn’t mind being pleasantly surprised here.
APRIL 27, 2022
“McKinsey & Company’s Conduct and Conflicts at the Heart of the Opioid Epidemic”, or
MCKINSEY CONSULTED FOR PURDUE AND FDA AT THE SAME TIME - CONFLICT OF INTEREST?
Relevant for: Management Consulting, Government Contracting, SUD, Life Sciences
This hearing was focused on whether or not McKinsey had a Organizational Conflict of Interest (OCI) when serving Purdue and other opioid-selling firms while serving the FDA at the same time. This is not to be confused with the investigation into McKinsey’s culpability in the opioid crisis by representing and advising companies like Purdue. On the latter issue, McKinsey settled with 49 state AGs for a hefty sum a few years back. Regardless, watching the McKinsey Head Bob Sternfels get roasted by furious committee members was a sight to behold.
The Committee put McKinsey on trial for the behavior of the entire government consulting industrial complex.
To be clear, this complex is in need of major reform, but the Committee seemed to position McKinsey as a bad actor (in terms of conflicts of interest, NOT the subject matter) for using its relationships with high level government officials to win commercial business - this is a feature of the system. Secondly, I don’t believe that McKinsey actually failed to inform the FDA of their Purdue engagement. It makes no sense that The Firm would open themselves up to that type of legal risk, amoral or not. Lastly, the work McKinsey did for FDA and Purdue had entirely unrelated scopes. Based on the current OCI definitions, McKinsey didn’t have a conflict of interest - even if what they were doing was morally reprehensible.
Other Takeaways
McKinsey may have a culture problem. In email conversation, two McKinsey partners discussed deleting evidence for the expected investigations. These partners were dismissed as a result, but how do people like that reach partner in the first place?
McKinsey has an image problem. One committee member brought up McKinsey’s youth prevention work with Juul, which was later used to target children’s favorite flavors. Not necessarily The Firm’s fault - but just another blemish on a growing list.
Punishment for the past or solutions for the present. Are we focusing too much on McKinsey for last decade’s transgressions because they’re an easy target? Solving our growing fentanyl crisis seems like a better use of taxpayer resources at this point.
Will McKinsey take a long term hit? Hard to say. Obviously this is going to hurt McKinsey federal bids for quite a while, but politicians have short memories. Even if it does, does Congress expect a morally superior firm to supplant them?
Can the entangled web of government and government contractors be reformed? No follow-up here, I don’t know how you would even start. Does the audience have any ideas?
APRIL 28, 2022
“U.S. Department of Veteran Affairs Budget Request for Fiscal Year 2023”, or
DVA WILL TACKLE SUICIDE, SUBSTANCE USE, AND HOMELESSNESS IN 2023
Relevant for: SUD/Behavioral Health, Patient Engagement, Women’s Health, Medicaid
This was a budget review for the Veterans Health Administration (VHA) in FY23 - which is pushing for $179B (~20% more than the President’s budget). The house committee members highlighted several key areas and initiatives, both ongoing and to be launched. Decreasing veteran suicide rates (50% higher than the population on average), reducing the veteran population experiencing homelessness (reduced by 55% since 2010), and identifying and treating veterans with Substance Use Disorder are the main focus points - as was increasing veteran engagement with the VA system overall.
Improving overall veteran engagement is critical to advancing the VA’s main goals; there is a heavy overlap between the needs of Medicaid beneficiaries and VA beneficiaries. The three major issues discussed -homelessness, suicide, and drug addiction - are certainly not exclusive to the veteran community. In particular, the underlying barrier of effective engagement affects healthcare models across the country, more so in underserved populations. I wonder what cross-functional collaboration between the VHA, SAMHSA, and CMS could look like in tackling these issues on a united front - though that type of partnership comes with the burdens of increased bureaucracy and complexity.
Other Takeaways
The VA representatives came across as both thoughtful and pragmatic, for the most part. I was especially impressed with the rigor behind three stage outreach campaign for at-risk vets. Cross-agency collaborations using the VA’s methodologies - yes, please.
Gender-specific care will take time to roll out. This is one of the VA’s key initiatives, from hiring more female PCPs to enabling more gender-specific training. These will likely occur across multiple administrations, so sustained commitment is imperative.
The VA embraces forward-thinking care models, including Whole Health and virtual mental health services. It’s heartening to see the VA leverage the success of recent commercial care models, and I’d love to see more of this going forward.
Staffing vacancies plague the VA, just like everywhere else. There are 50,000 (!) staffing vacancies in the VA system today. The VA discussed various programs to increase hiring, but I don’t think they have the magic bullet either.
The measurements for some of the VA pilot programs are lacking. For instance, the VA recently disbursed 59,000 disposable smart phones to at-risk veterans. No tracking, no way to measure if there were positive outcomes attributed to this decision.
Well, that’s it for April. Ideally, I’ll get these out closer to the beginning of the month once I’ve solidified the format and have a few reps under my belt. Please let me know if a) I’ve missed any important hearings, b) I’ve mischaracterized an issue, c) there are ways to make this more useful/compelling. Until next time…..