Kusserow on Compliance: OIG reports on background checking by home health agencies

In response to a congressional request, the HHS Office of Inspector General (OIG) conducted a review to analyze the extent to which Home Health Agencies (HHAs) employed individuals with criminal convictions and to explore whether these convictions should have—according to State requirements—disqualified them from HHA employment. HHAs provide care—usually unsupervised—to patients in their homes and ensuring that their employees undergo a minimum level of screening would help protect the safety of Medicare beneficiaries. Home health programs have been a high priority for Medicare; Medicaid is intended to provide an alternative to institutional care for people with severe disabilities and it is intended that the needed services be delivered in a beneficiary’s home. This industry sector accounts for more than $20 billion paid by Medicare on behalf of 3.4 million beneficiaries with another estimated $15 billion in outlays paid by Medicaid programs.

This is a sensitive issue area as no one wants someone with a violent criminal history or one of committing thefts to be sent to care for beneficiaries in their home. To underscore, government concern with HHAs, including those concerns expressed by the Department of Justice (DOJ) and OIG, have found considerable evidence to recognize that home health is among the most vulnerable healthcare programs to fraud and abuse. The Government Accountability Office (GAO) recently reported 40 percent of all fraud convictions initiated by a group of Medicaid fraud-control units were for home health. CMS has been active in curbing problems in this arena by making uses of authority under the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) to use temporary enrollment moratoria on home health providers in geographic areas of disproportionate crimes.

In their new report, the OIG noted that there are no federal laws or regulations that require HHAs to conduct background checks prior to hiring individuals or to periodically conduct background checks after individuals have been hired. State requirements for background checks vary as to what sources of information must be checked, which job positions require background checks, and what types of convictions prohibit employment. Though not stated in the report, what should be noted is that the background sanction-screening against the OIG’s List of Excluded Individuals/Entities (LEIE) is necessary and mandated in most states, along with screening State Medicaid sanction databases. However the problem is that most local criminal convictions are not related to violations of Medicare and Medicaid laws or regulation; and therefore not included in state reporting to the OIG LEIE.

In conducting the review, the OIG obtained a sample of Medicare-certified HHAs regarding all individuals they employed. It compared employee data with criminal history records to identify individuals with criminal convictions who were employed by the sampled HHAs. It also selected six employees for an in-depth review who had convictions for crimes against persons in the last five years and/or were registered sex offenders. Finally, it evaluated whether compliance with state laws would have led to disqualification of these six employees.

Findings

  • All HHAs conducted background checks of varying types on prospective employees.
  • Approximately half also conducted periodic checks after the date of hire.
  • Four percent of HHA employees had at least one criminal conviction that may or may not have disqualified them from employment.
  • Criminal history records reviewed were not detailed enough to enable a definitive determination of whether employees with criminal convictions should have been disqualified from HHA employment.
  • In-depth review of the six employees found that three had convictions for crimes against persons that would disqualify them from employment in HHAs, with the remaining three with convictions did not disqualify them from employment in their respective states.

Recommendation

CMS should promote minimum standards in background check procedures for HHA employee background checks by encouraging more states to participate in the National Background Check Program. CMS concurred with this recommendation.

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.

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Copyright © 2015 Strategic Management Services, LLC. Published with permission.

 

Low-volume hospitals bring high risks: a drive might save your life

Patients who undergo procedures at low-volume hospitals are subjecting themselves to an increased risk of complications and death because surgical teams at those hospitals perform too few procedures to maintain adequate levels of skill. According to a U.S. News & World Report analysis, large numbers of low-volume hospitals continue to put patients at increased risks despite three decades of research tying low-volume hospitals to higher incidents of complications and death.

Increased risk

According to an evaluation of five procedures from the U.S. News analysis, as many as 11,000 deaths might have been prevented between 2010 and 2012 if patients had undergone procedures at the highest-volume fifth of hospitals rather than the lowest-volume fifth. Some evaluations suggest that if other procedures are considered, tens of thousands of deaths might have been avoided. The increased risk of dying at a low-volume hospital from relatively safe procedures is staggering. For example, at one 25-bed Colorado hospital, the relative risk of death for elective knee replacement patients at the hospital was 24 times the national average. Similarly, at a 331-bed medical center in Florida, the relative risk of dying following a hip replacement was nine times the national average and, at a 316-bed New Jersey Medical Center, the risk for patients who had heart bypass surgery was four times above the national average.

