Aaron E. Carroll's Blog, page 2

State-level actions targeting unethical substance use disorder treatment practices: A qualitative study

Unethical practices are increasingly disrupting the quality of substance use disorder (SUD) treatment in the U.S., putting individuals seeking recovery at heightened risk of relapse and mistreatment. While evidence-based SUD treatments exist, there are gaps in regulatory oversight that allow unethical actors to exploit the current system.

These unethical practices include patient brokering, deceptive marketing, and fraud. Patient brokering, for instance, involves third parties profiting from referring individuals to treatment facilities, while deceptive marketing misrepresents services to attract patients and their families. These unethical practices harm those seeking care, resulting in unsafe treatment environments, inadequate care, and, in some cases, overdose deaths.

Unethical actors have exploited the increased insurance coverage of SUD treatment provided by the Affordable Care Act. Although some states have taken steps to combat these unethical practices, there is limited evidence on the effectiveness of these efforts.

New Research

In the study, “State-level actions targeting unethical substance use disorder treatment practices: A qualitative study,” we examined state-level efforts to address unethical SUD treatment practices. We explored the types of actions taken, factors that facilitate successful interventions, and barriers that hinder effective policy implementation. The goal was to better understand the variety of state-level efforts (e.g., certification requirements for recovery homes and trainings to raise awareness and improve education around SUD) to address unethical practices in these settings in the U.S.

Methods

From June 2022 to February 2023, we conducted semi-structured interviews with 15 key informants from 11 organizations, including national and state-level advocacy groups and state agencies. We selected the informants for their expertise in SUD treatment, policy implementation, or regulation. We analyzed the data by identifying recurring themes across interviews. This method helped identify patterns in responses related to the scope of unethical practices, the state actions taken to address them, and the context in which these actions were implemented.

Findings

Informants described several unethical practices in the SUD treatment field, such as patient brokering, deceptive marketing, overbilling and insurance fraud, and poor practices in recovery housing. These issues were often interrelated with both individuals and organizations working together to exploit vulnerable patients for profit.

Some states, such as Florida and Colorado, have made progress in addressing unethical practices by establishing task forces and enacting legislation; in total, twelve states have enacted laws targeting patient brokering or deceptive marketing. Informants viewed task forces or coordinating bodies with clear objectives to improve SUD treatment or prevent unethical practices as relatively effective. Legislation was seen as most effective when paired with more centralized efforts (e.g., national quality standards), strategic leadership, and a clearly designated agency responsible for regulation and enforcement. Informants also suggested stronger federal enforcement, since many unethical actors operate across state lines in the U.S., which limits the effectiveness of state-level responses.

Additionally, informants stressed the importance of adequate resources (i.e., funding and staffing) and highlighted how public awareness plays a key role in prompting action against unethical practices. While task forces and advocacy groups help raise awareness, they often lack the authority to enforce change without stronger regulatory support.

Conclusion

The siloed nature of SUD treatment from other medical services in the current health system has led to fragmented, inconsistent care and service gaps for patients with SUD. While laws targeting patient brokering and deceptive marketing may help deter unethical practices, the desired effect may be unlikely without adequate funding, clear regulatory authority, and the ability to coordinate across state lines. To address these challenges, states looking to implement new policies can learn from existing legislation but must also ensure they have the necessary tools and coordination to tackle this complex issue effectively.

The post State-level actions targeting unethical substance use disorder treatment practices: A qualitative study first appeared on The Incidental Economist.

FDA cuts may mean even less oversight of pet food

Regulation of commercial pet food in the US can be confusing for pet owners, making it difficult to identify safe, nutritious food.  The Food and Drug Administration (FDA) typically serves as the major regulator for commercial pet food. But recent mass layoffs, including those impacting the FDA’s Center for Veterinary Medicine , put the agency’s oversight at risk. There are other entities (states, private companies, and nonprofit organizations) that purportedly set standards and definitions to help consumers choose the best products. But they often produce more confusion than they clear up.The result is a sprawling pet food industry fraught with confusion, trendy diets, and a lot of misinformation. We need veterinarians – both locally and at the FDA – to cut through the noise.I wrote about this yesterday for STAT. You can read more here.The post FDA cuts may mean even less oversight of pet food first appeared on The Incidental Economist.

