Aaron E. Carroll's Blog, page 42

March 12, 2021

Vaccines & The Immune System

Part three of our six-part series on vaccinations, supported by the National Institute for Health Care Management Foundation, dives into the immune system. We explore some of the ins and outs of this system, how it responds to viruses, and how we’ve used that knowledge to protect ourselves from disease via vaccination.

 

@DrTiff_PhD

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Published on March 12, 2021 14:35

March 9, 2021

Recent publications from Boston University’s Department of Health Law, Policy and Management: March 2021 Edition

Below are recent publications from me and my colleagues from Boston University’s Department of Health Law, Policy and Management. You can find all posts in this series here.

March 2021 Edition

Aldridge AP, Barbosa C, Barocas JA, Bush JL, Chhatwal J, Harlow KJ, Hyder A, Linas BP, McCollister KE, Morgan JR, Murphy SM, Savitzky C, Schackman BR, Seiber EE, E Starbird L, Villani J, Zarkin GA. Health economic design for cost, cost-effectiveness and simulation analyses in the HEALing Communities Study. Drug Alcohol Depend. 2020 Dec 01; 217:108336. PMID: 33152672.

Bashar SK, Ding E, Walkey AJ, McManus DD, Chon KH. Noise Detection in Electrocardiogram Signals for Intensive Care Unit Patients. IEEE Access. 2019; 7:88357-88368. PMID: 33133877.

Crable EL, Feeney T, Harvey J, Grim V, Drainoni ML, Walkey AJ, Steiling K, Drake FT. Management Strategies to Promote Follow-Up Care for Incidental Findings: A Scoping Review. J Am Coll Radiol. 2020 Dec 02. PMID: 33278340.

Dong H, Dai J, Lipson SK, Curry L. Help-seeking for mental health services in Asian American college students: an exploratory qualitative study. J Am Coll Health. 2020 Dec 08; 1-8. PMID: 33289588.

Ellison JE, Hanchate AD, Kazis LE, Cole MB. Association of the National Dependent Coverage Expansion With Insurance Use for Sexual and Reproductive Health Services by Female Young Adults. JAMA Netw Open. 2020 Dec 01; 3(12):e2030214. PMID: 33337495.

Garrido MM, Lum J, Pizer SD. Vector-based kernel weighting: A simple estimator for improving precision and bias of average treatment effects in multiple treatment settings. Stat Med. 2020 Dec 16. PMID: 33327037.

Harris M, McDonald EG, Marrone E, El-Messidi A, Girard T, Gunn CM, Shapiro GD, Longo C, Dayan N. Postpartum Analgesia In New Mothers (PAIN) Study: a survey of Canadian obstetricians’ post-delivery opioid prescribing practices. J Obstet Gynaecol Can. 2020 Dec 12. PMID: 33321248.

Jay J, Bor J, Nsoesie EO, Lipson SK, Jones DK, Galea S, Raifman J. Neighbourhood income and physical distancing during the COVID-19 pandemic in the United States. Nat Hum Behav. 2020 12; 4(12):1294-1302. PMID: 33144713.

Knudsen HK, Drainoni ML, Gilbert L, Huerta TR, Oser CB, Aldrich AM, Campbell ANC, Crable EL, Garner BR, Glasgow LM, Goddard-Eckrich D, Marks KR, McAlearney AS, Oga EA, Scalise AL, Walker DM. Model and approach for assessing implementation context and fidelity in the HEALing Communities Study. Drug Alcohol Depend. 2020 Dec 01; 217:108330. PMID: 33086156.

Lefebvre RC, Chandler RK, Helme DW, Kerner R, Mann S, Stein MD, Reynolds J, Slater MD, Anakaraonye AR, Beard D, Burrus O, Frkovich J, Hedrick H, Lewis N, Rodgers E. Health communication campaigns to drive demand for evidence-based practices and reduce stigma in the HEALing communities study. Drug Alcohol Depend. 2020 Dec 01; 217:108338. PMID: 33152673.

Linsky AM, Stolzmann K, Meterko M. The Patient Perceptions of Deprescribing (PPoD) Survey: Short-Form Development. Drugs Aging. 2020 12; 37(12):909-916. PMID: 33026638.

