EpiPen® misclassification cost $1.27B over 10 years, says OIG

If the EpiPen® had been classified as brand name instead of generic for purposes of the Medicaid Drug Rebate Program, CMS would have saved $1.27 billion from 2006 to 2016, the HHS Office of Inspector General (OIG) found. This estimate is far greater than the $465 million settlement that the federal government and EpiPen’s manufacturer, Mylan Inc., entered into in October 2016 concerning the classification of the drug under the Program (see Mylan settles EpiPen Medicaid rebate dispute for $465M, Health Law Daily, October 11, 2016).

“The fact that the EpiPen overpayment is so much more than anyone publicly discussed should worry every taxpayer,” said Sen. Charles Grassley (R-Iowa). Grassley reported that CMS recently provided records showing that Mylan was made aware of the misclassification years ago but failed to act (see Federal EpiPen® spending up 463 percent, Mylan misclassified drug as generic, Health Law Daily, October 6, 2016). At the time Sen. Elizabeth Warren (D-Mass) opposed the settlement, calling it “shamefully weak” (see Warren: EpiPen® Medicaid rebate settlement shows ‘crime does pay,’ Health Law Daily, October 26, 2016).

Manufacturers generally owe a higher rebate amount for brand-name drugs than generic under the Medicaid Drug Rebate Program. The basic rebate amount for a generic drug is based on a percentage (currently 13 percent) of its average manufacturer price (AMP) (see 42 C.F.R. Sec. 447.509). The basic rebate amount for a brand-name drug is based on the greater of (1) a fixed percentage (currently 23.1 percent) of the drug’s AMP; or (2) the different between the drug’s AMP and best price. In addition to the rebate amount, manufacturers of brand-name drugs (and, beginning in 2017, manufacturers of generic drugs) pay an inflation-related rebate amount if a drug’s price has increased more than the rate of inflation.

The EpiPen controversy led Grassley to request that the OIG review the Medicaid Drug Rebate Program (see HHS Inspector General to investigate Medicaid Drug Rebate Program, Health Law Daily, December 12, 2016).

Warren: EpiPen® Medicaid rebate settlement shows ‘crime does pay’

Calling a purported settlement between the Department of Justice (DOJ) and Mylan Pharmaceuticals “shamefully weak” and “shockingly soft,” Sen. Elizabeth Warren (D-Mass) warned that the DOJ is failing to deter drug companies from engaging in schemes to defraud Medicaid. In a letter to Attorney General Loretta Lynch, Warren detailed her concerns about the settlement, and requested a full briefing from the DOJ on the matter. Warren’s letter echoed similar concerns raised by Sen. Richard Blumenthal (D-Conn), who asked the DOJ to reject the proposed settlement agreement.

Medicaid drug rebate program

The Medicaid drug rebate program, authorized by Sec. 1927 of the Social Security Act, requires drug manufacturers to participate in exchange for state Medicaid coverage of most drugs. Manufacturers pay a rebate on drugs for which payment was made under the state plan, and the rebates are shared between states and the federal government to offset the cost of Medicaid prescription drugs. The rebate for brand-name drugs is 23.1 percent of the average manufacturer price (AMP) per unit, adjusted for changes in drug costs that exceed the inflation rate; the rebate for generic drugs is 13 percent of AMP per unit, with no inflation adjustment. Manufacturers are responsible for ensuring that their drugs are correctly classified and for paying the correct rebate amount.

EpiPen classification

After cost increases in Mylan’s EpiPen® Auto-Injector came under scrutiny (see Mylan attempts to mitigate EpiPen® cost hike controversy, August 25, 2016), CMS Acting Administrator Andy Slavitt confirmed that since 1997, the EpiPen has been misclassified as a generic (non-innovator, multiple source) drug. Under CMS’ definitions, the EpiPen—approved under a New Drug Application (NDA) by the FDA, under patent protection, and with no therapeutic equivalents—should have been classified as a brand (single source) drug (see Federal EpiPen® spending up 43 percent, Mylan misclassified drug as generic, October 6, 2016). Further, Slavitt confirmed that CMS “expressly told Mylan that the product is incorrectly classified,” though the agency could not comment on the total amount of rebates owed by Mylan—which purchased the EpiPen from Merck in 2007—as a result of the misclassification.

