Wachler & Associates Health Law Blog

Published on: May 31, 2018

Pfizer Agrees to Pay $24 Million to Settle Anti-Kickback Claims

On May 24, 2018, the U.S. Department of Justice announced a $23.85 million settlement with Pfizer, Inc., to settle anti-kickback claims against the company. The settlement arose after an investigation led by U.S. Attorney Andrew Lelling, which looked into the drug industry’s support of patient assistance charities. Pfizer is now among a group of multiple drug companies (Celgene Corp., Aegerion Pharmaceuticals, and Jazz Pharmaceuticals) who have settled with the Department of Justice for their use of patient assistance charities. Pfizer also signed a five-year monitoring agreement with the Department of Health and Human Services Office of Inspector General, and is required to implement measures to ensure that its arrangements with patient assistance charities are in compliance with the law

Pfizer was allegedly using an “independent” charity to pay illegal kickbacks to Medicare patients, covering out of pocket costs for prescription drugs. Pfizer made donations to Patient Access Network Foundation (PAN), a copay assistance nonprofit organization, and used a specialty pharmacy, Advanced Care Scripts, to direct Medicare patients taking its drugs toward the foundation to cover their copays.

The scheme centered around three drugs, two for kidney cancer (Sutent and Inyalta), and one for arrhythmia (Tikosyn). Pfizer was allegedly aware that PAN used their donations to cover the copays of patients taking these drugs. In fact, PAN and the pharmacy would notify Pfizer when patients using these drugs got the copay assistance. Price increases of the drugs were concealed from patients but left Medicare with a higher bill.

Published on: May 24, 2018

Rebranding of the Medicare and Medicaid EHR Incentives Program

by Wachler & Associates, P.C.

On May 7, 2018, the Centers for Medicare and Medicaid Services (“CMS”) released a proposed rule that would rebrand the current Medicare and Medicaid Electronic Health Records (“EHR”) Incentives program into the Promoting Interoperability program (“PI”).

The EHR incentives program, created in 2011, encouraged eligible providers to adopt, implement, upgrade and demonstrate meaningful use of certified electronic health record technology (“CEHRT”). This program awarded over 544,000 health care providers with payment by February 2018.

With the great success of the incentives program, CMS is proposing changes that would create more transparency between patients and providers through greater access to health care information. To relieve burden to patients, and increase the ability to exchange health information among providers and patients, sharing and extracting files across systems is a new CEHRT requirement. Moreover, it will support increased patient access to their personal health information through secure email transmissions. The proposed PI program would also provide patients access to hospital price information via the internet.

Published on: May 15, 2018

OIG Issues Report on Toxicology Overpayments

by Wachler & Associates, P.C.

Urine drug testing is medical protocol for patients prescribed opioid drugs in order to monitor compliance and expose possible drug abuse or diversion. In the wake of the opioid crisis, there has been an increase in the frequency and cost of urine drug tests, resulting in a corresponding increase in spending by Medicare and private insurance on such tests. Between 2011 and 2014, spending on urine drug screens and genetic tests by Medicare and private insurance quadrupled to an estimated $8.5 billion per year.

The increase in the cost of urine drug tests is attributable to more expensive and high-tech ways of running the tests. Presently, laboratories are moving away from simple urine screenings and installing machines for urine drug tests. There is a financial incentive attached to machine tests; under Medicare rules, each drug tested for within a single specimen validity test may be billed individually.

The spike in reimbursement by Medicare and private insurance has caught the attention of the federal government. In 2010, the Centers for Medicare & Medicaid Services (“CMS”) imposed stricter rules on billing for simple urine screens; however, these rules do not cover machine testing. In addition, in 2011, the federal government settled with Millennium Health, LLC, one of the largest urine drug testing laboratories in the United States, for $256 million after it was alleged to have billed medically unnecessary urine drug and genetic tests.

Published on: April 11, 2018

OIG Issues Report on Outpatient PT Overpayments

by Wachler & Associates, P.C.

In March of 2018, the Department of Health and Human Services Office of the Inspector General (OIG) issued a report titled “Many Medicare Claims for Outpatient Physical Therapy Services Did Not Comply With Medicare Requirements” [summary] (the “Report”) identifying millions of dollars of overpayments for outpatient physical therapy services and signaling potential for increased governmental scrutiny to practitioners within the discipline.

