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Saturday, June 22, 2019

Court says CVS exec’s move to Amazon’s PillPack violated noncompete

  • CVS Pharmacy’s agreement restricting a former senior executive’s future employment was valid and enforceable, a federal judge ruled Tuesday. The employee, who headed up CVS Caremark’s retail network, went to work for Amazon’s PillPack while the noncompete was still in effect, a move the judge found violated the agreement because he was providing similar services to a competitor.
  • There’s a high bar for awarding injunctive relief, but the judge said CVS clearly met it, providing “substantial proof” John Lavin’s new employment for PillPack violated the terms of the noncompete agreement. CVS paid Lavin $150,000 to refrain from working for competitors for an 18-month term, but during the course of the agreement, he went to work for PillPack. The ruling likely will mean Lavin will have to stop working for PillPack during the duration of the noncompete.
  • Jefferies analysts said the case documents show Amazon is seeking to bypass pharmacy benefit managers and contract directly with payers for its services, a negative signal for the PBM industry.

Amazon’s PillPack unit, which aims to disrupt the nation’s pharmacy business, is now roiling employment waters, too. CVS, like other pharmacy chains, is involved in an ongoing struggle with Amazon for dominance in the mail-order prescription delivery market.
“The Court does not grant a preliminary injunction to enforce a non-compete clause lightly,” Judge John J. McConnell Jr. of the U.S. District Court for the District of Rhode Island said. “It is aware of the narrow and restricted application Courts should give to the agreements under Rhode Island law.”
But the court said the evidence in favor of CVS was clear.
“After reviewing all the evidence, the Court finds that the services Mr. Lavin was to perform at PillPack, a Competitor in the industry, are substantially like the services he provided for CVS Caremark,” the opinion said. “Moreover, the Court finds that it is highly likely that Mr. Lavin’s new employment will result in the disclosure of Confidential Information to CVS’s Competitor.”
The original job description for which PillPack hired Lavin included negotiating with payers, similar to his former position at CVS, the opinion said. Lavin was also expected to contribute to PillPack’s overall growth strategy and help drive its long-term disruptive strategy.
And there’s no doubt Amazon has disrupted the industry. PillPack delivers individualized packages of pre-sorted medicines, meant to help people manage multiple daily medications such as for chronic conditions.
When Amazon announced its estimated $1 billion acquisition of PillPack about a year ago, it sent shares of retail pharmacy companies like CVS and Walgreens plummeting.
Non-competes, also called restrictive covenants, can have legitimate business purposes, but they must meet certain criteria to be enforceable. The agreements must be reasonable in scope and companies often have to show that violation of the agreement would cause them substantial harm, for example. In this case, the judge said CVS easily met that standard.
For executives like Lavin, companies generally draw up noncompetes with terms from three to five years, Autumn Gentry, a litigator with Dickinson Wright in Nashville, told Healthcare Dive. The relatively short 18-month period of the agreement here was a point in CVS’ favor in the litigation. High-level employees like Lavin generally have quite a bit of knowledge about their competitors’ financing, pricing, terms and conditions, she said.
“The higher up you go in the industry, the more likely it is an agreement will be enforced,” Theresa Connolly, an employment defense attorney and co-managing partner of the Washington, D.C. offices of Fisher Phillips, told Healthcare Dive.
Left unanswered is what the remedy here will be. It’s likely Lavin will be required to stop working for PillPack for the duration of the agreement terms. It’s possible his violation of the agreement will start the clock anew on the 18-month employment prohibition, the remedy CVS asked for in its complaint. CVS is also seeking monetary damages and attorney’s fees.

Jefferson University Offering a Blockchain for Healthcare Course

Jefferson University has recently announced that they will be offering the country’s first graduate-level certification course for blockchain in healthcare. Beginning this September, the course will educate students on the ethics, privacy, and transparency in healthcare and the associated benefits of using blockchain in both clinical trials and management of patient records.

