D Flat: The Sweetest Note in Healthcare

09/13/2021 09:11 AM | Peter Pitts

Last week 132 organizations representing older Americans, patients, family caregivers, people with disabilities, diverse communities, and healthcare providers sent a letter to our Congressional healthcare leadership urging them to address the unaffordable and out of control out-of-pocket (OOP) costs facing America’s seniors. The timing is urgent.

A new analysis by the Kaiser Family Foundation has found that the number of non-Low-Income Subsidy (LIS) beneficiaries reaching the catastrophic phase of the Part D benefit has increased since 2010. In 2019, almost 1.5 million beneficiaries had out-of-pocket expenses exceeding the catastrophic threshold of $5,100 – and the arrow is going in the wrong direction.
 
Our national reality is that millions of American seniors cannot afford their medication due to high cost-sharing requirements and millions more will not be able to afford their medicines in the future unless Congress directly addresses this crisis. It’s time to “cap-and-smooth” Part D. Specifically:

* Congress should create an out-of-pocket maximum (an annual cap) on Medicare beneficiary Part D out-of-pocket expenses. Medicare is the only major insurer in the U.S. that lacks an OOP maximum. While all proposals under current consideration include an annual OOP cap, patients would derive greater benefit from a consistent, monthly cap on Part D OOP expenses.

* Any proposal that adopts an annual – rather than a monthly – OOP cap in Medicare Part D should be paired with a "smoothing mechanism." Smoothing would allow beneficiaries the option to evenly spread costs over a plan year, thereby avoiding large lump sum OOP expenses. Many beneficiaries cannot afford to make lump sum out-of-pocket payments at the pharmacy counter, leading to abandoned prescriptions and lower treatment adherence. This flexibility should be available to all beneficiaries, at any time during the benefit year, regardless of a beneficiary's level of OOP spending.

* Congress should ensure the program includes strong patient protections, such as hardship exceptions or other mechanisms to allow beneficiaries a payment grace period. There are legitimate reasons a beneficiary might miss a payment (e.g., illness or hospitalization, relocation) that should not disqualify them from utilizing the flexibility. Further, plans should be required to notify patients when they are behind on their payments and inform them of the ability to apply for a hardship exception.

* Congress should ensure that smoothing is the default position rather than requiring Medicare beneficiaries to opt-in or otherwise enroll. This approach will ease implementation and lower administrative barriers to participation.

* Congress should look to CMS’s Part D Senior Savings Model that allows patients with diabetes enrolled in participating Medicare Part D plans to access insulin for $35 per monthly prescription, to determine if expanding a low-cost maximum copay model would broadly improve outcomes for patients with other conditions.

But beware. While all proposals to address prescription drug spending should be evaluated, Congress should reject consideration of comparative cost-effectiveness methodologies. Measurement tools such as the Quality-Adjusted Life Year (QALY) assign a value between 0 (death) and 1 (perfect health) to the people for whom a given treatment is intended. The result is that patients (otherwise known as "people") who are sicker, older or have a disability are assigned lower “life values.” QALYs also fail to account for health disparities, incorporating and institutionalizing a bias that adversely impacts communities of color. When applied to healthcare decision-making by payers, this means that treatments for these more vulnerable beneficiaries are deemed "too expensive" and therefore "not cost-effective" to cover. Healthcare must never be red-lined.
 
The “ask” of the 132 signatories is simple: “Congress must take action to address the unsustainable OOP burden faced by Medicare Part D beneficiaries. We call on your committees to include Part D reforms that ensure patients can access the medications needed to improve and maintain their health in the budget reconciliation package.”

Let’s get this Part D started!
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The Futility of Prior Authorization

08/25/2021 09:39 AM | Peter Pitts

In a recent op-ed, ophthalmologist and Executive Vice President of the California Academy of Eye Physicians and Surgeons, Dr. Craig H. Kliger points out that Aetna now requires prior-authorization for all cataract surgeries. He is astounded. And rightfully so.

According to Aetna, prior-authorization, “helps [its] members avoid unnecessary surgery.” That’s healthcare shorthand for “We don’t want to pay for it.” H.L. Mencken said, “When somebody says it’s not about the money, it’s about the money.”  As Dr. Kilger comments, “Hard to believe this is any different.”

No other large medical insurer believes such a policy necessary.

Cataract surgery is the most effective and most common procedure performed in all of medicine with some 4 million Americans choosing to have cataract surgery each year and an overall success rate of 97 percent or higher. The impact feels almost biblical, as cataract surgery allows people to see again — and recover their lives. Study after study shows cataract surgery improves quality of life, cuts the risk of falls and car accidents, and reduces cognitive decline among older adults. 

Per Dr. Kilger, “As of this writing, I am aware of numerous cancellations of these surgeries as an unprepared Aetna attempts to implement a process about which it has provided little to no real training and direction.” His article ran three weeks ago.

This issue may be new to ophthalmologists – but it is hardly new.

Prior authorization, also known as pre-authorization, pre-certification or prior notification, is an extra set of steps some insurance carriers require before determining whether they will pay for a medical service or prescription medication. The physician, or other medical provider, is required to obtain approval from the insurance carrier before the carrier will agree to cover the cost of the medical service or prescription medication. Step therapy, also referred to as “fail-first,” requires patients to “fail’ on one or more less costly medications before the health insurance carrier will agree to cover a more expensive medication, even if a physician thinks it is a better option for the patient.

