Category: Blog

“No one should have to be fighting and insurance at the same time,” said Arete Tsoukalas, a 26-year-old who was diagnosed with leukemia. Tsoukalas’ treatment came at a hefty price, as she was forced to shell out a $13,000 per month copay for the treatment drug she required, a copay she simply could not afford as a college student. Isaac Rosenbloom, 43, doesn’t even know if he has cancer because his insurance company won’t approve an MRI for the “nodules on his lungs.” Melanie Duquette, 70, underwent an intense back surgery, after which she was sent to recover at a rehab center, at the behest of her doctor. However, after six weeks of coverage, her insurance company has denied her to stay any longer, even though “her medical team argued she should remain.” Duquette, speaking out against her insurer, said, “[t]hey deny people care while they’re making millions of dollars.”

Sadly, the denials that Tsoukalas, Rosenbloom, and Duquette have faced are just the tip of the insurance denial iceberg – with over 850 million insurance claims denied per year. According to appeals company, Claimable, and data from the health-policy nonprofit, Kaiser Family Foundation, over five billion payment claims are processed annually. Although almost twenty percent of claims are denied, “less than 1% of patients appeal.”

While there are law firms that specialize in insurance claim denials and understand the detailed appeals process for various insurers, attempting to appeal your claim denial as a customer – especially without the information, expertise, and resources these firms possess – can be a daunting task. 

Why is it so daunting you may ask. Cheryl Clark, a veteran health care reporter sought to answer this question. In her quest to create a guide for appealing insurance claim denials, she was met with the same response from insurance experts, lawyers, and physicians: “[g]reat idea. But almost impossible to do.” Clark noted that this project was essentially impossible because:

There are many kinds of insurance in the U.S., and they have different processes for appealing a denial. And no lawmakers or regulators in state and federal governments have forced all insurers to follow one simple standard.

Although the appeals process can be daunting, especially for individuals facing challenges such as battling cancer or being denied rehabilitative care (all while fighting the insurance company), the “few who appeal often win.” According to a report by the Wall Street Journal, the appeals process labors can prove worthwhile, with “up to three-quarters of claim appeals [being] granted.” 

While a one-size-fits-all guide to insurance denials is likely impossible to produce, some steps can be taken to appeal a denied health insurance claim. The Wall Street Journal suggests the following five steps:

1. Read up

   • Understand your coverage and benefits. 

2. Take note

   • Log dates of calls to your insurer, who you spoke with, billing codes for denied services, etc. 

3. Fight back

   • Call your insurance company and ask why your service was denied. 
   • Ask how to appeal. 

4. Get help

   • Nonprofits such as the Patient Advocate Foundation and the Medicare Rights Center may help craft appeals on your behalf. 

5. Escalate 

   • Write a letter explaining why your denied claim was not warranted. Have your doctor write to the insurance company explaining that the treatment prescribed was medically necessary. Appeal to a higher authority within the insurance company. 

By reading this article, you likely know more about insurance claim appeals than your counterparts. Although less than 1% of insurance patients appeal denied claims, over three-quarters of these appeals are approved. If the insurance company is not willing to fight for your health, you must fight for yourself. 

Artificial intelligence (AI) is significantly transforming the pharmaceutical industry by enhancing various aspects of drug discovery and development. Traditionally, bringing a new drug to market has been an arduous, costly, and time-consuming process, often taking more than a decade and requiring billions of dollars in investment. The high failure rate of drug candidates, coupled with the extensive trial-and-error approach in drug formulation, has long been a barrier to innovation in medicine. By analyzing complex biological data, AI accelerates the identification of potential drug candidates, thereby reducing both the time and costs associated with bringing new medications to market. 

Traditionally, drug discovery is a lengthy and expensive endeavor, often taking over a decade and costing approximately $2 billion, with a high failure rate in clinical trials. AI addresses these challenges by analyzing complex biological systems, identifying disease biomarkers, and simulating drug-target interactions, which streamlines the early stages of drug development.  

