The Department of Health and Human Services Office of Inspector General recently released its 2015 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’s job is to detect fraud, waste, and abuse; identify opportunities to improve healthcare program economy; and to hold “accountable those who do not meet program requirements or who violate 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 in planning internal audits and in training.
OIG states that in 2015 and beyond they will continue to focus on a number of areas, which broadly include:
- Security vulnerabilities in healthcare reform programs, such as the insurance marketplaces.
- Care quality and access in Medicare and Medicaid, as well as on public health and human services programs.
- The appropriateness of Medicare and Medicaid payments, including the efficiency and effectiveness of payment policies in inpatient and outpatient settings, for prescription drugs, and in managed care.
- The integrity of the food, drug, and medical device supply chains
- The security of electronic data
- The use and exchange of health information technology
- Emergency preparedness and response efforts.
Like in previous Work Plans, the 2015 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 2014 Work Plan again appear in the 2015 version. This list outlines new issues in the 2015 Work Plan, as well as certain carryovers from the 2014.
Hospitals
OIG noted a long list of priorities for hospitals in 2015, many of which are continuations from the 2014 Work Plan. The Plan places a priority on reconciliation of outlier payments and new inpatient admission criteria, which implicates the “two midnight policy.”
OIG also will review Medicare costs associated with defective medical devices. OIG “will review Medicare claims to identify the costs resulting from additional use of medical services associated with defective medical devices and determine the impact of the cost on the Medicare Trust Fund.”
OIG stresses that they will oversee pharmaceutical compounding in hospitals. “Most hospitals compound at least some pharmaceuticals onsite,” OIG notes. “Medicare oversees the safety of pharmaceuticals compounded at Medicare-participating hospitals through the accreditation and certification process. This work is particularly important in view of a 2012 meningitis outbreak resulting from contaminated injections of compounded drugs.”
OIG also will review provider data in the education context, specifically “duplicate graduate medical education payments,” and “indirect medical education payments.” On the latter point, OIG states: “Prior OIG reviews have determined that hospitals have received excess reimbursement for IME costs.” They plan to “review provider data to determine whether hospitals’ IME payments were made in accordance with Federal regulations and guidelines. We will determine whether the IME payments were calculated properly.”
The Plan also states that OIG will examine adverse events in post-acute care for beneficiaries in both inpatient rehabilitation facilities as well as in long term care facilities.
Medical Equipment and Supplies
The OIG will determine 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. They also promise to review the process CMS uses to conduct competitive bidding and to make subsequent pricing determinations for medical equipment items and services in selected competitive bidding areas under Rounds 1 and 2 of the competitive bidding program. OIG will examine the payments and billing of power mobility devices, including whether the requirement for a face-to-face meeting was met, as well as the billing for prosthetic limbs, nebulizer treatments, diabetes kits, and “frequently replaced supplies.”
Laboratory Billing
In the Work Plan, OIG provides a new priority to the list: they will review Medicare payments to independent clinical laboratories to determine laboratories’ compliance with selected billing requirements. The results of the reviews will be used to identify clinical laboratories that routinely submit improper claims. “Prior OIG audits, investigations and inspections have identified independent clinical laboratory areas at risk for noncompliance with Medicare billing requirements,” states OIG. “Payments to service providers are precluded unless the provider has, and furnishes upon request, the information necessary to determine the amounts due.”
Prescription Drugs
In 2015, OIG will also continue to examine prescription drugs. The note priority areas will be “comparisons of average sales prices to average manufacturer prices, as well as other pay policies. They will also “determine the extent to which publishers of authoritative prescription drug compendia recognized by CMS have publicly transparent processes for evaluating anticancer drug therapies and identifying conflicts of interest related to the therapies included in the compendia.”
In the Part D, Prescription Drug space, OIG adds another conflict of interest piece. OIG will determine “what steps CMS has taken to improve its oversight of Part D sponsors’ Pharmacy and Therapeutics (P&T) Committee conflict of interest procedures.” According to the report, “Federal law and regulations require Medicare Part D P&T committees to make prescription drug coverage decisions on the basis of scientific evidence and standards of practice. To comply with the law, Part D sponsors’ P&T committees must prevent conflicts of interest from influencing members to give preference to certain drugs.”
Also new to the list, OIG states that they will examine state collection of rebates for drugs dispensed to Medicaid managed care organization enrollees.
Accountable Care Organization
This year, OIG will also plan to conduct a risk assessment of the internal controls over CMS administration of the Pioneer Accountable Care Organization (ACO) Model.
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 provide meaningful advice on statutes in specific factual situations. OIG also issues special fraud alerts and advisory bulletins about practices that they determine are suspect. Examples are available on OIG’s Web site at:
- Advisory Opinions: http://oig.hhs.gov/fraud/advisoryopinions.asp
- Fraud Alerts: http://oig.hhs.gov/compliance/alerts/index.asp
- Compliance Guidance: http://oig.hhs.gov/fraud/complianceguidance.asp
- Open Letters: http://oig.hhs.gov/fraud/openletters.asp
- Other Guidance: http://oig.hhs.gov/compliance/alerts/guidance/index.asp
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Importantly, this article only addresses a handful of the issues OIG seeks to address in the coming year.
On Thursday (12/18) we will outline OIG’s plans regarding oversight of the Food and Drug Administration.