US probes disclosure of tax records on rich Americans

 

The Treasury Department has asked law enforcement authorities to investigate the disclosure of tax records cited in a media report that showed that some of America's richest people paid little to no income taxes, U.S. officials said on Tuesday.

U.S. media outlet ProPublica said it obtained "a vast trove of Internal Revenue Service data on the tax returns of thousands of the nation's wealthiest people, covering more than 15 years." The data indicated that billionaires including Amazon founder Jeff Bezos and Tesla founder Elon Musk paid no federal income taxes during some years.

White House Press Secretary Jen Psaki said that "any unauthorized disclosure of confidential government information" is illegal.

Treasury Department spokeswoman Lily Adams said in an emailed statement that the matter has been referred to the FBI, federal prosecutors and two internal Treasury Department watchdogs, "all of whom have independent authority to investigate."

The IRS, part of the Treasury Department, is the nation's tax-collecting agency and many tax records are considered confidential documents. IRS Commissioner Charles Rettig also confirmed that an investigation is underway.

"Obviously we take it very seriously," Psaki told a briefing.

ProPublica described the records as "confidential" and did not disclose how it obtained them.

President Joe Biden has sought tax increases on the wealthy to help fund proposed spending on infrastructure and social programs, including raising the top tax rate to 39.6% from the current 37% and nearly doubling the capital gains tax rate to 39.6% for Americans earning $1 million annually or more.

"We know that there is more to be done to ensure that corporations (and) individuals who are at the highest income are paying more of their fair share," Psaki said.

Rettig addressed the matter during testimony to the Senate Finance Committee.

"I can't speak to anything with respect to specific taxpayers. I can confirm that there is an investigation, with respect to the allegations that the source of the information in that article came from the Internal Revenue Service," Rettig said.

https://www.marketscreener.com/quote/stock/TESLA-INC-6344549/news/U-S-investigates-disclosure-of-tax-records-on-rich-Americans-35551692/

UnitedHealthcare to Crack Down on 'Non-Emergent' ED Claims

 UnitedHealthcare plans to take a closer look at emergency department (ED) claims beginning July 1.

In a June network bulletin posted to its website, the insurer said that it will assess ED facility commercial claims to determine if an event was emergent or non-emergent. Claims determined to be non-emergent will be subject to no coverage or limited coverage.

ED claims will be evaluated on many factors, UnitedHealthcare said, including the patient's presenting problem, the intensity of the diagnostic services performed, and other patient complicating factors.

"Unnecessary use of the emergency room costs nearly $32 billion annually, driving up health care costs for everyone," UnitedHealthcare said in a statement provided to MedPage Today. "We are taking steps to make care more affordable, encouraging people who do not have a health care emergency to seek treatment in a more appropriate setting, such as an urgent care center. If one of our members does receive care in an emergency room for a non-emergent issue, like pink eye, we will reimburse the emergency facility according to the member's benefit plan."

Aside from urgent care centers, members can also seek treatment for non-emergent issues through their primary care physician or telemedicine.

When an ED event is deemed non-emergent, there will be an opportunity to complete an attestation if the event met the definition of an emergency consistent with the prudent layperson standard, UnitedHealthcare said in its posted bulletin. A notice of the opportunity to submit an attestation will be sent to the ED facility that provided the care.

Those who are able to fill out out an attestation saying an event was emergent include the attending physician, as well as medical and nursing directors. If an attestation is not filled out, members will have the option to file an appeal.

Concern over UnitedHealthcare's move has been making the rounds in the emergency physician community.

In a statement provided to MedPage Today, the American College of Emergency Physicians (ACEP) said that it believes the insurer's new policy is in "direct violation" of the federal prudent layperson standard. The standard, they noted, requires insurers to provide coverage of emergency care based on a patient's presenting symptoms that brought them to the ED.

