Compliance TODAY July 2013
a publication of the health care compliance association
www.hcca-info.org
How an eye doctor’s son sees compliance an interview with Stephen Kiess Assistant General Counsel for Vidant Health
See page 16
22
Don’t fear the Sunshine (but wear your sunscreen) Mary B. Langowski, Kristen E. Ratcliff, and Rebecca Jones McKnight
27
31
38
PATH rules for physician oversight and billing
Texting and mobile devices: Partners in health care
After an allegation: Conducting an effective, efficient internal investigation
Bill Moran and Betta Sherman
Jim Sheldon-Dean and Vidyadhar Phalke
Rob Cepielik, Mike Little, and Greg Garrison
This article, published in Compliance Today, appears here with permission from the Health Care Compliance Association. Call HCCA at 888-580-8373 with reprint requests.
by Tom Ealey and Marcy Gilstad, MHSA
Mandatory compliance and long-term care: Part 1 »» Compliance programs are transitioning from the recommended era to the mandatory era. »» Although the regulations were not written by the March 23, 2013 implementation deadline, guidance is available to build a program. »» LTC facilities are subject to broader and deeper scrutiny; both integrity and quality issues are emphasized by regulators and auditors.
Tom Ealey (ealey@alma.edu) is Professor of Business at Alma College in Alma, MI and has three decades of involvement in long-term care finance, operations, and regulation. Marcy Gilstad (gilstadmr@gmail.com) is an Administrative Fellow with the Trinity Health St. Mary Mercy organization in Livonia, MI.
T
he Patient Protection and Affordable Care Act (PPACA)1 changed the landscape of compliance programs for skilled nursing facilities (SNFs) and nursing facilities (NFs), transitioning from an era of recommended compliance programs into the era of mandatory compliance programs. Under Section 6012, SNFs and NFs must have effective compliance and ethics plans in place by March 23, 2013. When this publication went to press (May 2013), the regulations defining effective programs were not yet issued, so long-term care (LTC) facilities must use prior official guidance and known best practices to craft effective plans. Programs put into place now will have to be amended and updated once the regulations are released, and regularly thereafter.
Long-term care has advantages and disadvantages The current LTC regulations and survey process micro-regulate nursing facility performance, down to the smallest details of clinical
care (e.g., how to administer eye drops) and evaluate documentation at a micro level (e.g., counting nurses’ initials in the medical administration and treatment records). Nursing facilities have been subject to attacks by consumer advocates, Ealey politicians, lawyers, and the media for decades, and the result has been hyper-regulation and heavy, duplicative documentation. LTC facilities received a heavy emphasis and were singled out with specific language in PPACA. Other health care providers have been spared the harsh regulatory regime directed at LTC, but subGilstad standard nursing facilities, many in long-past decades, have made LTC facilities a target of increased regulation. To be fair, much of this scrutiny was deserved; a few bad apples have caused the entire barrel to be overregulated. Compliance programs have normally focused on billing and transactional integrity, but LTC has been hit with a new overlay of clinical regulation as well. LTC facilities may have a perverse advantage in the new era of mandatory compliance—they have experience with hyper-regulation, paperwork beyond reason, 888-580-8373 www.hcca-info.org
Compliance Today July 2013
»» LTC facilities’ experiences with micro-regulation and defensive operations are valuable in designing and implementing compliance programs. »» A compliance program can be wedded to existing facility integrity and quality programs.
45
and defensive self-survey. A focus on compliance and self-survey is almost second nature. LTC facilities need to be intentional and thorough about compliance, because these facilities have been intentional with performance and documentation rules.
Where to turn for guidance? The 2000 and 2008 guidance statements published by the Office of the Inspector General (OIG) outline the components of a compliance program and the probable risk areas.2 The 2008 OIG compliance guidance lists five operational areas in LTC facilities that are likely to create compliance risks: ·· Quality of care ·· Submission integrity ·· Anti-Kickback Statute violations ·· HIPAA compliance ·· Other risks
compliance programs should be used with great caution, and a “paper only” compliance program is perhaps worse than no program at all. Neither the original 2000 nor the September 2008 supplemental guidance are intended to represent “complete” compliance plans, but both provide guidance toward that objective.