An Opportunity: Philanthropy Can Reshape Drug Innovation

Patent gaming and anti-competitive practices have been impacting drug innovation. Often, the federal government works to keep checks and balances on innovation practices – like the Biden era FTC crackdown on inhaler patent abuses. But, recent instability in the federal policy arena indicates that the government may not be a reliable regulatory partner. With this loss, however, philanthropy has the opportunity to step up and actively reshape the biotech innovation ecosystem – and they should. Michael Nguyen-Mason and I write about this in a recent piece with STAT First Opinion:

Since the dawn of biomedical research, philanthropy has played a pivotal role in defining the direction of biomedical innovation. The Rockefeller Foundation, for example, was a central institutional supporter of the collaboration between physicists and biologists leading to the birth of the field of microbiology in the 1920s.

Today there are many health-related foundations focused on innovating in health care, with particularly well-funded efforts being connected to cases where high-net worth individuals, or their loved ones, get afflicted with a rare disease. These foundations serve as an important model to subsidize private innovation efforts as well as increase the chances a drug is approved by the FDA.

Still, there is potential for foundations to more strongly bolster competition in the market for biotech — in both venture philanthropy and social justice philanthropy….

Read more on Stat First Opinion, here.

Research for this piece was supported by Arnold Ventures.

The post An Opportunity: Philanthropy Can Reshape Drug Innovation first appeared on The Incidental Economist.

Helping Medicare Beneficiaries Navigate Coverage: The Role of SHIP Counseling Services

Navigating Medicare is no small task. Beneficiaries must choose between Traditional Medicare and Medicare Advantage, decide whether to purchase a Medigap policy, evaluate the costs and coverage of Part D prescription drug plans, and so on. Plus, every Congressional cycle brings changes to the program. Making the “wrong” decision can mean increased care costs or gaps in coverage for beneficiaries – and, for those who are on a lower fixed income or have complex medical needs, challenges to affordable and comprehensive care are intensified. Similarly, the rise of deceptive marketing and misleading advertising of Medicare Advantage plans has only compounded the hurdles Medicare beneficiaries have to face.

To address these challenges, the federal government offers states funding for the State Health Insurance Assistance Program (SHIP). With federal oversight from the Administration for Community Living (ACL), states independently run SHIP counseling centers that provide outreach and education to Medicare beneficiaries, as well as individual counseling to help beneficiaries navigate Medicare’s many caveats. Despite being around for decades, SHIP services are not well known, and little academic work has evaluated their operations, successes, or challenges.

New Research

Evaluators at Boston University School of Public Health explored SHIP service access in a recent paper with Health Affairs Scholar. In it, they investigate SHIP staff members’ experiences providing counseling services to Medicare beneficiaries and potential barriers to SHIP service access.

Data and Methods

Researchers conducted a qualitative study interviewing SHIP coordinators and counselors. To identify potential participants, they randomly selected SHIP sites representing different levels of median household income, urban or rural status, and the number of available Medicare plans. Recruitment was facilitated through the ACL and state SHIP directors, who helped connect researchers and practitioners. Interviews were conducted via Zoom between April and September 2023.

In all, 22 SHIP coordinators and counselors were interviewed across 15 states. Participants offered a diverse mix of backgrounds, experience, and responsibilities within SHIP programs. Coordinators had experience ranging from 6 months to 17 years, with some transitioning from state or county agencies into the SHIP role.

Separate interview guides were developed for coordinators and counselors, and they were reviewed by ACL staff. Coordinators were asked about recruitment and retention strategies for volunteers and staff, while counselors were asked about common beneficiary concerns, particularly those affecting dual-eligible and low-income folks.