Long KC, Alphey L, Annas GJ, Bloss CS, Campbell KJ, Champer J, Chen CH, Choudhary A, Church GM, Collins JP, Cooper KL, Delborne JA, Edwards OR, Emerson CI, Esvelt K, Evans SW, Friedman RM, Gantz VM, Gould F, Hartley S, Heitman E, Hemingway J, Kanuka H, Kuzma J, Lavery JV, Lee Y, Lorenzen M, Lunshof JE, Marshall JM, Messer PW, Montell C, Oye KA, Palmer MJ, Papathanos PA, Paradkar PN, Piaggio AJ, Rasgon JL, Rašic G, Rudenko L, Saah JR, Scott MJ, Sutton JT, Vorsino AE, Akbari OS. Core commitments for field trials of gene drive organisms. Science. 2020 Dec 18; 370(6523):1417-1419. PMID: 33335055.

Mehta AB, Walkey AJ, Curran-Everett D, Matlock D, Douglas IS. Stability of Do-Not-Resuscitate Orders in Hospitalized Adults: A Population-Based Cohort Study. Crit Care Med. 2020 Dec 02. PMID: 33264125.

Minegishi T, Garrido MM, Stein M, Oliva EM, Frakt AB. Opioid Discontinuation Among Patients Receiving High-Dose Long-Term Opioid Therapy in the Veterans Health Administration. J Gen Intern Med. 2020 Dec; 35(Suppl 3):903-909. PMID: 33145683.

Minssen T, Outterson K, Rogers Van Katwyk S, Batista PHD, Chandler CIR, Ciabuschi F, Harbarth S, Kesselheim AS, Laxminarayan R, Liddell K, Osterholm MT, Price L, Hoffman SJ. Social, cultural and economic aspects of antimicrobial resistance. Bull World Health Organ. 2020 Dec 01; 98(12):823-823A. PMID: 33293739.

Morgan JR, Barocas JA, Murphy SM, Epstein RL, Stein MD, Schackman BR, Walley AY, Linas BP. Comparison of Rates of Overdose and Hospitalization After Initiation of Medication for Opioid Use Disorder in the Inpatient vs Outpatient Setting. JAMA Netw Open. 2020 Dec 01; 3(12):e2029676. PMID: 33320266.

Nguyen KH, Trivedi AN, Cole MB. Receipt of Social Needs Assistance and Health Center Patient Experience of Care. Am J Prev Med. 2020 Dec 10. PMID: 33309453.

Nocka K, Montgomery MC, Progovac A, Guss CE, Chan PA, Raifman J. Primary Care for Transgender Adolescents and Young Adults in Rhode Island: An Analysis of the all Payers Claims Database. J Adolesc Health. 2020 Dec 18. PMID: 33349532.

Rossheim ME, McDonald KK, Soule EK, Gimm GW, Livingston MD, Barnett TE, Jernigan DH, Thombs DL. Electronic cigarette explosion/burn and poisoning related emergency department visits, 2018-2019. Am J Emerg Med. 2020 Dec; 38(12):2637-2640. PMID: 33041151.

Shafer PR, Ndugga N. Fighting the Institutionalization of Racism in Medicaid. Am J Public Health. 2020 12; 110(12):1790-1791. PMID: 33058697.

Sprague Martinez L, Rapkin BD, Young A, Freisthler B, Glasgow L, Hunt T, Salsberry PJ, Oga EA, Bennet-Fallin A, Plouck TJ, Drainoni ML, Freeman PR, Surratt H, Gulley J, Hamilton GA, Bowman P, Roeber CA, El-Bassel N, Battaglia T. Community engagement to implement evidence-based practices in the HEALing communities study. Drug Alcohol Depend. 2020 Dec 01; 217:108326. PMID: 33059200.

Swaminathan S, Ndumele CD, Gordon SH, Lee Y, Trivedi AN. Association of Medicaid-Focused or Commercial Medicaid Managed Care Plan Type With Outpatient and Acute Care. JAMA Intern Med. 2020 Dec 01; 180(12):1672-1679. PMID: 33074283.

Wunsch H, Hill AD, Bosch N, Adhikari NKJ, Rubenfeld G, Walkey A, Ferreyro BL, Tillmann BW, Amaral ACKB, Scales DC, Fan E, Cuthbertson BH, Fowler RA. Comparison of 2 Triage Scoring Guidelines for Allocation of Mechanical Ventilators. JAMA Netw Open. 2020 12 01; 3(12):e2029250. PMID: 33315112.