Seven compliance program elements The seven standard OIG recommendations for compliance plan elements are listed here, with a cross reference to the equivalent PPACA sections in brackets: · Development of compliance policies and procedures, including standards of conduct; [(4) (A)]
· Designation of a compliance officer and compliance committee; [(4) (A)]
Compliance Today July 2013
All of these categories are important, but the quality of care is the most important in long-term care. The 2008 guidance document details the risks and recommends compliance program actions to minimize the risks. Here we examine the five targeted areas in the Quality of Care section. Updates to previous guidance statements Before PPACA, a compliance program had been recommended by the OIG, but not required. Practically and operationally, a compliance program was required for intelligent risk management, as any experienced health care lawyer would insist. PPACA now ends the suspense. Compliance programs are mandatory, effective March 23, 2013. The required program allows a great deal of latitude in design and operation of the program, and a compliance program can and should be customized to fit the size, resources, and risks of the organization. “Cookbook”
46 www.hcca-info.org 888-580-8373
· Development of open lines of communications; [(4) (D)] · Appropriate training and teaching; [(4) (D)] · Internal monitoring and auditing; [(4) (D)] · Response to detected deficiencies; [(4) (G)] and · Enforcement of disciplinary standards; [(4) (F)]
Some basics of federal long-term care regulation ·· List of SNF Federal Regulations www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/SNFPPS/List-of-SNF-Federal-Regulations.html
·· CMS Skilled Nursing Facility Center www.cms.gov/Center/Provider-Type/Skilled-NursingFacility-Center.html
·· RTI International MDS 3.0 Quality Measures Users Manual v5.0 03-01-2012 www.cms.gov/Medicare/Quality-Initiatives-PatientAssessment-Instruments/NursingHomeQualityInits/ Downloads/MDS30QM-Manual.pdf
The FY 2013 OIG Work Plan The Health and Human Services OIG has the following items listed in the FY 2013 Work Plan: ·· Adverse Events in Post-Acute Care for Medicare Beneficiaries ·· Medicare Requirement for Quality of Care in Skilled Nursing Facilities ·· State Agency Verification of Deficiency Correction (new) ·· Oversight of Poorly Performing Facilities ·· Use of Atypical Anti-psychotics ·· Hospitalizations for Nursing Home Residents ·· Questionable Billing Patterns for Part B Services During Nursing Home Stays ·· Oversight of the Minimum Data Set Submitted by Long-Term-Care Facilities (new) These areas of emphasis serve as red flags for facilities looking for compliance hot topics.
a determination of sufficiency, such as these indicators: ·· Resident care mix — acuity levels and types of care provided ·· Staff skill levels — do skill levels match acuity levels: registered nurse (RN) and licensed practical nurse (LPN) mix, years of experience ·· Staff-to-resident ratios — this is a hot button, especially in states with or considering mandatory ratios ·· Staff turnover — for certified nursing assistants (CNAs) and licensed nurses ·· Staffing — personnel schedules written, then comparing real hours worked versus posted schedules ·· Payroll and time card records ·· Disciplinary records (Are write-ups for clinical staff a necessary file filler?) ·· Adverse event reports (a.k.a., unusual incident reports) ·· Interviews with residents and families
The 2000 and 2008 guidance statements and the annual OIG FY 2013 Work Plan can be used to establish a respectable and effective compliance program. Quality of Care is the first category listed in the guidance. The OIG expands on five areas of concern, discussed briefly here. Providers should be familiar with relevant federal law on quality of care, general health care reform, and neglect and abuse issues. 1. “Sufficient” staffing For better or worse, quality is often measured in terms of quantity of employees. The OIG concedes that there is not always an exact correlation between quantity and quality. Staffing ratios, however, are an accessible data set and are an important measure for government regulators. The guidance states there is no set formula for defining “sufficient.” Numerous metrics and indicators can be reviewed for
2. Comprehensive resident care plans OIG considers the resident care plan an essential element of reducing risk. The facility must develop a care plan that covers each resident’s four areas of need: medical needs, nursing care needs, mental health care needs, and psychosocial needs. The plan must also include reasonable objectives and timetables (and by inference, the means to measure and evaluate progress toward each). OIG cites relevant Medicare and Medicaid statutory authority and “should do” steps toward meeting those requirements: ·· Appropriate scheduling to allow full team attendance ·· Completing clinical assessment before the meeting ·· Open lines of communication among all members of the team ·· Involving the resident and family and any legal guardian or power of attorney (POA) 888-580-8373 www.hcca-info.org
Compliance Today July 2013
The guidance we have now
47
