The Office of Inspector General (OIG) has published the latest additions to its Work Plan. PYA offers insights on three noteworthy items related to medication-assisted treatment at health centers, accuracy of drug manufacturers’ quarterly pricing data, and the skilled nursing facility adverse event screening tool.
Background
Each month, the OIG publishes the most recent additions to its Work Plan. The work plan development process is dynamic and requires adjustments throughout the year to meet the OIG’s “priorities and to anticipate and respond to emerging issues with resources available.” With a goal of transparency, the OIG updates its Work Plan website monthly, outlining recently added information. The following is a summary of the latest additions, the agencies affected, and what they mean for compliance leaders in healthcare organizations.
Access to Medication-Assisted Treatment at Health Centers (HRSA)
According to the OIG Work Plan update:
Medication-assisted treatment (MAT) is a significant component of the treatment protocols for opioid use disorder and plays a large role in combating the opioid epidemic in the United States. Congress has taken sustained action to support MAT services through broadened prescribing authorities, increased Federal funding, and enhanced insurance protections. However, a treatment gap continues to exist where less than 1 percent of the people in the United States who need treatment for substance use disorder receive it. OIG will examine access to MAT through health centers funded by the Health Resources and Services Administration (HRSA). Health centers are key entities to expand access to MAT because they provide both primary care and behavioral healthcare services and accept patients regardless of their ability to pay. Additionally, in recent years, HRSA has awarded grant funding specifically to expand access to substance use disorder treatment at health center sites. We will examine how many health centers provide MAT services, what types of services they provide (e.g., specific medications, behavioral health services such as counseling), how many of their providers are waivered to prescribe MAT drugs, and how many patients they are treating with MAT. We will also examine the factors that may either facilitate or hinder the provision of MAT in health centers.
What You Need to Know:
In 2015, HRSA, through the Bureau of Primary Health Care, issued a notification of the availability of supplemental funding for the Substance Abuse Service Expansion. The purpose of this two-year funding opportunity is to improve and expand the delivery of substance abuse services through existing health centers, with a focus on MAT in opioid use disorders. The program was initiated with $100,000,000 for up to 310 grants at $325,000 each.
Research demonstrates that a combination of medication and behavioral therapies is most successful in treating opioid use disorders.1 MAT includes combining medications with counseling and behavioral therapies to provide a whole-patient approach to treatment. MAT uses Food and Drug Administration (FDA)-approved opioid agonist medications for the maintenance treatment of opioid use disorders, and opioid antagonist medication to prevent relapse of opioid use.
What You Need to Do:
Health centers must assure that the use of these treatments is consistent with corresponding federal statutes and regulations, including:
- The Controlled Substances Act (CSA), which contains Federal drug policy regulations for the manufacture, importation, possession, use, and distribution of controlled substances.
- The SUPPORT for Patients and Communities Act of 2018, which expands the ability of qualified physicians to treat up to 100 patients if they meet certain requirements.
- Drug Addiction Treatment Act (DATA) of 2000, which permits qualified physicians to treat opioid dependency with FDA-approved narcotic medications in treatment settings other than opioid treatment programs (OTPs). DATA also permits qualified physicians to obtain a waiver from the separate registration requirements of the Narcotic Addict Treatment Act to treat opioid dependency with Schedule III, IV, and V medications or combinations of such FDA-approved medications.
- Certification of Opioid Treatment Programs (OTPs) 42 Code of Federal Regulations (CFR) Part 8, which acknowledges that opioid addiction is a medical disorder and that different patients, at different times, could need vastly different treatment services. Oversight of treatment medications used in MAT is carried out in a multilateral, cooperative system involving states and federal agencies, e.g., Substance Abuse and Mental Health Services Administration (SAMHSA), Health & Human Services (HHS), Department of Justice (DOJ), and the Drug Enforcement Agency (DEA). The Certification of OTPs (42 CFR, Part 2) also includes the mandatory protection of patient confidentiality through restrictions concerning the disclosure and use of patient records pertaining to substance use treatment.
Health centers are a critical component in a comprehensive system of care for substance abuse. There is tremendous opportunity to increase access to treatment in outpatient primary care settings using opioid agonist2 and antagonists3 medications as part of an integrated MAT program. Accordingly, adequate internal controls must be built into the program to ensure operational integrity and regulatory compliance, such as operational policies and procedures, effective systems for documentation/coding/billing to assure accuracy and integrity, work force training and competency, scheduled auditing and monitoring, and regular reporting to management and the organizational governing body.
Accuracy of Drug Manufacturers’ Quarterly Pricing Data (CMS)
According to the OIG Work Plan update:
CMS uses manufacturer-reported average sales price (ASP) and average manufacturer price (AMP) data to calculate Medicaid rebate amounts and Part B drug reimbursements. When these data are not accurate, CMS and States might not set appropriate reimbursement or rebate amounts for drugs. This can result in CMS, States, and Medicare beneficiaries paying more for these drugs. The Social Security Act provides a mechanism for monitoring market prices and limiting potentially excessive ASP-based payment amounts by requiring the OIG to compare ASPs with AMPs. As part of this comparison, each quarter OIG manually reviews publicly available documentation from manufacturers’ websites and other sources, as appropriate, to validate the drug product and pricing information for selected national drug codes (NDCs). OIG may correct data associated with certain NDCs or exclude certain drug codes from the quarterly comparison if it identifies potential errors or inconsistent data. This study will determine the number of NDCs reported to CMS by manufacturers that contained potential errors in ASP and/or AMP data as well as the number of drug codes excluded from quarterly comparisons because of potential errors in the manufacturers’ data.