Findings

The study found that SHIP services are crucial in guiding Medicare beneficiaries through complex enrollment decisions, particularly for low-income and dually eligible individuals. Persistent challenges limit their impact, however, including staffing shortages, accessibility barriers, and growing complexity of Medicare information and misinformation. Some staff expressed frustration with the complexity of the information within the Medicare system and some indicated they would benefit from additional training, particularly on Medicaid and dual eligibility for Medicare and Medicaid.

Researchers also asked counselors about modes of service delivery and potential barriers to access. Staff report that virtual counseling became more frequent during the onset of the COVID-19 pandemic and is more popular for beneficiaries in rural settings. But, it isn’t a one-size-fits-all solution. Staff report that many beneficiaries, especially those with mobility or transportation limitations, prefer virtual counseling, whereas those without access to technology and/or are dually eligible prefer in-person counseling. Language barriers were common among beneficiary recipients, although most counselors reported satisfaction using a phone-based language-line interpretation service. Counselors did face difficulties, however, with translating Medicare jargon and in cases in which beneficiaries declined to use the translation line.

SHIP staff reported that counseling sessions covered a wide range of topics, with significant attention paid to helping clients understand the differences between Traditional Medicare and Medicare Advantage plans. Counselors helped clients assess their needs based on factors such as health care usage, pre-existing conditions, and financial considerations. Low-income and dually eligible individuals were frequently counseled on Medicaid, Medicare Savings Programs, and low-income subsidies (e.g., the Extra Help program). A key challenge faced by counselors was dealing with misinformation from television advertisements or brokers, which led beneficiaries to make uninformed decisions about their Medicare options.

Limitations

While the qualitative approach provides in-depth insights into SHIP operations and challenges from the perspective of SHIP staff, it does not capture beneficiaries’ perspectives. Similarly, interview participation relied on state SHIP directors for participant referrals, which may have introduced selection bias both in the staff and sites recruited to participate.

Conclusion

SHIPs hold a vital role in guiding Medicare beneficiaries through complex coverage decisions. Counselors frequently combat misinformation from ads and brokers, often assisting with unintended enrollments. Expanding training to include information on Medicaid and increasing paid staff are essential to strengthening SHIP’s ability to provide accurate, unbiased support to those who need it most.

The post Helping Medicare Beneficiaries Navigate Coverage: The Role of SHIP Counseling Services first appeared on The Incidental Economist.

Caring Letters Sent by a Clinician or Peer to At-Risk Veterans

Suicide prevention is a critical priority for the Veterans Health Administration (VHA), as Veterans face a suicide rate 1.5 times higher than the general U.S. adult population. The Veterans Crisis Line (VCL), VHA’s 27/7 crisis support hotline, has managed over 5 million calls since 2007. Caring Letters interventions, involving periodic mailings to individuals expressing care and concern, are effective in reducing suicide rates among high-risk individuals post-hospitalization. However, the effectiveness of caring letters for crisis line callers has not been evaluated previously.

New Research
In April 2024, evaluators from the Puget Sound VA and Partnered Evidence-based Policy Resource Center (PEPReC) published a paper “Caring Letters Sent by a Clinician or Peer to At-Risk Veterans” in the Journal of the American Medical Association Network Open. The primary objective was to examine the outcomes of the VCL caring letters intervention and determine whether there were differences in outcomes by signatory (letters sent by a clinician versus a peer). Authors previously reported details implementing the intervention.

Methods
Authors conducted an effectiveness-implementation hybrid type 1 evaluation. They performed a randomized evaluation of the impact of peer versus clinician letters on outcomes, as well as an observational evaluation of outcomes associated with caring letters receipt. Data collection included linking VCL contact records with national VHA administrative. All Veterans who contacted the VCL with an identifiable address in the VHA’s Corporate Data Warehouse (CDW) and who contacted the crisis line between June 11, 2020, and June 10, 2021, were screened for inclusion in the caring letters cohort. Veterans were randomized to receive 9 caring letters for 1 year from either a clinician or peer Veteran signatory. Enrollment occurred between June 11, 2020, and June 10, 2021, with 1 year of follow-up. Analyses were completed between July 2022 and August 2023.

