Where Did All the Data Go? PhRMA Seeks Open Payments Transparency

An organization representing biopharmaceutical research and discovery companies nationwide is asking CMS to explain why it allegedly removed one-third of the data it collected from its Open Payments website. Pharmaceutical Research and Manufacturers of America (PhRMA) Assistant General Counsel John Murphy notes that data was removed, despite the fact that PhRMA member companies seemed to comply with CMS guidelines in submitting information. Murphy asked CMS to offer more transparency about its decision to remove the data and to clarify the reporting regulations.

Open Payments

Section 6002 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) established a program requiring group purchasing organizations (GPOs) and manufacturers of covered drugs, devices, biologicals, or medical supplies to provide HHS with information regarding their financial transactions with physicians or teaching hospitals. The program, known as “Open Payments” or the “Physician Payment Sunshine Act,” is scheduled to report such financial information on a website beginning September 30, 2014, to allow for public transparency. After manufacturers and GPOs reported information, physicians and teaching hospitals were given until August 27, 2014 to review the accuracy of the information submitted about transactions in which they were involved.

System Shutdown

Unfortunately, the system was shut down for two weeks while CMS addressed technical issues brought to light by a physician who claimed that payments made to a doctor with the same name were attributed to him. CMS resolved the issues and reopened the system on August 15, 2014, extending the deadline for doctors and hospitals to review information until September 8, 2014 (see Reopening the Open Payments system, CMS extends physician review, (Aug. 20, 2014)). The information is still scheduled to be available to the public on September 30, 2014.

Removal of Data

Policy and Medicine, a website that explores health care compliance issues of interest to life science manufacturers, suggests that the deletion of data may be related to the National Plan and Provider Enumeration System (NPPES) and the Provider Enrollment, Chain and Ownership System (PECOS) databases. For example, errors may occur when a physician’s information, including his or her National Provider Identifier (NPI) does not exactly match against the NPPES or the physician’s NPI is not included in the record.

In the meantime, PhRMA, which supports the Sunshine Act, is seeking to ensure that its members’ diligence in complying with requirements is not disregarded in the future. According to Murphy, “Our industry is committed to working with CMS and the physician community to ensure that all data is accurate, and that proper context is provided to explain how collaborations between companies and physicians can improve patient care and help promote medical innovation.”

Chronic Use Drives Rise in Opioid Consumption Among Medicare Disabled

An increase in chronic users may be the reason behind increased opioid consumption among disabled Medicare beneficiaries. A study of disabled beneficiaries under age 65 published in Medical Care showed that the percentage of beneficiaries with any opioid use decreased slightly from 43.9 percent in 2007 to 43.7 in 2011. However, the percentage of chronic users rose from 21.4 percent to 23.1 percent. Although they recognize that some chronic use can be beneficial, the authors suggest that Medicare administrators and clinicians find ways to monitor pain management to avoid unnecessary use.


The authors were interested in opioid use among disabled workers who received social security disability benefits due to musculoskeletal conditions, which are commonly treated with opioids. They examined opioid prescription fill patterns among a pool of disabled Medicare beneficiaries under age 65, as SSDI beneficiaries make up most of that group, from 2007 through 2011. Individuals were present an average of 3.3 of the 58 years studied.


Overall use peaked in 2010, but declined slightly in 2011. However, chronic use increased. In the authors’ words, the chronic use was “intense,” with 20 percent receiving 100 milligrams of morphine equivalents per day and 10 percent receiving 200 milligrams or more. Although musculoskeletal conditions are more prevalent in the disabled Medicare population (65 percent compared to 50 percent in the general U.S. adult population) and even more extreme among chronic users (94 percent), this did not appear to account for chronic use. The presence of regional differences in prescription fills regardless of the strictness of state drug laws was troubling to the authors, because it suggested inconsistent approaches. For example, “oxycodone was prominent on the eastern seaboard, whereas Texas prescribers all but eschewed these products,” despite similar regulations among states.

The authors encourage the possible use of quality measures for chronic opioid management, as well as measures to limit the number of prescribers per user, monitoring, and consultations with pain specialists. They recognize that such programs will require expenditures. However, they believe “inaction will also come at a substantial cost.”

Decline in Medicare Patients’ Heart Hospitalizations Sends Hearts Racing

Medicare patients saw a 38 percent decrease in heart attack hospitalizations between 1999 and 2011. The amount of Medicare patients hospitalized with blood-clot-related strokes fell 34 percent, and angina-related hospitalizations decreased by an astounding 84 percent. Additionally, the risk of dying within a year of being hospitalized decreased by 13 percent for patients suffering from heart failure and stroke and by 23 percent for those who suffered heart attacks.