What should students expect from the course

The course will be comprised of the following three-credit classes:
  • Introduction to Blockchain for Health Care
  • Blockchain: Real World Case Uses
  • The New Trust Network: A Technical Review
  • Blockchain Policy & Standards — for around 15 to 18 hours per week.
These courses will require 15-18 hours per week and will be instructed by Mike McCoy, Adjunct Professor of Emerging Technologies at Jefferson and Blockchain Implementation Manager at Accenture. Alongside McCoy in the endeavor is fellow Jefferson professor Joseph C. Guagliardo. Guagliardo is also a partner at Pepper Hamilton LLP, where he is the chair of the Blockchain Practice and co-leader of the Technology Group.

Why is Blockchain Important to the Future of Medicine

McCoy stated that blockchain allows health systems to make specific information anonymous, preventing this data from being compromised. He feels blockchain will revolutionize healthcare, being that companies currently tend to compete over ownership of data.
“Blockchain creates a single, end-to-end view of data and information like we have never seen before,” said McCoy. “Tons of companies like 23andMe, Ancestry and healthcare providers spend millions of dollars to obtain patient data to use and sell to companies for leverage without a customer fully knowing or having the ability to be paid for their data. Blockchain helps with the transparency of data as well as the ability for individuals to earn their data back to them.”
The Jefferson course will aim to help students identify problems and opportunities in the healthcare system, understand how blockchain works with medical systems and existing technologies, understand Distributed Ledger Technology and Consensus Mechanism, and communicate innovative ideas to those within and outside of healthcare systems. McCoy feels that this course puts the school at the forefront of digital health education by educating students on blockchain before graduating.
“I imagine kids [from communities in need] being taught in blockchain technology to help create incentive programs for them to do the right thing and to be able to trust institutions that are created to help keep them healthy,” he said. “[This course] is a huge opportunity that we all need to come together for.”
After completing the program, students will be able to pursue careers as Business and Data Analysts Hospital Administrators, Technology Engineers, Informational Technology Managers, Physician Liaisons, and more according to Jefferson.

More on Blockchain Technology

Distributed ledgers, such as blockchain, are predicted to play a crucial role in both identity management and payments in the healthcare setting. Such systems not only reduce waste and unnecessary costs but can increase quality of care as well. Distributed ledgers offer a trusted set of data to healthcare providers that eliminates the need for verifying information from different sources. Currently, a patients’ medical records are fragmented across several providers and specialists. Physicians must often track down records to assemble the puzzle that is their patient’s medical history, a tedious process that may lead to exclusion of important information. The core concept behind blockchain technology is creating a decentralized, transparent, and immutable record of transactions. Its integration into the healthcare system is a hot topic due to its potential ability to produce a private and comprehensive collection of patient health records.

New Portable Device May Help Doctors Treat Strokes Faster

Researchers from the Army Medical University and China Academy of Engineering Physics have recently developed a hybrid device that detects blood flow changes associated with strokes. Using near-infrared light to analyze these characteristics, the portable device could be used for stroke diagnosis in the emergency setting. The researchers’ work was published online in AIP Advances on June 11.

Current Issues in Detecting Strokes

Strokes are among the most common causes of death and can result in severe physical, cognitive, and emotional defects. Roughly 90% of all strokes occur due to cerebral ischemia (lack of blood flow to the brain), however the remaining 10% are caused by cerebral hemorrhage (internal bleeding in the brain). Ischemic stroke can be treated if addressed promptly, but rarely is due to procedures that must be done first to rule out hemorrhagic stroke. Although earlier identification of ischemic stroke has been achieved by mobilizing imaging technologies, diagnosing stroke in the emergency setting could be facilitated via cheaper, more portable devices.