Currently, prior authorization and fail-first protocols are primarily paper-based, and non-standardized. Each insurance carrier has its own set of requirements, which can vary among plans, even within the same carrier’s portfolio of coverage options. To meet prior authorization requirements physicians must complete a time-consuming series of faxes, phone calls, emails, input of data into insurance carrier web sites and, in some cases, letters.  

Two independent nationwide surveys, one by the American Medical Association (AMA) and the other from the American College of Rheumatology (ACR) shows broad physician dissatisfaction with the insidious practices of prior-authorization and step therapy – specifically the ways in which it impacts the ability of physicians to treat patients.

The AMA-conducted survey shows that physicians are running into roadblocks because of prior authorization, or the process of requiring health care professionals to obtain advance approval from health plans before a prescription medication or medical service is delivered to the patient. 

The 1,000 practicing physicians surveyed in December 2020—when new COVID-19 cases were soaring — reported that prior authorization was widespread.  Eighty-three percent of respondents indicated that prior authorizations for prescription medications and medical services have increased over the past five years. Along with this increased volume of requirements, most physicians reported a continued lack of transparency in prior authorization programs, with a majority of physicians stating that it is difficult to determine whether a prescription medication (68 percent) or medical service (58 percent) requires prior authorization. An overwhelming majority (87 percent) of physicians also reported that prior authorization interferes with continuity of care.

“You would think insurers would ease bureaucratic demands throughout a pandemic to ensure patients’ access to timely, medically necessary care. Sadly, you would be wrong,” said AMA President Susan R. Bailey, M.D. 

In parallel, the American College of Rheumatology reports that: 

* About 48% (47.94%) of patients receiving treatment for their rheumatic disease reported that their provider needed to obtain prior authorization for their prescription in the past year.

* About 47% (46.17%) of patients receiving treatment for their rheumatic disease reported that they were required to undergo step therapy, a process where patients are required to try therapies preferred by their insurance company before they can receive the therapy their doctor originally prescribed — even when doctors are not confident the insurer-preferred option will be effective.

The American Medical Association, the American College of Rheumatology and the American Acadamy of Ophthamology are calling on Congress to remedy the problem by passing The Improving Seniors’ Timely Access to Care Act (HR 3173). 

This bipartisan legislation would require Medicare Advantage (MA) plans to implement a streamlined electronic prior authorization process that complies with technical standards developed by the Department of Health and Human Services, in consultation with relevant stakeholders. In addition, the bill would require increased transparency for beneficiaries and providers, as well as enhance oversight by the Centers for Medicare & Medicaid Services on the processes used for prior authorization. Moreover, to ensure that routinely approved care and treatments are not subjected to unnecessary delays, the program would provide for real-time decisions by an MA plan with respect to certain prior authorization requests.  Importantly, the bill would also require MA plans to meet beneficiary protection standards, such as ensuring continuity of care when patients change plans. 

As for cataract surgery prior-authorization, Aetna has provided no reason and offered no evidence for pre-approval for all cataract surgeries. According to the American Academy of Ophthalmology (AAO), “Because Aetna published no updated policy documents and provided limited prior education, the new policy is already causing chaos at the doctor’s office. This at a time when ophthalmology practices are struggling to fit patients in as they work through a backlog of surgeries due to COVID-19 shutdowns.”

Per the AAO, “The policy has been implemented in such an inefficient manner that we estimate that 10,000 to 20,000 Aetna patients will have their cataract surgery unnecessarily delayed in the month of July alone. Just yesterday, a confused patient called their ophthalmologist in anger to blame him for cancelling surgery. One day before the effective date, and it’s already threatening to erode trust between patients and physicians. There must be a better way to solve this unstated issue Aetna wishes to fix; a way that helps consumers improve their health and simplify their health care experience. The nation’s ophthalmologists are committed to finding a solution that does not delay or deny our patients access to vision-restoring surgery.”

Sadly, prior authorization ends up raising healthcare costs. If doctors can only prescribe “less expensive," less effective treatments, folks will get sicker, be hospitalized more frequently, and require more expensive care. That demand will drive up overall healthcare costs and overwhelm doctors and hospitals with waves of new patients.

It’s time for change. It’s time for action. Lives are at stake.
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FDA and "Right to Repair" -- Nullum gratuitum grandium.

07/27/2021 04:45 PM | Peter Pitts

I had the privilege and pleasure earlier today of participating in the FDA’s webinar, “Remanufacturing of Medical Devices Draft Guidance and Strengthening Cybersecurity Practices Associated with Servicing of Medical Devices Discussion Paper.”

Bottom line – big problems – and it begins with accurately identifying where those problems come from.  According to Josh Silverstein, a CDRH Regulatory Advisor, a majority of the comments, complaints, and adverse event reports received by the FDA that referred to inadequate “servicing” causing or contributing to adverse events or deaths actually related to “remanufacturing.”

What’s the difference? That is a key question, and much of the FDA presentation was focused on clarifying definitions. It’s not as simple as “repair.” The nuances are many and they are all important ranging from reprocessing, servicing, reconditioning and rebuilding, to remanufacturing and repairing.

Importantly, the FDA made it clear from the outset that the draft guidance is not intended to adopt significant policy changes, but to clarify the agency’s current thinking on applicable definitions and “clarify, not change” various regulatory requirements.

