Dr Archana Nagarajan, a freelance scientist specialising in medical devices at Kolabtree, the online freelance platform for scientists, explains the changes made to the European medical device market in light of the pandemic.

Rapid News Group has announced the decision to postpone Med-Tech Innovation Expo, the UK’s flagship event for the medical device industry to 2021.

AdvaMed has announced the launch of a new platform, which will attempt to connect ventilator companies with component suppliers to ensure quick scale production and distribution of these devices during the Covid-19 pandemic.

House Energy and Commerce Committee Chairman Frank Pallone Jr. (D-NJ) and Senate Finance Committee Ranking Member Ron Wyden (D-OR) called on the Trump administration to address the lack of financial relief for Medicaid providers fighting the COVID-19 pandemic. The two Committee leaders voiced concerns that, to date, roughly $70 billion has been distributed to health care providers under the CARES Act in a way that discriminates against Medicaid-dependent health care providers. “HHS’s continued neglect for the needs of Medicaid-dependent providers struggling to deal with the COVID-19 crisis is unacceptable,” the members wrote. “The country is in the middle of a pandemic. The Medicaid program is a first responder, and the providers it relies on must be treated with equity. At a bare minimum that should include expeditious access to the [provider fund] as intended by Congress.”  The Provider Relief Fund that Congress created as a part of the CARES Act, within the Public Health and Social Services Emergency Fund (PHSSEF), was intended to support health care providers including those who participate in Medicare and Medicaid. However, to date only Medicare-enrolled providers have been able to access funds, and these funds are being allocated according to a methodology that rewards providers with high levels of privately-insured individuals while providers supporting the safety net are left waiting. This imbalance discriminates against critical health care providers that primarily service the Medicaid population, such as frontline hospitals, nursing homes and home-based providers, behavioral health providers, maternal health care providers and pediatricians. In the letter, sent to Health and Human Services (HHS) Secretary Alex Azar, Pallone and Wyden called on the Trump administration to describe how much funding will go to Medicaid-dependent providers and the steps it has taken to understand the needs of these providers during the pandemic. The full letter is available here. ###

Dr Reshma Kewalramani has been made the new Vertex CEO.

Vertex’s Chief Medical Officer Dr Kewalramani will succeed current CEO Jeffrey Leiden who has is now stepping aside from the role after seven years as Chief executive at the Boston-based firm. In stepping down Leiden will serve as executive chairman until the first quarter of 2023.     

Fourty-six year old Dr Kewalramani, who has been at Vertex since 2017, will thus become the first woman to head the firm. Prior to joining Vertex, Kewalramani spent more than 12 years at Amgen.

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Immunotherapy-focused pharmaceutical company Midatech Pharma has appointed Stephen Stamp as Chief Financial Officer (CFO) with immediate effect.

He will be replacing Nick Robbins-Cherry, who has stepped down after five years since joining in 2014. Robbins will nevertheless remain at Midatech until October to facilitate Stamp’s handover in an orderly fashion.

Stamp has most recently served as CEO of pharmaceutical firm Ergomed for two years, stepping down in January citing health reasons. Prior to this he was CFO at Ergomed for a year beginning in 2016.

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London consultant and public health professor, Chris Whitty, has begun his role as England’s Chief Medical Officer, taking over from Dame Sally Davies, who has now stepped down from the position.

Whitty has served as the Department of Health and Social Care’s Chief Scientific Adviser since 2016 and was announced as Dame Sally Davies successor earlier in June this year.

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Gilead Sciences have announced that Merdad Parsey will join the company as Chief Medical Officer, effective November 1st.

Dr Parsey will be responsible for and oversee the company’s global clinical development and medical affairs organisations – reporting directly to Daniel O’Day, Gilead’s Chairman and Chief Executive Officer.

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The Association of the British Pharmaceutical Industry (ABPI) has appointed Dr Richard Torbett as its new Chief Executive. He will assume the position on 1 January 2020.

The appointment comes after his predecessor, Mike Thompson, stepped down in June. He had served in the role since March 2016. Torbett was unanimously selected by the ABPI board after an external recruitment process with an executive search agency.

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Ipsen has named Dr Steven Hildemann as its new Executive Vice President, Chief Medical Officer, Head of Global Medical Affairs and Pharmacovigilance.

In his new role, which begins on 1 March 2020 and will be based in Paris, he will report directly to Ipsen CEO Aymeric Le Chatelier. His remit will include the provision of medical strategy to the company’s scientific, clinical and business teams, while also working in tandem with its R&D operations to design and direct clinical trials efforts to generation of post-launch data.

