This week, I’m rerunning some popular posts while I prepare for this Friday’s video webinar: Industry Update and COVID-19 Impact: PBMs & Payers.

Today's rerun highlights one of the most effective tactics that PBMs have developed to extract deeper discounts from brand-name drug makers. COVID-19 seems likely shift the U.S. payer mix away from commercial health plans. Expect even tighter formulary management and more restrictions as PBMs work even harder to cut costs for their plan sponsor clients.

Click here to see the original post and comments from January 2020.

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For 2020, the two largest pharmacy benefit managers (PBMs)—Express Scripts and the Caremark business of CVS Health—have again increased the number of drugs they have excluded from their standard formularies. The 2020 formulary exclusion lists are available below for your downloading pleasure.

Below, I highlight my key takeaways from the 2020 lists:

• The number of exclusions

• Management of specialty drugs

• Indication-based formularies

• The slow adoption of biosimilars

• The PBMs’ patient-unfriendly exclusions in the hepatitis C category

Formulary exclusions have emerged as a powerful tool for PBMs to gain additional negotiating leverage against manufacturers. The prospect of exclusion leads manufacturers to offer deeper rebates to avoid being cut from the formulary. Exclusions are therefore a key factor behind falling brand-name net drug prices.

Read on for a look at this year’s exclusions along with some closing thoughts on what exclusions mean for patients.
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Investigation of combination therapies including Bayer’s chloroquine and interferon beta-1b to foster much needed solutions for patients in fight against coronavirus pandemic / Bayer Canada to make CAD 1.5 million (approximately 1 million euros) financial commitment and to supply products in support of the research / Plans to include more than 60 contributing research locations involving 6.000 patients

A Phase 3 study of Sanofi and Regeneron’s Libtayo (cemiplimab) as a monotherapy for advanced or metastatic non-small cell lung cancer (NSCLC) has been stopped early after showing strong overall survival benefit, it has emerged.

Click to view a price quote on ELAN.

Canada-based Bausch Health Companies, along with its wholly-owned subsidiary, Salix Pharmaceuticals and…

Novartis is using familiar faces—real patients from its Cosentyx TV commercials—to thank healthcare workers and promise support for patients. It’s a shift away from product-centered TV ads as Novartis adjusts its Cosentyx DTC effort during the COVID-19 crisis to highlight resources for patients, the drugmaker said.

RE/MAX East-West, a real estate firm in Elmhurst, Ill., and one of its former real estate agents, John DeJohn, have agreed to pay $120,000 to settle allegations that they illegally steered prospective homebuyers toward and away from certain neighborhoods based on race and national origin. The consent decree was signed on Feb. 17, 2009, by U.S. District Judge Ruben Castillo.

The United States has intervened in a whistleblower suit filed in the District of New Mexico against Community Health Systems Inc. (CHS) and three of its hospitals in New Mexico: Eastern New Mexico Medical Center in Roswell, Mimbres Memorial Hospital in Deming, and Alta Vista Regional Hospital in Las Vegas. The suit alleges that CHS and its three hospitals violated the False Claims Act (FCA) by knowingly causing to be presented to the United States false claims for federal matching Medicaid funds.

A current Baltimore City Police Department officer and two retired officers were charged in a six-count federal indictment unsealed today with civil rights and obstruction of justice violations stemming from an April 2004 incident during which officers allegedly assaulted a handcuffed and shackled juvenile with a baton and pool stick.

Alta Colleges Inc. and its wholly-owned collegiate schools in Texas have agreed to pay the United States $7 million to resolve allegations under the False Claims Act that the Texas schools submitted false claims for federal student aid funds. The United States alleged that Alta’s Texas colleges obtained the requisite state licenses by misrepresenting to the state licensing agency that they complied with state job-placement reporting requirements and that their interior design programs complied with requirements for a professional license.