Translation – regulation of medical device remanufacturing and servicing is going to become more risk-based, robust and regular – and this will be particularly true when it comes to on-site inspections. This isn’t surprising since the best way to keep people honest is to keep them guessing as to when and where an inspection might happen.

CDRH laid out six “Guiding Principles” –

1- Assess whether there is a change to the intended use

2- Determine whether the activities, individually and cumulatively, significantly change the safety or performance specifications of a finished device

3- Evaluate whether any changes to a device require a new marketing submission

4- Assess component, part, or material dimensional and performance specifications

5- Employ a risk-based approach

6- Adequately document decision-making

In short – there’s going to be a lot more requirements for responsibility and accountability on the part of those medical device owners who oversee, operate and remediate problems When it comes to FDA-regulated medical devices, “Right to Repair," doesn’t mean “cheap and easy.” The FDA has made that very clear. Anyone who thinks otherwise isn’t paying attention – or doesn’t want to.

And that doesn’t even include the discussion of medical device cybersecurity. Per Katelyn Bittleman, CDRH Policy Analyst, “Cybersecurity is a shared responsibility among all stakeholders. The FDA expects manufacturers to appropriately secure their devices to continue to assure the devices’ safety and effectiveness. Non-OEM servicing entities play an important role in maintaining the quality, safety, and efficacy of medical devices without compromising cybersecurity."

Nullum gratuitum grandium.
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Addressing "Temporary" Insanity

07/23/2021 08:05 AM | Peter Pitts

I just googled “temporary vaccine waiver” under “news” and got 31,900 hits.

Then I ran the same exercise for “Pfizer and BioNTech Announce Collaboration with Biovac to Manufacture and Distribute COVID-19 Vaccine Doses within Africa.” I got 1300 hits.

That’s upside down and unfortunate since it’s the Pfizer/BioNTech announcement that’s going to save lives.

Here’s the rest of the story:

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union.

“We aim to enable people on all continents to manufacture and distribute our vaccine while ensuring the quality of the manufacturing process and the doses”

Biovac will perform manufacturing and distribution activities within Pfizer’s and BioNTech’s global COVID-19 vaccine supply chain and manufacturing network, which will now span three continents and include more than 20 manufacturing facilities. To facilitate Biovac’s involvement in the process, technical transfer, on-site development and equipment installation activities will begin immediately.

Pfizer and BioNTech expect that Biovac’s Cape Town facility will be incorporated into the vaccine supply chain by the end of 2021. Biovac will obtain drug substance from facilities in Europe, and manufacturing of finished doses will commence in 2022. At full operational capacity, the annual production will exceed 100 million finished doses annually. All doses will exclusively be distributed within the 55 member states that make up the African Union.
“From day one, our goal has been to provide fair and equitable access of the Pfizer-BioNTech COVID-19 Vaccine to everyone, everywhere,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “Our latest collaboration with Biovac is a shining example of the tireless work being done, in this instance to benefit Africa. We will continue to explore and pursue opportunities to bring new partners into our supply chain network, including in Latin America, to further accelerate access of COVID-19 vaccines.”

“We aim to enable people on all continents to manufacture and distribute our vaccine while ensuring the quality of the manufacturing process and the doses,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “We believe that our mRNA technology can be used to develop vaccine candidates addressing other diseases as well. This is why we will continue to evaluate sustainable approaches that will support the development and production of mRNA vaccines on the African continent.”

“We are thrilled to collaborate with Pfizer and BioNTech to produce and distribute the Pfizer-BioNTech COVID-19 Vaccine within Africa. This is testament of the long-standing relationship we have had with Pfizer through the Prevenar 13 vaccine,” said Dr. Morena Makhoana, CEO of Biovac. “This is a critical step forward in strengthening sustainable access to a vaccine in the fight against this tragic, worldwide pandemic. We believe this collaboration will create opportunity to more broadly distribute vaccine doses to people in harder-to-reach communities, especially those on the African continent.”

Pfizer and BioNTech select contract manufacturers using a rigorous selection process based on several factors: quality, compliance, safety track record, technical capability, capacity availability, highly trained workforce, project management abilities, prior working relationship, and commitment to working with flexibility through a fast-paced program. Pfizer and Biovac have worked together since 2015 on the sterile formulation, fill, finish and distribution of the Prevenar 13 vaccine.

To date, Pfizer and BioNTech have shipped more than 1 billion COVID-19 vaccine doses to more than 100 countries or territories in every region of the world. The companies are firmly committed to working towards equitable and affordable access for COVID-19 vaccines for all people around the world, actively working with global governments as well as global health partners with the aim to provide 2 billion doses to low and middle income countries in 2021 and 2022 – 1 billion each year. This includes an agreement to supply 500 million doses to the U.S. Government at a not-for-profit price, that the government will, in turn, donate to the African Union and the COVAX 92 Advanced Market Commitment (AMC) countries, as well as a direct supply agreement with the COVAX facility for 40 million doses.
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About that FDA Report on Third Party Medical Device Servicing

07/20/2021 09:18 AM | Peter Pitts

The “Right to Repair” issue pertains to FDA-regulated medical devices and the unintended negative consequences for patient health and safety that would result if unregulated third-parties were allowed to work on these highly sophisticated pieces of equipment.

“Right to repair” advocates point to FDA’s 2018 report they claim led the agency to “take a pass” on regulating third party device servicing because they could find no evidence of a problem. Cheery-picked quotes describe third-party servicers as providing “high quality, safe, and effective servicing of medical devices … critical to the functioning of the U.S. healthcare system.”

