Look to the EU for Generic Versions of Expensive Brand Name Drugs

U.S. Patent protection for drugs lasts 20 years, although most pharmaceutical companies only get the medication to market after as much as half of that time has already elapsed. This exclusive period to sell the patented drug allows companies to recoup their research and clinical trial investments. It also covers the development costs of drugs that never get to market. At the end of the patent period, generic formulations enter the market, causing a decrease in the price of the drug by up to 90%. Therefore, these conditions incentivize pharma companies to take all legal means to extend the length of their patents.

Due to loopholes in the patent law, companies use these minor changes in formulation or intended use to extend patent protection. For example, suppose a drug’s initial patented intended use is for hypertension. In that case, a pharma company can submit a subsequent patent for the drug where the indication may extend to congestive heart failure. Suppose a drug manufacturer releases a generic at the end of the initial patent protection. In that case, the indicated use can only be for hypertension, not for congestive heart failure, as that patent protection may still be in place. Although companies use “skinny labeling” approaches so that only hypertension is an indicated use on medication packaging, even this approach is under review by the courts and may be outlawed.

And this does not describe the legal thicket created by additional patents submitted claiming protection for minor formulations and drug purity changes. For example, AbbVie protected its blockbuster immunosuppressant Humira, which generated more than $17.3 billion in U.S. sales, with more than 70 patents. The generic version of Humira will be available later this year, five years later than in the European Union, and the EU does not permit this type of patent manipulation.

Pharma companies are entitled to the profits generated due to the financial risk they take developing these lifesaving drugs. Yet, there needs to be a balance. Excessive profits hurt consumers and misappropriate taxpayer dollars that fund Medicare and Medicaid, especially when not plowed back into drug development. Currently, Congress is considering revising patent law to address this problem. Let us hope they choose a solution that encourages continued drug development while lowering the cost of these much-needed drugs.

Source – https://www.nejm.org/doi/full/10.1056/NEJMp2216020

When Bean Counters Manage Patient Care

My nurse colleague with more than 20 years of experience in-patient care started working at an ambulatory care clinic about two years ago. Soon after she joined, a large for-profit healthcare company purchased the non-profit clinics. Initially, work went on as usual. Patients were well-served, and clinicians were happy.

Over the last four months, things changed. Management put controls in place to track the effort of every nurse. For example, if assigned to phone triage, each nurse needed to log in at the start of their shift. If interrupted to assist a physician with a procedure, the nurse was required to log out. If a nurse failed to do so, the IT system logged the mistake, and the nurse received an email or verbal reprimand. Failure to log out hurt productivity numbers by lowering the number of calls per hour per nurse. The system’s deployment rigidity does not account for clinical judgment, even as justifiable as leaving phone triage to assist a physician in treating a patient. Unfortunately, the reporting system also makes clinical workflow burdensome and inefficient.

Rather than focus on patient care and clinical outcomes, senior management focuses on questionable productivity reports. And for what purpose? With provider organizations struggling to hire nurses, creating such a disrespectful and oppressive work environment seems illogical. Yet it exists. And I hear stories from colleagues of similar ill-advised productivity tracking schemes in other industries.

The ability to collect data does not mean it has a valuable purpose. And only some of us think the number of patients seen or the number of calls taken is a good measure of clinician productivity. We should consider using our IT tools more responsibly and focus on reworking clinical workflows to achieve productivity gains. Demoralizing nurses and physicians is a poor strategy that ultimately hurts patients.

Smart Benefit vs. Cost Data Collection

As a young disease-chasing EIS officer at the CDC, my managers instructed me to weigh the benefit of data collection versus its cost. When collecting patient survey information during a disease outbreak investigation, I kept my questionnaires to a single page, knowing that anything longer would lead to fewer responses. Keeping questionnaires short is a classic example demonstrating how less is more.

The recent CMS announcement in the New England Journal of Medicine shows that CMS finally learned that simple lesson.

More than 20 years ago, CMS began collecting quality-performance data and reporting results to the public. This data determined quality bonus payments, developed clinician networks, and facilitated provider marketing. Over these two decades, CMS expanded the amount of data collected as various CMS departments implemented their program-specific quality metrics. In addition, private entities began their quality performance journeys by creating metrics requiring a unique data set. The burden on clinicians, provider organizations, and payers became confusing and unmanageable. Organizations struggle to prioritize metrics and collect the needed data to report results. Some clinician burnout we see today is due to this unreasonable request for data.

CMS plans to streamline its metrics into a core set that, and I quote, “focus providers’ attention on measures that are meaningful for the health of broad segments of the population.”

This initiative by CMS intends to reduce provider burden by streamlining measures and allowing the automatic digital reporting of results. As CMS builds upon its foundational metrics, I hope it better leverages our investment in EMRs so that data already collected as part of care delivery further informs quality performance reports. The streamlining of metrics is a reasonable and necessary first step by CMS, and I look forward to seeing how it plays out in the future.