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Khondrion has revealed that Dr Rob van Maanen has joined the company as its new Chief Medical Officer (CMO).

Dr van Maanen’s career has spanned more than 20 years and seen him take on roles at major industry names such as Roche, Astellas and Eisai. In the role, he will manage the company’s medical operations and clinical strategy.

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Galecto has announced Bertil Lindmark as their new Chief Medical Officer. He began his posting on 1 February 2020.

Lindmark joins from the eTheRNA immunotherapies, which is a Belgian mRNA immunotherapy company. He has also had an extensive and successful career in the pharmaceutical industry.

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Dr Lisa von Moltke has left Aklermes and has joined Seres Therapeutics as its new Chief Medical Officer.

Chief Executive Officer at Seres, Eric Shaff, said Seres will benefit from von Moltke’s “extensive experience directing successful development programs, leading clinical teams, and interacting with regulatory agencies across multiple areas of medicine.”

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If we’re going to have a central database of conflict of interest disclosures in medicine – and there is one, created by law – it’s high time that people start using it.

The companyâs global analysis from thousands of studies and sites indicates dramatic shifts in enrollment across several countries since the pandemic began.

Informa Connect-CBI’s 22nd Annual Medicaid and Government Pricing Congress
May 19-21, 2020 | Orlando, FL
www.cbinet.com/medicaidandgovernment

Exclusive Offer: Register by April 10th and save $500* (mention promo code MDCDC5).

With a volatile healthcare system combined with an election year upon us, the stakes are incredibly high for life sciences manufacturers. Staying on the pulse of industry trends, policies and regulations has never been more critical. The 22nd Annual Medicaid and Government Pricing Congress delivers critical updates and industry best practices to effectively contract, report and comply with state and federal healthcare programs. Gain timely, up-to-the-minute insights on:

• State Invoicing and Disputes
• GTN Models
• Innovative Contracting Strategies
• State Price Transparency and Reporting Requirements
• 340B Oversight and Compliance
• Preparing, Negotiating and Implementing FSS Contracts
• Bona Fide Service Fees and FMV
• And many other critical topics

Download the complete program agenda.

The 2020 agenda features 75+ speakers and 50+ sessions customizable by company type and size, as well as 10 hours of dedicated networking. Bio/pharma, regulatory and government experts representing HHS, Pfizer, Daiichi Sankyo, Sobi, Maryland Department of Health, BMS, Jazz, Novartis, Amneal, J&J, Sunovion, Gilead, VA, Granard, Insmed, UCB, Alnylam, Louisiana Department of Health, AstraZeneca, CMS, CSL Behring, Astellas, Lilly, Oklahoma Healthcare Authority, Theravance, Indivior, Sandoz, Alvogen, Takeda, OIG, AMAG, Aimmune, Exelixis, South Dakota Department of Healthcare Services, Regeneron, Sun Pharma, Teva and many others are set to drive the dynamic dialogue.

Drug Channels readers can register today and use promo code MDCDC5 to save $500.

*Discount offer valid through 4/10/2020; applies to standard rates only and may not be combined with other offers, categories, promotions or applied to an existing registration. Offer not valid on workshop-only or non-profit registrations.

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The content of Sponsored Posts does not necessarily reflect the views of Pembroke Consulting, Inc., Drug Channels, or any of its employees.

Today’s guest post comes from David Holladay, President of CoverMyMeds and Austin Raper, Healthcare Writer at CoverMyMeds.

First, David discusses how CoverMyMeds supports medication access. Then, Austin highlights key findings from CoverMyMeds’ 2020 Medication Access Report. This new report includes industry research, patient interviews, novel survey data, and strategies for boosting patients’ medication access.

Read on for David’s and Austin’s insights.
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The U.S. economy is in a medically-induced coma. Unemployment is soaring. Companies are teetering on the brink of bankruptcy. It is unclear when our lives will return to their pre-pandemic state.

One thing seems apparent: As people lose jobs and health insurance, Medicaid enrollment will jump, perhaps by as much as 20% to 30%. This will have profound implications for the drug channel.

Today, I focus on how this increase will affect retail pharmacies and pharmacy benefit managers (PBMs). Below, I review Medicaid enrollment trends, how states manage prescriptions, and the factors driving the coming boom in Medicaid enrollment.

As I explain, many (but not all) retail pharmacies will benefit from Medicaid growth. PBMs, however, will not fare as well. Read on and see if you agree.