"According to the CDC, only 3% of emergency visits are 'non-urgent,'" ACEP said. "In many instances, even physicians do not know if a patient's symptoms require emergency treatment without undergoing medical examination and tests. Our main concern is that dangerous policies such as this will leave millions fearful of seeking medical care, right as we're just getting hold of the COVID-19 pandemic and trying to get as many people vaccinated as possible."

UnitedHealthcare said that its new action will apply to commercial fully insured ED facility claims in many states for dates of service on July 1 or later. It added that it plans to expand the capability to additional states and segments, subject to regulatory approval.

The insurer did not immediately provide figures for its volume of non-emergent claims or their financial impact on its business.

UnitedHealthcare saw revenues of $55.1 billion in the first quarter of the year, up about 8% from the same quarter in 2020. Operating earnings were $4.1 billion for the first 3 months of 2021, compared with $2.9 billion for the same period last year.

https://www.medpagetoday.com/special-reports/exclusives/92985

Linux Foundation readies Global COVID Certificate Network

 When the coronavirus vaccines first started arriving many assumed that most people would get a vaccine. But thanks to a shortage of supply in many countries, misinformation, and paranoia, even in the United States, only just over half of the population has been vaccinated. Easily imitated paper vaccinated certificates are almost useless for proving vaccination status. So, there's been lots of talk, but not much action, on a reliable, easily accessible vaccination record, aka a vaccination passport. Until now. The Linux Foundation Public Health (LFPN) is getting the Global COVID Certificate Network (GCCN) ready for deployment.

here are many needs for a secure vaccination record. For example, some states, such as Texas, want to forbid employers from firing potentially unvaccinated employees. However, employers usually have the right to discharge employees who deliberately put the lives of their coworkers and customers in jeopardy. 

The GCCN isn't designed for that purpose. Instead, it really is a coronavirus vaccine passport. It will do this by establishing a global trust registry network. This will enable interoperable and trustworthy exchanges of COVID certificates among countries for safe reopening and provide related technology and guidance for implementation. 

It's being built by the Linux Foundation Public Health and its allies, Affinidi, AOKPass, Blockchain Labs, Evernym, IBM, Indicio.Tech, LACChain, Lumedic, Proof Market, and ThoughtWorks. These companies have already implemented COVID certificate or pass systems for governments and industries. 

Together they will define and implement GCCN. This, it's hoped, will be the model for a true international vaccine registry. The United Nations and the European Union are considering deploying for this very purpose. Eva Kaili, Member of the European Parliament and Chair of its Science and Technology Options Assessment (STOA) Panel said: 

We are interested to learn about how LFPH is taking bold steps in creating the Global COVID Certificate Network in order to facilitate trust-building and interoperability for safe borders reopening. …  I look forward to the next steps of the LFPH that could provide us with more ideas and insights on strategies that enhance the use of a certificate in a safe way, and also to provide further technical options for the EU that could be adopted and could help and enable our system to work in a harmonized way. As soon as we achieve that, then we could immediately share the methodology to connect with the rest of the world and move to the new normal of our post-COVID digital era.

Indeed the LFPH is being built in part to be compatible with the EU Digital COVID Certificate (formerly the Digital Green Certificate). The lack of a global trust architecture and ready-to-deploy tools to build compatible systems in other countries is a real barrier for safely reopening borders between EU and non-EU countries. 

The LFPH is also following the Good Health Pass Collaborative (GHPC)'s Interoperability Blueprint. This is an industry coalition that has defined COVID certificates principles and standards. The LFPH helped draft the Interoperability Blueprint.

This will use, along with other open technologies, the COVID-19 Credentials Initiative (CCI) and the Trust over IP Foundation (ToIP). These are both Linux Foundation projects. CCI has been working with public health departments globally to understand their specific needs for verifiable vaccine credentials. ToIP is defining a complete architecture for internet-scale digital trust. This combines cryptographic trust at the machine layer and human trust at the business, legal and social layers.

