Compliance program effectiveness requires annual measurement of risks and identification of trends

Annual measurement and proactive evaluation of program elements and risks through reports and metrics is necessary to routinely determine the effectiveness of a compliance program, according to Bret S. Bissey, Senior Vice President, Compliance Services MediTract. Bissey presented practical suggestions and best practices for evaluating a compliance program in a webinar sponsored by the Health Care Compliance Association (HCCA) on March 21, 2017.

Guidance

Bissey noted specific guidance that compliance officers should refer to when evaluating their compliance programs, Office of Inspector General (OIG) Compliance Program Guidance for Hospitals, OIG Supplemental Compliance Program Guidance for Hospitals and the Department of Justice’s (DOJ’s) Compliance Program Guidance on Evaluation of Corporate Compliance Programs published in February 2017. Bissey pointed out that the OIG guidance recommends benchmarking compliance program progress and provides two examples, claims processing evaluation and surveys. Claims processing evaluation requires a benchmark for error rates and standards that include sample size net dollar value, and consistency of universe.

Although not specific to the health care industry, the DOJ guidance identifies elements that can be used to evaluate a compliance program. The guidance consists of compliance-focused questions that the DOJ Fraud Division might consider when evaluating a corporate compliance program, including such topics as analysis and remediation of underlying misconduct, conduct of senior and middle management, autonomy of the compliance function, and compliance program funding and resources.

Surveys to measure effectiveness

Bissey stressed the importance of measuring organizational compliance culture to provide evidence of the effectiveness of the compliance program. He said that surveys can provide evidence of program effectiveness and recommended using surveys to measure covered persons’ attitudes regarding the organization’s commitment to compliance. Through surveys compliance officers can determine how well the operations of the compliance program are understood and the obligations of the people involved. Surveys and questionnaires are important to measure whether organizational culture encourages ethical conduct and a commitment to compliance with the law. Surveys also should be used to measure employee compliance knowledge. He added that both types of surveys allow the compliance professional to benchmark and measure compliance effectiveness over time.

Elements of evaluations

To begin to evaluate compliance performance, Bissey emphasized the importance of measurement and defining expectations of performance. He suggested identifying a set number of elements, some of which should be kept from year to year to measure trends. Compliance officers should identify metrics that are available, develop a score card, and report achievements, including any reasons for variance and year to year comparison of results. Trending data is the key, he said.

Bissey identified the following elements with suggested standards to consider in an evaluation:

  • hotline calls, including logging, investigations, disciplinary action;
  • education provided to staff, physicians, board of directors, and executives; establish standards for different groups and obtain board support;
  • audit/monitoring results; potential areas of trending coding and billing results; including consistent measurement, annual reviews, random samples, and net dollar value error rate;
  • potential areas of trending billing and coding results, including short stays, observation, evaluation and management, research billing, diagnosis related groups;
  • audit benchmarking scorecard, can be part of annual review and built into the work plan;
  • annual audit work plan completion based on an approved annual work plan by the compliance committee or board; use trends to explain need for resources and make future plans;
  • budget analytic, identify trends of budget and actual expenses over several years; and
  • other data points to trend year to year, such as focus arrangements, payments made to nonemployed physicians without evidence of time and effort for approval, quality improvement.

Other considerations

Bissey stressed the importance of the independence of the chief compliance officer independence as well as ensuring that the chief compliance officer has the knowledge and experience necessary for the role. Finally, Bissey recommended that the organization consider an independent external review at some predetermined interval of time such as every two or three years.

Gatekeeping vital to a best practice organization

Gatekeeping should be viewed as a first line of defense, protecting not only a healthcare organization, but the patients as well. In a Health Care Compliance Association (HCCA) webinar titled “Gatekeeping & Monitoring – Developing Sound Processes for Screening, Removal & Reinstatement,” Amy Andersen, Director of Operations at Verisys Corp., noted that every organization can be sorted to a risk aversion spectrum. On one end, the most risk-averse organizations use best practice compliance to achieve stellar outcomes. On the other end, non-compliant organizations risk fines and loss of reputations. The greatest cost to organizations in terms of monetary impact to establish gatekeeping measures is the change management and system implementation. Regardless, best practices organizations need to be proactive about gatekeeping and monitoring, not after the fact.