The Report revealed that an audit found $367 million in improper payments for outpatient physical therapy services between July 1 and December 31, 2013. The finding was based upon data extrapolation, in which the OIG reviewed 300 sample claims and determined that 184 of the claims (61.33%) did not comply with Medicare requirements for medical necessity, documentation, or coding.

The OIG directly faulted the Centers for Medicare and Medicaid (CMS) for the overpayments, finding that the current controls in place are insufficient to prevent improper payments to providers. The OIG issued three recommendations to CMS in order to prevent future incorrect expenditures:

Published on: April 11, 2018

Court Orders AHA to Provide Strategies for Eliminating Medicare Appeals Backlog

by Wachler & Associates, P.C.

On March 22, 2018, the latest development in American Hospital Association (AHA) v. Azar (formerly referred to as AHA v Burwell) emerged as Judge Boasberg issued an order to have the AHA develop strategies to assist the Department of Health and Human Services (HHS) in reducing the Medicare appeals backlog. The request comes in response to a lack of effective action by HHS to reduce the number of backlogged appeals.

Major events in the case include:

May 22, 2014: Initial complaint filed by the AHA, alleging that HHS was violating Federal law by failing to process appeals within the legally-mandated timeframes. The problem was and continues to be highlighted at the administrative law judge (ALJ) level of appeals, where wait times for the processing of claims regularly takes years;

Published on: January 22, 2018

DOJ and Kmart Reach $32.3 Million Settlement to Pharmacy False Claims Suit

by Wachler & Associates, P.C.

On December 22, 2017, the U.S. Department of Justice (DOJ) announced a $32.3 million settlement (the Settlement) with Kmart Corporation, to settle False Claim Act (FCA) allegations against the company. The Settlement was based upon allegations that Kmart’s in-store pharmacies misled government payers by knowingly failing to report discounted prices and representing its drug prices as being higher than what was offered to the general public. Per the Settlement, Kmart does not admit to any wrongdoing.

The Settlement arises from a whistleblower suit filed in 2008. The suit alleged that Kmart failed to report discounted drug prices to Medicare Part D, Medicaid, and TRICARE. To determine reimbursement rates for medications, the government generally relies on a pharmacy’s “usual and customary prices” charged to consumers. According to the allegations, Kmart offered discounts to certain cash-paying customers but did not disclose those discounted prices when reporting its pricing to the government. Kmart argued that the special discount prices offered to a limited consumer base did not constitute “usual and customary” costs, but this argument was rejected in favor of increased transparency by pharmacies.

The Settlement sends a message to pharmacies regarding the importance of transparency, and that even prices offered only to a limited number of patients should be reported to the government. According to Acting Assistant Attorney General Chad Readler of the DOJ, “This settlement should put pharmacies on notice that there will be consequences if they attempt to improperly increase payments from taxpayer-funded health programs by masking the true prices that they charge the general public for the same drugs.” The whistleblower who brought the original suit will receive $9.3 million of the $32.3 million settlement, potentially sending a strong message to prospective whistleblowers as well.

Published on: November 13, 2017

HHS OCR Issues Guidance on Mobile Devices and Compliance with HIPAA

by Wachler & Associates, P.C.

In October 2017, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued Health Insurance Portability and Accountability Act (HIPAA) guidance regarding the use of mobile devices in the healthcare field. The guidance recognizes the risks of mobile device use while also acknowledging the central role such devices play in many businesses.

The first risk noted by the OCR is of mobile devices being lost or stolen. Since devices used to create or access protected health information (PHI) may be taken off-site, the risk of being lost or stolen is much greater. Regardless of the nature of the device, if it has unsecured PHI, a breach of that PHI could trigger breach notification obligations for covered entities and business associates.

The other risks raised by the OCR are those involving unsecure Wi-Fi and cloud storage applications, as well as the danger of having a mobile device infected with viruses or malware through email, websites or the downloading of apps. Entities that handle PHI must institute security protocols to assure that hackers cannot gain control of PHI and other private information through these methods.

Published on: August 18, 2017

AHA v Burwell Questioned by DC Circuit Court

by Wachler & Associates, P.C.