In early May, Drug Channels Institute will host two live video webinars: Industry Update and COVID-19 Impact: Retail & Specialty Pharmacies (May 1) and Industry Update and COVID-19 Impact: PBMs & Payers (May 8). CLICK HERE TO LEARN MORE AND SIGN UP. DCI will donate 20% of all profits from these events to The Center for Disaster Philanthropy’s COVID-19 Response Fund.

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Today’s guest post comes from Miranda Gill, Senior Director of Provider Network at CoverMyMeds.

Miranda reviews how the pandemic affects the ability of healthcare workers to complete administrative responsibilities like prior authorization. She then outlines how electronic automation is helping patients get needed medications while face-to-face interactions are restricted.

Learn more about healthcare IT solutions for providers and patients in CoverMyMeds’ 2020 Medication Access Report, or schedule a virtual meeting.
Read more »

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that the risks from using Picato are too high to end its suspension.

Privately-held Italian pharma group Mediolanum Farmaceutici has acquired the French immuno-oncology specialist…

While Gilead has yet to present a marketing plan for remdesivir—much less a price—ICER figures the COVID-19 drug could be cost-effective at up to $4,460 per patient. That means it could easily rake in blockbuster sales this year, at least theoretically.

Even a pandemic can’t slow down Seattle Genetics and Astellas' new bladder cancer treatment Padcev, which "blew out sales expectations" for the first quarter, analysts said. And now, they're jacking up their long-term sales estimates for the drug as a result.

The number of confirmed coronavirus cases in Germany increased by 1,251 to 168,551, data from the Robert Koch Institute (RKI) for infectious diseases showed on Saturday.

The owner and operator of HME Solutions Inc., dba Lifecare Medical (Lifecare Medical), a licensed pharmaceutical wholesale company in Miami, pleaded guilty today to defrauding the Medicare program in connection with a $5.3 million HIV-infusion fraud scheme.

A former member of the U.S. armed services pleaded guilty today in the U.S. District Court for the District of Arizona in Tucson for his role in a widespread bribery and extortion conspiracy. The charges arise from Operation Lively Green, an undercover investigation conducted by the FBI that began in December 2001. To date, 56 additional defendants have been sentenced for their roles in the conspiracy.

Six Miami-Dade County residents have been indicted in connection with an alleged $10 million Medicare fraud scheme operated out of Midway Medical, a Miami clinic that purported to specialize in treating HIV/AIDS patients.

The Department announced the transfer to the United Kingdom of Binyam Mohammed, an Ethiopian national and former resident of the United Kingdom who had been held at the Guantanamo detention facility since 2004.

The Department announced today the resolution of the lawsuit filed by the United States against the state of Vermont to enforce the reporting requirements of the Uniformed Overseas Citizen Absentee Voting Act (UOCAVA). UOCAVA is designed to ensure that members of the uniformed services and overseas citizens may effectively participate in federal elections.

A federal jury in Miami today convicted two physicians and two medical assistants in connection with a $5.3 million Medicare fraud scheme. After a two-week trial in federal court in Miami, a jury found David Rothman, M.D., 66; Keith Russell, M.D., 65; Eda Marietta Milanes, 43; and Jorge Luis Pacheco, 50; guilty on all charged counts, including conspiracy to commit health care fraud and multiple counts of health care fraud for submitting claims to Medicare for unnecessary medications.

Four Miami-area residents pleaded guilty today in connection with a $10 million Medicare fraud scheme involving HIV infusion clinics. Dr. Roberto Rodriguez, 54; Dr. Carlos Garrido, 69; Gonzalo Nodarse, 38; and Alexis Carrazana, 41; all pleaded guilty before U.S. District Judge Paul C. Huck to one count of conspiracy to commit health care fraud.

Methodist Hospital in Houston has agreed to pay the United States $9.99 million to settle allegations that it defrauded the federal Medicare program. The settlement resolves allegations that Methodist improperly increased charges to Medicare patients in order to obtain enhanced reimbursement from Medicare.

The Department’s Antitrust Division today announced the appointment of its new leadership team including the Chief of Staff, four Deputy Assistant Attorneys General, and a Special Counsel for Competition Policy. Two Deputies will oversee civil matters, one Deputy will oversee economic analysis and one Deputy will oversee international, policy and appellate issues.

U.S. District Judge Deborah K. Chasanow today sentenced Victor Ramirez, a/k/a “Mousey,” age 30, a native of El Salvador who resided in Hyattsville, Md., to 60 years in prison, followed by five years of supervised release.

