U.S. pays nearly twice as much for drugs compared to other countries

A recent HHS analysis revealed that prices charged by drug manufacturers to wholesalers and distributors in the United States are 1.8 times higher than in other countries for the top drugs by total expenditures separately paid under Medicare Part B. U.S. prices were higher for most of the drugs included in the analysis, and U.S. prices were more likely to be the highest prices paid among the countries in the study (ASPE Report, October 25, 2018).

Medicare Part B

Drugs typically administered to patients by healthcare practitioners are covered and paid under Medicare Part B, which is part of the fee for service traditional Medicare benefit. Under Part B, providers buy and bill for these drugs. Medicare pays suppliers and providers based upon the Average Sales Price (ASP) for each product, as reported by manufacturers to CMS. Physician offices that buy and bill Part B drugs are paid 106 percent of the drug’s ASP, and hospitals are reimbursed either at 106 percent or 77.5 percent of ASP, depending on the hospital outpatient department’s participation in a safety net drug pricing program. Spending on Part B drugs has doubled since 2006.

The analysis and results

Data was compiled on the top drugs based on total Medicare reimbursement to either physician offices, hospital outpatient departments, or overall under Medicare Part B in 2016. Countries included in the analysis included: the United States, Austria, Belgium, Canada, Czech Republic, Finland, France, Germany, Greece, Ireland, Italy, Japan, Portugal, Slovakia, Spain, Sweden, and the United Kingdom. The analysis identified thirty two Medicare Part B drugs among the top twenty drugs in spending for each setting. These thirty two drugs accounted for $18 billion in spending, out of a total $27 billion on Part B drugs across these settings. The main analysis reports on twenty seven Part B Drugs.

Across the twenty seven drugs in the study, the U.S. ex-manufacturer prices were 1.8 times than average international ex-manufacturer price. There was not any one country that consistently had the highest or lowest prices compared to the U.S. for twenty of the drug products; U.S. prices exceeded the average international price by more than twenty percent. In addition, for nineteen of the twenty seven products the U.S. prices were higher than any other country. Excluding the U.S., Germany and Canada had the highest prices for six drugs and Japan for five drugs. France and the United Kingdom had the lowest prices for four drug products. Japan, Sweden and Slovakia had the lowest prices for three drug products each. Finally, the analysis calculated that the Medicare program and its beneficiaries spent an additional $8.1 billion (47 percent more) on these twenty seven products that it would have, if payments based upon ASP were scaled by the international price ratios.

Overall, prices and reimbursement rates for Part B drugs are significantly higher for the U.S. providers than purchasers outside the U.S., except for a few outlier cases. The amount by which U.S. prices exceeded those of international comparators varied significantly by product, and there was no clear pattern as to which countries were consistently paying lower prices. The analysis suggests that Medicare Part B could achieve significant savings if prices in the U.S. were similar to those of other large market based economies.

Kusserow on Compliance: OCR releases new guidelines on software vulnerabilities and patching

The HHS Office for Civil Rights (OCR) recently released a report focuses on software bugs and patches designed to reduce the vulnerability of computer systems that put electronic personal health information (ePHI) at risk. The OCR noted that last year researchers discovered a widespread vulnerability in computer processors that were sold over the previous decade. These vulnerabilities, known as Spectre and Meltdown, allow “malware” to bypass data access controls and potentially access sensitive data. This security flaw has been present in nearly all processors produced in the last 10 years and affects millions of devices. Upon discovery of these defects, vendors scrambled to release patches that addressed this problem. Managing patches plays an important role in maintaining HIPAA Security Rule compliance and without them vulnerabilities will not be fixed. The health care sector relies on software to manage ePHI and organizations are required under the HIPAA Security Rule to use appropriate technical safeguards to ensure the security of ePHI, including the evaluation of software vulnerabilities, the assessment of potential risks, and the implementation of solutions to keep risk at a reasonable minimum. The OCR suggested the following for effective patch management:

  • Evaluate patches to determine if they apply to your software/systems.
  • Test patches on an isolated system for any unwanted side effects.
  • Once patches have been evaluated and tested, approve them for
  • Deploy patch installation on live systems.
  • Test and verify to ensure correct patch installation and no unforeseen side effects

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on Google+ or LinkedIn.