Ultra-low-volume

Ultra-low-volume hospitals were identified as those which treated “fewer than 25 traditional Medicare inpatients from 2010 through 2012 for nearly 20 frequent procedures and conditions.” Between 2010 and 2012, ultra-low-volume hospitals performed or treated an average of 3.3 hip replacements per year, 3.7 knee replacements per year, 4.1 basic heart bypass surgeries per year, 3.9 cases of heart failure per year, and 4.3 cases of chronic obstructive pulmonary disease per year. Knee-replacement patients at the ultra-low-volume hospitals had “double the national average death risk and a 25 percent higher rate of readmission because of post-discharge complications.” Similarly, “hip-replacement patients faced a 77 percent higher risk of death and a 25 percent higher risk of readmission.” The problem stems from the simple fact that surgical teams at low-volume hospitals are out of practice.

Patients

The problem is exacerbated by the fact that few patients ask hospitals or physicians how many similar procedures a hospital has treated. U.S. News offers questions that patients can ask hospitals when trying to determine whether a low-volume hospital is a safe place to undergo a particular procedure. The findings of the analysis suggests that longstanding patient preference for local care should give way to a preference for travel and better outcomes, if safety is what patients are after.

Wheels of justice turning quickly: DOJ puts on the HEAT

The Department of Justice (DOJ) has made progress in several health care fraud cases in the past few days. Additionally, the DOJ announced the appointment of a new acting administrator of the Drug Enforcement Administration (DEA). Assistant Attorney General Caldwell also offered remarks at an American Bar Association conference, pointing out that the DOJ has had success in health care fraud prosecutions, but is now also faced with industry cybersecurity challenges.

Florida settlement

The U.S. has reached a settlement with nine hospitals in the Jacksonville, Florida area, as well as one ambulance company. These hospitals allegedly ordered basic life support transportation, even when it was not medically necessary. This was accomplished by providing Certificates of Medical Necessity that stated the need for basic life support. The ambulance company, Century Ambulance, allegedly up-coded claims submitted to federal health care programs from basic to advanced life support. These allegations included charges under the False Claims Act (FCA) (31 U.S.C. §3729). The settlements totaled $7.5 million.

Miami sentencing

The owner of a home health care agency in Miami, Longcare Home Health Corporation (Longcare), pleaded guilty to one count of conspiracy to commit health care fraud. Alexander Lara admitted to fraudulently billing Medicare for physical therapy and home health services. These services were either not medically necessary, or not provided. As part of the scheme, he paid kickbacks and bribes to beneficiaries in exchange for referrals, as well as patient recruiters. He also paid doctors’ offices and clinics for fraudulent prescriptions for unnecessary therapy and services. Medicare paid about $13.7 million for these fraudulent claims from January 2009 through November 2014. Lara was ordered to forfeit the amount paid and sentenced to 10 years in prison.

CVS must pay up

CVS Health settled allegations against two of its retail stores to the tune of $22 million. During an investigation as part of the DEA’s efforts to put a halt to Florida pill mills, it was discovered that these two retail locations were filling prescriptions written without regard to medical need. These prescriptions had “red flags” indicating that they were not prescribed for legitimate purposes. CVS acknowledged that the pharmacies had a responsibility to issue drugs only based on medical need, and that its retail stores also failed to completely fulfill compliance obligations under the Controlled Substances Act (21 U.S.C. §801).

California supply company owner sentenced

Across the country, a registered nurse in the Los Angeles area was sentenced to 4 years in prison for her part in a Medicare fraud scheme. Olufunke Ibiyemi Fadojutimi was convicted by a jury in July 2014 of seven counts of health care fraud, one count of conspiracy to commit health care fraud, and one count of money laundering. Fadojutimi was a registered nurse and the owner of Lutemi Medical Supply. Through the company, which was a supplier of durable medical equipment, she billed Medicare over $8 million for equipment that was not medically necessary. Between September 2003 and May 2010, the scheme involved paying kickbacks to physicians for fraudulent prescriptions and patient recruiters in exchange for referrals. Medicare paid almost $4.3 million on a total of $8.3 million in submitted claims.

Not getting off easy in the Big Easy

A New Orleans jury convicted two doctors, a nurse, and an office manager for participation in a Medicare fraud scheme. The scheme involved claiming that thousands of Medicare beneficiaries in the area required nursing and therapy home health services when the patients were actually not homebound. Medicare paid approximately $50.7 on over $56 million in mostly fraudulent claims. Nine other defendants have already pleaded guilty to their roles in the scheme. These settlements are part of the government’s focus on combating health care fraud via the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by the Departments of Justice and Health and Human Services.