The Near-Infrared Hybrid Device

By combining two light measuring techniques into a hybrid device, these researchers have created what may potentially serve as this mobile tool. The technology uses diffuse optical spectroscopy to analyze the light scattered from tissues to measure oxygen and blood volume, and diffuse correlation spectroscopy to analyze fluctuations in scattered light to measure the rate of blood flow. These specific parameters are known as tissue oxygen saturation (StO­2), total hemoglobin concentration (HbT), and blood flow index (BFI). The device was designed to detect changes in these metrics that are associated with lack of blood flow, indicating a potential ischemic stroke.
strokeThe team tested the instrument by placing the near-infrared probe on a human’s forearm, then inflating a cuff around their bicep to block blood flow. This artificial blockage was done to test whether their device could detect associated changes in blood flow. The researchers found that their probe successfully identified these changes, detecting an StO2 decrease of 12% in 3 minutes and an immediate 16% reduction in BFI. They also noted that the expected increases in HbT, StO2 and BFI were seen once the cuff was removed.
“We can measure blood volume, blood oxygenation and blood flow using suitable near-infrared techniques,” said study author Liguo Zhu, adding that near-infrared light penetrates 1-3 centimeters under the skin.
Another author of the study, Hua Feng, notes that their device provides a comprehensive profile of one’s blood dynamics, whereas other instruments only analyze specific aspects of blood flow. Blood characteristics associated with a stroke are complex, and Feng emphasizes the importance of obtaining as many metrics as possible in diagnosing. In addition to its ability to measure several blood flow parameters, this hybrid device presents as an inexpensive and compact diagnostic tool as well.
“(Both techniques) share the same detectors, which decreases the number of detectors (compared to other instruments),” Zhu said. “The optical switch makes the combination of incoherent and coherent light sources simple, and the custom software makes measurement quick.”

Areas for Potential Development

The researchers note that there is room for improvement, specifically in adding shorter wavelengths sensitive to deoxy-hemoglobin. The team also noted that they should create a “quantitative brain reconstruction model,” and that “there is software available that may help to achieve this goal.”
Heriot-Watt Medical Education Lab@HeriotWattMEL
Researchers have developed a device that uses near-infrared light to monitor blood flow. The hybrid instrument which is cheap and easy to use could be used to quickly and noninvasively diagnose cerebral ischemia.  https://phys.org/news/2019-06-hybrid-device-doctors-quickly.html 

Hybrid device may help doctors treat strokes more quickly

Stroke, one of the leading causes of death worldwide, is normally caused by poor blood flow to the brain, or cerebral ischemia. This condition must be diagnosed within the first few hours of the…
phys.org
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Reforming pharmacy benefit managers may spur drug cost savings: JAMA