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Copyright © 2018 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: OIG toolkit for calculating opioid levels and opioid misuse risk

The OIG toolkit provides detailed steps for using prescription drug claims data to analyze patients’ opioid levels and identify certain patients who are at risk of opioid misuse or overdose. It is based on the methodology that OIG has developed in its extensive work on opioids. This provides technical information to support the OIG’s public and private sector partners, such as Medicare Part D plan sponsors, private health plans, and State Medicaid Fraud Control Units. It is intended to assist OIG partners with analyzing their own prescription drug claims data to help combat the opioid crisis. It provides steps to calculate patients’ average daily morphine equivalent dose (MED), which converts various prescription opioids and strengths into one standard value. This measure is also called morphine milligram equivalent (MME). The toolkit includes a detailed description of the analysis and programming code that can be applied to the user’s own data. The resulting data can be used to identify certain patients who are at risk of opioid misuse or overdose. Users can also modify the code to meet their needs, such as identifying patients at other levels of risk. The toolkit has three chapters:

 

(1) Analysis of Prescription Drug Claims Data,

(2) Explanation of the Programming Code To Conduct the Analysis, and

(3) Programming Code.

 

Opioid abuse and overdose deaths are at epidemic levels in the United States. As one of the lead federal agencies fighting health care fraud, the OIG is committed to supporting public and private partners in its efforts to curb the opioid epidemic. These partners include Medicare Part D plan sponsors, other private health plans, State Medicaid Fraud Control Units, State prescription drug monitoring programs, and researchers. They can use this toolkit to analyze claims data for prescription drugs and identify patients who may be misusing or abusing prescription opioids and may be in need of additional case management or other follow-up. This toolkit can also be used to answer research questions about opioid utilization.

Copies can be obtained by contacting the Office of Public Affairs at Public.Affairs@oig.hhs.gov.

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on Google+ or LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2018 Strategic Management Services, LLC. Published with permission.

Device manufacturer’s misrepresentations result in $12.5M FCA settlement

Medical device manufacturer AngioDynamics, Inc., settled with the United States for $12.5 million following allegations that the company caused health care providers to submit false claims related to the use of the LC Bead® and the Perforator Vein Ablation Kit® (PVAK) to Medicare, Medicaid, and other federal health care programs. The government alleged that the manufacturer both provided instructions to use inaccurate billing codes and misrepresented Medicare billing policy related to the devices. The settlement came as a result of a suit filed under the whistleblower provision of the False Claims Act (FCA) (31 U.S.C. § 3729).

LC Bead allegations

The medical device manufacturer will pay $11.5 million—$10.9 million paid to the federal government and $600,000 paid to state Medicaid programs—to resolve allegations that the company caused the submission of false claims for procedures involving an unapproved drug delivery device marketed with false and misleading promotional claims. The government alleged that between 2006 and 2011, AngioDynamics served as the distributor for the manufacturer of the LC Bead and marketed the product for use as a drug delivery device in combination with chemotherapy drugs. Employees of the manufacturer routinely claimed that this use of the LC Bead was “better,” “superior,” “safer,” and “less toxic” than alternative treatment, despite lack of clinical evidence to support the statements and despite the FDA’s repeated declination to approve the product. Knowing that many insurers did not provide coverage for certain LC Bead procedures, the company instructed health care providers to use inaccurate billing codes for claims related to these uses.

PVAK allegations

AngioDynamics will also pay $1 million to resolve allegations that the company caused the submission of false claims in connection with the use of PVAK, used to close or collapse malfunctioning veins and which was approved by the FDA only for use in treating superficial veins and not for perforator veins. The manufacturer voluntarily recalled the PVAK and reissued the product under the name “the 400 micron kit.” Despite the recall and rebranding, certain AngioDynamics employees took part in a continued campaign to market the device to treat perforator veins, falsely representing to providers that Medicare would cover this use