Main Findings
Peer signatory and clinician signatory recipients had similar rates of suicide attempts within 12 months of their call to VCL (7.4%, 7.6%, respectively). They also had similar rates of secondary outcomes, including mortality (3.8% of peer and 3.7% of clinician recipients died within 12 months of the index call) and health care use (69.0% of peer recipients and 68.5% of clinician recipients had at least 1 outpatient mental health visit in the 12 months following the index call).

When comparing outcomes among those who received either type of caring letters to those who did not receive caring letters, 6,801 caring letter recipients (7.7%) and 10,910 nonrecipients (7.8%) had a suicide attempt in the 12 months following the index call. There was no evidence of an association between receipt of caring letters and mortality. However, Veterans who received caring letters were significantly more likely to have subsequent inpatient and outpatient care (e.g., mental health care, ED visits).

Conclusion
Caring letters were not associated with suicide attempts or all-cause mortality, but they were associated with higher probabilities of outpatient and inpatient mental health care use, ED visits, and any outpatient or inpatient VA care use. No differences in outcomes were identified when cards were sent from a peer Veteran vs a clinician the recipient had not met. These results will be used by the VCL to optimize the caring letters intervention.

PEPReC, within the Veterans Health Administration and funded in large part by the Quality Enhancement Research Initiative (QUERI), is a team of health economists, health services and public health researchers, statistical programmers, and policy analysts who support VA efforts to improve Veterans’ lives through evidence-driven innovations using advanced quantitative methods.

The post Caring Letters Sent by a Clinician or Peer to At-Risk Veterans first appeared on The Incidental Economist.

Healthcare Costs Are Not a Simple Fix

In 2022, the United States spent $4.5 trillion on healthcare—an astonishing $13,500 per person. That’s a level of spending no other country can fathom. We manage it every year through taxes, insurance premiums, and out-of-pocket expenses. This system touches nearly every part of American life, and we all carry its cost. Private insurance is not the singular villain many assume it to be. It accounts for 29% of healthcare spending, about $1.3 trillion. Even if we eliminated significant administrative overhead, profit, and executive compensation in that sector, the savings would be somewhat marginal compared to the total cost. We would still be spending far more than any other country.

 



The post Healthcare Costs Are Not a Simple Fix first appeared on The Incidental Economist.

RFK Jr. and Trump are Torpedoing Alzheimer’s Research

With the confirmation of Robert F. Kennedy Jr. as Secretary of the Department of Health and Human Services , Alzheimer’s and dementia research is at risk. RFK Jr. and the Trump administration have made clear that National Institutes of Health research investigating Alzheimer’s is on the chopping block. They’ve done so by eliminating diversity, equity, and inclusion from clinical trials, slashing funding for rigorous projects, and firing researchers working to find a cure. I wrote about this in The Boston Globe:

“DEI in research means that all populations, regardless of race, ethnicity, or gender, are included in rigorous science to find the best treatments and cures possible.Two-thirds of Americans with Alzheimer’s are women. Older Black and Hispanic Americans are at greater risk of developing the disease than their white counterparts. We cannot investigate Alzheimer’s disease without considering DEI.” 

You can read more here or in print in the March 1st issue. The post RFK Jr. and Trump are Torpedoing Alzheimer’s Research first appeared on The Incidental Economist.

A Systematic Review of the Effectiveness and Cost-Effectiveness of Palliative Care

For persons living with serious illness, palliative care can relieve symptoms and stress. This type of care benefits both the patient and their family and is delivered by a multi-disciplinary team comprised of clinicians, social workers, and clergy. These team members work in tandem with other doctors to provide an extra layer of care.

