Kusserow on Compliance: Breaking News: HHS OIG posts its mid-year Work Plan update

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The Office of Inspector General (OIG) has posted a mid-year update on its Fiscal Year 2015 Work Plan, effective May 2015. It is worth reviewing, as it describes audits, evaluations, and certain legal and investigative initiatives that are ongoing, as well as those deleted, completed, postponed, or canceled. The OIG has added 20 new items that have been started since October 2014. For each project in the revised Work Plan, the agency included the subject, primary objective, criteria related to the topic, identification code for the review, and when it expects reports to be issued for the review. The update also forecasted areas for which it anticipates planning and/or beginning work in the upcoming fiscal year and beyond. These broader areas of focus are based on the results of OIG’s past work and have been identified as significant management and performance challenges facing HHS.

The OIG intends to continue reviews of the appropriateness of Medicare and Medicaid payments with possible additional work on the efficiency and effectiveness of payment policies and practices in inpatient and outpatient settings, for prescription drugs, and in managed care. Other areas it has under consideration include: (1) the integrity of the food, drug, and medical device supply chains; (2) security of electronic data; (3) use and exchange of health information technology; and (4) emergency preparedness and response efforts. It also plans to continue to focus on emerging payment, eligibility, management, and information technology systems security vulnerabilities in health care reform programs, such as the Health Insurance Marketplaces, as well as care quality and access in Medicare and Medicaid.

Among the new reviews schedule for Medicare and Medicaid program are the following:

  • Medicare outpatient payments for intensity-modulated radiation therapy (IMRT);
  • Hospital preparedness and response to high-risk infectious diseases;
  • Competitive bidding on beneficiary access to durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS);
  • Payments for the top 25 clinical diagnostic laboratory tests charged to Medicare;
  • Inpatient rehabilitation facility prospective payment system (IRF PPS) compliance, including required documentation to support claims paid by Medicare;
  • Accountable care organization (ACO) Medicare Shared Savings Program (MSSP) use of electronic health records (EHRs) to achieve their care coordination goals;
  • Medicare Part D billing trends, including changes in billing for commonly used opioid drugs;
  • States’ reporting of their federal share of Medicaid rebate collections;
  • Determinations of whether generic drug prices increased more than inflation for urban consumers;
  • Drug manufacturers’ treatment of sales of generics in their calculation of average manufacturer price (AMP) for the Medicaid drug rebate program; and
  • State submissions of Transformed Medicaid Statistical Information System (T-MSIS) data.

The OIG makes it clear that the Work Plan is constantly being updated and changed according to needs and circumstances and as such it does not provide status reports on the progress of the reviews, however it does periodically update the Work Plan.

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.

Kusserow on Compliance: OIG reports on FDA generic drugs oversight and inspection

Congress requested the Office of Inspector General (OIG) conduct an evaluation of whether the FDA is achieving parity in inspections of foreign and domestic manufacturers. The expressed concern is related to the safety and quality of generic drugs produced by foreign manufacturers. Currently nearly 80 percent of all drug prescriptions filled in the United States were for generic drugs. Recalls of generic drugs in recent years have raised concerns about the adequacy of the FDA’s oversight of manufacturers, particularly those outside the United States. In their review, the OIG analyzed FDA data and conducted interviews of the staff to determine:

  • the number and types of inspections for manufacturers of generic drugs;
  • whether manufacturers listed on approved applications had registered with FDA as required; and
  • the extent to which it is progressing toward achieving parity in domestic and foreign inspections and more efficient processes for inspections.

 Findings

  • FDA has increased its preapproval inspections of manufacturers of generic drugs by 60 percent between 2011 and 2013.
  • FDA conducted surveillance inspections of all generic manufacturers that it had identified as high risk.
  • FDA also reported progress towards achieving parity in inspections of foreign and domestic manufacturers of generic drugs and ensuring compliance with generic manufacturer registration.
  • FDA did not conduct all of the preapproval inspections requested by its own generic drug application reviewers during this time period.
  • FDA has created some policies and procedures to request manufacturer records in lieu or in advance of an inspection, but has not yet used these procedures to request records

Recommendations

The FDA should:

  • conduct outstanding preapproval inspections of manufacturers of generic drugs, which could lead to more timely approval of these drugs;
  • ensure compliance with the requirements of manufacturers of generic drugs to register with FDA as a complete and up-to-date registration database that would facilitate the implementation of their plans for conducting inspections; and
  • use its authority to request records in lieu or in advance of inspections which could increase their capacity for inspections and review of records in advance, which could, in turn, free up staff time during onsite portion of inspections.

The FDA concurred with all the OIG recommendations.

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

 

 

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.

Connect with Richard Kusserow on Google+ or LinkedIn.

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

 

Kusserow on Compliance: OIG on swing beds at critical access hospitals

The OIG has issued a report that notes costs for swing bed usage at critical access hospitals (CAHs) are significantly increasing since 2005 at an average of almost four times the cost of similar services at alternative facilities. Of the 100 CAHs sampled in the OIG study, it found that 90 percent could have been provided at alternative facilities within a 35-mile radius with available skilled nursing care. The report estimated that Medicare could have saved $4.1 billion over a 6-year period if payments for swing bed services at CAHs were made using skilled nursing facility prospective payment system (SNF PPS) rates.

The OIG called for new legislation to adjust CAH swing bed reimbursement rates to the lower SNF PPS rates paid for similar services at alternative facilities. This proposal would significantly change the way rural-based hospitals are reimbursed for care provided in post-acute care swing beds. The OIG further recommended that the agency switch CAH reimbursement to the SNF prospective payment rate as soon as possible. CMS agreed with the OIG findings that CAH’s swing bed utilization has increased, but not necessarily the calculations of savings. CMS also disagreed with the OIG recommendation for a legislative solution because of concerns about the availability of skilled nursing services at nearby alternative facilities.

It did not take long for those representing the affected parties to line up behind CMS and oppose the changes promoted by the OIG. Leading the pack was the American Hospital Association (AHA), who quickly weighed in on the issue, echoed CMS concerns, and noted as such in a published statement. The AHA said it “continue(s) to strongly advocate for maintaining the CAH program as it is currently structured in order to help ensure that all patients in rural communities have access to health care.”

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