·· Documenting the length and content of each meeting The compliance plan should be geared toward evaluating the plan-of-care process and provide timely feedback on care failures in the process. 3. Medication management The 2008 guidance spares no words: “A failure to manage pharmaceutical service properly can seriously jeopardize resident safety and even results in resident deaths.” OIG emphasizes that management processes must be put in place to advance patient safety, minimize drug interactions, and insure discovery and correction or irregularities. These include policies and procedures for maintaining accurate drug records and medications tracking—very obvious, of course. The guidance points out the importance of the consultant pharmacist, policy and procedure development, and medication management processes designed to optimize outcomes, minimize adverse reactions, and detect and correct errors. A compliance effort should be developed and implemented to be certain the medication management system is working effectively. Facilities should be aware of recent Drug Enforcement Agency (DEA) activity targeting medication orders and paper trails for Schedule
II narcotics;3 and the “nurse agent” compromise created to allow residents to receive medications in a timely manner. The lack of a physical presence by physicians on most days requires a three-part approach that links the charge nurse, the pharmacist, and the physician, usually by telephone and fax. Controls on receipt of medications, narcotic counts, and medicine administration records (MAR) must be tight and consistently enforced. The compromise appears to be more workable than the original regulations, and is being monitored by the DEA, the industry, and Congress. Perhaps the DEA now understands how LTC facilities differ from hospitals.
Compliance Today July 2013
The guidance points out the importance of the consultant pharmacist, policy and procedure development, and medication management processes designed to optimize outcomes, minimize adverse reactions, and detect and correct errors.
48 www.hcca-info.org 888-580-8373
4. Appropriate use of psychotropic medications Nursing homes have been targeted for decades on the issue of “chemical restraints,” and as new psychotropic drugs have been developed and widely used, criticisms have developed about overuse and misuse or psychotropic medications on elderly residents. Psychotropic medications create risks of violating two standards of care: ·· Inappropriate use of chemical restraints ·· Requirement to avoid unnecessary drug usage
All facilities should have proper safeguards in place, although the facility and staff are often caught between regulations and
5. Resident safety — mistreatment, neglect, abuse The 2008 guidance outlines an effective compliance program to prevent problems, investigate complaints, and respond to incidences as: .…policies, procedures, and practices to prevent, investigate, and respond to instances of potential resident abuse, neglect or mistreatment, including injuries resulting from staff-on-resident abuse and neglect, resident-on-resident abuse, and abuse from unknown causes.
A confidential internal whistleblower mechanism is listed as being key to an effective resident safety program. The mechanism could include a telephone hotline or lock box for written comment cards. Sincere and appropriate follow up are critical, as a program without genuine follow-up activity may be taken as a sign of bad faith. Resident-on-resident abuse is recognized as a growing problem, because residents with severe dementia, Alzheimer’s, and mental health diagnoses sometimes do significant harm to other residents. Harried staff must find ways, within regulations (i.e., few or no physical or chemical restraints) to prevent resident-on-resident abuse.
Billing and cost reporting integrity Billing integrity is a major and original focus of the OIG. Every election cycle, politicians pledge to eliminate fraud and abuse by health care providers, and each expects the OIG to
perform this duty. Although the OIG has performed admirably, eliminating all fraud and abuse has proven to be elusive. The 2000 OIG guidance statement mentions these specific concerns for long-term care: ·· Billing for items or services not provided or rendered (false claims) ·· Billing for equipment, supplies or services not medically necessary ·· Billing Medicare Part A for ineligible patients ·· Duplicate billing ·· Failure to refund credit balances (per the new 60-day rule) ·· Billing for items or services not ordered ·· Knowingly billing for inadequate or substandard care ·· Misleading information on the Minimum Data Set (MDS) assessment or for Resource Utilization Group (RUG) assignment ·· Upcoding ·· Billing Medicare or private insurance for items or services already included in a per diem (unbundling) ·· Billing residents for items or services included in a per diem ·· Altering documentation or forging a physician signature ·· Failing to maintain sufficient documentation to support: • Diagnosis • Treatment justification • Course of treatment and results • Continuity of care ·· False or inaccurate cost reports Billing (and associated medical records) should be subject to constant scrutiny and internal auditing for accuracy and completeness. Having created a hopelessly complicated revenue stream, the government expects complete and accurate compliance. Facilities should be leery of consultants and accountants who promise reimbursement 888-580-8373 www.hcca-info.org
Compliance Today July 2013
physician orders, requiring diplomacy in dealing with physicians. Risks may be accelerated with staff turnover, pharmacy changes, newer physicians, physicians not sensitive to LTC regulations, or sloppy coordination among departments.