This is out of context, wrong and dangerous. The fact of the matter is that the FDA report said the agency didn’t have enough data to make a definitive conclusion about third party servicing. The FDA doesn’t have that data because unregulated servicers aren’t required to register with the agency and FDA can’t even establish how many third-party servicers are actually out there – though the agency estimates there are between 16,000 - 21,000.

Further, the FDA’s 2018 report showed the majority of inadequate services reported should actually be categorized as remanufacturing, meaning that the device in question is no longer the device the FDA gave clearance/approval to. Big difference. Big problem.

In truth, the agency laid out a roadmap to address this issue and has been executing against it over the last several years through remanufacturing guidance and cybersecurity discussion papers. This is where the FDA should concentrate its efforts: educate, surveil and enforce actions on remanufacturing to ensure service activity doesn’t cross over into regulated activity.

On July 27, the FDA is holding a public meeting on this topic. It couldn’t come at a better time. The proper servicing and security of medical devices and other health care technologies mustn’t be allowed to be undermined by third-party servicing apologists willing to employ bad faith tactics and misrepresent the facts.
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On Cyber Security & Medical Device Servicing

07/19/2021 08:01 AM | Peter Pitts

The other week, the HHS Inspector General released a report about just how little oversight the Medicare program has over medical device cybersecurity (and what little discretion is does have, it rarely uses).

If you’ve been following the news lately, you’ll know that cybersecurity in the healthcare space is a big problem. Hospitals and health systems large and small have increasingly been on the receiving end of hacks, cyber-attacks and ransomware intrusions. Not to mention that an estimated 275 million medical images are currently vulnerable due to unsecured picture archiving communication systems.  HHS just released another alert about that just days after the Inspector General report came out.

The report focused on the role of Medicare accrediting organizations’ failure to keep proper tabs on whether hospitals were maintaining proper cybersecurity of their networked devices. According to the report: 

CMS’s survey protocol does not include requirements for networked device cybersecurity, and the AOs [accrediting organizations] do not use their discretion to require hospitals to have such cybersecurity plans. However, AOs sometimes review limited aspects of device cybersecurity.

For example, two AOs have equipment maintenance requirements that may yield limited insight into device cybersecurity.  If hospitals identify networked device cybersecurity as part of their emergency-preparedness risk assessments, AOs will review the mitigation plans. AOs told us that in practice, however, hospitals did not identify device cybersecurity in these risk assessments very often.

But most importantly, the OIG’s report underscored the lopsided cybersecurity expectations in the healthcare industry. Cybersecurity is supposed to be a shared responsibility between device manufacturers and providers. For their part, the manufacturers are tightly regulated by the FDA and are required ensure their products are secure through a carefully designed protocols subject to frequent updates. Alas, the best-designed devices in the world can’t compensate for negligence or poor practices on the part of the end-user.

Which brings me to the point I raised in The Hill recently about how unregulated medical device servicing poses serious risks for cybersecurity. Original equipment manufacturers and their servicers are regulated by the FDA. Third party servicers – who could really be anyone since there are no universal training and licensing requirements to service these devices either – are not. Third-party servicers claim they’re held to the same standards as OEMs due to hospital accreditation. The OIG report flies in the face of that claim.

If the goal is to get rid of the “blind spots” that lead to cybersecurity incidents, ensuring that those who control repairs and maintenance of these highly sophisticated pieces of health care technology are FDA-regulated makes the most sense to me. Hiding behind accreditations that Medicare isn’t watching doesn’t. It’s clear no one is watching the proverbial coup on the hospitals’ end.

If hospitals and imaging providers can’t keep tabs on their own cyber security, how can we expect them to handle the servicing of highly sophisticated medical devices?
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U.S. PIRG's "Right-to-Repair" position is Ill-considered and anti-patient

06/21/2021 02:19 PM | Peter Pitts

According to the U.S. PIRG, “Manufacturers of ventilators, dialysis machines and other critical medical devices routinely restrict access to essential repair materials. That leaves hospital repair technicians, commonly known as biomeds, without the tools they need to fix medical equipment as soon as it breaks. Instead, they have to wait days, weeks or even a month for a manufacturer-branded technician to travel onsite and make the repair well within the biomed’s capabilities. In the meantime, that broken ventilator can’t be used to deliver life-saving treatment to a patient.”

As my grandmother used to say, “A half-truth is a whole lie.”

At first glance, “Right-to-Repair seems like a good idea. Why not make it easier for consumers to fix their broken electronics, without having to pay a costly sum to the original manufacturer? But, as HL Mencken reminds us, “For every complex problem there is an answer that is clear, simple, and wrong.” The reality is that Right-to -Repair presents many dangerous unintended consequences. The Number One problem is that it compromises patient safety.

The core of Right-to-Repair laws is to require innovative technology companies to make product repair information, replacement parts, and tools readily available to consumers and third-party repair shops. Should that be the case for devices such as Automated External Defibrillators and hospital ventilators? What about electrocardiograph (ECG) machines? Can physicians and patients be confident in non-FDA compliant vendors without the advanced training and technical ability to properly repair and recalibrate life-saving machines? Who could argue that “anyone can do it?”

Well – U.S. PIRG for one.

