The Office of Inspector General (OIG) has published the latest additions to its Work Plan. PYA offers insights on three noteworthy items related to the well-being of unaccompanied alien children, patient abuse policies, and specialty drugs.
Background
The OIG publishes Active Work Plan audits, evaluations, and inspections that are underway or planned. 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 this information means for compliance leaders in healthcare organizations.
ORR-Funded Facilities’ Efforts to Ensure Health and Safety of Unaccompanied Alien Children (ACF)
According to the OIG Work Plan update:
The Unaccompanied Alien Children (UAC) program, operated by the [Office of Refugee Resettlement (ORR), Administration for Children and Families] ACF, provides temporary shelter, care, and other related services to unaccompanied children in its custody. These children are often cared for in facilities operated by grantees that receive funding from ORR. We will identify vulnerabilities in facilities’ efforts to protect children in their care from harm and to provide needed physical and mental health services, including efforts to address trauma. OIG will also explore the challenges facilities face, including challenges presented by external factors such as Department of Health and Human Services (HHS) policies and management decisions. This review will focus on the care and well-being of all children residing in ORR-funded facilities, including the subset of children who were separated and deemed ineligible for reunification. For these children, OIG will also explore efforts made to contact and reunify with their parents and/or identify a suitable sponsor. OIG will gather information for this review by rapidly deploying multidisciplinary teams of evaluators, auditors, investigators, and lawyers to conduct comprehensive facility visits across the country. OIG will also conduct interviews with decision makers, including HHS senior leadership.
What You Need to Know:
The Division of Refugee Assistance (DRA) serves under the ORR and is governed by the ACF, a part of HHS. The DRA “supports, oversees and provides guidance to State-Administered, Public Private Partnership and Wilson/Fish programs that provide assistance and services to refugees, asylees, certain Amerasian immigrants, Cuban and Haitian entrants (collectively referred to as refugees).” Its goal is to support refugees acclimating to the United States and assist them in becoming self-sufficient. This scope of work includes oversight and reviews of program budgets, state plans, service delivery plans, and reports. Additionally, DRA provides technical assistance to ensure regulations are followed and services and performance are maintained. DRA is responsible for reimbursing states and programs for services that provide cash and medical assistance to refugees. Various other DRA programs fund social services, employment programs, hospitals, health and mental health programs, education, and integration services.
The Division of Refugee Health (DRH) was recently created by the ORR and works to provide cash, medical, and social services to refugees, asylees, Cuban/Haitian entrants, Amerasians, unaccompanied alien children, and survivors of torture. States, or their designated health agencies and programs, can receive federal grants and funding to support the health and well-being of eligible populations who need critical healthcare resources. These funds are to be used to facilitate medical screenings, provide health service support that focuses on reducing the spread of infectious disease, cover medical treatment, and promote preventive health services.
What You Need to Do:
Having the OIG “rapidly deploy multidisciplinary teams of evaluators, auditors, investigators, and lawyers to conduct comprehensive facility visits” presents a challenge. This disruption in a provider’s daily business of caring for patients can only be likened to a form of “compliance apocalypse.” Regardless of whether the patient is in the demographic of an ORR-eligible population, organizations should look closely at admission-to-discharge processes, complete and legally appropriate documentation, and ensure accurate claim submission and payment. In order to provide the best possible transition for the patient and ensure organizational readiness for this level of audit scrutiny, organizations should also shore up monitoring and audit reviews with added elements of cultural sensitivity and thoughtful care through the use of social and community services.
An organization should first assess its compliance with the National Culturally and Linguistically Appropriate Services (CLAS) Standards in order to provide equitable and understandable care and services that are respectful in diverse cultural health beliefs and practices. Then, the organization should review signage and patient materials to ensure the information is linguistically appropriate, and integrate policies, procedures, and staff education that address language assistance availability for individuals who have limited English proficiency. The use of inappropriate interpretation methods and services, such as untrained individuals, should be prohibited. The organization should evaluate policies, procedures, treatment protocols, and response methods to reduce or eliminate the spread of infectious disease. Collaboration between provider treatment plans and rehabilitation services focusing on key pivot points between case managers and patient discharge, transfers to other facilities, or engagement with social service agencies should be facilitated. Document and execute a plan that addresses ongoing medical needs and mental and behavioral health resources, and that considers social needs and services for this patient demographic. Organizations should establish their own multidisciplinary team to assess best practices and govern the actions and transition of this culturally sensitive population patient base.
Sufficiency and Implementation of Indian Health Service Patient Abuse Policies (IHS)
According to the OIG Work Plan update:
Details surrounding the recent conviction of a former Indian Health Service (IHS) physician for patient abuse raised concerns about IHS policies and procedures to prevent and address patient abuse. IHS partners with 573 federally recognized tribes to provide healthcare services to its 2.3 million American Indian and Alaska Native beneficiaries, and IHS directly operates 25 acute-care hospitals in 7 Areas. IHS has recently adopted new policies regarding this issue, including revising procedures in the Indian Health Manual, which governs IHS hospital practices. This study will evaluate the sufficiency and implementation of these policies. We will review and evaluate IHS policies and procedures related to patient abuse, including comparing them to policies developed by nationally recognized medical professional organizations. We will also conduct interviews with IHS officials and staff, and other stakeholders such as State and Federal law enforcement.
What You Need to Know:
Reporting patient abuse in the form of verbal, physical, or sexual abuse, or by exploitation, neglect, retaliation, discrimination, or coercion against patients, employees, or others falls under the ethical principle of nonmaleficence and beneficence. Healthcare employees have an obligation to protect patients from abuse or neglect, and to report information concerning abuse and neglect occurrences. The Federation of State Medical Boards (FSMB) adopted a formal position statement in its Duty to Report in April 2016, which addressed reporting and information sharing by outlining the responsibility of physicians, hospitals and health organizations, insurers, and the public to provide reports of information related to patient safety, physician impairment, and professional misconduct to state medical boards.