49
miracles. This scenario has played out many times, and the facility usually loses.
to supplement the payments. A not-for-profit may solicit and accept donations unrelated to the care of a specific resident.
Anti-Kickback regulation
Anti-supplementation Medicare and Medicaid payments are designed to be payment in full for covered items and services, subject to available co-insurance or co-payments.5 Neither the beneficiary nor any person in lieu of the beneficiary (e.g., family member, guardian) may be required
HIPAA Nursing facilities have special issues with HIPAA compliance. The facility truly is a “home” for many residents, there is a constant flow of families and visitors through the facility (access is guaranteed by regulation), and many facilities are, in the best sense, communities. This does not excuse the facility from HIPAA compliance, but the facility faces different information flows and different dynamics than most providers. Facilities should be studying the recently released final rules and updating HIPAA privacy and security protections.6
Summary Combined with an increasing emphasis on contractor audits, fraud-and-abuse investigations, and a political desire to ratchet down health care costs, compliance becomes a critical issue. This is a new era for LTC facilities enrolled in Medicare and Medicaid programs. Compliance programs can provide positive benefits by providing information useful to improving both the clinical and administrative functions of LTC operations.
1. The Patient Protection and Affordable Care Act (Public Law 111-148) as supplemented by the Health Care and Education Reconciliation Act of 2010 (Public Law 111-152), often referred to as Health Care Reform. Long-term care rules can be found at P. L. 111-148 Subtitle B, Nursing Home Transparency and Improvement, Part I, Section 6102 2. OIG Supplemental Compliance Program Guidance for Nursing Facilities, Sept 2008. http://www.oig.hhs.gov/fraud/docs/ complianceguidance/nhg_fr.pdf 3. Drug Enforcement Administration Practice Resource Center: Controlled Medication in Long Term Care. Available at https://www.ascp.com/ articles/drug-enforcement-administration-dea 4. 42 USC § 1320a – 7b(b) Criminal Penalties for Acts Involving Federal Health Care Programs. Available at http://www.law.cornell.edu/ uscode/text/42/1320a-7b 5. 42 USC § 1395cc(a) - Agreements with Providers of Services; Enrollment Processes. Available at http://www.law.cornell.edu/ uscode/text/42/1395cc. Also CFR 447 and 483 6. See the revised HIPAA regulations in the Federal Register, January 25, 2013. Available at https://www.federalregister.gov/ articles/2013/01/25
888-580-8373 www.hcca-info.org
Compliance Today July 2013
The federal government, via Medicare and Medicaid, pays for up to half of the national health care bill each year, and has a natural concern for receiving fair value for the payments. The federal Anti-Kickback Statute (AKS) restrains providers from certain forms of business arrangements relating to items or services reimbursable by the Medicare and Medicaid programs.4 In plain English, providers cannot buy or reward referrals of Medicaid or Medicare patients, subject to criminal penalties. Practices common and legal in other businesses are not legal for health care providers. The AKS prohibits offering or paying anything of value for patient referrals. The AKS goes on to broadly define conduct with regard to purchases of goods, services and leases, as well as prohibiting direct or indirect payment or remuneration for referrals. Penalties, in addition to criminal prosecution, include Civil Monetary Penalties (CMP), federal program exclusion, and additional liability under the False Claims Act. LTC facilities receive referrals from physicians, hospitals, therapists, etc., and also make referrals to physicians, hospitals, pharmacies, therapists, etc. The government wants all referrals to be made on the basis of good clinical care and not on improper remuneration.
51