By allowing third parties without any FDA competence to repair regulated, complicated medical devices, Right-to-Repair also opens the door to breaches in cybersecurity. According to the FDA, “Cybersecurity is a widespread issue affecting medical devices connected to the Internet, networks, and other devices. Cybersecurity is the process of preventing unauthorized access, modification, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient.”

In a recent FDA discussion paper, “Strengthening Cybersecurity Practices Associated with Servicing Medical Devices: Challenges and Opportunities,” the agency asks, “How can entities that service medical devices contribute to strengthening the cybersecurity of medical devices?” According to the discussion paper, “FDA defines service to be the repair and/or preventive or routine maintenance of one or more parts in a finished device, after distribution, for purposes of returning it to the safety and performance specifications established by the original equipment manufacturer (OEM) and to meet its original intended use.” In other words, the first step in advancing medical device cybersecurity is to limit and ensure that those who control repairs and maintenance of these highly sophisticated pieces of healthcare technology are regulated FDA manufacturers.

On July 27th, the FDA is holding a public meeting on this topic. It couldn’t be timelier. The proper servicing and security of medical devices and other healthcare technologies is too important for uniformed posturing. U.S. PIRG should know better.

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Speaker Pelosi's Mistaken HR 3-Peat

04/22/2021 08:15 AM | Peter Pitts

Word on the street is that H.R. 3 is going to be reintroduced today.

New Congress. Same bad ideas. A hit parade of bad ideas.  For example:

An International Pricing Index. Patients often lose access to the best medicines when their government adopts price controls. Of the drugs launched in the last seven years, only 60% were available in Sweden. And only half made it to patients in Canada. In the United States, meanwhile, nearly 90% of those medicines were available. Americans will no longer enjoy generous access to the newest drugs if we embrace price controls. Importing the socialist pricing tactics of foreign governments is no way to stand up for Medicare patients. Bad idea when it comes from the White House, Bad idea when it comes from the People’s House.

Direct Government Negotiation. Is the direct federal negotiation of drug prices a good idea? Consider the “non-interference clause” that currently prohibits such actions in Medicare Part D — the federal program that subsidizes prescription drugs for seniors. A repeal of the non-interference clause would result in a sharp increase in Medicare drug prices and a substantial decline in patient choice.

The Congressional Budget Office observed that Part D plans have “secured rebates somewhat larger than the average rebates observed in commercial health plans.” According to the CBO, to achieve any significant savings, the government would have to follow through on its threats of “not allowing [certain] drug[s] to be prescribed.” In other words, the government would drop some drugs from Medicare’s coverage to save money. That would be a raw deal for patients. The average Part D plan provides access to more than 95 percent of the top 200 Medicare Part D Drugs. (PS/ The Non-Interference Clause was written by Senators Ted Kennedy and Tom Daschle.)

Rebates to Off-Set Price Hikes. When Americans say, “My drugs are too expensive,” what they generally mean is that their co-pays at the pharmacy are too expensive. And they’re right. But co-pays aren’t tied to list prices. Consider this: payers negotiate discounts of between 30-50% of the list price – and then base the co-pay off of the list price. What happens to the discount? They pocket the difference. When payers say that higher co-pays are a result of higher list prices they are lying. Surprisingly absent from H.R. 3 is any call for pricing transparency. Shameful.

The primary difference from the previous version is that this “new” itereation will not specify how the funds will be used – Speaker Pelosi’s goal is to use this as a pay-for in the American Family Act

H.R. 3 is a cruel joke. Cruel to patients.
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New CMPI Book: The Value Equation

01/07/2021 08:11 AM | Peter Pitts

The Value Equation Charts Pathway for 21st Century Medical Innovation
Former FDA Associate Commissioner Details Urgency of Advancing the Healthcare Ecosystem

In his new book, The Value Equation: A Journey Through the Innovation Ecosystem in the Time of COVID, Peter Pitts argues that healthcare innovation saves lives, saves money, promotes economic growth, and provides hope for hundreds of millions of people (both patients and care-givers) in the United States and around the world. But that innovation isn’t easy and the path forward is neither smooth not brightly lit.

The Value Equation features essays by Pitts and a host of experts covering a wide range of “urgencies” including the urgency of innovation, quality, information sharing, 21st century medicines regulation, safety, the evolving patient voice, value-based healthcare technology assessment and the lessons learned from COVID-19.

According to Professor Pitts, President of the Center for Medicine in the Public Interest, a Visiting Professor at the University of Paris Descartes School of Medicine and a former FDA Associate Commissioner, “There are many roadblocks beyond those of discovery and development. The complicated and conflicting dynamics of politics, perspectives on healthcare economics, of friction between payers, providers, manufacturers, and regulators, the battle for better patient education, and the need for a more forceful and factual debate over the value of innovation all create the need for a more balanced and robust debate.”

“Excellence,” wrote Aristotle, “is never an accident. It is always the result of high intention, sincere effort, and intelligent execution; it represents the wise choice of many alternatives. Choice, not chance, determines your destiny.” The Value Equation address many of these choices – and their consequences.

The Value Equation: A Journey Through the Innovation Ecosystem in the Time of COVID is necessary reading for anyone interested in charting a new, urgent path forward for patient-centric healthcare innovation.