The post Recent publications from Boston University’s Department of Health Law, Policy and Management: March 2021 Edition first appeared on The Incidental Economist.

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Published on March 09, 2021 09:00

March 8, 2021

Cancer Journal: The PET Scan

In December, I got a computerized tomography (CT) scan to determine whether the radiation treatment I had received had destroyed the tumour in my throat. The report from that scan misinformed me that I now had not just a throat tumour but also a lung tumour. This was an error: a radiologist didn’t proofread his dictated report before he saved it to my electronic health record. When contacted he corrected the report: the CT scan showed no evidence of lung cancer. The CT scan showed, however, that there were residual tumour masses in my throat and in the lymph nodes in my neck. My radiation oncologist thought that these tumours were likely dead, but you can’t confirm this from a CT scan. So he ordered a positron emission tomography (PET) scan.

You might imagine that when your physician writes an order for a diagnostic procedure, you get the procedure. This has not been my experience. When I first developed cancer symptoms, my family doctor ordered some imaging. All this got me was a place on a waitlist. I was only diagnosed after I went to the Emergency Department, coughing blood. Similarly, weeks passed without a response from Nuclear Medicine, the people who do PET scans. I stopped by their office one afternoon to ask why. No one was there and the person in the next office said that everyone left at 3:30. Finally, I got someone on the phone who was able to find an opening due to a cancellation.

I wonder what Nuclear Medicine did with my oncologist’s order. I imagine a meeting like the one in the last scene of Raiders of the Lost Ark.

Indy and Dr. Brody are trying to convey to a bureaucrat the urgency of researching the Ark. The bureaucrat tells Indy that “Top men” are working on it.


Indy (acid skepticism); Who?


Bureaucrat: Top. Men.


In reality, the crate containing the Ark has been lost in the warehouse. Perhaps my oncologist’s order was stacked on top of that crate.

In any event, on February 26th I got the procedure. In a PET scan, you are first injected with a radioactive sugar solution. Cells eat sugar and in doing so they absorb the radioactive material. Cancer cells have crazy high metabolisms and eat voraciously. This means that they pick up more radiation than other cells. In a PET scan, therefore, cancer cells glow brightly in the image against the background of healthy cells.

I do not see that image; it goes to a nuclear medicine fellow, who interprets it and writes a report. But in the new world of electronic health records open to patients, I was the first person on my care team to read the report.

What my PET scan showed was that a portion of my throat tumour has survived my radiation treatment. Similarly, the metastatic lymph nodes in my neck still have active cancerous cells.

Me: Uh. Oh.

I wrote my radiation oncologist with QUESTIONS. Impressively, he got back to me in less than 24 hours, and I’d summarize his reaction as, “Our first attempt to treat this didn’t work.”

So what now?

Radiation is no longer an option: apparently, I’ve had all I can tolerate. My radiation oncologist has referred me back to the surgeon who biopsied me back in July. The journey isn’t over. I will let you know what my options are after I have spoken to him.

The PET scan was BAD NEWS, but it was far from the WORST NEWS.* Surgery can work in these circumstances. I feel healthy, I’m hopeful, and I am prepared for whatever comes next. Writing about this experience is helping me get through it. Unfortunately, I still have more to say about being a cancer patient in the COVID pandemic. But there it is.

*There was actually GOOD NEWS, which was that the scan revealed no new metastases. Or maybe goodish news, because there are limits to what you can see in a PET scan. The problem is that, like case numbers in epidemics, cell counts in tumours grow exponentially. Suppose that a cell from my original tumours had escaped into my lymphatic system and migrated to a new site. At the new site, it might start growing, with cell counts doubling every so often. While those counts are small, the new tumour would be too small to register in a PET scan. By the time it became large enough to be imaged, each doubling would manifest as a rapid, aggressive expansion. In short, the absence of evidence of new metastases in a PET scan is only weak evidence that they are absent.

@Bill_Gardner

To read the Cancer Posts from the start, please begin here.

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Published on March 08, 2021 05:15

March 5, 2021

A Variety of Vaccines: A History of Vaccine Development, Part II

Part two of our six-part series on vaccinations, supported by the National Institute for Health Care Management Foundation, explores the history of vaccine development following the world’s first vaccination.

 

@DrTiff_PhD

The post A Variety of Vaccines: A History of Vaccine Development, Part II first appeared on The Incidental Economist.