Though doctors are not able to pinpoint an exact cause for the encouraging decreases, the steady decline is likely attributed to people smoking less, the diabetes epidemic’s affect on afflicted peoples’ diets and exercise habits, and the fact that more elderly adults are taking cholesterol-lowering medications.

Perhaps, the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) may have helped in attaining these successes.

Section 10411 of the ACA was designated the Congenital Heart Futures Act (Act), enacted March 2010. Through this Act, HHS established a National Congenital Heart Disease Surveillance System through the Centers for Disease Control and Prevention (CDC), which facilitates research into the types of health services used by patients and to identify possible areas for educational outreach and prevention. The collected data will be stored in a national, population-based database that can be used by researchers and the public to monitor the epidemiology of congenital heart disease.

The Congenital Heart Disease Surveillance System is designed to:

  • collect data regarding congenital heart disease’s prevalence in the United States;
  • collect and store congenital heart disease data regarding risk factors, population demographic factors, causes, treatments, and outcome measures that would provide best practices and guidelines for patients; and
  • ensure the collection and analysis of longitudinal data related to all individuals who have congenital heart disease.

Under the ACA, the director of the National Heart, Lung, and Blood Institute is also authorized to expand congenital heart disease research and any related activities.

Dr. Harlan M. Krumholz, director of the Yale-New Haven Hospital Center for Outcomes Research and Evaluation in Connecticut, is encouraged and says that with an increased focus on heart disease, doctors’ ability to identify and treat high blood pressure and secure fast, appropriate treatment to heart attack sufferers improved between 1999 and 2011. Krumholz also attributes the decline in hospitalizations to the fact that “[a] lot of people and organizations have been working really hard for the past 10 to 15 years to make better use of the knowledge we have.” It is possible that the ACA surveillance system contributed to this knowledge.

Not all the news is positive. The director of women’s heart health at the Heart and Vascular Institute at New York’s Lenox Hill Hospital, Suzanne Steinbaum, worries that the positive trends will reverse if obesity and diabetes in young Americans, who are ineligible for Medicare, continue to grow. She notes that heart attack rates are increasing in younger women, especially African Americans, and the CDC notes that there are 800,000 heart-related deaths each year.

Howard Herrmann, director of Interventional Cardiology and Cardiac Catheterization at the Hospital of the University of Pennsylvania, stresses continued vigilance in heart disease awareness and prevention as a key factor to keeping the rates of heart disease and death on a downward trend.

With the ACA surveillance system as a potential backdrop for proactive physician and patient approaches to heart health, how many more lives and health care expenses can be saved?

AHA Seeks Metamorphosis of OIG’s ‘Kafkaesque’ Overpayment Burden

On August 21, 2014, the American Hospital Association (AHA) sent a second strongly worded letter to the HHS Secretary complaining of the HHS Office of Inspector General’s practice of improperly using extrapolation to determine a hospital system’s estimated Medicare overpayment, as well as its misconstruction and misapplication of a number of other Medicare regulations and policies. Rick Pollack, Executive Vice President of the AHA, told Secretary Burwell that he had hoped the OIG’s extrapolation approach, which “grossly exaggerates” overpayments and “leads to excessive recoveries” had been halted after the AHA submitted a June 2, 2014 letter to former Secretary Sebelius. In the earlier letter, Pollack complained, “The Kafkaesque burden of imposing duplicative audits on hospitals and recouping payments from them without correcting the OIG’s manifold and glaring errors is abusive and unfair to hospitals and a waste of government resources.” (See Hospitals claim OIG compliance audits are redundant and not following the law, June 5, 2014.)

Recent Audit

The August letter states that the recent audit report calculated overpayments due for erroneously paid inpatient claims because patients’ medical records did not include admission orders signed by physicians. However, the letter argues that the claims were made prior to 2013 and that regulations did not require such an order until October 1, 2013. In Pollack’s prior words, “The OIG invented a physician order requirement that . . . did not exist.” Furthermore, the OIG failed to offset the hospital system’s alleged Medicare overpayments due for inpatient claims that should have been billed as outpatient claims by the amount of Part B payments that the hospital would be entitled to receive.

Other Complaints

In addition to the issues discussed above, the AHA’s earlier letter accused the OIG of misinterpreting section 1870 of the Social Security Act (the Act), which presumes that hospitals are “without fault,” absent contrary evidence, when overpayment determinations are made after the third year following the year in which the Part A payment was originally made. The AHA stated that hospitals could not be at fault after 2012 for payments made in 2009, but the OIG interpretation deemed hospitals to be at fault for any incorrect application of Medicare manual provisions. The AHA also accused the OIG of basing audits on claims made more than four years ago, which could not be reopened, and conducting audits redundant to recovery audit contractor (RAC) audits.