This week, the OIG published its Mid-Year Update to its 2015 Work Plan, which we previously summarized. The Mid-Year Update adds several new monitoring activities to the existing Work Plan, summarized below.

  • review of financial interests reported under the Sunshine Act: The OIG plans to review the number and nature of financial interests that were reported to CMS under the Sunshine Act’s Open Payments Program. More specifically, the OIG plans to review the extent to which CMS oversees compliance with data reporting requirements and whether the required data for physician and teaching hospital payments is accurately displayed in the public database. The Affordable Care Act (ACA) requires that manufacturers disclose to CMS payments made to physicians and teaching hospitals. Manufacturers and group purchasing organizations (GPOs) must also report physician ownership and investment interests.
  • inpatient rehabilitation facility payment system requirements (IRF PPS): The OIG plans to review compliance with the IRF PPS, including the documentation required to support claims paid by Medicare. IRFs provide rehabilitation for patients who require an inpatient hospital-based interdisciplinary rehabilitation program, supervised by a rehabilitation physician. Discharges occurring on or after January 1, 2010 must meet all documentation and coverage requirements to ensure that IRF services are “reasonable and necessary.”
  • FDA’s monitoring of imported food recalls: The OIG plans to review FDA’s monitoring of imported food recalls. The audit will determine the extent to which FDA has implemented the Food Safety and Modernization Act (FSMA) regarding the recall of food products and whether it has an effective recall process in place to ensure food safety.
  • treatment of authorized generic drugs: The OIG will review drug manufacturers’ treatment of sales of authorized generics in their calculation of Average Manufacturer Price (AMP) for the Medicaid drug rebate program. Specifically, the OIG plans to examine whether manufacturers included sales of authorized generics to secondary manufacturers in their AMP calculations. The OIG is concerned that manufacturers that also include the sales of an authorized generic to a secondary manufacturer “could lower AMP and consequently a lower rebate to be paid to the State.”
  • annual analysis of Medicare clinical laboratory payments: The OIG plans to analyze Medicare payments for clinical diagnostic lab tests, including the top 25 clinical diagnostic lab tests by Medicare expenditures in 2014. Previous OIG work has found that Medicare pays more than other insurers for certain high-volume and high-expenditure lab tests.
  • review of federally funded grants: The OIG announced plans to examine the extent to which certain grant awards are managed in accordance the award requirements. Specifically, the OIG plans to review (1) the National Institute of Environmental Health Sciences’ (NIEHS) Funding for Bisphenol A safety research; (2) President’s Emergency Plan for AIDS Relief fund; (3) HRSA Maternal, Infant, and Early Childhood Home Visiting grants.
  • review of the National Institute of Environmental Health Sciences’ (NIEHS) Funding for Bisphenol A safety research: The OIG plans to determine the extent to which NIEHS has funded research on the safety of BPA and whether NIEHS followed its grant application processes related to peer review when awarding funds for BPA research. BPA is a chemical used primarily in the production of polycarbonate plastics used in food and drink packaging that may leach into food or drink and be consumed by humans.
  • grantee’s use of President’s Emergency Plan for AIDS Relief fund (PEPFAR): The OIG plans to examine whether selected foreign grantees managed PEPFAR funds in accordance with the grant requirements. The OIG plans to assist the DOJ in developing and pursuing Federal False Claims Act (FCA) cases against institutions that receive grants from NIH and other public health agencies.
  • state agency oversight of HRSA Maternal, Infant, and Early Childhood Home Visiting grants: The OIG plans to review selected states’ controls to monitor and report on Maternal, Infant, and Early Childhood Home Visiting program grant activities. The ACA provided $1.5 billion over 5 years for states and nonprofits to provide evidence-based home visiting programs to promote improvement in maternal and newborn health; prevention of child injuries, child abuse, neglect, or maltreatment; reduction of emergency department visits; improvement in school readiness and achievement; reduction in crime or domestic violence; improvements in family economic self-sufficiency; and improvement in coordination and referrals for other community resources and supports.
  • intensity-modulated radiation therapy (IMRT) payments: The OIG plans to review Medicare outpatient payments for IMRT services to determine whether the payments were made in accordance with federal rules and regulations. Prior OIG reviews have identified hospitals that have incorrectly billed for IMRT services, including services performed as part of developing an IMRT plan.
  • billing trends for Part D drugs and commonly abused opioids: The OIG plans to evaluate trends in Part D billing from 2006 to 2014, including changes in billing for commonly used opioid drugs. The OIG reports that there has been a significant increase in Part D fraud.
  • access to durable medical equipment in competitive bidding areas: The OIG will determine the effects of the competitive bidding program on Medicare beneficiaries’ access to certain types of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). In an effort to reduce waste, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) updated Medicare’s payment system for certain DMEPOS from a fee schedule to a competitive bidding program. This program allows DMEPOS suppliers compete on price to supply to particular geographic areas. According to the OIG, anecdotal reports allege that competitive bidding has led to reduced access to DMEPOS for government beneficiaries.
  • Part D oversight portfolio: The OIG plans to summarize OIG audits, evaluations, legal opinions, and investigative work on Medicare Part D and provide recommendations to improve CMS, Plan Sponsors, and MEDIC oversight of the Part D program.
  • analysis of generic price increases compared to price index: The OIG plans to analyze generic drug prices over a period of time to determine whether prices increased more than the increases in inflation as measured by the consumer price index for urban consumers (CPI-U). Under the Medicaid drug rebate program, manufacturers are required to pay an additional rebate when the AMP for a brand-name drug increases more than the CPI-U increases.
  • federal share of manufacturer rebates: The OIG plans to review states’ reporting of the federal share of Medicaid rebate collections to determine whether states are correctly identifying and reporting the increases in rebate collections.
  • use of electronic health records to support care coordination through Accountable Care Organizations (ACOs): The OIG plans to review the extent that providers participating in ACOs in the Medicare Shared Savings Program use of electronic health records to exchange health information to achieve their care coordination goals.
  • hospital preparedness and response to high-risk infectious diseases: The OIG plans to analyze hospitals’ efforts to prepare for the possibility of public health emergencies resulting from infectious diseases. The OIG is looking to identify lessons learned from recent experiences with pandemics or highly-contagious diseases, such as Ebola.

*Savannah Wiseman is admitted only in Texas. Practice supervised by principals of the firm admitted in the District of Columbia.