Purported settlement

In October 2016, Mylan announced that it had settled allegations of fraud against the Medicaid drug rebate program related to the company’s classification of the EpiPen® Auto-Injector as a generic drug, rather than a brand drug; the DOJ, however, has not released any information about the alleged settlement (see Mylan settles EpiPen® Medicaid rebate dispute for $465M, October 11, 2016). According to Mylan, it will pay $465 million and enter into a corporate integrity agreement with the HHS Office of Inspector General (OIG), resolving all potential rebate liability claims by federal and state governments, and with no finding of wrongdoing.

Shame and shock 

In her letter, Warren wrote that there is no excuse for Mylan’s misclassification of the EpiPen, since the company “had multiple opportunities, over multiple years” to correct the classification. According to calculations done by Warren’s staff, Mylan should have paid an estimated rebate of $416 per dose, rather than the $58 per dose it paid; as a result, Warren says, Mylan underpaid Medicaid rebates by an estimated $530 million. The $465 million settlement, therefore, would reward Mylan by fining the company about $65 million less than the amount Mylan earned by its purportedly fraudulent classification of the EpiPen. Warren reminded the DOJ of “extensive tools” to hold the company accountable, including penalties of up to $100,000 per item of false classification under the Medicaid drug rebate law (42 U.S.C. §1396r-8(b)(3)(C)(ii)), treble damages under the False Claims Act (31 U.S.C. §3729(a)(1)), and criminal penalties under the Health Care Fraud law (18 U.S.C. §1347). She called the announced settlement terms a “limp response” that fails to hold Mylan accountable and with “no deterrent value to prevent drug companies from engaging in abusive schemes to defraud Medicaid and rip off taxpayers.”

Federal EpiPen® spending up 463 percent, Mylan misclassified drug as generic

Medicare and Medicaid spending on Mylan’s EpiPen increased by 463 percent from 2011 to 2015 not accounting for rebates and other point-of-sale concessions, from $86 million to $487 million. In a letter to the Senate Finance Committee, CMS Acting Administrator Andy Slavitt also indicated that the EpiPen has been improperly classified as a generic, rather than a brand-name, drug under the Medicaid Drug Rebate Program since the fourth quarter of 1997. CMS “expressly told Mylan,” which acquired the EpiPen from Merck in 2007, that the drug is misclassified. The misclassification has financial consequences for federal and state governments and could subject the manufacturer to liability under the False Claims Act (FCA) (31 U.S.C. § 3729, et seq.) and other penalties.

In September 2016, Senate Finance Committee Ranking Member Ron Wyden (D-Ore) and House Energy and Commerce Committee Ranking Member Frank Pallone, Jr., (D-NJ) notified HHS of its concerns that the EpiPen—the source of public outcry stemming from its shocking price increase—was improperly classified under the Medicaid Drug Rebate Program and that Mylan was receiving improper payments from Medicaid (see Mylan CEO highlights EpiPen® access improvement efforts before House committee, Health Law Daily, September 22, 2016; Mylan attempts to mitigate EpiPen® cost hike controversy, Health Law Daily, August 25, 2016). It asked HHS pointed questions about EpiPen’s classification under the Program, which requires participating drug manufacturers to enter into and maintain national rebate agreements with HHS in exchange for state Medicaid coverage of most of the manufacturer’s drug, and helps to offset federal and state costs of most outpatient prescription drugs dispensed to Medicaid patients.

In the October 2016 letter, Slavitt stated that the EpiPen is misclassified as a generic—non-innovator, multiple source—drug, despite the fact that it is approved under a New Drug Application (NDA) by the FDA, has patent protection, and has no therapeutic equivalents, making it properly classified as a brand—single source—drug. Slavitt indicated that brand drugs pay a rebate of the greater of 23.1 percent of the average manufacturer price (AMP) or the difference between the AMP and the drug’s best price. (The difference is increased by a rebate if the rate of increase of the AMP outpaced the rate of inflation.) The rebate for generic products, however, is only 13 percent of the AMP. Mylan thus paid less in rebates than it should have. Slavitt noted that manufacturers that fail to accurately report product and pricing data and pay inadequate rebates may be subject to FCA liability, penalties of up to $100,000 per item of false information, and other government claims.

