Find a friendly format to ensure compliance guidance is followed

Modify the HHS Office of Inspector General (OIG) Compliance Program Guidance (CPG) documents so they make more sense and will be followed by the organization, according to Frank Ruelas, Facility Compliance Professional at St. Joseph’s Hospital and Medical Center/Dignity Health, during a webinar hosted by the Health Care Compliance Association (HCCA).CPGs, particularly for hospitals, provide valuable guidance for compliance professionals to follow in assessing their compliance programs and can be used by compliance officers of all types of facilities. The key is to make sure some sort of guidance is being followed and that assessments are verifiable.

Making use of the CPG

CPGs provide valuable information but few people read them and follow them, according to Ruelas. The problem is often that the original format of the OIG CPGs, from the Federal Register, is hard to read and navigate. Ruelas suggests taking the “text” format document from the Federal Register website and reformatting it into a “friendlier” format to help drive effectiveness. The revised format could contain a table of contents (to act as an inventory or checklist), hyperlinks to resources, headings, and anything else that would make the document more useable to perform an assessment of the organization’s compliance program.

When it comes to using the reformatted document to perform an assessment, Ruelas suggests going through and highlighting each action item contained in the CPG in one of three colors: green (acceptable demonstrated compliance), yellow (some demonstrated compliance), or red/pink (no demonstrated compliance. This will demonstrate the level of compliance and will easily show which items need additional attention. Ruelas stressed the importance of self-assessments being verifiable. Compliance officers must be able to show how he or she reached their assessment, right down to each item.

Just how many elements are there?

Ruelas warns that depending on which guidance you are following, the elements may vary slightly. The OIG has seven elements in a compliance program. The Affordable Care Act (ACA) (P.L. 111-148) and the Federal Sentencing Guidelines have eight and nine elements, respectively, but most elements overlap. All guidances are applicable, and no matter which framework you use—there is no established framework—it provides instructions on how to move forward to make your compliance program more effective, Ruelas noted.

How to get started

Ruelas stressed the importance of a supportive mindset when assessing an organization’s level of compliance. It could be that a compliance officer is coming into an already established program, so it is important to expect challenges. Then, Ruelas says to use the “plain, simple, old school” tried-and-true “5W1H Model”—start by identifying Who, What, When, Where, Why, and How regarding the compliance program, down to each item. If those are not identifiable, start with the compliance officer requirements of a compliance program, Ruelas noted, because that forces the compliance officer to focus on his or her own role and responsibilities. It also provides an opportunity to optimize the compliance officer’s job description and to meet with organization leadership.

Highlight on Florida: Prison for administrator involved in home health Medicare fraud conspiracy

Medicare was scammed of $2.5 million in false and fraudulent claims and another of the conspirators is heading to prison. A home health administrator was sentenced to 126 months in prison for his role in the scheme after a two-week jury trial convicted him in December 2016 of one count of conspiracy to commit health care fraud and wire fraud and one count to defraud the U.S. and pay and receive health care bribes and kickbacks.

While the administrator was the manager of Mercy Home Care Inc. and a billing employee for D&D&D Home Health Care Inc. in Miami-Dade County, Florida, he and others submitted false claims through the companies to Medicare between October 2014 and June 2015, based on services that were (1) not medically necessary, (2) not provided, and (3) for patients brought to the companies through payment of illegal kickbacks to providers and recruiters. The claims the administrator submitted to Medicare were based on forged prescriptions and falsified medical documentation, backdated so services were supposedly provided in prior years, and for beneficiaries who were coached to say they needed services when they were not homebound. According to evidence from trial, he also destroyed evidence prior to his arrest. Medicare paid approximately $2.5 million for false and fraudulent claims submitted by Mercy and D&D&D.

Ten other co-conspirators previously pleaded guilty or were convicted by the Southern District of Florida, including the owner and president of Nerey Professional Services, Inc. That co-conspirator was convicted of one count of receiving kickbacks in connection with a federal health care program and one count of conspiracy to defraud the U.S. and pay health care kickbacks and sentenced to 60 months in prison on May 27, 2016. According to evidence from trial, the co-conspirator was involved in the conspiracy to accept kickbacks in return for referring Medicare beneficiaries to Mercy and D&D&D to serve as patients, even those who did not qualify for home health care services, between October 2014 and September 2015.

Highlight on Puerto Rico: Just how bad will Puerto Rico’s Medicaid funding crisis be?

Puerto Rico is in danger of a serious Medicaid funding crisis beginning late 2017, according to a data point report by the Office of the Assistant Secretary for Planning and Evaluation (ASPE) under the HHS Secretary from January 12, 2017. Under the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148), territories like Puerto Rico receive not only an increased funding rate, but a temporary additional Medicaid funding amount for spending above their statutory caps for use between July 2, 2011 and September 30, 2019 (ACA sec. 2005), and another sum provided in lieu of funding for individuals enrolling in health insurance exchanges to be used by December 31, 2019 (ACA sec. 1323). (States only would only receive the sec. 1323 funding when the sec. 2005 funding is exhausted.) Amounting to $6.4 billion, these funds will not reach 2019 but instead will be depleted as early as the first quarter of fiscal year 2018 (or the fall of 2017). The route that Puerto Rico takes in responding to this funding crisis could take this situation from bad to worse.