One notable advancement is the use of AI in predicting protein structures, a critical aspect of understanding disease mechanisms and developing targeted therapies. For instance, AI models have been developed to accurately predict the three-dimensional structures of proteins, facilitating the design of drugs that can effectively interact with specific biological targets. Moreover, AI algorithms can process extensive patient data, including genetic information, medical records, and lifestyle factors, to create personalized treatment plans.  By analyzing patterns and correlations within this data, AI can identify hidden insights and predict individual treatment responses with unprecedented accuracy. 

Clinical trials are essential for evaluating the safety and efficacy of new drugs but are often time-consuming and costly. AI streamlines this process by improving patient selection, predicting drug responses, and automating data analysis. By analyzing electronic health records and genetic information, AI identifies suitable candidates for trials more efficiently, potentially reducing trial durations and costs. Additionally, AI can enhance the design of clinical trials by simulating various scenarios and optimizing protocols to increase the likelihood of success. Machine learning models can predict potential outcomes based on historical data, allowing researchers to make informed decisions about trial designs.  

While AI offers numerous benefits, its successful application in drug development depends on the availability of high-quality data and the careful consideration of ethical concerns. Ensuring data privacy and addressing biases in AI models are critical for the reliable and equitable development of new therapies. Integrating AI into existing pharmaceutical workflows requires collaboration between data scientists, clinicians, and regulatory bodies to establish standardized practices and guidelines. As AI continues to evolve, ongoing research and development are essential to fully realize its potential in revolutionizing drug discovery and development. 

AI is poised to revolutionize pharmaceutical development by expediting drug discovery and enhancing the efficiency of clinical trials. As technology continues to advance, integrating AI into pharmaceutical research holds the promise of delivering more effective and personalized treatments to patients worldwide. 

Earlier this month, a Texas judge granted an injunction to halt a New York doctor, Margaret Daley Carpenter, from prescribing and sending medication abortion pills to patients in Texas and imposed a $100,000 fine. The case is the first known to openly challenge an abortion shield law, passed by eighteen states and the District of Columbia in response to the Supreme Court striking down Roe v. Wade in 2022, and is expected to make its way to the highest court.

Dr. Carpenter is a reproductive health specialist based in New Paltz, New York, and co-founder of the Abortion Coalition for Telemedicine, which advocates for providing access to abortion medications in all 50 states. In December, Texas Attorney General Ken Paxton charged her with violating Texas law by providing two abortion medications (mifepristone and misoprostol) by mail to a 20-year-old woman in Texas that resulted in a medical abortion. Dr. Carpenter, who is facing similar charges in Louisiana, has not appeared in court in Texas, resulting in the judge declaring a default judgment in favor of the State. Instead, she is relying on the State of New York’s Abortion Shield Law to protect her from any punishment the State of Texas may try to exact from her activities. 

Abortion shield laws are designed to protect providers and patient medical records from civil and criminal consequences from assisting out-of-state patients with abortions, such as extradition, subpoenas, or medical records requests. Championed as a way to circumvent red-state abortion restrictions, pro-choice groups such as the Center for Reproductive Rights have proposed shield laws as the best solution to maintaining access to abortion care nationwide. Red states such as Texas, argue that these laws erode their state sovereignty and go against the full faith and credit clause of the Constitution, which requires states to honor the final judgments of courts in other states. Additionally, it is undisputed that the laws go against long-standing precedent of interstate cooperation and sharing of information. New York will likely argue that Texas has no jurisdiction over New York providers and Texas cannot get the assistance of the New York courts because of the shield law. 

Despite stringent restrictions imposed on abortions in the wake of the Dobbs decision, it is estimated that more than 10,000 pills per month are sent to women in states with bans. If shield laws are found to be unconstitutional, it could be the final nail in the coffin for abortion access in much of the country, and abortion providers acting under the protection of these laws could find themselves in legal jeopardy.