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Published on March 05, 2021 16:18

February 26, 2021

Variolation, Innoculation, and Vaccination: A History, Part I

Part one of our six-part series on vaccinations, supported by the National Institute for Health Care Management Foundation, dives into the history of variolation, exploring the beginning of the long road that led to vaccines as we know them today.

 

@DrTiff_PhD

The post Variolation, Innoculation, and Vaccination: A History, Part I first appeared on The Incidental Economist.

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Published on February 26, 2021 12:17

February 23, 2021

What can we expect from re-opening HealthCare.gov? Hope.

David Anderson (@bjdickmayhew) is a health insurance researcher at Duke University Margolis Center for Health Policy. Paul Shafer (@shaferpr) is an Assistant Professor at the Boston University School of Public Health

In the first week of his term, President Biden showed his commitment to supporting Americans having access to affordable health insurance coverage by signing an executive order re-opening HealthCare.gov enrollment for three months starting February 15. Even though millions have lost health insurance during the COVID-19 pandemic because of lost hours or lost jobs, nearly half of uninsured adults haven’t even looked for Marketplace or Medicaid coverage. They assume that it would cost too much for Marketplace coverage or that they wouldn’t qualify for Medicaid, with two-thirds knowing little or nothing about financial help being available to make insurance affordable. There is a big hill to climb in getting the word out to say the least.

As part of re-opening the Marketplace, the Centers for Medicare and Medicaid Services, which runs HealthCare.gov, has pledged to spend over $50 million on advertising and outreach. This is a radical departure from the Trump administration, which drastically cut back on advertising and enrollment assistance, leaving over a billion dollars of so-called “user fees” unspent. These user fees were collected from insurers that sold ACA plans and the fees were intended to support Healthcare.gov operations, advertising and outreach.  Yet the money just sat there as millions became and stayed uninsured.

These moves should be cheered loudly for what they symbolize, a return to an administration that wants to support and promote the ACA rather than sabotage it. A return to finding ways to help people get coverage, not make it harder.

Why is this so important? Well besides the fact that there is a very real pandemic still going on, health insurance is critical to making health care affordable for Americans. Being uninsured means significant barriers in accessing health care. Medicaid expansion under the Affordable Care Act decreased the mortality rate among adults in expansion states by over 9 percent and outreach to those in violation of the now-defunct individual mandate also showed reduced mortality attributable to gaining coverage.

We should not expect massive new enrollment increases from this Special Enrollment Period.

The traditional open enrollment period ended less than two months ago (December 15, 2020) for HealthCare.gov and many state-based Marketplaces were open even longer.  This year saw the first increase in enrollment under the Trump administration, presumably due to the economic crisis induced by the pandemic leaving more people without employer-based insurance. The state-based Marketplaces, like those in California, New York, Massachusetts, and Maryland, had extensively promoted special enrollment periods due to COVID and already had longer open enrollment periods than HealthCare.gov.

However, the support that a President and administration shows (or doesn’t) for a policy can have a notable impact. We have seen this in our own and others’ work studying the ACA. Before now, the shift had only gone one way—from supportive to negative—at the state and then federal level. Kentucky was one of the early success stories of the ACA with its state-based Marketplace (kynect) and adoption of Medicaid expansion. A new Republican governor, Matt Bevin, campaigned hard against anything to do with the ACA including the Medicaid expansion and shutting down kynect. After his election, the states canceled all television advertising for kynect in the middle of open enrollment, which led far fewer people to seek out information or signing up for health insurance online. Similarly, we found that applications submitted to HealthCare.gov dropped by about a quarter after President Trump took office in January 2017.

From both the ACA and COVID, we also know that partisanship matters a lot in how people behave. Advertising has modest effects on enrollment, depending on who is pushing it—states and the federal government seem to be more effective while insurers are mainly out for themselves. A supportive President and a lot more visibility leads us to believe that some of the millions of Americans who are eligible for Medicaid or subsidized Marketplace coverage will enroll, gaining access to telehealth visits, prescriptions, and whatever care they need as we work towards herd immunity and a return to “normal.”

 

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Published on February 23, 2021 09:00

February 19, 2021

The Rising Crisis of Underinsurance: How the Biden Administration May Shape Inequities in Patient Affordability

Cecille Joan Avila is a policy analyst with the Boston University School of Public Health (@cecilleavila). Paul Shafer, PhD, is an assistant professor of Health Law, Policy, and Management at the Boston University School of Public Health (@shaferpr). Megan B. Cole, PhD, MPH, is an assistant professor of Health Law, Policy, and Management at Boston University School of Public Health (@meganbcole). 

