The Department of Health and Human Services Office of Inspector General recently released its 2016 Work Plan. OIG’s annual Work Plan summarizes new and ongoing reviews and activities that OIG plans to pursue with respect to HHS programs and operations during the current fiscal year and beyond.
The OIG was created to detect fraud, waste, and abuse; to identify opportunities to improve healthcare program economy; and to hold “accountable those who do not meet program requirements or who violated Federal health care laws.” The OIG conducts audits and investigation, and can impose civil monetary penalties where appropriate, so their Work Plan is often of great interest to those working with Federal healthcare programs. As a summary of some of the OIG’s current enforcement initiatives, the Work Plan can serve as a useful resource for companies to use in planning internal audits and in training.
Similar to previous Work Plans, the 2016 Plan covers a broad array of projects related to CMS programs, organized by type of provider and federal reimbursement scheme. Of note, many of OIG’s focal points from their 2015 Work Plan again appear in the 2016 version. This list outlines new issues in the 2016 Work Plan, as well as certain carryovers from the 2015 Plan.
Hospitals
OIG once again listed an extensive list of priorities for hospitals in 2016, many of which are continuations from the 2015 Work Plan. The Plan places a priority on the reconciliation of outlier payments and new inpatient admission criteria, which implicates the “two midnight policy.”
OIG once again stated that they would make reviewing Medicare costs associated with defective medical devices a priority. They will review Medicare claims to identify the impact on beneficiary safety and quality of care, as well as the costs to Medicare, resulting from additional use of medical services associated with defective medical devices. OIG will focus on making a determination of a reasonable means of tracking services from the recall of the medical devices in question.
This year, the OIG added a new priority for determining whether Medicare payments for replaced medical devices were made in accordance with Medicare requirements. Per federal regulations, the replacement of implanted devices requires reductions in Medicare payments, and prior OIG reviews have determined that MACs have made improper payments to hospitals for inpatient and outpatient claims for replaced medical devices.
Medical Equipment and Supplies
A new priority for this year is determining whether potential savings can be achieved by Medicare and its beneficiaries if osteogenesis stimulators are rented over a 13-month period rather than acquired through a lump-sum purchase. This priority is in addition to a continuation of a previous priority of determining whether potential savings can be achieved by Medicare if certain power mobility devices are rented over a 13-month period rather than acquired through a lump-sum purchase.
Prescription Drugs
OIG revised their priorities for Part B payments for drugs purchased under the 340B program. OIG will determine the financial impact on 340B-covered entities, the Medicare program, and Medicaid beneficiaries of three different shared savings arrangements that would enable Medicare and its beneficiaries to share in the cost savings resulting from 340B discounts. Previous OIG work found that some Medicare payments to providers for 340B-purchased drugs substantially exceeded the providers’ costs. Policymakers have questioned whether some of the savings mandated through the 340B Program should be passed on to Medicare and its beneficiaries.
OIG will also continue to review the oversight actions that CMS and its claims processing contractors take to ensure that payments for Part B drugs meet the appropriate coverage criteria and identify challenges that contractors face when making coverage decisions for drugs.
Medicare Part D – Prescription Drug Program
As a new priority for this year, HHS OIG will focus on Medicare Part D beneficiaries’ exposure to inappropriate drugs pairs. OIG will do this by determining whether Medicare Part D beneficiaries are being prescribed drugs that should not be prescribed in combination with other drugs, including drugs that have a severe interaction when used in combination with other drugs and drugs that should not be co-prescribed with component drugs.
OIG is revising their priority of reviewing financial interests reported under the Open Payments Plan. OIG will determine the number and nature of financial interests that were reported to CMS under the Open Payments Program and will also determine the extent to which CMS oversees manufacturers’ and GPOs’ compliance with data reporting requirements and whether the required data for physician and teaching hospital payments are valid.
Another new priority this year is evaluating the extent to which pharmacy reimbursement for brand-name drugs under Medicare Part D changed between 2010 and 2014 and comparing the rate of change in pharmacy reimbursement for brand name drugs under Medicare Part D to the rate of inflation for the same period.
False Claims Act Cases and Corporate Integrity Agreements
When adequate evidence of violations exists, OIG staff works closely with prosecutors from the DOJ to develop and pursue federal False Claims Act cases against both individuals and entities that defraud the government. OIG determines whether to invoke their exclusion authority on the basis of the defendant’s conduct.
Providers’ Compliance with Corporate Integrity Agreements
OIG often negotiates compliance obligations with health care providers as part of the settlement of Federal health care program investigations arising under false claims statutes and review a variety of types of information submitted by providers to determine whether their compliance mechanisms are appropriate and identify problems and establish a basis for corrective action.
Important Advisory Opinions and Other Industry Guidance
OIG responds to requests for formal advisory opinions on applying the anti-kickback statute and other fraud and abuse statutes to specific business arrangements or practices. Advisory opinions can provide meaningful advice on statutes as they relate to specific factual situations. OIG also issues special fraud alerts and advisory bulletins about practices that they determine are suspect. Examples are found on OIG’s website at:
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Importantly, this article only addresses a handful of the issues OIG seeks to address in the coming year.