Efforts to control health care costs in the United States often focus on the listed prescription drug prices, but a perspective published by the Journal of the American Medical Association suggests that unregulated pharmacy benefit manager practices also may contribute to escalating expenses.
Researchers from the University of North Carolina Lineberger Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine and Boston University Questrom School of Business examined the impact of Ohio Medicaid’s switch in 2011 from a fee-for-service model to a managed care model to administer its outpatient prescription drug benefits.
They report that an independent audit in 2018 found the change to a managed care program, which uses pharmacy benefit managers, saved the Ohio Medicaid $145 million annually. Pharmacy benefit managers are intermediaries in the drug supply chain that function as third-party administrators of pharmacy benefits. The savings were largely derived by the lower prescription claims prices the pharmacy benefit managers billed.
These savings, however, came at a cost, said Trevor Royce, MD, MS, MPH, the paper’s corresponding author and an assistant professor of Radiation Oncology at UNC School of Medicine and UNC Lineberger. His coauthors were Sheetal Kircher, MD, MS, of Northwestern and Rena M. Conti, PhD, of Boston University.
“Ohio policymakers should be applauded for their empirical approach in tackling the cost of prescription drugs,” said Royce. “The Ohio audit found pharmacy benefit managers engage in opaque pricing practices that likely contribute to the rising costs of care and prescription drugs.”
The authors identified several issues of concern. Ohio pharmacists believed pharmacy benefit managers used anti-competitive practices and manipulated drug pricing. This included offering different drug pricing to affiliated pharmacies than independent pharmacies. Some pharmacy benefit managers implemented “gag clauses” that prevented pharmacies from counseling patients on the most cost-effective medication options. A more controversial practice, said Royce, was the use of “spread pricing,” in which pharmacy benefit managers charged Ohio Medicaid a high price for a drug but paid pharmacies a lower price.
The pricing difference could produce significant revenue for the pharmacy benefit managers. An analysis in 2017 found that a 30-day supply of the generic form of imatinib mesylate, a drug to treat leukemia, cost $3,859, but Ohio Medicaid was charged $7,201.
The independent review of pharmacy benefit manager practices commissioned by Ohio found an 8.8 percent difference between what the pharmacy benefit managers billed to Ohio Medicaid managed care plans and what it paid to the pharmacies between March 2017-2018. The more than 39 million prescription transactions produced a spread pricing difference of $223.7 million.
Ohio officials have implemented several policy changes following the audit. The state’s managed care plans ended its contracts with pharmacy benefit managers. They also implemented a “pass through” pricing model in which the managed care plan pays the pharmacy benefit managers the exact amount paid to the pharmacy for a prescription drug plus a dispensing fee and an administrative fee.
They also tried to ban the gag clauses used by pharmacy benefit managers, but the Ohio Senate didn’t vote on the bill before the legislative session ended in 2018. This was remedied on the federal level in October 2018, when the Patient Right to Know Drug Prices Act and Know the Lowest Prices Act, which banned gag clauses, were signed into law.
Royce said other states wanting to reduce health care costs can learn from what took place in Ohio.
“The Ohio Medicaid experience provides an important window into pharmacy benefit manager practices,” said Royce. “Efforts to address drug pricing tend to focus on the pharmaceutical company or the drug manufacturer, while traditionally the pharmacy benefit managers may be overlooked. This is likely changing as a growing number of states have introduce bills pertaining to pharmacy benefit manager practices, and more are surely to come.”

Boehringer leads investment in digital therapy for myopia

Digital startup Dopavision has raised cash in a seed funding round backed by Boehringer Ingelheim, to develop a smartphone-based digital therapy for myopia (short-sightedness).
Dopavision is developing a digital therapeutic that aims to slow down myopia progression in children and adolescents through the activation of dopamine.
Proof-of-concept experiments conducted together with a German university confirmed the scientific hypothesis behind the technology, which was filed for patent in 2017.
The company already has 1.4 million euros in backing from the German government and this seed funding round raised 1.2 million euros.
Lead investor was Boehringer Ingelheim Venture Fund, joined by business angel Ralf Meister and existing shareholder Flying Health in the financing round in May.
The team will use the capital to perform pre-clinical experiments, making it one of the world’s first digital therapeutics to be validated in an animal model.
The technology delivers light stimulation to specific photosensitive cells on the retina which in turn modulate dopamine, a neurotransmitter that is important for the regulation of eye growth.
High myopia is a serious medical condition that can lead to severe vision deficits like retinal detachment and even blindness.
Founded in 2017, Dopavision GmbH is supported by the German government via the “Industrie-in-Klinik” programme of the BMBF (Bundesministerium für Bildung und Forschung/German Federal Ministry of Education and Research).
Dr Hamed Bahmani, Dopavision’s co-founder, said: “Since the light stimulus in Dopavision’s approach is delivered from a digital device like a smartphone, it is truly a digital therapeutic.
“Its specific advantage is that it’s invisible to the user, because the stimulated cells on the retina are not part of the image-forming visual system. Therefore, the treatment can be combined with other activities on the device like games or watching movies.”
Dr Oliver Reuß, executive director and investment manager of Boehringer Ingelheim Venture Fund, said: “This investment also reflects our strong interest in the back-of-the-eye disease area. We are convinced that digital therapeutics will play an important role as a treatment technology in health care in the future, and we’re excited to be part of the development of a breakthrough technology.”