Once completed, the GCCN's trust registry network will enable each country to publish a list of the authorized issuers of COVID certificates that can be digitally verified by authorities in other countries. This will bridge the gap between technical specifications (e.g. W3C Verifiable Credentials or SMART Health Card) and a complete trust architecture required for safe reopening. 

This is vital because as Brian Behlendorf, the Linux Foundation's General Manager for Blockchain, Healthcare, and Identity explained, "The first wave of apps for proving one's COVID status did not allow that proof to be shown beyond a single state or nation, did not avoid vendor lock-in and did not distinguish between rich health data and simple passes. The Blueprint gives this industry a way to solve those issues while meeting a high bar for privacy and integrity, and GCCN turns those plans into action." 

Once in place, the GCCN will support Global COVID Certificates (GCC). These certificates will have three use cases: Vaccination, recovery from infection, and test results. They will be available in both paper and digital formats. Participating governments and industry alliances will decide what COVID certificates they issue and accept. The GCC schema definitions and minimal datasets will follow the recommendations of the Blueprint, as well as GCCN's technical and governance documents, implementation guide, and open-source reference implementations, which will be developed in collaboration with supporting organizations and the broader LFPH community.

Besides setting the specs and designs, the GCCN community will also offer peer-based implementation and governance guidance to governments and industries to help them implement COVID certificate systems. This will include how to build national and state trust registries and infrastructure. They'll also provide guidance on how to leverage GCC into their existing coronavirus vaccine systems. 

Why go to so much trouble? That's easy. As Eric Piscini, IBM Watson Health's VP of  Emerging Business Networks said "For health passes to work globally, helping countries to restart economies and reopen borders, they need to be trusted globally. Through the Global COVID Certificate Network, Linux Foundation Public Health is working to address this challenge by bringing together a network of trusted and interoperable Trust Registries, so that the holder of a certificate can use it whenever they need and wherever they are. IBM is excited to collaborate with Linux Foundation Public Health on this important initiative at this critical time in our history." 

If you want to help with the GCCN, you'll be more than welcome. You can get in touch with the LFPH via e-mail. 

https://www.zdnet.com/article/linux-foundation-readies-global-covid-certificate-network/

Biogen to ship Alzheimer's drug in two week

 

It won't be long before Alzheimer's patients get access to the new Biogen drug. Just one day after getting the government's approval, the biotech company said Tuesday it plans to start shipping Aduhelm in about two weeks.

Biogen said more than 900 infusion centers will be ready to administer the treatment.

It can't come sooner for the more than 6 million Americans living with Alzheimers and the first approved treatment in 18 years.

Ronald Petersen heads the Mayo Clinic's Alzheimer's Disease Research Center.

"I think this is an exciting day for people with Alzheimer's disease. They now have some hope that a drug is going to be on the market that is going to have an impact on the underlying disease process itself."

While patient advocates and some neurologists hailed the drug, others said the clinical trial results were inconsistent and more testing was needed on the drug's effectiveness. Still, it could soon be a boon to Biogen, which says revenue from Aduhelm could start ramping up next year.

Analysts at Guggenheim estimate the drug - which will cost patients $56,000 per year - could generate over $1 billion in sales in 2022.

But Brown University Medical School Neurology Professor Stephen Salloway hopes competition will lower that price tag.

"Hopefully this is the first, and there'll be more to come, and then there'll be competition, and hopefully competition will lead to better pricing. And then hopefully there'll be other treatments that we can discover that are more economical."

Most of the cost will be covered by U.S. health insurers and the government's Medicare program.

