The Art of Ethics in Compliance & Clinical Activities

Home care and hospice organizations working to maximize their quality of care and financial performance are placing increasing emphasis on the development of ethics standards in their comprehensive compliance programs.  The role of ethics in compliance is paramount with the goals of sharing information and protecting organizations when individual and organizational values are challenged by patient/family concerns or quandaries about business practice.

"We are operating in a high-risk environment where differences in values, opinions and preferences are pushing the limits for patients, families and providers," says Kathleen Hessler, RN, JD, Director of Compliance and Risk at Simione Healthcare Consultants.

"How can you safely operate in an industry where what is legal, may be unethical, or what is ethical may be illegal? We recommend a clear process for "doing the right thing;" not simply because it is considered desirable, but because attention to values in a health care organization has significant implications for quality of care and reimbursement," Hessler says.  "Diligence with ethical processes will help home care and hospice organizations advance patient care in the face of growing accountability with new regulations, changing payment models, and higher expectations for quality reporting."

Ethical conflicts are far from new in healthcare; their history dates back to pre-World War II with exposed abuses in human experimentation, and in several highly public decisions involving the right to refuse life-sustaining treatment since the 1970s. The resulting case law, statutes and regulatory decisions over the last four decades have propelled the growth of an entire industry focused on ethical diligence and standards inclusive of business operations and patient care, according to Hessler.

"While it may seem elementary in most healthcare circles, ethical discussions in home care and hospice settings present a unique opportunity for agencies as the role for post-acute settings expands. Many agencies are cornerstones in their communities with direct access to promote and support respect for patient autonomy, and deliver a level of customer service that enhances their reputations as well as their bottom lines," Hessler explains.

Ethical Principles and the Law
Ethics in home care and hospice encompasses every aspect of care delivery from staffing credentials and conduct to quality standards and billing.  In these and other areas, the values of an individual, team or organization "govern" the business as a way of life, and typically evoke disparate reactions of a social, religious or economic nature based on differing values in people, cultures, communities, and organizations. While statutory, regulatory or common/case law are often the basis for many ethical discussions, they bring a totally different dynamic. For instance, while alleged violations of law are dependent upon facts and subject to more concrete level of accountability and penalty, ethical issues are dependent on one's behaviors in relation to the values and morals that govern.

Ethical principles and compliance mandates for home care and hospice play an important role in discussion and decision-making that, when appropriately incorporated, will support legally sound business operations and a high level of patient advocacy to prevent scrutiny regarding fraud, abuse or waste. In particular, bioethics discussions help to address medical issues, patient preferences, patient quality of life issues and financial or family issues, while corporate ethics discussions support issues such as conflict of interest, appearances of impropriety, discipline and the working environment.

Government oversight of home care and hospice organizations as key receivers of Medicare and Medicaid payments includes an increasing array of mandates and monitoring by CMS and the Office of the Inspector General (IOG). We are seeing an increase in investigations and enforcement actions, MACs, RACs, state laws, state Medicaid fraud unit scrutiny, and Department of Justice (DOJ) convictions.

This reality underscores the need for increased application of ethical principles in home care and hospice.  "The government is on watch for fraud, abuse and waste in health care.  Specifically in home care and hospice, Medicare spends billions of dollars every year, and settlements in the millions of dollars are surfacing every year," adds Hessler. These outcomes are evident in OIG reports and work plans, fraud alerts and corporate integrity agreements (CIAs), as well as new regulations that dictate new compliance practices, and government enforcement actions reported by the DOJ.

Seven Core Elements of an Ethics and Compliance Program
As with other areas of emphasis in compliance, the core elements of an active and effective ethics and compliance program include:

  • Written policies and procedures that include standards/code of conduct and address high-risk areas of practice
  • Oversight by company compliance officer, governing body and compliance/ethics committee
  • Development and implementation of regular, applicable education and training
  • A reporting system, such as a hotline to receive complaints and to ensure effective communication between the compliance officer and employees, with the option for anonymity
  • Use of audits/other systemic practices to monitor and identify ethical concerns and implement corrective action measures
  • Disciplinary measures to enforce standards of conduct, address violation and apply applicable sanctions
  • Policies that ensure prompt investigations, reporting and corrective actions

"Your plan for incorporating ethical principles into compliance programs will encounter shades of gray," Hessler says, "the only clear approach is to understand that the program will evolve and change in order to keep pace with the rate of industry change."

When issues arise, Hessler said, a consistent approach outlined in policy and procedure is key to convening an effective and ongoing ethics discussion. "It doesn't matter whether it's related to a clinical or corporate issue. What is needed is a clear process and prompt facilitation to address situations, identifying the individuals, roles, interests and values to determine any clinical, legal, and financial response that may be required to seek resolution and protect your agency."

Key Statutes and Activities in the Ethics & Compliance Arena

  • Operations Restore Trust (ORT) Pilot 1995 (successful recoveries of $42.3 million in 5 states with 35 criminal convictions and 18 civil settlements)
  • Focus on Anti-Kickback Statute (criminal) Statute 42 U.S.C. Sec 1320a-7b(b) (Whoever knowingly…offers or accepts remuneration for …referrals)
  • False Claims Statute: 31 U.S.C. Sections 3729-3733 (knowingly, deliberate ignorance, reckless disregard)
  • The Patient Protection and Affordable Care Act (PPACA) also known as ACA 2010 requires all certified Medicare providers to establish and implement a compliance program that contains…core elements established by the DHHS CMS (Section 6401 (a) (7)
  • Office of Inspector General (OIG) Voluntary Compliance Guidance (Home health and hospice regulations in 1998-99)

Key Areas of Ongoing Government Oversight in Home Care and Hospice

  • Billing for services not rendered = false claims
  • Falsification of care plans
  • Certifications/re-certifications
  • Face to Face
  • Quality reporting
  • Kickback issues (inappropriate referrals and beneficiary inducements)
  • Therapy
  • Employment of home health aides with criminal convictions
  • MAC (claims oversight)
  • Home health PPS requirements
  • State survey and certification/quality
  • Trend in expenses and revenues (cost report analysis)
  • Marketing practices
  • Financial relationships with nursing facilities
  • Hospice in assisted living facilities
  • General Inpatient care (GIP) services (services billed, but not received or increased utilization)

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