Background and ACA

Both states and the federal government pitch in to jointly fund the Medicaid program. The amount that comes from the federal government is called the federal medical assistance percentage (FMAP). How much FMAP a state receives is based on its per capita income, with the average being 57 percent (50 percent for wealthier states, 75 percent for the poorest), adjusted on a three-year cycle. U.S territories, like Puerto Rico, however, receive an FMAP amount that varies greatly from that of states because their rates are capped by statute.

Puerto Rico faces immense poverty, with individuals being eligible for Medicaid with an annual income of only $6,600 (compared to $15,800 for the continental U.S.) and families with an income of $10,200 ($32,319). Over one million people are enrolled in Medicaid in Puerto Rico. Under the per capita income formula used to calculate the FMAP of states, and still considering the statutory maximum that is in place, Puerto Rico would receive 83 percent (93 percent absent the statutory maximum). Instead, Puerto Rico’s Medicaid expenditures are matched at 55 percent. This is an increase from the 50 percent that was in effect prior to passage of the ACA.

 Possible scenarios

Two scenarios are provided in the report as options for Puerto Rico to approach the exhaustion of funds. First, Puerto Rico could continue to spend the same amount of its own funds in fiscal year (FY) 2018 as in 2017, adjusting for inflation on a per-enrollee basis, which would result in a decrease in spending to 44 percent less than that required to maintain current enrollment of over one million today. Around 500,000 people would lose coverage. Although this scenario is similar to the funding that was in place prior to the ACA, considering that officials may choose to prioritize infrastructure and debt payments over Medicaid, they may decide on scenario two.

The second option is that Puerto Rico spends none of its own unmatched funds over those necessary to get the maximum federal funding, but that would result in spending being 80 percent less than that required to maintain the current enrollment, and nearly 900,000 individuals would lose Medicaid coverage.

In either case, it is assumed the Puerto Rico will reduce coverage (lowering income eligibility levels or capping enrollment) rather than reduce benefits for those covered by Medicaid.

Cost-Benefit Analysis to Weigh Into Antibacterial Soap Debate

The recent announcement by the Food and Drug Administration (FDA) to investigate the use of “antibacterial” soaps has further fueled the debate over the effectiveness and safety of these washes, as well as the possible detrimental effects of their use. As anyone who has shopped for hand soap in recent years probably has noticed, you are hard-pressed to find more than a couple of options that do not include an “antibacterial” label. While much controversy has existed over the need for these soaps in the past, the attention it is receiving by the FDA may help to resolve the debate.

Background

The use of antibacterial hand soap and washes has become ubiquitous in recent years. According to Colleen Rogers, Ph.D., lead microbiologist with the FDA, this is despite the fact “there currently is no evidence that over-the-counter (OTC) antibacterial soap products are any more effective at preventing illness than washing with plain soap and water.” Not only is the effectiveness questioned, but the safety of its long-term use are “unproven” due to chemical ingredients such as triclosan and triclocarban, neither of which are generally recognized as safe (GRAS) or generally recognized as effective (GRAE) under FDA standards. Currently, some of the long-term risks of antibacterial use shown from studies on rats shows a decrease in thyroid hormones. Triclosan use may even contribute to “making bacteria resistant to antibiotics,” according to the FDA. While the idea of removing triclosan from some products was first raised in 1978, no action was taken.

FDA Announcement

 Under the new Proposed rule, determinations of under what circumstances such antibacterial soap and wash products are GRAS and GRAE will be made. Now the FDA will require manufacturers to show that not only that their use is more effective than just soap and water, and also that they are safe in the long-term. Effectiveness will be measured by its clinical benefits, meaning the ability to prevent illnesses and the spread of infection.

Dr. Sandra Kweder, deputy director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research was quoted in a recent CNN article as saying that, “[the FDA’s] goal is, if a company is making a claim that something is antibacterial and in this case promoting the concept that consumer who use these products can prevent the spread of germs, then there ought to be data behind that.”

The FDA welcomes comments from consumers, clinicians, environmental groups, scientists, and industry representatives, among others, with regard to this topic.

Opinions

In October 22, 2013 interview with “Frontline” report David Hoffman, on National Public Radio’s “Fresh Air,” cited Professor Stuart Levy of Tufts University, a well-known commentator on the topic.  With regard to the use of antibacterials, in hand soap and other types of cleaners, Levy’s opinion is that “this craze that we had for antibacterials in home cleansers was really kind of an error, that we didn’t need them, but by using all this kind of antibacterial stuff – soap suds and so on – and washing it down the drain, we were essentially polluting our environment with the kinds of antibacterials that would create resistance in the environment,” Hoffman noted. He went on to state that “we’re going to wind up with super bugs in our environment.”

Dr. Janet Woodcock, director of the Center of Drug Evaluation and Research with the FDA, was quoted as saying that “[a]ntibacterial soaps and body washes are used widely and frequently by consumers . . . where the risk of infection is relatively low.” She further noted that “there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk.” And this is what the FDA hopes to determine through its investigation.