New Bipartisan Bill Could Transform The Way We Pay For Hospital Care

A new proposal from the Senate Health, Education, Labor, and Pensions Committee could have a meaningful impact on the high cost of U.S. hospital care—if it survives an onslaught from industry lobbyists.
The bill, called the Lower Health Care Costs Act, is the product of bipartisan negotiations led by the HELP Committee’s chairman, Sen. Lamar Alexander (R., Tenn.) and its ranking Democratic member, Sen. Patty Murray (D., Wash.). Overall, its provisions could be thought of as incremental in scope. But some—especially those around transparency—could have a significant impact.
Hospitals routinely engage in anticompetitive practices
Hospitals have a lot of tools at their disposal when it comes to raising prices on consumers. A wave of mergers and acquisitions has led to the rise of regional hospital monopolies that force insurers to accept their high prices, or risk jeopardizing their patients’ access to hospitals in their communities. A new study from the RAND Corporation finds that on average, hospitals charge the privately insured 2.4 times what they charge those on Medicare for the same services.
Behind closed doors, it gets worse. An investigation by Anna Wilde Mathews of the Wall Street Journal found that hospitals use their market power to force insurers to accept higher prices from them, instead of allowing insurers to steer patients to lower-cost, higher-quality alternatives.
Along with anti-steering clauses, hospital systems love to employ all-or-nothing clauses in contracts with insurers. Say a hospital system is comprised of 12 hospitals, some of which are in rural areas where they’re the only game in town. The hospital will demand that any insurer who contracts with one of the rural hospitals must accept the system’s above-market prices in more competitive areas.
Insurers are unable to complain publicly about these contracts, they say, because the contracts contain confidentiality clauses that bar insurers from disclosing their contracts’ contents.
To top it all off, three-fourths of all hospitals in America are “non-profit.” (You would never know by looking at the seven- to eight-figure salaries of their top executives.) The Federal Trade Commission is barred by law from investigating the anti-competitive practices of these “non-profits.” Why?
A game changer for abusive hospital practices
The Lower Health Care Costs Act directly targets these abuses in ways that are refreshing.
The bill directly prohibits anti-steering and all-or-nothing clauses in payer-provider contracts. It also prohibits most favored nation provisions under which a dominant insurer demands that it always gets a hospital’s lowest price.
It also prohibits hospitals and insurers from signing contracts that prevent the terms of their contracts from being shared with the employer who is, in theory, sponsoring the plan. This way, employers could have their own lawyers or other experts review the contracts for anti-competitive features.
The bill would create what’s called an all-payer claims database, or APCD, that would be accessible to researchers, insurers, employers and patients.
The bill would ban “gag clauses” that prohibit patients, employers, and doctors from seeing quality and cost data on hospitals and specialists. It would also ban clauses in contracts that prevent employers from seeing anonymized claims data that they could use to see if they were getting good prices and efficient coverage. It would require insurers to maintain accurate, up-to-date, online directories of in-network providers, so patients can avoid out-of-network claims.
These are real reforms that could start to roll back the most abusive practices that hospitals are deploying today to enrich themselves at the expense of the public.
Ending the surprises, but not the bills
While I’ve highlighted what I think is the most interesting and impactful part of the Lower Health Care Costs Act, the bill contains four other titles, which tackle issues like surprise medical billing, pharmaceutical prices, public health, and digital health reform. In general, the reforms in these parts of the bill are constructive, incremental, and modest.
Most notable—because it has been a hot topic in Washington—is the bill’s provisions regarding surprise bills in the emergency room. A number of different bills have been introduced in Congress to tackle this problem, and while they differ in certain ways, each and every one of them can be summarized as ending the surprises, but not the bills.
When I wrote about surprise medical bills earlier this year, I talked about how the issue comprises two separate problems. The first problem is the surprises: that patients with health insurance who thought they were doing everything right are still getting hit with stratospheric out-of-pocket bills from providers that turn out to be out of network.