The company's shares soared 38% Monday after the Food and Drug Administration approved Adulhelm as the first ever drug to target a likely cause of Alzheimer's disease. The shares gave back some of those gains in early trading Tuesday even though a number of brokerage analysts upgraded the stock and raised their price targets.

https://www.marketscreener.com/quote/stock/BIOGEN-INC-4853/news/Biogen-to-ship-Alzheimer-s-drug-in-two-weeks-35551229/

PDS Lead Program Gets Overall Tumor Reduction of 67% In HPV16 Positive Cancer

 

• PDS Biotechnology Corporation (NASDAQ: PDSB) has announced interim data from the Phase 2 trial led by the National Cancer Institute (NCI) evaluating PDS0101 (Versamune-HPV16) in combination with two investigational immune-modulating agents - bintrafusp alfa and NHS-IL12 for HPV16 positive cancers.

• Data were presented at the American Society of Clinical Oncology 2021 Annual Meeting.

• 83% (5/6) of the patients demonstrated an objective response in relapsed or refractory checkpoint inhibitor naïve advanced cancer patients.

• The reported objective response rate with the current standard of care checkpoint inhibitor treatment is 12-24%.

• 100% (6/6) are still alive at eight months.

• 80% (4/5) of patients with an objective response still have an ongoing response at eight months. One patient had a complete response.

• In patients who have also failed checkpoint inhibitor therapy, tumor reduction was observed in 58% (7/12), with an overall objective response rate of 42% (5/12) already achieved.

• 83% (10/12) of patients are still alive at eight months.

• Also, in patients with HPV16-negative cancer, 0% (0/7) experienced tumor reduction was observed.

• 80% (4/5) of checkpoint inhibitor naïve patients are still alive at eight months. 0% (0/2) checkpoint inhibitor refractory patients are still alive at eight months.

https://finance.yahoo.com/news/pds-biotechs-lead-versamune-program-114401942.html

Verily loses FDA bid to add Parkinson’s assessments to clinical research smartwatch

 Though wearable devices have proven to be incredibly helpful in monitoring a variety of health conditions—from diabetes to atrial fibrillation—the FDA is sending Verily back to the drawing board in its efforts to add a Parkinson’s disease symptom assessment to its clinical research-focused smartwatch.

The agency issued a rejection letter to Alphabet’s life sciences arm after Verily submitted a request earlier this year for clearance of its virtual motor exam, to help track the progression of Parkinson’s in patients already diagnosed with the disease.

Verily was seeking a green light for its virtual exam as a clinical outcome assessment, which would allow the data collected in the exam to be used in drug development studies.

In its January letter of intent, Verily noted that its virtual motor exam was designed to mitigate the difficulties of collecting consistent data tracking the effects of various treatments on physical Parkinson’s symptoms.

To do so, Verily developed an eight-part assessment to measure motor abilities affected by the disease, as outlined in Part III of the International Parkinson and Movement Disorder Society’s standardized Parkinson’s disease rating scale, or MDS-UPDRS.

It launched a broad study of the assessment that includes three patient groups: those newly diagnosed with Parkinson’s, those with mild to moderate cases diagnosed within the last five years and those with moderate to severe cases diagnosed at least five years ago.

The study is being conducted in the Netherlands and Japan, and Verily noted that it plans to expand the study to the U.S., U.K., Spain, France, Poland, Germany, Italy and Canada by the end of this year.

Once a week, the Verily Study Watch prompts study participants to complete the eight motor tasks, including tapping the smartwatch, opening and closing their hand, stomping their foot and standing still. The tasks can be completed at home, and at a time selected by the wearer.

Verily wrote in its letter that using the wearable device to track the results of this assessment at a set time each week would strengthen the reliability of Parkinson’s motor exams and allow for more frequent exams, while also ensuring all assessments were consistently held to the standards set down by MDS-UPDRS Part III.

In its response to Verily’s letter of intent, however, the FDA asserted that the rating scale—and therefore Verily’s virtual motor exam—"are limited in their capacity to evaluate meaningful aspects of concepts of interest that are relevant to the patients’ ability to function in day-to-day life.”