While palliative care plays a pivotal role for patients, data demonstrating its effectiveness and cost-effectiveness can be muddled by confounding and selection bias.

For example, people with severe illness are more likely to receive palliative care. Illness severity is also correlated with poor outcomes. But problems can arise if an analysis doesn’t account for the ways in which illness severity is associated with both likelihood of palliative care and with poor outcomes. This might lead to an incorrect inference that palliative care is harmful

To better understand these relationships, a team of investigators from Trinity College (Dublin), Boston University, and the University of Southern California conducted a systematic review of ‘natural experiments’ in palliative care.

Natural experiments, also called quasi-experiments, are useful in contexts like palliative care where it would be unethical or impractical to conduct clinical trials. In natural experiments, investigators apply statistical techniques to previously collected data to make treatment and comparison groups look as similar as possible, other than receipt of treatment. To review the extent to which natural experiments exist in the palliative care literature, investigators considered four research designs.

Interrupted time series analysis: repeated measures of a given outcome in a population over time.Difference-in-differences: controlled before-and-after studies that examines outcomes at two or more time points for two groups.Regression discontinuity: compare outcomes for two groups on either side of an arbitrary threshold.Instrumental variables: explain variation in the treatment variable but have no independent effect on the outcome of interest.

With these study designs in mind, investigators were guided by four research questions:

How many studies have evaluated palliative care using causal frameworks and what specific methods were used?What results have been reported from these studies?What are these studies’ strengths and weaknesses?What are the implications for expanding use of this methodological framework given research challenges in palliative care?

To answer these questions, investigators identified peer-reviewed studies from seven databases, two hand-searched journals, and grey literature. The search returned nearly 750 articles which  were narrowed down to 17 relevant studies that met inclusion criteria. These studies were available in English and included study designs investigating causal inference with observational data.

To ensure thoroughness and quality, multiple reviewers reached consensus for study inclusion during data extraction and screening. Individual studies were assessed for methodological quality using both a custom-built tool and the STROBE checklist.

Results

Most studies (seven of 17) used a difference-in-differences study design; five employed instrumental variables and another five employed interrupted time series analysis. Studies spanned from 2002 to 2021, and the median year of publication was 2018.

Nine studies examined intensity of care (e.g., acute hospitalizations length of stay, and intensive care unit admissions). Others examined palliative care’s effects on costs.

Overall, most studies showed that palliative care reduced health care costs, lowered health care utilization, and resulted in less aggressive care at end of life (consistent with prior reviews on the subject).

There were some differences from prior systematic reviews, though. For example, the magnitude of cost-savings was lower than previously reported in less rigorous research designs and null results were common (i.e., palliative care had no effect on health care utilization or costs).

Investigators noted a few limitations related to the individual studies they found, as well as the systematic review they undertook. Namely, reporting standards varied across all three experimental frameworks (difference-in-difference, interrupted time series, instrumental variables) used by individual studies. Regarding this systematic review, investigators noted that they included a wide variety of treatments and policy changes in their criteria, as well as a broad population. Therefore, investigators assert that only general conclusions can be made without deriving meta-analysis effect estimates.

Takeaway

Palliative care is a critical component of health care for patients with serious illnesses and their families, yet research about this care can be blurred by confounding and selection bias. This systematic review demonstrates that natural experiments are one important tool to strengthen the evidence base for palliative care being effective for patients and cost-effective for the wider system.

The post A Systematic Review of the Effectiveness and Cost-Effectiveness of Palliative Care first appeared on The Incidental Economist.

Another year, another round of Shkreli awards

The Lown institute keeps an eye on fraud, waste, and dysfunction in American healthcare, and every year they present the Shkreli awards, named for infamous pharmabro Martin Shkreli. Here we summarize the top 10 terrible operators of 2024

 



The post Another year, another round of Shkreli awards first appeared on The Incidental Economist.