What You Need to Know:
Congress established the Medicaid Drug Rebate Program in 1990. The Medicaid Drug Rebate Program requires participating drug manufacturers to enter into and have in effect national rebate agreements with HHS in order for Federal Medicaid payments to be available for manufacturers’ covered outpatient drugs. Manufacturers are required to submit and certify product and pricing information to HHS and pay rebates to the State Medicaid programs for each unit of the covered outpatient drugs that the State Medicaid programs reimburse.
Although Medicare Part D covers most outpatient prescription drugs, CMS continues to cover a limited number of outpatient prescription drugs and biologicals under the Medicare Part B outpatient drug benefit. In setting Part B payment amounts, CMS relies on ASP data reported by manufacturers. Medicare payment amounts for most Part-B-covered drugs and biologicals are based on a price-plus-percentage calculation on reported Healthcare Common Procedure Coding System (HCPCS) “J” codes, which define drugs by name and billing unit size.
CMS has implemented a process to validate that the sales price data reported by drug manufacturers are complete and accurate. First, before a manufacturer submits a report containing data, CMS requires that the CEO, CFO, or authorized official of each drug manufacturer attests to the accuracy of the information provided in that report by signing the ASP Certification Form. Second, once it receives the sales data from the manufacturer, CMS performs a series of electronic data checks to assess the completeness of the submitted data. In cases where CMS identifies discrepancies through its data checks, agency officials attempt to resolve the issue directly with the manufacturer. If CMS is unable to resolve the issue directly with the manufacturer, the agency refers the case to the OIG, which determines appropriate enforcement, if needed.
What You Need to Do:
While the OIG’s focus here is primarily on the drug manufacturers, this Work Plan item flags important considerations, given the potential for reimbursement errors and the overall complexity of the CMS pharmacy pricing systems. Provider organizations need to have processes in place to ensure pharmacy revenue integrity. For instance, the stakes are high when it comes to implementing controls to assure correct pharmacy charge capture and coding, particularly those that prevent duplicate discounts in 340B programs. These efforts directly affect reimbursement, regulatory compliance, and the organizational bottom line.
Skilled Nursing Facility Adverse Event Screening Tool (CMS)
According to the OIG Work Plan update:
OIG developed the skilled nursing facility (SNF) adverse event trigger tool as part of its study, “Adverse Events in Skilled Nursing Facilities: National Incidence Among Medicare Beneficiaries” (OEI-06-11-00370), released in February 2014. The tool was developed with assistance from clinicians at the Institute for Healthcare Improvement (IHI), which also published the tool for industry use. This product will describe the purpose, use, and benefits of the SNF adverse event trigger tool and the guidance document released by IHI, including the methodology for developing the instrument and the instrument’s use in developing the February 2014 report findings. It will also describe related guidance to providers issued by the Centers for Medicare & Medicaid Services. The goal of this product is to disseminate practical information about the tool for use by those involved with the skilled nursing industry.
What You Need to Know:
The OIG’s findings in the 2014 report stated that one out of three Medicare beneficiaries experienced an adverse or temporary harm event in their first 35 days of a skilled nursing facility stay. The results of these events ranged from extending a resident’s stay to causing a resident’s death. Additionally, the OIG determined many of these events were likely or clearly preventable.
According to the IHI Resources Website:
The IHI Skilled Nursing Facility Trigger Tool for Measuring Adverse Events provides an easy-to-use method for accurately identifying adverse events (harm) and measuring the rate of adverse event incidence over time in skilled nursing facilities (SNFs). The tool is based on the IHI Global Trigger Tool methodology, a retrospective review of a random sample of inpatient hospital records using “triggers” (or clues) to identify possible adverse events.
What You Need to Do:
Review the tool for process improvement assistance with SNF adverse events, which includes:
- Step-by-step instructions for using this methodology to identify adverse events in SNFs, and determine the level of harm associated with such events.
- Detailed guidance on designing a Trigger Tool review.
- A list of SNF-specific triggers and definitions.
- Examples of adverse events that occur in SNFs.
- An extensive list of Frequently Asked Questions.
As nursing homes work to prevent, detect, and mitigate certain categories of harm while honoring each resident’s rights and preferences, this tool can serve as a key resource to improve quality of care and patient safety for facility residents.
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1U.S. Department of Health & Human Services. Assistant Secretary for Planning and Evaluation, Issue Brief: Opioid Abuse in the United States and HHS Actions to Address Opioid-Drug Related Overdoses and Deaths. March 26, 2015. Available at: http://aspe.hhs.gov/sp/reports/2015/OpioidInitiative/ib_OpioidInitiative.pdf
2An opioid agonist binds to the same receptors in the brain that were activated by the drug of abuse, but in a safer and more controlled manner. These medications can reduce the symptoms of withdrawal and reduce cravings, allowing for a more gradual, controlled recovery process while reducing the risk of relapse. The two opioid agonists used in MAT are methadone and buprenorphine.
3An opioid antagonist is non-addictive medication that blocks and binds the opioid receptors and is reported to reduce opioid cravings. If a person relapses and uses the problem drug, naltrexone prevents the feeling of getting high. A common opioid antagonist used in MAT is naltrexone.
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