A federal grand jury has returned an 18-count superseding indictment charging Thomas E. Parenteau of Columbus, Ohio; Dennis G. Sartain of Hilliard, Ohio; and Bonnie Helt-Adams of Dublin, Ohio, with tax fraud, bank and wire fraud, money laundering and obstruction of justice.

The Department filed a lawsuit in U.S. District Court in Baltimore alleging that the city of Baltimore’s zoning code discriminates against individuals with disabilities by requiring substance abuse treatment facilities to go through a burdensome “conditional ordinance” zoning process in order to locate in any zone.

Anadarko Petroleum Co., and two related oil production companies have agreed to pay a civil penalty of more than $1 million and implement injunctive relief, develop facility response plans, and revise spill prevention as well as containment plans at a cost of more than $8 million during the term of the settlement in order to resolve violations of the Clean Water Act.

The U.S. Court of Appeals for the Federal Circuit has affirmed a judgment upholding the Navy’s termination for default of a contract with McDonnell Douglas and General Dynamics for the A-12 stealth attack aircraft.

Two Baltimore businessmen were indicted today for conspiring to rig bids at tax lien auctions in Maryland for more than five years. The one-count felony indictment filed today in the U.S. District Court in Baltimore alleges that Harvey M. Nusbaum and his business partner, Jack W. Stollof, participated in a conspiracy to rig bids in tax lien auctions conducted by the city of Baltimore and various counties in the state of Maryland beginning in or around the Spring of 2002 and continuing until at least Aug. 9, 2007.

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.

John D. Stacey, a resident of Phoenix, was convicted today of income tax evasion, corrupt interference with the due administration of the Internal Revenue Service (IRS) and multiple counts of fraudulent use of a social security number. A federal jury convicted Stacey of all counts of the indictment following a three week trial before Judge Neil V. Wake in Phoenix.

A federal jury in New York has rejected the $24 million tax refund claim filed by Altria Group Inc. relating to its investment in lease-in, lease-out (LILO), and sale-in, lease-out (SILO) tax shelters. The verdict follows a three-week trial in the Southern District of New York before U.S. District Judge Richard J. Holwell.

Western Energy Company, the operator of the Rosebud Mine on federal coal leases outside of Billings, Mont., has paid the United States more than $12 million in mineral royalties and accrued interest as the result of a settlement agreement. Under the agreement that was filed in U.S. District Court for the District of Columbia, Western Energy has agreed to pay $12,239,538 in additional royalties and interest, 49 percent of which will be shared with the state of Montana because the production occurred on federal lands in that state.

Helmerich & Payne Inc. (H&P) has entered into an agreement with the Department of Justice to resolve improper payments by H&P to government officials in Argentina and Venezuela in violation of the Foreign Corrupt Practices Act (FCPA).

Paul Revere Transportation LLC, a bus company based in Boston, has agreed to pay a $650,000 civil penalty after being found liable by a jury in June for violating federal and state clean air laws for idling their buses for extended periods of time. The company was found liable on June 8, 2009, after a six-day trial in U.S. District Court in Boston, for 234 separate violations of the Clean Air Act and a Massachusetts anti-idling regulation.

A federal grand jury in Denver has charged Donald Hertz with transmitting a threat in interstate commerce and with violating the Freedom of Access to Clinic Entrances (FACE) Act for allegedly threatening an employee of a Colorado abortion clinic.

American pharmaceutical giant Pfizer Inc. and its subsidiary Pharmacia &Pfizer”) have agreed to pay $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice, to resolve criminal and civil liability arising from the illegal promotion of certain pharmaceutical products.

The Department announced a settlement agreement to make Donna’s, a café and restaurant located in the Mt. Vernon neighborhood of Baltimore accessible to people with disabilities.

Detroit residents Dierdre Teagen, Robert Wynn, Ernest Neal, James Harris and Steve Sherman pleaded guilty for their roles in various Medicare fraud schemes.

“It is critical that Medicare providers base their DME purchasing decisions on what is in the best interests of their patients,” stated Tony West, Assistant Attorney General for the Civil Division.