Your Therapist Doesn’t Accept Insurance? Here’s Why.

Finding the right therapist is hard. Finding one that takes insurance can be even harder.  

Insurers are required to cover mental health care under the Mental Health Parity and Addiction Equity Act. Yet, almost a third of therapists still don’t accept insurance at all or limit the number of insured clients they treat. The ongoing therapist shortage, exacerbated by the pandemic, has made the hunt for a provider even more difficult. Therapists that do take insurance are often fully booked.  

And accepting insurance has its perks, like widening access to a larger client pool.  

So why would a therapist not accept insurance in the first place? It turns out, it doesn’t pay as much and can be a real hassle.  

Low pay 

A 2023 Government Accountability Office report concluded that low insurance reimbursement rates are one of the main reasons why mental health care has become so inaccessible. Therapists just don’t recoup their costs with insurance, so there isn’t much incentive to accept it.  

The national average cost of a psychotherapy session is $100-$200/hour, varying based on state, licensure, specialty, and demand for services. While reimbursement rates aren’t publicly available, we do know that they are low, sometimes only a fraction of the cost to provide care.  

For instance, fee-for-service Medicaid rates in 2022 for common psychiatry services, including psychotherapy, were only 81% of Medicare’s rates. And Medicare reimbursement rates for behavioral health are already low, hitting far below what other care providers are reimbursed for. 

Providers who work with private insurance have voiced that reimbursement rates can be “insulting.” It also doesn’t help that rates haven’t significantly increased in decades. 

Given the overhead costs of maintaining licensure and owning or participating in a private practice, these low rates are unsustainable. What’s more, salaried therapists in community rehabilitation centers often make even less, as little as $30,000 a year.  

The end result is that the profession isn’t a financially attractive path to take, contributing to the therapist shortage.  

Insurance is a pain to deal with, too. 

Beyond the pay, the logistical challenges that come with insurance are another reason why mental health care providers often opt out.  

For one, the administrative responsibilities add up. Filing insurance claims and advocating on behalf of a client requires a learning curve, all done in unpaid time. Getting credentialed with an insurance company is also time-consuming, and reimbursement isn’t immediate. 

Insurers impact the care provided, too. For example, to receive reimbursement, therapists must make an official diagnosis. This can be problematic because mental health diagnoses are not always helpful for treatment. Clients may not even meet diagnostic criteria, especially during the first few sessions. Yet, diagnoses remain permanent in health records regardless.  

Insurers can then also dictate how much care they will pay for, such as the number of sessions or the length of the sessions. Those decisions don’t always align with what the therapist and client know is necessary for healing.  

The alternative: paying more out-of-pocket 

For these reasons, clients are often left paying cash and seeking reimbursement from their plan for an out-of-network visit, if their plan even offers any out-of-network therapy coverage. Sometimes therapists offer sliding payment scales based on the client’s financial situation, for which an affordable rate is agreed upon by both the therapist and client.  

Still, these options often mean higher out-of-pocket costs compared to having in-network insurance coverage or paying to see a primary care provider. 

While mental health care parity is the goal, we are clearly far from it. To this day, insurers unlawfully delay and deny coverage, perhaps to encourage patients with chronic mental illnesses – who are more expensive to cover – to drop coverage or switch to another insurer. 

We are in the throes of a mental health crisis as a nation. With care out of reach for so many though, solving the crisis feels unattainable. Paying mental health workers more, incentivizing insurance acceptance, and increasing reimbursement rates may alleviate some of the access burden. 

Mental health has been undervalued as a profession, a policy priority, and an important part of overall health for far too long. The effects of unaffordable access to care are not going away, especially as demand for care grows and the workforce struggles to keep up. It’s time we listen to the voices of both those providing and receiving care, and treat mental health like any other form of care. 

The post Your Therapist Doesn’t Accept Insurance? Here’s Why. first appeared on The Incidental Economist.