To speak with Peter Pitts or receive a copy of The Value Equation: A Journey Through the Innovation Ecosystem in the Time of COVID, please contact Mario Coluccio at mcoluccio@cmpi.org.
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The Dangers of Foreign Entanglements

11/23/2020 10:36 AM | Peter Pitts

CMS anticipates one implication of the President’s insistence on foreign price controls is that Medicare beneficiaries will lose access to medicines because of the policy:

“While there are significant savings as a result of this model, a portion of the savings is attributable to beneficiaries not accessing their drugs through the Medicare benefit, along with the associated lost utilization. This estimate does not capture any impacts to other program costs as a result of lower utilization.”

This rule is bad not only for the future of healthcare innovation but also for patient outcomes.

Actions have consequences.
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UnitedHealthcare to HCPs: Das is nicht alles

10/05/2020 08:22 AM | Peter Pitts

UnitedHealthcare is demanding that HCPs rat out their patients who are using copay coupons. Per a letter sent by United Healthcare to HCPs, “Effective 1/1/21 providers must submit specialty medication medical claims and manufacturer copay coupon reimbursement information to UnitedHealthcare.”

By way of explanation, UH offer the following:

“In order to align employer costs for specialty medications with actual member out of pocket and deductibles, UnitedHealthcare is launching the Accumulator Adjustment Medical Benefit program. This program requires providers to submit patient information received from drug manufacturer copay coupon programs which are applied to a member’s cost share when billing for specialty medications as a medical benefit drug claim.”

That’s right, UH has the chutzpah to refer to this as a “medical benefit program." Talk about a large dose of Orwellian NewSpeak. Shame on UH for behaving like a 21st century Stasi.

(With a big hat tip to Adam Fein over at Drug Channels.)
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An Importation Poison Pill

09/25/2020 07:30 AM | Peter Pitts

Meanwhile back at the ranch – drug importation.

In the midst of a global pandemic, a Presidential election and a Supreme Court vacancy the FDA has issues its “Safe Importation Action Plan.”

Per the FDA press release:

The final rule implements a provision of federal law that allows FDA-authorized programs to import certain prescription drugs from Canada under specific conditions that ensure the importation poses no additional risk to the public’s health and safety while achieving a significant reduction in the cost of covered products to the American consumer.

The FDA spells out two pathways.

Under Pathway 1, a Notice of Proposed Rulemaking (“NPRM”) would rely on the authority in the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) section 804 to authorize demonstration projects to allow importation of drugs from Canada. The NPRM would include conditions to ensure the importation poses no additional risk to the public’s health and safety and that it will achieve significant cost savings to the American consumer.

Under Pathway 2, manufacturers could import versions of FDA-approved drug products that they sell in foreign countries that are the same as the U.S. versions. Under this pathway, manufacturers would use a new National Drug Code (NDC) for those products, potentially allowing them to offer a lower price than what their current distribution contracts require.

Assuming that Pathway 2 is a non-starter, let’s have a look at some key codicils of Pathway 1:

Non-Eligible Drugs: The NPRM would restate the exclusions listed in section 804(a)(3); namely, controlled substances, biological products, infused drugs, intravenously injected drugs, drugs inhaled during surgery, and certain parenteral drugs would be excluded from this pathway. The NPRM would additionally exclude any drug with a REMS.

The NPRM will help address this issue by requiring applicants to demonstrate how they will. comply with: track and trace requirements to allow drug tracing from manufacture to pharmacy; certain labeling requirements to ensure the imported drugs meet all labeling requirements of the FD&C Act; requirements to ensure foreign sellers engaged in the distribution of the imported drugs are registered;  importation entry requirements (e.g., providing certain electronic information demonstrating that each shipment should be allowed into the U.S.); and post-importation requirements such as adverse event reporting, procedures to facilitate recalls, and cGMP for certain manufacturing activities such as relabeling.

Cost Requirements: The NPRM would explain the requirement for demonstrating that drugs imported under this pathway must result in a significant reduction in the cost of covered drug products to the American consumer. As such, the NPRM would seek feedback on the best way to identify the expected acquisition cost of the imported drug, the cost of assuring the drug is safely imported, and the mechanism for delivering those savings to the consumer (as opposed to the savings being absorbed by the supply chain).

Transparency: The NPRM would require some indication in the labeling that drugs imported under this program were originally intended for distribution in Canada. In particular, the NPRM would seek comment on requiring that the label include the NDC, part of which would be unique to drugs imported under this program.

One item of importance not addressed in the agency’s plan is whether or not the Canadian government will change its position and allow American importation programs. That’s more than a minor detail. Canadian officials have already stated that “Canada does not support actions that could adversely affect the supply of prescription drugs in Canada and potentially raise costs of prescription drugs for Canadians.”

If Ottawa maintains its no-go policy, it’s an importation poison pill.

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The End of the Era of Smoking?

09/23/2020 05:52 PM | Robert Goldberg

Since becoming Juul’s CEO in 2019, K.C Crosthwaite has cut the company’s workforce in half and pulled most of its well-known e-cigarette products off the market, thereby deliberately cutting sales.

To Crosthwaite that’s progress.  Juul’s rapid growth was the target of got anti-smoking groups, suburban moms terrified their kids – who were getting high and drinking with parental foreknowledge if not consent – would become addicted to nicotine and media coverage that framed Juul as a trojan horse for increased cigarette use.   

Slowing down and paring back growth is tied to Crosthwaite’s goal of building up a body of evidence demonstrating that the use of the device reduces the harm of smoking.  Most critically, in August “Juul submitted a Premarket Tobacco Product Application (PMTA) for the JUUL device as well as its Virginia Tobacco and Menthol flavored JUULpod.”