On February 3^rd, New York Governor Kathy Hochul signed into law a bill adding an extra layer of protection for providers, beyond their initial shield law, by allowing pharmacies to print a practice’s name on pill bottles rather than the prescriber’s. The Governor reiterated she would stand firm with abortion care providers and would not sign off on any extradition orders. The move seemed to signal that the State of New York will not give way to Texas or any other state’s demands, and they will see Attorney General Paxton in court.

Considering recent declines in research grants, the federal scientific workforce, and public access to research, the future of medical innovation is uncertain. However, even before these challenges arose, there were already parts of the system that limited progress. 

One problem is that pharmaceutical patents held by large drug manufacturers limit generic drug production. This is because a generic drug maker cannot apply for a generic drug approval if the brand name drug is still patented. The Food and Drug Administration will not approve a generic drug that infringes on an approved brand drug. 

One of the issues is that the FDA generally avoids getting involved with drug patents. The FDA publishes the Orange Book, in which it collects all the drugs it approves and their active patents, but these patents are reported by the pharmaceutical companies that hold them. While the FDA will ensure that all patents directly related to the drug or its method of use are published, the agency generally does not check or remove any other reported patents. The FDA’s role in Orange Book patent policing is “purely ministerial.” 

This can become a problem because many large pharmaceutical companies do not only patent the active ingredient and method of use of a drug; they usually build patent thickets. These are overlapping patents for the same drug that expire at different times; sometimes more than twenty years after the first patent related to a drug is filed. Pharmaceutical companies reported these additional patents to the FDA alongside the active ingredient and method of use patents. 

In the last two years, the Court of Appeals for the Federal Circuit has addressed some of this excessive reporting. In 2023, the Federal Circuit held in Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC. that only drug and method of use patents, as narrowly defined by patent law, should be listed in the Orange Book. In December 2024, the Federal Circuit held in Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC. that these drug and method of use patents must specifically claim the active ingredient in the approved drug, and the approved drug product must infringe on the listed patents. A drug product includes the drug substance (active ingredient) and any other substance used to make the finished administrable medicine. In both cases, the court ordered the FDA to delist other patents they listed in the Orange Book. 

Overall, if drug developers are limited in the patents that they can list in the Orange Book, then the FDA is less likely to refuse to approve a generic drug because this approval would infringe on a listed patent. This would remove one hurdle to generic drug approval and allow more of these accessible drugs to enter the market. Of course, given the complexity of drug patenting, it is unclear how useful these changes will be. 

Telehealth, health care through technological services, has been an increasingly used form of care since the COVID-19 pandemic when digital health care became increasingly necessary to limit in-person interactions. Telehealth is conducted completely online and, therefore, has the potential to be revolutionary for disabled folks who would benefit from the convenience of a digital platform. The digital aspect of telehealth would allow patients to avoid barriers to accessibility that come with in-person appointments, such as issues like transportation and mobility or the need to avoid potential exposure to communicable diseases.

While patients could avoid the barriers to in-person care through telehealth, telehealth has proven to come with digital barriers of its own, largely stemming from a lack of digital accessibility. Telehealth, in theory, would expand access to health care for disabled individuals. In practice, telehealth has not realized its potential because of the inequities associated with online access, such as website inaccessibility. This has resulted in an increasingly inequitable healthcare landscape, where disabled people continue to bear the brunt of systemic inaccessibility. The health care costs are higher for disabled folks with intersecting identities, whereas disabled Black and Latino folks are more likely to suffer from poor health outcomes.

Telehealth is usually inaccessible for several reasons that the Department of Justice (DOJ) has outlined, including poor color contrast, use of color alone to give information, lack of text alternatives on images, no video captions, inaccessible online forms, and mouse-only navigation. In an age where access to information and health services is a health determinant, inaccessible internet access is unacceptable. Digital accessibility is a civil rights issue.

While the Americans with Disabilities Act (ADA) does not explicitly discuss digital accessibility, courts have interpreted Title II of the ADA, a section on discrimination based on disability by state and local governments, to include protecting digital accessibility. This precedent supports protecting digital accessibility for government healthcare agencies. Despite this precedent, legislative action should establish enforceable website accessibility requirements under Title II.