On May 15, 2009, the Fifth Circuit, in Klamath Strategic Investment Fund v. United States (No. 07-40861), affirmed the district court’s decision denying over $50 million in claimed tax losses arising from the taxpayers’ investment in a “Son of Boss (BLIPS)” tax shelter.

Special Litigation Counsel Kristy Parker, a senior attorney in the Civil Rights Division’s Criminal Section, has been selected to receive the 2009 Top Prosecutor Award from the Women in Federal Law Enforcement (WIFLE).

The owner of a Costa Rica-based telemarketing call center and two employees of another Costa Rica call center were sentenced for their roles in schemes that targeted and defrauded thousands of American victims of more than $10 million.

Four Miami-area residents were sentenced today in connection with a $10 million Medicare fraud scheme involving HIV infusion clinics. Alexis Dagnesses, 44; Gonzalo Nodarse, 38; Alexis Carrazana, 41; and Dr. Carlos Garrido, 69, all pleaded guilty in March 2009 to one count of conspiracy to commit health care fraud before U.S. District Judge Paul C. Huck.

The University of Medicine and Dentistry of New Jersey (UMDNJ) has agreed to pay the United States $2 million to resolve federal civil fraud allegations that its hospital defrauded Medicaid. From 1993 to 2004, UMDNJ’s University Hospital submitted claims to Medicaid for outpatient physician services that were also being billed by doctors working in the hospital’s outpatient centers.

Media executive John C. Malone will pay a $1.4 million civil penalty to settle charges that he violated premerger reporting and waiting requirements when he acquired Discovery Holding Co. voting securities. The Department’s Antitrust Division, at the request of the Federal Trade Commission, filed a civil antitrust lawsuit today in U.S. District Court in Washington, D.C., against Malone for violating the notification requirements of the Hart-Scott-Rodino (HSR) Act of 1976. At the same time, the Department filed a proposed settlement that, if approved by the court, will settle the charges.

“As demonstrated by today’s charges and arrests, we will strike back against those whose fraudulent schemes not only undermine a program upon which 45 million aged and disabled Americans depend, but which also contribute directly to rising health care costs that all Americans must bear,” said Attorney General Holder.

Eight Miami-Dade County, Fla., residents have been indicted in connection with an alleged $22 million Medicare fraud scheme operated out of Miami businesses purporting to specialize in home health care services. A temporary restraining order freezing assets of the indicted defendants and their companies was also filed.

Miami physician Roberto Rodriguez, 54, was sentenced today to 97 months in prison for his role in a Medicare fraud scheme involving HIV infusion services.

A federal jury in Los Angeles convicted a physician assistant late yesterday for his role in a $7.7 million Medicare fraud scheme.

Endoscopic Technologies Inc. (Estech), a medical device manufacturer, has agreed to pay the United States $1.4 million to resolve civil claims in connection with the alleged promotion of its surgical ablation devices. Surgical ablation devices use focused energy to create controlled lesions or scar tissue on a patient’s heart or other organs.

Dr. Gabriel DeCandido, a physician practicing internal medicine in Largo, Fla., has agreed to pay the United States $1.7 million to settle allegations that he defrauded the Medicare program. In a complaint filed in the United States District Court for the Middle District of Florida, United States ex rel. Michael Flanery v. Dr. Gabriel DeCandido, et al., the United States alleged that Dr. DeCandido violated the False Claims Act by billing the Medicare program for higher levels of service than he actually rendered to patients and by billing for services not provided.

A federal jury in Los Angeles convicted the owners and operators of a Los Angeles-area durable medical equipment company of Medicare fraud. After a one-week trial in federal court in Los Angeles, the jury found Gevork Kartashyan, 45, guilty of conspiracy to commit health care fraud and health care fraud; and Eliza Shurabalyan, 42, guilty of health care fraud. U.S. District Judge Stephen V. Wilson of the Central District of Los Angeles scheduled sentencing for Oct. 5, 2009.

The state of New York and New York City have agreed to pay $540 million to settle allegations that they knowingly submitted, or caused to be submitted, false claims for reimbursement for school-based health care services, primarily speech therapy and transportation, provided to Medicaid eligible children from 1990 to 2001. The settlement is a record federal recovery by the Justice Department for the Medicaid Program.

Miami physician Keith Russell, 65, and physician’s assistant Jorge Luis Pacheco, 50, were each sentenced to 97 months in prison, and physician’s assistant Eda Marietta Milanes, 43, was sentenced to 63 months in prison, for their roles in fraud schemes that involved billing Medicare for $10,903,509 worth of unnecessary HIV infusion treatments.