As part of that submission, JUUL has provided data on the persistence and rates of switching to their product from cigarettes.  It turns out that 43 percent of dual users (people who smoke cigarettes and use JUUL devices) switched entirely to an e-cigarette over a 12-month period.  

Additionally, JUUL has been monitoring the effect of programs it has in place to limit and reduce underage use of its products. JUUL has generated real-world evidence demonstrating that uptake by people 21 and younger declined.

Speaking at the (virtual) Global Tobacco & Nicotine Forum (GTNF) Crosthwaite noted that the emergence of non-combustible products has created a historic opportunity to drive down cigarette use around the world.  Unfortunately, most public health agencies are outlawing or limiting e-cigarette sales while allowing tobacco sales to continue.  The same agencies have made a point of inflating and identify the risks of e-cigarettes so that most consumers think they are riskier than tobacco.  No wonder that cigarette consumption has been increasing, a trend that began before the pandemic and continues even now. 

As Crosthwaite pointed out, the rebound in cigarette sales due to the fearmongering and counterproductive regulation of non-combustible nicotine products increases the risk of tobacco-related death and disease.  Let’s hope the PMTA process can be used to move past such obstacles so that we can continue to eradicate smoking from the planet. 




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How Can Health Data Ownership Overcome the Interoperability Barrier?

08/17/2020 03:36 PM | Robert Goldberg

My interview with Seqster CEO Ardy Arianpour on how his company's platform for generating personal health records solves the interoperability and data assess challenges.   Read More & Comment...

Are We Suffering From COVID Overreaction??

08/17/2020 03:34 PM | Robert Goldberg

My interview with Paul Offit on pandemic hysteria.  Read More & Comment...

When it comes to CBD, what you don't know CAN hurt you

07/10/2020 12:27 PM | Peter Pitts

Per Congressional mandate, the FDA has submitted a report to Congress on the state of the CBD marketplace.

The report outlines studies the agency has performed on the contents and quality of cannabis-derived products that it has tested over the past six years. As predicted in my testimony at the FDA’s June 2019 Part 15 hearing, there is significant inconsistencies between cannabinoids concentrations that are listed on labels and what the products actually contain.  Some relevant verbatims from the FDA report:

“FDA recognizes the significant public interest in CBD products,” the agency wrote. “However, there are many questions about the characteristics of currently marketed CBD products because the Agency lacks significant information on what CBD-containing products are on the market and there are little data available on those products themselves.”

“FDA believes that understanding the characteristics of marketed CBD products is critical to making informed decisions about how best to protect public health in the current marketplace."

“Of the 102 products that indicated a specific amount of CBD, 18 products (18%) contained less than 80 percent of the amount of CBD indicated, 46 products (45 percent) contained CBD within 20 percent of the amount indicated, and 38 products (37 percent) contained more than 120 percent of the amount of CBD indicated.”

Only one of 133 samples had potentially hazardous materials.

Well – that’s reassuring.

FDA is undertaking a more extensive CBD product testing effort that will involve using “a sampling methodology to create a representative, random sample of the current CBD product marketplace.”

“The Agency is purchasing data on brands, product categories, and distribution channels for CBD products.” The FDA is also “in the process of developing its own comprehensive list of brands operating in the CBD market space by assembling data from targeted internet searches and analytics. FDA intends to leverage both data sets to randomly sample products across brands, product categories, and distribution channels, while favoring products with a higher market share.”

The sampling is expected to cover cannabis tinctures, oils, extracts, capsules, powders, waters and other beverages, food items, cosmetics, personal lubricants, tampons, vape cartridges and products sold for pets.

It is unlikely the FDA’s bark will be worse than its bite.

Per the FDA, “Together, this information will provide the Agency with a better understanding of product characteristics in the current CBD marketplace and will help protect and promote public health.”
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Copay Accumulators. Soon to be banned in Boston?

07/07/2020 06:23 PM | Peter Pitts

A new study out of the Bay State regarding the importance of copay assistance programs and the downside of accumulators. 

The Massachusetts Health Policy Commission (HPC) examined copay accumulators and the use and impact of prescription drug coupons in Massachusetts.  (The Massachusetts HPC is an independent state agency charged with monitoring health care spending growth in Massachusetts and providing data-driven policy recommendations regarding health care delivery and payment system reform.)
 
Of note, the study finds that, “Continued growth in high deductible plan enrollment, coupled with increasing drug prices, suggests that patient affordability challenges will only increase. Eliminating the availability of coupons at this time – without substantial protections for patient affordability – would likely create serious challenges for many patients in the Commonwealth.” 
 
As to copay accumulators, “they are unlikely to encourage patients to use lower cost alternatives. Copay accumulators shift costs from the payer to the manufacturer and patient, potentially resulting in lower premiums. However, copay accumulators may preserve the affordability challenges that patients originally faced in their plan design, which could lead to lower access and adherence. In addition, these programs may increase administrative complexity for payers and PBMs and add confusion to patients navigating an increasingly complicated health care system.”
 
Facts are stubborn things; and whatever may be our wishes, our inclinations, or the dictates of our passion, they cannot alter the state of facts and evidence – John Adams
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Patients Rising Podcast on Safer and Cheaper Drugs With Janet Woodcock

06/23/2020 09:20 AM | Robert Goldberg

Enjoy!