Title III of the ADA, which discusses private businesses and public accommodations, is less resolved when it comes to its protections on website accessibility, creating a lack of uniform protections. Some courts have held that telehealth platforms are places of accommodation, meaning that they fall under ADA requirements of protection, but others have found that they do not qualify. Protections for disabled folks are therefore different by location and private telehealth services can have digital accessibility barriers without consequence. Because Title III lacks enforceable digital accessibility standards, these barriers remain unaddressed.

Given that telehealth is an increasingly relevant mode of healthcare, we should advocate for improved access to its services for everyone by enshrining digital accessibility into the ADA. The exclusion of disabled folks through digital barriers is unacceptable when they are a group that could benefit the most from its benefits. Disabled folks already disproportionately receive less health care because many are disproportionately below the poverty line, making payment impossible, and face issues with accessible in-person services, transportation, and communication. Making healthcare access more difficult by not improving accessibility in all spaces, including digital spaces, leads to more negative outcomes for disabled people, especially for disabled people with intersecting identities. Without stronger enforcement of compliance with digital accessibility guidelines, disabled patients will continue to face digital barriers to healthcare.

Health inequities affecting people with disabilities remain a persistent and often overlooked issue within the U.S. healthcare system. Despite efforts to make healthcare more inclusive, provider biases and financial challenges continue to prevent millions from receiving equitable care. With recent policy pushes for broader health equity, now is the time to address the unique needs of this population.

Provider bias and a lack of training on disability-specific care create another layer of inequity. Many healthcare providers have limited knowledge of the unique healthcare needs and challenges faced by people with disabilities. The National Council on Disability (NCD) reports that these gaps in provider training lead to miscommunication, inadequate treatment, and a lack of understanding about the disabilities themselves. This can result in healthcare providers making assumptions about patients’ quality of life or failing to take complaints seriously, impacting the overall quality of care. Addressing these biases is crucial to ensure that providers offer compassionate, informed care that respects everyone’s needs.

Individuals with disabilities often encounter significant financial challenges that impede access to necessary healthcare services. These challenges stem from increased medical expenses, limited employment opportunities, and systemic economic disparities. A comprehensive report by the Financial Health Network reveals that nearly half (46%) of working-age individuals with disabilities have unmanageable levels of debt, and only 51% can pay all their bills on time. This financial instability is exacerbated by the fact that people with disabilities are more likely to live on low incomes. The National Disability Institute reports that 45% of working-age individuals with disabilities have annual household incomes under $30,000, compared to 21% of those without disabilities. Public safety net programs, such as Supplemental Security Income (SSI) and Social Security Disability Insurance (SSDI), are intended to support individuals with disabilities. However, only about a third of working-age individuals with disabilities receive these benefits. Even among those with low incomes and significant barriers to employment, many do not receive the assistance they need. These financial barriers not only limit access to healthcare but also contribute to a cycle of poverty and poor health outcomes. Addressing these challenges requires comprehensive policy interventions aimed at improving employment opportunities, enhancing public benefits, and reducing the additional costs associated with living with a disability.

Recent policy efforts seek to address these disparities, but much work remains. The Americans with Disabilities Act (ADA) laid an essential foundation for disability rights, yet it does not mandate comprehensive healthcare accessibility or provider training. The National Council on Disability’s 2024 Progress Report recommends that policymakers enhance provider training in disability care, increase funding for facility accessibility improvements, and expand Medicaid and Medicare services to cover a broader range of disability-specific needs.

Ensuring health equity for people with disabilities will require more than incremental improvements; it demands systemic change. Addressing physical, educational, and financial barriers within the healthcare system is crucial. By pushing for stronger policies, comprehensive training, and expanded financial support, we can bridge the gap and create a healthcare system that serves everyone equally. Ongoing advocacy and reform are essential to ensure that all individuals, regardless of disability, receive the quality care they deserve.