The Affordable Care Act (ACA) made historic strides in expanding access to health insurance coverage by covering an additional 20 million Americans. President Joe Biden ran on a platform of building upon the ACA and filling in its gaps. With Democratic majority in the Senate, aspects of his health care plan could move from idea into reality.

The administration’s main focus is on uninsurance, which President Biden proposes to tackle in three main ways: providing an accessible and affordable public option, increasing tax credits to help lower monthly premiums, and indexing marketplace tax credits to gold rather than silver plans.

However, underinsurance remains a problem. Besides the nearly 29 million remaining uninsured Americans, over 40% of working age adults are underinsured, meaning their out-of-pocket cost-sharing, excluding premiums, are 5-10% of household income or more, depending on income level.

High cost-sharing obligations—especially high deductibles—means insurance might provide little financial protection against medical costs beneath the deductible. Bills for several thousand dollars could financially devastate a family, with the insurer owing nothing at all. Recent trends in health insurance enrollment suggest that uninsurance should not be the only issue to address.

A high demand for low premiums

Enrollment in high deductible health plans (HDHP) has been on a meteoric rise over the past 15 years, from approximately 4% of people with employer-sponsored insurance in 2006 to nearly 30% in 2019, leading to growing concern about underinsurance. “Qualified” HDHPs, which come with additional tax benefits, generally have lower monthly premiums, but high minimum deductibles. As of 2020, the Internal Revenue Service defines HDHPs as plans with minimum deductibles of at least $1,400 for an individual ($2,800 for families), although average annual deductibles are $2,583 for an individual ($5,335 for families).

HDHPs are associated with delays in both unnecessary and necessary care, including cancer screenings and treatment, or skipped prescription fills. There is evidence that Black patients disproportionately experience these effects, which may further widen racial health inequities.

A common prescription has been to expand access to Health Savings Accounts (HSAs), with employer and individual contributions offsetting higher upfront cost-sharing. Employers often contribute on behalf of their employees to HSAs, but for individuals in lower wage jobs without such benefits or without extra income to contribute themselves, the account itself may sit empty, rendering it useless.

A recent article in Health Affairs found that HDHP enrollment increased from 2007 to 2018 across all racial, ethnic, and income groups, but also revealed that low-income, Black, and Hispanic enrollees were significantly less likely to have an HSA, with disparities growing over time. For instance, by 2018, they found that among HDHP enrollees under 200% of the federal poverty level (FPL), only 21% had an HSA, while 52% of those over 400% FPL had an HSA. In short, the people who could most likely benefit from an HSA were also least likely to have one.

If trends in HDHP enrollment and HSA access continue, it could result in even more Americans who are covered on paper, yet potentially unable to afford care.

Addressing uninsurance could also begin to address underinsurance

President Biden’s health care proposal primarily addresses uninsurance by making it more affordable and accessible. This can also tangentially tackle underinsurance.

To make individual market insurance more affordable, Biden proposes expanding the tax credits established under the ACA. His plan calls for removing the 400% FPL cap on financial assistance in the marketplaces and lowering the limit on health insurance premiums to 8.5% of income. Americans would now be able to opt out of their employer plan if there is a better deal on HealthCare.gov or their state Marketplace. Previously, most individuals who had an offer of employer coverage were ineligible for premium subsidies—important for individuals whose only option might have been an employer-sponsored HDHP.

Biden also proposes to index the tax credits that subsidize premiums to gold plans, rather than silver plans as currently done. This would increase the size of these tax credits, making it easier for Americans to afford more generous plans with lower deductibles and out-of-pocket costs, substantially reducing underinsurance.

The most ambitious of Biden’s proposed health policies is a public option, which would create a Medicare-esque offering on marketplaces, available to anyone. As conceived in Biden’s proposal, such a plan would eliminate premiums and having minimal-to-no cost-sharing for low-income enrollees; especially meaningful for under- and uninsured people in states yet to expand Medicaid.

Moving forward: A need to directly address underinsurance

More extensive efforts are necessary to meaningfully address underinsurance and related inequities. For instance, the majority of persons with HDHPs receive coverage through an employer, where the employer shares in paying premiums, yet cost-sharing does not adjust with income as it can in the marketplace. Possible solutions range from employer incentives to expanding the scope of deductible-exempt services, which could also address some of the underlying disparities that affect access to and use of health care.