Patients Rising Podcast 16  Read More & Comment...

The QALY is Discriminatory

06/23/2020 09:18 AM | Robert Goldberg

Real Clear Health

Should Our Health Care System Place a Dollar Value on Lives?
By Charles Camosy & Robert Goldberg
June 22, 2020
The COVID-19 pandemic is proving to be a catalyst for a long-overdue discussion in this country about our health care system and whether some lives should be considered more valuable than others. Are some Americans comparably more expendable and less deserving of measures to save or extend their lives?

Earlier this month, Oklahoma provided the nation what we believe is the only just answer: it banned state agencies from deciding who gets treatments based upon a bureaucratic measure of the value of life called a QALY.


Those who haven’t heard of the acronym QALY should get to know it. It stands for Quality Adjusted Life Year and it is a scoreboard that divides our population into health care winners and losers. QALYs are used to prioritize the use of ventilators and hospital beds for the younger and healthier and able-bodied—while denying care to those with lesser physical or mental capabilities.

And it’s used by policymakers to decide who should get new medicines, including those to treat COVID-19. Increasingly, unelected and unaccountable organizations such as the Institute of Clinical and Economic Review (ICER) are being used by policymakers, government health programs and insurers to ration care. ICER’s use of QALYs in making these recommendations is inherently discriminatory and may even violate the federal civil rights of the elderly and disabled to be treated equally in medical facilities which get federal funds.

As if this huge moral and legal problem with using QALYs wasn’t bad enough, there are other problems. For instance, ICER arbitrarily decided that an additional year of healthy life is worth $50,000. This dollar value was established in 1982 to determine how much kidney dialysis would be needed to keep someone with kidney failure alive. This while the EPA assumes an additional year of life is worth up to $3 million.

Further, the QALY benchmark inherently assumes people with disabilities or older or harder to treat are worth less. People with disability or your underlying illness – be it heart disease or diabetes – your QALY score is lower and the value assessment scorekeepers will likely recommend that insurance coverage simply isn’t warranted. And if you are someone with a rare disorder such as ALS or Parkinson’s your worth is lower still.

Further, ICER claims that no matter how valuable a drug is — even if it cures — we should only spend $1 billion a year on it. Their rationale: since new drugs might be needed to be taken for a long time, the people who use them might live longer if they stay on a medicine, then total health care spending will increase. By comparison, as ICER states, medicines that help people who are healthy are more ‘cost-effective.’

Recently ICER rushed out a price recommendation of $4300 for remdesivir, the new drug that treatments people hospitalized with COVID-19. In making that assessment, ICER ignores circumstances that any ethical person would consider.

Remdesivir, at the very least, reduces the amount of time people spend in the hospital with COVID-19 by four days. $38,755, depending on the cost-sharing provisions of their health plan.  That doesn’t include post- COVID-19 cost or the fact that for every additional day in the ICU, readmission and death rates post hospitalization climb. It also doesn’t include that fact that if Remdesivir had been available before the pandemic, we wouldn’t have had the overflow of ICU patients.  Cutting length of stay by four days would have increased hospital bed turnover, freeing up enough ICU and non-critical care capacity.  And that would have meant not shutting down the economy.

And yet the talk is about rationing drugs like Remdesivir. Incredibly, those that would be harmed most by rationing are precisely the people who suffered most because of the policies designed to free up hospitalization. Rationing would target the frail veterans who were herded into nursing homes where they died and those whose care was already delayed despite the very people at greatest risk of COVID-19.

The pandemic exposed the fact ICER’s justification for rationing has little to do with scarcity and lot to do with protecting a set of relationships and institutions that support a culture who discards the most vulnerable.

This throwaway culture has a primary value: maintaining a consumerist lifestyle. Proponents of this kind of rationing claim that health care spending – particularly money spent on those with the greatest unmet need – will not be as economically efficient. In an example of brutal honesty, then, groups like ICER want to obtain good outcomes by excluding care and other resources for those who need it the most.  

The QALY systematically deprives those who have been marginalized the same right to health and those of us who are more privileged take for granted. It makes a mockery of our nation’s founding claim that all of us are created equal.

As we move into – and beyond – this new phase of the pandemic, we should follow Oklahoma’s lead. We should reject a discriminatory culture reinforced by QALY-based policies. And we should support a counterculture in which the marginalized are encountered, embraced, cared for, and protected in the fullness of human equality before the law.

Charles C. Camosy is Associate Professor of Theological and Social Ethics at Fordham University and author of “Resisting Throwaway Culture: How a Consistent Life Ethic Can Unite a Fractured People, New City Press”, 2019.  Robert Goldberg is Vice President, Center for Medicine in the Public Interest and co-cost of the Patients Rising podcast.  Read More & Comment...

The Young and the COVID Restless

06/21/2020 04:52 PM | Peter Pitts

Big h/t to Scott Gottlieb:

Bernstein Research shows a correlation between mobility trends and COVID-19 outbreaks; predicts states like Arizona, Arkansas, Alabama, Mississippi, North Carolina, South Carolina are likely to see intensification in the epidemic on top of recent increases. Google mobility data shows that areas of “high-mobility” (states in more advanced stages of “opening) and lower levels of testing most at risk.

Conclusion – Smart opening must be matched with enhanced personal responsibility. What messages are most useful and impactful for un-masked youth?
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