The HHS Office of Inspector General (OIG) annually reviews risks in HHS programs, including the Medicare and Medicaid programs and implementation of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148), and creates a Work Plan setting its priorities for the next year. The 2017 Work Plan, published in November 2016, provides information about the OIG’s ongoing activities, including the areas it is planning to pay attention to in the coming year. The OIG considers mandatory requirements, requests made or concerns raised by Congress, HHS’ top management and performance challenges list; and other factors as it determines its priorities each year. The OIG identified Medicare Part A and Part B as its top priority, giving hospitals, physicians, and compliance officers a way to prepare for the agency’s upcoming scrutiny. The OIG also discussed the importance of electronic health record (EHR) security, reminded Medicare and Medicaid participants of the usefulness of the self-disclosure protocol, and reiterated a continued focus on compounding facilities (see Focus remains on Medicare, Medicaid payments in 2017 OIG Work Plan, November 10, 2016).
This Strategic Perspective reviews five major aspects of the 2017 Work Plan that will affect health care providers, with input from Wolters Kluwer contributor Richard P. Kusserow, former HHS Inspector General and chief executive officer of Strategic Management Services, LLC. It also includes information presented in three Health Care Compliance Association (HCCA) webinars on the OIG Work Plan—Home Health and Hospice, presented by Bill Musick, Senior Associate & Consulting Projects Manager, Corridor Group; Part B Physicians and Non-physician Providers, presented by Margaret Hambleton, Vice President and Corporate Compliance Officer, Dignity Health, Dawnese Kindelt, Senior Compliance Director, Dignity Health, and Cynthia Swanson, Senior Manager, Seim Johnson; and Hospitals, presented by Hambleton and Lea Fourkiller, Chief Compliance Officer, Conifer Health Solutions.
1. OIG Priorities Inform Compliance Planning
According to the Work Plan, the OIG’s biggest priority remains Medicare Part A and Part B. The Work Plan lists 15 activities completed in 2016 and adds 24 new activities; of the incomplete activities, five were revised and five removed. The next largest area of concern for the OIG is Medicaid. The OIG completed six activities in 2016 and listed nine new ones. Far behind risks identified for review under Part A and Part B, are Medicare Part C and Part D, with two activities completed, one revised, and five new; the ACA, with two completed and two revised activities but no new ones; and EHR, with two completed activities and no new or revised.
Musick recommends that health care providers, compliance officers, and health attorneys review the Work Plan to see what the OIG will prioritize and plan accordingly for additional scrutiny or barriers. However, Hambleton, Kindelt, and Johnson cautioned against reading only the sections of the Work Plan that may apply specifically to a single provider or organization—familiarity with the entire Work Plan can help prevent surprises and ensure effectiveness of compliance programs, adding that the Work Plan should be viewed as a starting point to staying current on health care changes and related compliance issues. Kusserow explained that the Work Plan is published, in part, to encourage health care entities to examine and improve their programs.
2. Medicare Parts A & B Are Expensive and Challenging
The OIG identified HHS’ main performance challenge as ensuring program integrity for Medicare Part A and Part B. Spending is significantly increasing as the U.S. population ages and per capita health care costs rise. Although the Health Care Fraud and Abuse Control Program has been successful at fighting fraud and recovering some lost funds, improper payments under Part A and Part B account for billions of dollars annually. HHS and the OIG are specifically looking at personal care services due to common characteristics in many fraudulent cases. Musick noted that such cases lead to patient harm. He recommends screening standards that include background checks and determining whether additional controls are needed. Similarly, Hambleton and Fourkiller warned that disproportionate share hospitals will face scrutiny over incorrect medical assistance days claimed, and inpatient psychiatric facilities should expect inquiries into increased outlier payment claims. The OIG regularly makes recommendations to improve program integrity, but notes in the Work Plan that many of its findings have not been acted upon, and many suggestions have not been implemented.
When President-elect Donald J. Trump (R) announced his candidacy in June 2015, he spoke of removing fraud and abuse from the Medicare program while not making any cuts to coverage, saying "Save Medicare, Medicaid and Social Security without cuts. Have to do it. Get rid of the fraud. Get rid of the waste and abuse, but save it. People have been paying it for years. And now many of these candidates want to cut it. You save it by making the United States, by making us rich again, by taking back all of the money that’s being lost." The ACA, which Trump has promised to repeal, extended the solvency of the Medicare Trust Funds, however, and included provisions to reduce fraud, such as the 60-day overpayment return rule. It is unknown whether Trump will repeal such provisions or find a way to continue these programs.
3. EHR Security Issues Are Here to Stay
CMS has made more than $30 billion in incentive payments through the Medicare and Medicaid EHR incentive programs. The security of EHR is a major concern for HHS and the OIG as cyberattacks against government agencies and "soft targets" like health care providers climb. The OIG will be fighting against fraud in the EHR incentive programs, as well as ensuring the privacy and security of information. The ubiquity of mobile devices adds another layer to cybersecurity, and the OIG recognizes that significant challenges exist with respect to health information technology (IT) adoption. The OIG will focus on the meaningful use of health IT, including interoperability across providers, across HHS, and between providers and patients.
4. Self-Disclosure Saves Time and Money
The Work Plan reports on the OIG’s CMS-related legal activities, including litigation of program exclusions and civil monetary penalties (CMPs) and assessments, negotiation and monitoring of corporate integrity agreements (CIAs), and other activities. Within that capacity, the OIG continues to encourage providers to promptly disclose conduct that violates or may violate the requirements of participation in the federal health care programs. In the first half of 2016, the OIG reported recoveries of nearly $50 million from self-disclosures. Kusserow noted that the self-disclosure protocol is particularly useful for organizations with "effective" compliance programs, due to the ACA’s mandate to disclose and return an overpayment within 60 days after identification or the date any corresponding cost report is due, whichever is later. He reminded providers that the OIG leaves it to the provider to ensure the conduct ended at the time of disclosure, or that corrective action is undertaken within 90 days of submission to the protocol, and stated that damage estimation is a particularly critical step in the self-disclosure process. For violating participation requirements, providers face exclusions from federal health programs, CMPs, CIAs, and False Claims Act investigations. According to the OIG, the Provider Self-Disclosure Protocol gives providers an opportunity to minimize the potential costs of a full-scale OIG audit or investigation, to negotiate a fair monetary settlement, and to potentially avoid being excluded from participation.
5. Compounding Facilities Remain Under Scrutiny
Drug compounding, the process by which a pharmacist combines, mixes, or alters ingredients to create a tailor-made drug to address the medical needs of an individual patient, is a traditional component of pharmaceutical practice. The drug compounding industry has shifted from compounding one prescription treatment for one patient to compounding large quantities in anticipation of future prescriptions for multiple patients. The Work Plan says that the OIG is studying hospitals’ increased reliance on compounding facilities, and plans to determine the extent to which compounders that produce compounded sterile preparations without a patient-specific prescription have registered with the FDA.
The OIG, now in its 40th year, has big plans for ensuring the integrity of HHS’ programs, including those related to the Medicare and Medicaid programs, EHR and health IT, and the safety of the nation’s food and drugs. It is charged with overseeing 25 percent of the federal government’s spending, amounting to $1 billion, and plans to continue its efforts to guarantee that fraud and abuse are minimized while keeping HHS efficient and effective. The Work Plan provides a road map for how the OIG will accomplish its goals; therefore, it should be studied by stakeholders to assist in compliance.
Companies: Strategic Management Services, LLC; Health Care Compliance Association; Corridor Group; Dignity Health; Seim Johnson; Conifer Health Solutions, Inc.
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