“With the nation’s focus on health care, this settlement demonstrates the Justice Department’s commitment to ensuring that federal health care dollars are spent appropriately,” said Tony West, Assistant Attorney General for the Civil Division.

Twenty defendants have been charged in seven cases for allegedly participating in Medicare fraud schemes that resulted in more than $26 million in fraudulent bills to the Medicare program.

A federal court in Boston issued a judgment against Excel Home Care Inc. in the amount of $473,510.76 for unpaid federal employment and unemployment taxes after its owner Diane E. Porter consented to the entry of an order of permanent injunction that prohibits her or anyone else from operating this Tewksbury, Mass., home health care provider.

Detroit-area residents Baskaran Thangarasan, Sandeep Aggarwal and Wayne Smith pleaded guilty this week for their roles in connection with several Detroit-area health care fraud schemes.

The United States and the state of New York have entered into settlement agreements with three home health agencies to resolve allegations that they submitted false claims to the New York Medicaid and Medicare programs.

Jackson, Mich., resident Terrence Hicks and Detroit residents Muhammed Al Mahdi and John Saunders pleaded guilty in U.S. District Court in the Eastern District of Michigan this week for their roles in a $4.2 million Medicare fraud scheme.

Chevron Corporation, Texaco, Unocal Incorporated and their affiliates (the Chevron companies) have agreed to pay the United States $45,569,584.74, to resolve claims that they violated the False Claims Act by knowingly underpaying royalties owed on natural gas produced from federal and Indian leases.

“As this case demonstrates, we are committed to vigorously pursuing those who defraud Medicare.”

UTStarcom Inc. (UTSI) has entered into an agreement with the Department of Justice, agreeing to pay a $1.5 million fine for violations of the Foreign Corrupt Practices Act by providing travel and other things of value to foreign officials, specifically employees at state-owned telecommunications firms in the People’s Republic of China.

John D. Stacey of Mesa, Ariz., was sentenced by U.S. District Judge Neil V. Wake to 77 months in prison and ordered to pay $1.5 million dollars in restitution on Jan. 7, 2010.

Manual Deluna has pleaded guilty to one count of conspiracy to commit health care fraud in connection with his role in Memorial Medical Supply, a Houston durable medical equipment company.

Dennis G. Sartain of Hilliard, Ohio; and Bonnie Helt, of Columbus, Ohio, pleaded guilty today to conspiring to commit mortgage fraud, money laundering and obstruction of justice.

Troy, Mich., physician Toe Myint was convicted today by a Detroit jury of conspiracy to commit health care fraud in a $4.2 million Medicare Fraud scheme.

Detroit-area resident Jessica Vigil pleaded guilty today for her role in a Detroit-area home health care fraud scheme.

Sylvia Smith, 64, a retired nurse, was convicted today of conspiracy to commit health care fraud and health care fraud.

“Health care fraud affects all Americans and demands a coordinated, national response,” said Attorney General Holder.

"Today’s summit marks a critical step forward in the work being done by HEAT, our Health Care Fraud Prevention and Enforcement Action Team," said Attorney General Holder.

Atlanta real estate firms Coldwell Banker Joe T. Lane Realty Inc., Coldwell Banker Bullard Realty Company Inc. and Rodney Lee Foreman, one of their former real estate agents, have agreed to pay $160,000 to settle allegations that they illegally steered prospective homebuyers toward and away from certain neighborhoods based on race and color.

Detroit-area resident Muhammad Shahab pleaded guilty today for his role in organizing a Detroit-area home health care fraud scheme.

Cummins Inc., a major motor vehicle engine company based in Columbus, Ind., will pay a $2.1 million penalty and recall 405 engines under a settlement agreement resolving alleged violations of the Clean Air Act.

“Equal access to housing is a basic necessity and a civil right, and the Fair Housing Act guarantees that all individuals can access that right free from discrimination,” said Thomas E. Perez, Assistant Attorney General for the Civil Rights Division.