The agency singled out the finger-tapping test as an example. Changes in finger rigidity or tapping abilities, the FDA wrote, “cannot be directly interpreted as being meaningful to patients,” as they don’t necessarily indicate any significant change in a Parkinson’s patient’s everyday abilities, especially in comparison to changes in speech, eating and dressing—qualities measured in the preceding Part II of the MDS-UPDRS.

The FDA also suggested that since Verily’s assessment is performed without clinical supervision and then quantified by a software algorithm, it may not paint a complete picture of changes in a patient’s motor abilities.

“For these reasons, when evaluating drug efficacy in Parkinson’s disease, the FDA prefers content that is more representative of daily life functioning,” the agency concluded, pointing to MDS-UPDRS Part II as a better framework for those measurements. Verily has yet to respond to the agency’s decision.

If Google's sister company chooses to rework its Parkinson’s assessment, it’ll now have the advantage of a former FDA insider to guide those efforts. Earlier this month, Verily announced the appointment of Amy Abernethy, former principal deputy commissioner of food and drugs at the FDA, as president of Verily’s clinical research business.

In her new role, Abernethy will oversee the company’s long-term plans to develop a platform for clinical trials and real-world evidence studies and continue building health data management and analysis tools under Verily’s Project Baseline banner.

https://www.fiercebiotech.com/medtech/verily-loses-fda-bid-to-add-parkinson-s-motor-function-assessment-to-clinical-research

Biden unveils plan to resurrect U.S. drug manufacturing

 After investigating America’s supply chains, including those for drugs and pharmaceutical ingredients, the Biden administration has revelations to share—and it's proposing a sweeping strategy to boost domestic drug production.

Under the plan, the White House is establishing a public-private partnership to select 50 to 100 essential medicines "to be the focus of an enhanced onshoring effort," the plan says. Further, the government is committing around $60 million to research new technologies to boost domestic API production.

The blueprint follows a February executive order demanding a multi-industry review of key American supply chains. The fact that much of America’s drug production is based overseas isn’t exactly news, but the pandemic put those problems into sharp relief.

While praising the speed of U.S. innovation that brought the world critical COVID-19 vaccines, the administration conceded that the country is “critically dependent on imports for a range of key pharmaceutical products and APIs,” which make up 90% of all prescription medicines filled in the U.S.

Meanwhile, some 87% of generic active pharmaceutical ingredient facilities are located abroad, leaving U.S. supplies of essential meds “vulnerable,” the administration said.

To start righting the ship, the administration has called on the Department of Health and Human Services (HHS) to establish a public-private consortium—leveraging the Defense Production Act and existing partnerships—to bolster the production of critical drugs on U.S. soil. To start, the consortium will identify 50 to 100 drugs from the Food and Drug Administration’s essential medicines list to prioritize.

Separately, HHS will invest around $60 million from the DPA appropriation in the American Rescue Plan to create “novel platform technologies” for domestic API production. The move could help safeguard American supplies of drugs in shortage, especially in the event of future crises, the administration said.

In addition to the $60 million commitment, the administration also calls for agencies to increase funding of advanced manufacturing technologies for drug and API production. The move would leverage both “traditional” manufacturing techniques, as well as “on-demand manufacturing capabilities for supportive care fluids, APIs, and finished dosage form drugs.”

The administration didn’t say what those advanced manufacturing approaches were, but recent actions by the FDA and other organizations like United States Pharmacopeia (USP) could hold clues. For years, the U.S.’ drug regulator has been pressing companies to adopt advanced manufacturing approaches like 3D printing and continuous manufacturing.

The last piece of Biden’s plan hinges on transparency. It calls for HHS to develop and make recommendations to Congress on new authorities that would help it track API sourcing, as well as production on a facility-by-facility basis. The move would also require the provenance for all drug ingredients and finished drug products to be identified on the label.  

https://www.fiercepharma.com/manufacturing/biden-administration-unveils-plan-to-resurrect-drug-manufacturing-stateside