The second problem is the bills: the high prices that providers of emergency medical services charge, because they know that patients undergoing real medical emergencies are in no position to shop for care or negotiate a better price. These prices are egregious and exploitative, whether or not they are imposed on the patient as a “surprise.” Doctors whose work revolves around emergency care routinely charge patients 9 times what Medicare pays, even if it’s the insurer that is directly paying the bill, and not the patient.
The various congressional proposals to deal with surprise billing try to solve the “surprise” part in differing ways. Some require that hospitals accept the median in-network prices for out-of-network doctors. Others suggest that a government arbitrator decide whether the hospital or insurer is right. Yet others would require all physicians working at a hospital to be in-network.
Each of these ideas is flawed. Having a government-appointed arbitrator pick the price gives, well, arbitrary power to someone with no expertise in health care prices. That lack of expertise leads many arbitrators to side with hospitals, incentivizing even higher emergency care prices.
Requiring all physicians affiliated with an in-network hospital to be also in-network would, again, end the surprises, but it wouldn’t affect the ability of hospitals and doctors to charge high prices: indeed, it would enhance that ability, because most hospital markets are monopolistic in character. All this kind of “reform” would do is rearrange the deck chairs of how extreme prices are funded: instead of being paid out-of-pocket by the patient, they would be paid through higher insurance premiums on everyone.
The least bad of the three options is to tie out-of-network care to the median in-network reimbursed rate. As I mentioned, median in-network rates are still extremely high, but at least they’re lower than the out-of-network surprise billing rates. And if out-of-network providers are billed at the median in-network rates, insurers might have a game theory incentive to kick high-priced in-network providers out-of-network, leading to a lower median in-network price.
The best option, by far, would be to learn from Medicare Advantage, which pays out-of-network providers at Medicare’s much more reasonable fee-for-service rates. Surprise medical bills from out-of-network providers should be paid at the lower of the median in-network rate and Medicare’s fee-for-service rates. Not only would such an approach curtail exploitative pricing practices, but it would create a market-based incentive for insurers to drive prices even lower.
A better model for hospital competition
Stronger stuff has emerged in the House of Representatives, where two congressmen—Rep. Jim Banks of Indiana and Rep. Bruce Westerman of Arkansas—have introduced robust legislation to reduce the high cost of hospital care and prescription drugs.
Banks’ bill, the Hospital Competition Act of 2019, would end the ability of monopoly hospitals to exploit their market power to charge egregious prices, by capping rates in monopoly markets at Medicare’s fees.
Westerman’s bill, the Fair Care Act of 2019, would do that and more, by also improving competition for prescription drugs.
The White House is poised to act
And more reforms are coming. The Trump administration is finalizing a regulatory change that would require hospitals to disclose their contractual arrangements and prices to the public—providing essential transparency to the murky world of hospital prices.
At a ceremony in the Rose Garden last Friday, Trump said “another big announcement” was coming in a matter of weeks that will have a “profound effect on the things we’re talking about…it’s going to be something really incredible.” While he didn’t say for sure, this is almost certainly related to transparency in hospital contracts.
It has been encouraging to see more interest among policymakers in the problem of high medical bills. But too much of the focus has been on the politics—which centers around out-of-pocket costs—and not enough on the economics, which drives premiums and taxpayer subsidies higher.
Hospitals have enormous lobbying power, because they are usually the largest or second-largest employer in every congressional district. Hospitals claim that if they aren’t allowed to charge whatever they want, they’ll be forced to close and leave their patients without hospital care. Such claims are wildly exaggerated, and require factual scrutiny. Transparency may be the first step in getting us there.
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UPDATE: The HELP Committee announced Wednesday that it would be holding a vote on the Lower Health Care Costs Act on June 26.

Liver disease biotech Mirum Pharmaceuticals files for $86M IPO

Mirum Pharmaceuticals, a clinical-stage biotech developing therapies for rare liver diseases, filed on Friday with the SEC to raise up to $86 million in an initial public offering.
The Foster City, CA-based company was founded in 2018 and it plans to list on the Nasdaq under the symbol MIRM. Citi, Evercore ISI and Guggenheim Securities are the joint bookrunners on the deal. No pricing terms were disclosed.