DEA administrator

Chuck Rosenberg has been appointed to serve as the new DEA acting administrator. He is currently the chief of staff to the director of the FBI. In this role, he worked on issues such as counterterrorism, intelligence, and criminal investigations including cyber investigations. Previously, he served as the U.S. Attorney of the Eastern District of Virginia and the Southern District of Texas. He has also spent time working in private practice and as a federal prosecutor. Attorney General Loretta E. Lynch stated that his appointment was “well-deserved” and that she could “think of no better individual to lead this storied agency.”

New challenges in combating fraud

Assistant Attorney General Leslie R. Caldwell spoke at the American Bar Association’s 25th Annual National Institute on Health Care Fraud, highlighting the success the DOJ has had in prosecuting health care fraud over the last 25 years. She reflected on the days when law enforcement was reactive to fraud cases and waited on CMS to refer cases. Now, she said, the Medicare Fraud Strike Force is taking steps to investigate areas that are known for fraudulent billing practices, such as durable medical equipment in Miami, Florida, to identify and halt fraudulent schemes as early as possible. She also noted that as criminal attacks causing health care data breaches continue to rise, the Cybersecurity Unit is developing best practices to mitigate risk. She also requested that companies begin partnering with the unit to exchange ideas and experiences to more effectively put a stop to attacks before they happen.

Substance abuse data suppression: safeguarding privacy or hindering research?

In the United States, the use of drugs like cocaine is down, but a more socially accepted but no less dangerous type of substance abuse is persistent and widespread. It has been reported that opioids are the leading cause of drug deaths in the United States. Prescription drug abuse has become such a problem throughout the country that the Centers for Disease Control and Prevention (CDC) has stated that prescription drug overdose is an epidemic. The White House website even has a section devoted to combating prescription drug abuse. Despite the fact that the United States seems awash with substance abuse problems, the New York Times is reporting that researchers who would like to study the association between drug users and the illnesses that disproportionately affect them are thwarted because of a CMS policy that has been limiting their access to records vital to research.

In December of 2014, researchers were shocked to discover that during the prior year, HHS CMS had begun to redact Medicare records that contained any claim codes related to substances abuse diagnoses. In 2014, CMS began to do the same to Medicaid records. CMS justifies the redaction of any Medicare or Medicaid files containing substance abuse codes by citing to the confidentiality of drug and alcohol abuse patient records regulations (42 C.F.R. Sec. 2). According to CMS, “when researchers need access to more detailed claims information than that which is included in limited data set files or public use files, there is a risk that the data could be used to identify a patient receiving treatment for alcohol or drug abuse. Therefore, to ensure compliance with [Substance Abuse and Mental Health Services Administration (SAMHSA)] regulations, after gathering requested data for a researcher, CMS redacts any substance abuse related claims from the resulting research identifiable files based on codes within the claims. CMS implemented this in November 2013 for Medicare claims and March 2014 for Medicaid claims.” The records redactions impacted 7 to 8 percent of all inpatient hospital records and an estimated 4.5 percent of inpatient Medicare claims and about 8 percent of inpatient Medicaid claims.

According to a recent article in the New England Journal of Medicine, the suppression of the data has not only had a chilling effect on researcher’s work, but could also negatively impacted health care reform and the work of accountable care organizations (ACOs)and health information exchanges because the consent requirements make patient data sharing related to substance abuse problems nearly impossible. As a result, substance abuse information is removed from the records, which undermines the ability of the health care providers to improve both case and efficiency. Also, the suppression of the data may extend from its intended target because many of the withheld data relate to not to substance disorder admissions, but conditions that are made worse by substance abuse. Additionally, some have argued that the suppression of data also limits health care providers’ ability to care for patients because doctor’s offices and hospitals cannot share data on substance abuse. Therefore, a doctor may be unknowingly prescribing pain killers to an individual with a diagnosed painkiller addiction, but would have no way of knowing it due to the limitation on data. This may true even if the doctor is working with another to coordinate the patient’s care.

There may be a glimmer of hope for researchers as Politico is reporting that the suppression of data may soon be coming to an end as health officials are planning a Proposed rule that would grant researchers access to substance abuse data. Pam Hyde, Administrator for SAMHSA, reportedly stated that it is trying to grant researchers access to the data without having to wait for Congress to act to change the law: “We are having to work with the law and the regs and the lawyers about what it takes to get that and still be in line with the way the law is currently written,” she said. However, some have cautioned that excitement may be premature, as the proposed rule could be stalled at any point during the lengthy rule-making process.