Medications Are a National Security Issue

Over the past several years, patients experienced medication shortages that included cancer drugs, antibiotics for sepsis, and, most recently, over-the-counter pediatric analgesics. Worried parents with children suffering from RSV or the flu are purchasing $4 over-the-counter drugs for $30 and up online due to shortages. And these problems are not due to supply chain issues created by the pandemic.

Shortages of critical medications go back more than a decade, with the FDA issuing an annual report on the subject since 2012. The 2020 CARES Act established an ad hoc committee to examine the security and resilience of U.S. medical supply chains. The committee report released last year identifies preparedness as one of the four vital protective layers to secure an adequate supply of medications. The preparedness layer calls explicitly for the stockpiling of medical products on a regional basis to reduce the chance of crucial medication shortages.

With our healthcare bill surpassing $4 trillion, we have the resources to ensure our hospitals and pharmacies have an adequate supply of life-saving drugs. It is time for us to invest in raw material supply chains, manufacturing capacity, and stockpiling of medications to protect patients from unnecessary harm.

The Long Tail Effects of the Pandemic

With the Administration ending the Covid public health emergency on May 11th, some believe that date marks the end of the pandemic. While that may be true from a policy perspective, the impact of the pandemic on healthcare delivery both here and around the world continues. In a February 2nd N.Y. Times article, David Wallace-Wells reviewed data on the number of excess deaths reported over the past two years. While researchers agreed there were excess deaths, there was no consensus on what percentage were due to Covid. Scientists remain equally divided in other OECD countries with even better data sources.

And according to a January 15th report in the Economist, all OECD countries are experiencing problems similar to those in the U.S. Clinical staff shortages are worsening. Ambulance response times have lengthened. Waiting lists for routine care and elective surgeries have grown. Some researchers attribute excess deaths to the inability of patients to obtain care soon enough to prevent advanced disease. Cancer screening rates are down while mortality has increased. This is all happening against a backdrop of rapidly growing healthcare costs. So, what is the cause?

The pandemic reduced demand for routine patient care early on as clinicians managed Covid patients and populations isolated at home. As society opened up, this delayed service demand was released. Couple that with the loss of clinicians due to Covid burnout. It is easy to see a mismatch between supply, the capacity of providers to deliver care, and demand, the number of patients asking for services. I am not sure how all this will play out over the next few months and years, but the impact of Covid on care delivery will likely exist for a considerable amount of time. And that requires us to take steps to address a growing problem.

Healthcare’s Groundhog Day

We all know about Groundhog Day, February 2, when Punxsutawney Phil emerges from hibernation and predicts whether we will have six more weeks of winter. But there is a second Groundhog Day, which is January 1. On that day, about 20% of patients switch healthcare plans and need to notify their providers and pharmacies of their new insurance coverage. January 1 is Groundhog Day for patients trying to access healthcare services. They must inform the plan of their current primary care physician or choose a new primary care physician since their existing PCP is no longer in the network. It is a tedious and unwelcome process that occurs the same way every time a patient changes her medical plan.

Without meaningful interoperability, this creates a massive hassle for patients and places an enormous administrative burden on hospitals, medical practices, and caregivers. For patients with pre-existing conditions like asthma or hypertension, medications that they have been on for years now need new pre-authorization by the medical plan administrator. The past approvals do not carry over, and medical records rarely can be used as evidence to obtain authorization. Nurses in physician’s offices spend their January days on the phone or in front of a fax machine trying to provide insurers with the necessary justification for medications rather than caring for patients.

We are not talking about $10,000 drugs here. Advair, a common asthma medication, costs just $275 yet often requires documentation for medical appropriateness. And when approvals are delayed, patients do not have the drugs they need to remain healthy.

Our healthcare system is filled with inefficiencies and friction in workflows that waste resources and hurt patients. And the current healthcare IT infrastructure fails to improve the situation. With a bit of creativity in its use, I think it could. #medicalplan #insurance #groundhogday #healthcare #drbarryspeaks

We Need to Take Care of Them….So They Can Take Care of Us

Researchers estimate that more than 3,600 healthcare workers died due to COVID in 2020. For those who escaped severe illness, the suffering of their patients during that dark time remains. Many struggle to manage periods of PTSD in a form, like soldiers who fought on the battlefield.

The triple assault of sicker patients, understaffing, and inefficient workflows make the work environment of the average clinician unsatisfying and unhealthy. No wonder clinicians are increasingly burnt out and quitting. What are we going to do when there are not enough of them to take care of us? To learn more, take 3 minutes to read my latest article on this topic in Health Data Management.

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Interoperability: Healthcare’s Betamax vs. VHS War

Review of the reasons for the slow adoption of interoperability of healthcare information.