The burden of high cost-sharing often falls on those who cannot afford it, while benefitting employers, healthy employees, or those who can afford large deductibles. Instead of encouraging HSAs, offering greater pre-tax incentives that encourage employers to reabsorb some of the costs that they have shifted on their lower-income employees could prevent the income inequity gap from widening further.

Under the ACA, most health insurance plans are required to cover certain preventative services without patient cost-sharing. Many health plans also exempt other types of services from the deductible – from generic drugs to certain types of specialist visits – although these exemptions vary widely across plans. Expanding deductible-exempt services to include follow-up care or other high-value services could improve access to important services or even medication adherence without high patient cost burden. Better educating employees about what services are exempt would make sure that patients aren’t forgoing care that should be fully covered.

Health insurance is complicated. Choosing a plan is only the start. More affordable choices are helpful only if these choices are fully understood, e.g., the tradeoff between an HDHP’s lower monthly premium and the large upfront out-of-pocket cost when using care. Investing in well-trained, diverse navigators to help people understand how their options work with their budget and health care needs can make a big difference, given that low health insurance literacy is related to higher avoidance of care.

The ACA helped expand coverage, but now it’s time to make sure the coverage provided is more than an unused insurance card. The Biden administration has the opportunity and responsibility to make progress not only on reducing the uninsured rate, but also in reducing disparities in access and patient affordability.

The post The Rising Crisis of Underinsurance: How the Biden Administration May Shape Inequities in Patient Affordability first appeared on The Incidental Economist.

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Published on February 19, 2021 05:00

February 15, 2021

How Genomics Improve Cancer Survival and Patient Quality of Life: The Healthcare Triage Podcast

Dr. Bryan Schneider and Dr. Milan Radovich return to the podcast to break down the latest developments in personalized genomic medicine, share findings from their triple negative breast cancer research, and talk about their current and upcoming breast cancer studies, including EAZ171 and PERSEVERE.

 

This episode of the Healthcare Triage podcast is sponsored by Indiana University School of Medicine whose mission is to advance health in the state of Indiana and beyond by promoting innovation and excellence in education, research and patient care.

IU School of Medicine is leading Indiana University’s first grand challenge, the Precision Health Initiative, with bold goals to cure multiple myeloma, triple negative breast cancer and childhood sarcoma and prevent type 2 diabetes and Alzheimer’s disease.

Available wherever you get your podcasts! Including iTunes 

@DrTiff_PhD

The post How Genomics Improve Cancer Survival and Patient Quality of Life: The Healthcare Triage Podcast first appeared on The Incidental Economist.

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Published on February 15, 2021 15:00

The End of Surprise Billing for Medical Care?

Recently, the US adopted a law (going into effect in 2022) that ended surprise billing for most medical services. So what is surprise billing, and what does the new law look like?

 

@DrTiff_PhD

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Published on February 15, 2021 11:35

February 12, 2021

Drug Prices by Committee: One Way Biden Could Lower Costs

The following originally appeared on The Upshot (copyright 2021, The New York Times Company). 

The United States receives worthwhile innovation (and also some not so worthwhile innovation) as a result of its high drug prices. But there is no consensus about what the “right” level of innovation should be, so it’s unclear how much to lower or raise prices.

Other countries at least have ways to think about this at a national level. The United States doesn’t — the topic has been a third rail — but the Biden administration could change that.

U.S. brand-name prescription drug prices are the highest in the world. For those available from only one manufacturer, prices are three to four times higher than those in Britain, Japan or Ontario, Canada, on average.

Policies to reduce prescription drug prices have an obvious benefit: Drugs we buy today would cost less. But they create a less obvious problem: Drugs we would like to buy in the future might not exist. In other words, innovation could be slowed.

Higher prices mean higher potential profits, and more money to invest in development of new drugs. Although there is considerable debate over the value of the innovation motivated by the promise of higher profits, it’s clear there’s a connection. Several studies indicate that limiting the market and profits for drugs would slow innovationOne found that when Medicare created a new drug benefit in 2006, preclinical testing and clinical trials increased for drugs for older patients — those most likely affected by the policy.

Another study found that policies in the 1980s that expanded the market for vaccines encouraged 2.5 times more new vaccine clinical trials per year for each affected disease. This fits with the general finding that more new drugs enter expanding markets that promise greater profits.