On August 11, 2017, a further development came in the Medicare appeals backlog saga, as the D.C. Circuit Court reached a decision on the Department of Health and Human Services’ (HHS’) appeal to the case American Hospital Association (AHA) v Burwell. The decision (“Appeal Decision”) handed down last week was decidedly pro-HHS, and is a setback for the AHA and healthcare providers with appeals pending at the administrative law judge (ALJ) level. The Appeal Decision has the potential to completely undo any progress created by the original December decision.

The Circuit Court came to a 2-1 decision, ordering the District Court to reconsider its mandate that HHS completely eliminate the Medicare appeal backlog by the end of 2020. The Circuit Court based its decision on the idea that the District Court decision had the potential of mandating that HHS violate its legal duty to only pay out legitimate Medicare claims. HHS is required to “protect” the Medicare trust fund, and in the process taxpayer dollars. However, HHS is also required by law to process ALJ appeals within 90 days, a duty which has gone unmet for years and was the basis of the District Court’s decision.

The AHA filed its initial suit in 2014, and after being initially dismissed, the AHA received a favorable decision in December 2016, a decision that is now in jeopardy of being undone. The December decision dictated certain yearly “targets” for HHS and the Center of Medicare and Medicaid Services (CMS) to meet regarding decreases to the number of backlogged appeals at the ALJ level. HHS objected to these benchmarks, and in fact to any mandated reduction, based on several arguments, including that the backlog cannot be eliminated without arbitrary settlements regardless of the actual merits of the claims.

Published on: July 31, 2017

OIG Reveals Plans to Scrutinize EHR Incentive Payments

by Wachler & Associates, P.C.

In July 2017, the Department of Health and Human Services Office of Inspector General (OIG) revealed its plans to review the $14.6 billion in incentive payments the Centers of Medicare and Medicaid Services (CMS) made to hospitals between January 1, 2011 and December 31, 2016, pursuant to Medicare’s electronic health record (EHR) technology program. The OIG plans to review these payments in order to identify errors and inaccuracies which may have resulted in overpayments to hospitals

This announcement comes less than a month after the June report from the OIG, titled “Medicare Paid Hundreds of Millions in Electronic Health Record Incentive Payments That Did Not Comply with Federal Requirements” (the “Report”) (an official OIG summary is available here). The Report was based upon a review of EHR Incentive Program payments made to 100 professionals, which found 14 improper payments in the amount of $291,222. Extrapolating these results, the OIG estimated a total of $729.4 million in improper payments to the over 250,000 EHR incentive eligible providers in the CMS system. According to the OIG, the $729 million figure is roughly 12% of the total payments made in connection with the EHR incentive program. A majority of the 14 improper payments discovered during the OIG’s review were based on providers failing to maintain accurate and detailed records—an issue which often arises with Medicare overpayments.

The OIG completed its report by making several recommendations to CMS:

Published on: June 12, 2017

HHS’ 2nd Update on Appeals Backlog Shows Little Progress

by Wachler & Associates, P.C.

In early June 2017 the Department of Health and Human Services (HHS) issued its second status report on the Medicare appeals backlog. The December 2016 case American Hospital Association v Burwell, in addition to dictating that HHS clear the backlog by 2020, required that HHS release a quarterly status report every 90 days to detail the progress being made toward eliminating the backlog.

The Burwell case was a significant victory for healthcare providers in their attempts to get the Medicare backlog reduced and have administrative law judge (ALJ) appeals processed within the statutory timeframes. In addition to status reports every 90 days and the complete elimination of the backlog by 2020, HHS is also required to observe several intermediary benchmarks: 30% reduction by the end of 2017, 60% by the end of 2018, 90% by the end of 2019, and then ultimately 100% elimination by the end of 2020.

However, despite these court mandated benchmarks, it has become clear to all parties involved that these goals are unlikely to be met without significant developments; HHS itself has maintained since the requirements were instituted that the elimination of the backlog would not be possible. This prediction is supported by the facts: HHS released its first status report in March, with the somber prediction that a backlog of 1,009,768 appeals would be pending by the end of 2021. June’s report saw a slightly improved projection of 950,520 claims remaining by that time, but this projection is still very far from meeting the court order.