Providers’ Obligation to Report Medicare Overpayments Clarified in New Rule

A final rule issued by the Centers for Medicare and Medicaid Services (CMS) on February 11 requires health care providers to report Medicare overpayments within 60 days of “identification” or risk liability for treble damages and crippling fines under the False Claims Act and Civil Monetary Penalties Laws. The rule implements an Affordable Care Act (ACA) requirement that practitioners, hospitals, and other Medicare participants identify and return reimbursement overpayments made in error or as a result of improper claim submissions within an abbreviated time period. The ACA and the final rule require that an overpayment be reported and returned by the later of 60 days after the date on which the overpayment was identified or the date any corresponding cost report is due, if applicable. Overpayments can result from errors on the part of Medicare contractors or providers and from receipt of payment for claims arising from violations of the Stark Law or Anti-Kickback Statute. The final rule clarifies that providers are obligated to exercise “reasonable diligence” by undertaking proactive compliance activities to monitor claims and by performing reactive investigations after receiving “credible information about a potential overpayment.” The final rule further requires Medicare participants to “look back” six years to identify overpayments that may have been received during that extended time period. Pursuant to the rule, the 60-day clock does not begin to run until an overpayment is identified and quantified. An investigation to identify and quantify an overpayment must be completed within six months of receiving credible information about a potential overpayment.

New Core Clinical Quality Measures Released by Public, Private Collaborative

The Centers for Medicare and Medicaid Services (CMS) and America’s Health Insurance Plans (AHIP) recently released, as part of a Core Quality Measures Collaborative, seven sets of clinical quality measures designed to be harmonized across commercial and government payors. The Collaborative’s goal in developing the core quality measures was that they be meaningful to patients, consumers, and physicians, while reducing variability in measure selection, burden, and cost. The core measures were released in seven sets: Accountable Care Organizations, Patient Centered Medical Homes and Primary Care, Cardiology, Gastroenterology, HIV and Hepatitis C, Medical Oncology, Obstetrics and Gynecology, and Orthopedics. CMS intends to implement the new core measures in connection with various existing Medicare quality programs while eliminating redundant measures falling outside the core measures in future rulemaking. Additional information on the new quality measures can be found at https://www.cms.gov/ Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/Core-Measures. html.

Opioid Abuse Gets the Attention of US Senate and Centers for Disease Control

Responding to the opioid prescription drug abuse and heroin epidemics that have swept the nation, the U.S. Senate on March 10 passed the Comprehensive Addiction and Recovery Act (CARA) of 2016 (S. 524) by a vote of 94-1. The bipartisan legislation authorizes grants for states to address the opioid and heroin crises, directs the Department of Health and Human Services (HHS) to develop an interagency task force charged with developing best practices for pain management, and calls for the creation of a program to curtail the overprescribing of opioids to Medicare beneficiaries by preventing those beneficiaries from shopping multiple physicians and pharmacies in search of large quantities of opioids. The bill, which requires House approval before becoming law, is seen as a start in dealing with the opioid problem. The Senate Health, Education, Labor and Pensions Committee will turn to additional legislation aimed at addressing the opioid epidemic later this month.

Meanwhile, on March 15, the Centers for Disease Control and Prevention (CDC) responded to a sharp increase in opioid-related deaths by releasing new guidelines recommending that physicians reconsider treating patients suffering from chronic pain with opioids. Noting that the incidence of opioid-related deaths has quadrupled since 1999 and that 2014 had more opioid-related deaths than any year on record, the CDC encouraged providers to initially seek alternative courses of treatment, such as exercise or anti-inflammatory drugs, and advised that if patients must be prescribed opioids, it should be in low doses and in conjunction with alternative therapies.

Rise in Drug Prices Being Eyed by Congress and Regulators

Recent headlines surrounding the aggressive pricing strategies employed by pharmaceutical companies such as Turing Pharmaceuticals, which increased the price of a drug to treat parasitic infections by 5000%, have drawn the attention of both legislators and regulators. While Turing provides the most notorious example of skyrocketing prices, the company is symptomatic of a larger trend in prescription drug price increases. A recent study by Bloomberg Business cited by a March 13 article in the Washington Post found that prices for 60 medications had more than doubled since December 2014 and, in the case of 20 of those medications, had more than quadrupled. The Post noted that these widespread increases have thrown hospital finances into disarray.

While the CEO of Turing went to Capitol Hill to testify before Congress last month, it appears the more immediate action may come from the National Institutes of Health (NIH). NIH Director Francis Collins testified at a House appropriations subcommittee hearing on March 16 that NIH, which funds drug development, would be open to exercising its “march-in rights” rights under the Bayh-Dole Act. The “march-in rights” permit an agency to intervene and ignore exclusivity rights on a patent, and issue patent licenses on its own when “reasonable terms are not being met” on drug pricing and the agency has intellectual property rights on the drug.