Gatekeepers

The best way to protect organizations is to implement a gatekeeping strategy. Gatekeeping is ensuring that information is properly disseminated among an organization and its association. Thus, the first consideration for an organization is which parties are being let into the organization. Organizations should not only focus on the healthcare professionals within their organizations, but the vendors and contractors employed by the organization. Andersen noted that the vendor space was one of the most overlooked areas in protecting an organization.

Secondly, once an organization permits vendors or individuals into the organization, it must readily identify any gaps. In essence, Andersen said that the organization should understand what it knows and does not know about the admitted vendor or individual.

Finally, the organization should establish criteria for admittance of these vendors or individuals. Thus, an organization’s gatekeeping strategy should include three parts: (1) identification, (2) communication, and (3) remediation.

Identification, communication, and remediation

At a most basic level, identification starts with screening and monitoring. Some barriers to gatekeeping include data “hoarders,” those entities who do not share what they know or require you to go through a gate itself. These entities can be threats to the organization.

Andersen advised that organizations should examine and avoid unconsidered risks. In terms of credentialing, Andersen stressed “verify, verify, verify.” These risks are created when an organization silos information within itself. She cautioned against this, noting that organizations should do holistic reviews to determine whether the departments within the organization are communicating any risks effectively.

Access to information is vital. Once identification generates data for the organization, relevant information must be made visible. After policy and procedure access occurs, the organization must take action in a consistent manner. This is includes removal of individuals from the organization or vendor from a business relationship, expectations should be laid out clearly. Any auditing that is done should be unbiased and adhere to industry standards.

Will the AHCA affect Medicaid’s nonelderly adults with disabilities?

The changes to Medicaid under the American Health Care Act (AHCA), as approved by the House Energy and Commerce Committee, carries potential implications for the nearly seven million nonelderly adults with disabilities currently covered under Medicaid, according to a Kaiser Family Foundation (KFF) issue brief. KFF’s issue brief describes how the AHCA would change Medicaid and offers insight on its potential effect upon nonelderly adults with disabilities by examining the type of insurance nonelderly adults with disabilities have, how they qualify for Medicaid, what their characteristics are, what services they receive from Medicaid, and how much Medicaid spends on the disabled.

The AHCA would change Medicaid in three major ways: (1) it would change Medicaid’s financing structure to a per capita cap, resulting in an estimated $880 billion reduction in federal Medicaid spending from 2017 to 2026, according to the Congressional Budget Office (CBO cost estimate of AHCA) (see CBO: Republican plan saves billions as 24M lose coverage, Health Law Daily, March 14, 2017); (2) it would repeal the enhanced federal matching funds for Patient Protection and Affordable Care Act’s (ACA, section 2001) (P.L. 111-148) enrollees as of January 1, 2020, except for those enrolled by December 31, 2019, who do not have a break in eligibility of more than one month; and (3) it would end the enhanced federal matching funds for Community First Choice (CFC) (ACA, section 2401), which provides attendant care services for people with disabilities, as of January 1, 2020 (see ‘American Health Care Act’ earns first stamp of approval, Health Law Daily, March 9, 2017).

Here is a summary of the KFF findings:

  • Type of health insurance. Thirty-six percent of nonelderly adults with disabilities are working for pay compared to 77 percent of those without disabilities. Among those who are working, 64 percent have access to employer-sponsored health insurance, compared to 68 percent of nondisabled workers. Thirty-one percent of nonelderly adults with disabilities have Medicaid, compared to 10 percent of those without disabilities. Only 41 percent have private insurance, compared to 74 percent of those without disabilities.
  • How do they qualify for Medicaid? KFF found that some nonelderly adults with disabilities are eligible for Medicaid through the ACA’s Medicaid expansion and some through a disability-related pathway based on both their low income and functional limitations.
  • Nearly 85 percent of nonelderly adults with disabilities have incomes below 200 percent of the federal poverty level (FPL) ($24,120 per year for an individual in 2017). Fifty-seven percent are white, 23 percent black, 16 percent Hispanic, and 3 percent Asian. About one-third of those enrolled in Medicaid have three or more functional limitations, which is more than two and one-half times the rate for those disabled who are privately insured and more than double the rate of those who are uninsured.
  • What services do they receive from Medicaid? Through Medicaid, nonelderly adults with disabilities have access to regular preventive care as well as medical care for illnesses and chronic conditions. States must provide certain minimum services for adults, such as inpatient and outpatient hospital, physician, lab and x-ray, and nursing home services. States also can choose to provide a broad range of optional services, including prescription drugs, physical therapy, private duty nursing, personal care, rehabilitative services, and case management. Most home and community-based services (HCBS) are also provided at the option of the state.
  • ACA expansion options. Section 2001 of the ACA offered states the option to expand Medicaid to nearly all nonelderly adults with income up to 138 percent of the FPL. As of 2017, 32 states have adopted the expansion. Section 2401 of the ACA created the CFC option to provide attendant care services and supports with a 6 percent enhanced federal matching funds. Eight states elected this option as of 2016. Section 2402 of the ACA also allowed states (17 as of 2015) to offer HCBS through the section 1915(i) option ( Sec. Act §1915(i)), which allows states to serve people with functional limitations that do not yet rise to an institutional level of care. Section 2703 of the ACA also created the Medicaid health homes option, which enables states (22 as of 2016) to provide care coordination services for people with chronic conditions at a 90 percent enhanced federal match for the first two years.
  • How much does Medicaid spend on people with disabilities? As of 2011, people with disabilities accounted for 15 percent of total Medicaid enrollment but 42 percent of program spending. Per enrollee spending for people with disabilities totaled $16,643 in 2011, more than five times higher than for adults without disabilities ($3,247) and nearly seven times higher than for children without disabilities ($2,463). One-half of states spend between $15,000 and $19,999 per enrollee for people with disabilities, and another third of states spend between $20,000 and $34,999 per enrollee for people with disabilities.

KFF believes that the AHCA’s per capita cap and elimination of the enhanced federal financing under the ACA expansion will put the states under budgetary pressures due to a reduction in Medicaid funds. It believes that these budgetary pressures may result in the limitation of Medicaid services for recipients, including the nonelderly disabled. KFF believes that careful consideration of the AHCA implications is warranted.

Opioid painkiller benefits fall short of abuse risks

The benefits derived from the use of Endo International Plc’s opioid drug no longer outweighs its risks, according to an FDA advisory panel. As opioid abuse, overdose and addiction have reached epidemic proportions in the United States, partly due to unrestricted prescription of narcotic painkillers, as well as the paucity of access to substance-abuse treatment programs, the FDA has undertaken review of the uses of the painkiller in a variety of settings. Eighteen panelists recommended that the risks of the reformulation eclipse the benefits, while eight disagreed and one member abstained from voting. The FDA generally follows advisory panel recommendations, but is not required to do so.

The FDA advisory panel reviewed the abuse rate of Endo’s Opana® ER – a long acting painkiller similar to oxymorphine and other oxymorphone drugs. Opana was approved in 2006, and in 2012, the drug maker introduced a new formulation to attempt to deter abuse of the drug. Although the reformulation (in nasal form) reduced abuse rates, intravenous abuse increased in the same timeframe. The panel was unable to conclude whether this rise was related to the reformulation, but noted that the trend was observed before the reformulation. Additionally, abuse rates for similar oxymorphone drugs are as high as Opana.

One factor that triggered the advisory panel’s review was the increased rate of rare blood disorders and human immunodeficiency virus (HIV) linked to the IV abuse of the reformulation.

Some advisory panel members expressed concerns that the voting question posed did not permit consideration of the risk-benefit profile for an intended user versus use by an addict. Others questioned whether withdrawing the product would stop an addict from abusing other opioids, or whether oxymorphone was still an integral part of the arsenal of treatments for chronic pain.