In February 2016, CMS issued the covered outpatient drug final rule, which stated that covered outpatient drugs approved by the FDA under an NDA must be reported as brand drugs, and will be classified as brand drugs by default, until the manufacturer applies for, and CMS grants, an exception to classify the drug as generic (see CMS paves the way for bigger, better Medicaid drug rebates, Health Law Daily, February 1, 2016). Manufacturers of drugs currently reported as generic, but marketed under an NDA, have until March 31, 2017, to submit an exception request before CMS takes administrative action.

In response to CMS’ letter, Wyden and Pallone noted, “While Mylan irresponsibly raised the price of EpiPen, they were also bilking taxpayers out of millions of dollars” (see Mylan calculatedprofitability using 37.5% tax it doesn’t pay, Health Law Daily, September 27, 2016; Mylan and Congress agree:the epinephrine auto-injector market needs a generic, Health Law Daily, August 30, 2016). They stated that Mylan and other drug companies must take responsibility for their actions to keep “essential medicines” from families, and pledged to get taxpayers their due.

Highlight on Georgia: State focused on promoting access to care

Georgians have received several pieces of good health care access news lately as the state works ensure that young adults and those living in rural areas get the care they need. Despite constant financial concerns surrounding health care, the state seems to be making it a priority.

Rural Healthcare 180

Rural Healthcare 180 is an effort to promote the new donation program that gives tax credits to both individuals and corporations that make donations to rural hospitals. Kim Gilman, chief executive of Phoebe Worth Hospital and Southwest Georgia Regional Medical Center, said that the hospitals need to upgrade expensive equipment and provide raises to employees.

In total, 48 rural hospitals are eligible to receive the donations. Tax credits will be supplied for donations of up to $4 million, with caps starting at $50 million in 2017 and increasing by $10 million each year for the next two years until program expiration. The potential of additional funding will hopefully address the crisis, as many rural hospitals seem to be set for the same fate as the five that have closed in the past four years.

Mental health center expansion

A new Atlanta campus of a mental health facility will open in October, adding 32 beds for young adults aged 18 to 26. This Rollins Campus, named for a gift received from the O. Wayne Rollins Foundation, is Skyland Trail’s second Atlanta campus. The nonprofit treatment organization operates 48 beds, and 60 percent of patients treated are young adults. Older adults have found Skyland Trail to be a lifeline, including a 63-year-old physician who reported experiencing her first psychotic episode at 56 years of age. She spent five months at Skyland Trail, where she attended to more than her mental health and was able to lose weight through the organization’s nutritional program.

State could be an example for EpiPens® in schools

In the wake of the EpiPen pricing controversy and stories about children in schools denied access to their own pens, Georgia’s approach may offer solutions to ensure safety in situations where students might be unknowingly exposed to food allergens. Karen Harris, mother to three children with severe allergies, founded Food Allergy Kids of Atlanta (FAKA) in 2007 in order to unite families like her own. Her goal is to ensure that this “first-line treatment” is accessible to everyone with any type of allergies.

In 2013, Georgia Governor Nathan Deal (R) signed the Emergency Epinephrine Act, which was introduced by Senator Chuck Hufstetler (R-Rome) and backed by FAKA. The law encourages (but does not require, unlike some states’ legislation) schools to stock EpiPens for emergency use, and authorizes providers to write a prescription in the name of a school. The law also protects anyone who uses the medication in good faith through its good Samaritan provision. A second piece of state legislation allows professionals to prescribe EpiPens for many public entities, including churches, restaurants, and arenas, provided that they register with the state. According to Georgia Health News, only 12 non-school entities have registered, and the article points out that no discount programs are offered to these entities.

Although some are concerned about parents depending on school-stocked pens and failing to provide for their children’s needs, a Georgia school nurse was thankful that they were able to receive donated pens through Mylan’s school program. She noted that in rural settings, quick access to epinephrine is vital when hospitals are some distance away. She has trained 25 teachers to administer the medication in the event of anaphylaxis.