What You Need to Do:
Organizations must know and understand state and federal regulations and laws for reporting patient abuse and neglect, as well as respond to law enforcement requests for Protected Health Information (PHI) disclosure. Policies and procedures that outline how a covered entity will determine and respond to allegations or information indicating abuse or neglect must be in place. Healthcare personnel should immediately report suspected cases of patient abuse and neglect to their organization’s internal authorities as outlined in their policies and procedures for reporting. Examples of proper internal authorities include the risk management department, nursing administrator, or security personnel. Other agencies and organizations such as local, state, and federal law enforcement also have an obligation to investigate allegations of abuse and neglect.
Policies must outline and provide guidance on the procedural responsibilities referencing the Duty to Report. Employees and staff must have annual training on detecting and reporting patient abuse, and the corrective action plan implementation process. Procedural processes will require a factual report describing the abuse or neglect, along with medical record documentation describing the event, patient assessment, treatment interventions, notification of primary care providers, and follow-up plan of care. Supervisors and managers should take immediate action to secure and physically control the scene to protect patients and staff and to preserve any evidence. Victims of patient abuse should be provided with counseling and support directed at re-establishing therapeutic relationships and addressing the impact of the abuse or neglect. Follow-up investigations and reports must be completed addressing the contributing cause, processes, and corrective actions taken to manage the event.
Allegations and investigations of patient abuse and neglect may be disclosed to law enforcement agencies. Under 45 C.F.R. §164.512(f)(1) through (f)(6), PHI may be disclosed as required by law for reporting certain types of wounds or other physical injuries. Permitted PHI disclosures for crimes committed on covered entities’ premises are highlighted in 45 C.F.R. §164.512(f)(6), if the covered entity believes in good faith that evidence of criminal conduct occurred on the premises. Law enforcement requests must be compliant with the limited and relevant requirements of a court order or court-ordered warrant, subpoena, or summons issued in response to a grand jury or judicial officer. An investigative demand, or similar process authorized under law, is also permitted for release of PHI, provided that the information sought is relevant and material to a legitimate law enforcement inquiry and is limited in the scope and purpose for which the information is sought. Outside of disclosures required by law, a covered entity may disclose PHI in response to a law enforcement official’s request for information about an individual, either suspected to be or confirmed as a victim of a crime. If the individual agrees to the disclosure, or is unable to agree due to incapacity or other emergent circumstances, use of the information is limited to the determination of a violation of law and should not to be used against the victim.
Specialty Drug Coverage and Reimbursement in Medicaid (CMS)
According to the OIG Work Plan update:
Medicaid spending on specialty drugs has rapidly increased. There is no standard definition for specialty drugs. They may be expensive; be difficult to handle, monitor, or administer; or treat rare, complex, or chronic conditions. We will describe States’ definitions of, and payment methodologies for, Medicaid specialty drugs and determine how much States paid for specialty drugs. We will also review strategies that States use to manage specialty drug costs, such as formularies, cost sharing, step therapy, and prior authorization.
What You Need to Know:
Specialty drug costs continue to drive up Medicaid’s pharmacy expenditures, which in turn increases the cost of Medicaid Fee-for-Service (FFS). Specialty drugs treat complex, chronic, or rare health conditions. They frequently have high prices due to special handling or patient monitoring.
According to the health information technology company IQVIA, formerly IMS Health, specialty drugs are:
- Often initiated by a specialist.
- Generally injectable and/or not self-administered.
- Distributed by specialized wholesalers or pharmacies.
- Typically expensive and treat costly diseases.
Additionally, specialty drugs require or may require:
- An additional level of care in the chain of custody (such as refrigeration).
- Payment assistance.
- Extensive or in-depth monitoring/patient counseling.
For specialty drugs, retail price, net price, drug rebates, and discounts from manufacturers account for and affect Medicaid pricing and payment methodologies.
What You Need to Do:
Since this OIG Work Plan update is directed at Medicaid plans and how they manage drug costs, providers and payers should use this opportunity to make sure their pharmacy is in order. Requests for audits could increase so that Medicaid plans can respond to increased information requests from the Centers for Medicare & Medicaid Services.
Reviewing policies and procedures and making updates as they relate to pharmacy practices are important. Procedures should be in place to regularly monitor staff access to drug systems. It is also important to implement and enforce appropriate termination policies. Also, review and implement controls to assure the pharmacy formulary is appropriate and accurate, and that all drugs have been approved. Organizations should establish a robust process to monitor and audit dispensation of pharmaceuticals; conduct discrepancy reviews; and account for returns, credits, overrides, and failed logins to ensure accountability and oversight.
Conducting a review and assessment of the way in which specialty drugs are ordered, listed on the claim, and paid creates opportunities to identify:
- Discrepancies in unit measurements.
- Missing or inaccurate formulary codes.
- A lack of, or failed, drug authorizations.
- Rebate identifiers.
- Other types of payer denials.
An assessment of patient payment plans and charity care policies can help organizations ensure they address the high cost of specialty drugs against their patients’ financial considerations.
How PYA Can Help
PYA compliance consultants combine regulatory expertise with practical experience in healthcare organizations. Our compliance subject matter experts will provide a customized approach to assist you and your organization with today’s ever-changing compliance landscape.
If you would like more information about any matter involving compliance, valuation, or strategy and integration, contact one of our PYA executives below at (800) 270-9629.
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