“There is a trend between how much is spent on research and development by pharmaceutical companies and how much they will earn in profit,” said Ronald Aubert, visiting professor at Brown University School of Public Health. “But there’s a remaining question about whether the innovation that stems from that research and development addresses the unmet needs of the population.”

In other words, is the innovation well targeted?

The extent to which profitability prompts innovation has limits. Scholars see the law of diminishing returns at work, with each additional dollar of investment in pharmaceutical research and development yielding less gain in innovation than the prior dollar.

This means that some of the additional money going to drug innovation because of higher prices might be better spent elsewhere, producing greater health and well-being than the new drugs they incentivize.

We’re not accustomed to openly managing this trade-off in the United States, partly because of the power of health care interest groups, and perhaps because of a more individualistic culture.

Not so in other countries. The vast majority of European nations, and many Asian ones, have a process for deciding what drugs should cost.

2011 German law, for example, established a system by which a central body evaluates the benefits of new drugs. Then health insurers jointly negotiate prices, which are capped relative to existing drugs for the same condition if the new drug has no demonstrable additional benefit. Those prices apply to all statutory health insurance plans, which cover 90 percent of the population, and are typically adopted by private payers as well.

France, Britain and other nations also have systems to limit drugs’ prices and assess the value they provide, seeking to balance innovation and profit. Many countries peg the prices of drugs to those established by other nations — something the Trump administration had proposed for drugs purchased by Medicare.

For the last few decades, Canada has relied on a mixture of national and provincial organizations to protect against what it considers “excessive” prices. But the Trudeau government “has judged these approaches insufficiently effective, appearing to have concluded that the high prices have not led to sustained research and development investment in Canada,” said Christopher McCabe, chief executive of the Edmonton-based Institute of Health Economics. So starting in July, after a delay because of the pandemic, the Patented Medicines Price Review Board will set Canadian prices “without consideration of the prices paid in the United States and Switzerland, and for some drugs, with explicit consideration of cost effectiveness,” he said.

In the United States, drug prices reflect what the market will bear, under the influence of government-granted monopolies for novel medications. Because of the byzantine political compromises they reflect, there is no good reason to believe that the duration of those monopolies — or the prices they support — match the value of the drugs for which they’re provided or the degree of innovation they motivate.

The tool is blunt, so in some cases drug prices are arguably too low, even if they’re very often arguably too high. (This problem of pricing is not unique to prescription drugs, but pervasive throughout the health system. Both health care markets and policy have flaws that lead to prices for health services that are often too high and sometimes too low relative to their value.)

Yet the United States does have some history of assessing the value of health care treatments, albeit limited. Before Congress abolished it in 1995, the U.S. Office of Technology Assessment advised the body on Medicare coverage decisions, including those for pneumococcal vaccination, and screening for breast cancercervical cancer and colorectal cancer.

Subsequently, the Centers for Medicare and Medicaid Services applied cost-effective analysis in considering coverage for screening for H.I.V. and lung cancer, and counseling for alcohol use disorder. Other government agencies (including the C.D.C.N.I.H., the V.A. and D.O.D.) have either funded or have the authority to use cost-effectiveness analysis, as have private health plans.

One state — New York — has a program to limit prices for drugs purchased by its Medicaid program based on therapeutic value. But the state cannot compel drug manufactures to sell at the prices it offers. One company, Vertex, refused New York’s price for its cystic fibrosis drug Orkambi.

Recent efforts by both the former Trump administration and the current Biden team to link drug prices to value suggest an increasing acceptance of doing so in the United States. President Biden could take the framework of the former health secretary Alex Azar’s international reference pricing model for Medicare, and give more power to an independent review board.

The private Institute for Clinical and Economic Review evaluates the effectiveness of drugs relative to their cost. Its reports may be gaining influence, but its conclusions on prices and value are without the force of government.

Peter Neumann, director of the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center, who’s writing a book on the topic, said high prices aren’t as worrisome for some drugs. For others, maybe so.

“We should undertake our own assessment of value,” he said. “The markets don’t work. Rather than taking France or Germany’s price, we should establish our own.”

@afrakt

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Published on February 12, 2021 08:00

Aaron E. Carroll's Blog

Aaron E. Carroll
Aaron E. Carroll isn't a Goodreads Author (yet), but they do have a blog, so here are some recent posts imported from their feed.
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