New York Healthcare Business Compliance and Risk Advisory Services

Lawyers and Advisors Addressing Regulatory Compliance and Risk Management for Healthcare Organizations in New York City

Healthcare organizations operate within one of the most heavily regulated industries in the United States. They face oversight from multiple federal and state agencies, and they are required to meet standards related to the quality of patient care, billing practices, privacy protections, professional conduct, and more. Hospitals, medical practices, nursing homes, home health agencies, and other healthcare entities will need to address complex requirements related to Medicare/Medicaid, state departments of health, professional licensing boards, and other regulatory authorities.

In addition to regulatory compliance, healthcare organizations may need to address a variety of operational, financial, and cybersecurity risks that can threaten their sustainability and their ability to serve patients effectively. The consequences of inadequate risk management can be severe, including monetary penalties, civil liability, the possibility of criminal prosecution, discipline to professional licenses, and more. Proactive compliance and risk management programs can help organizations identify and address issues before they develop into crises.

At CO Health Advisory, our advisors work with healthcare businesses and organizations across the United States to address regulatory compliance and risk management. We understand the laws and regulations that apply to healthcare organizations, and we work with clients to develop and implement effective compliance programs.

Compliance Program Development and Implementation

Effective compliance programs will establish frameworks for preventing, detecting, and correcting violations of laws and regulations. These programs may include written policies and procedures, compliance officers and committees, training and education, lines of communication between stakeholders, and systems for monitoring, performing audits, and taking corrective action. We can assist with:

• Policies and Procedures: An organization can establish expectations regarding ethical conduct and the steps followed to maintain compliance with regulations. Policies may address high-risk areas such as billing, referrals, documentation requirements, privacy and security, quality of care standards, and conflicts of interest.
• Compliance Officers: Key personnel can serve as resources for staff members with compliance questions, coordinate training and audits, investigate potential violations, and provide reports to senior management and boards. Compliance officers may be authorized to implement policies and take corrective actions when necessary.
• Training Programs: Employees should be educated about their requirements, the organization's policies, and the procedures for reporting concerns. Training should be provided during onboarding, on a regular basis, and when policies change or when new regulations take effect.
• Reporting: Compliance concerns may be reported through hotlines, web-based reporting systems, or designated personnel. Anonymous reporting options will encourage people to disclose issues without fear of retribution or other penalties. Reports should be investigated promptly, and corrective actions should be taken to address violations.
• Monitoring and Auditing: Regular reviews should be performed to uncover compliance issues. Audits may address billing procedures, referral sources, privacy, or other issues. Issues uncovered through audits may be addressed through corrective actions or improvements to compliance programs.

Regulatory Investigations and Enforcement

In some cases, healthcare organizations may face investigations by regulatory bodies due to complaints, routine audits, billing anomalies, or other factors. Key personnel will need to respond to investigations promptly and take the correct steps to protect the interests of the organization while cooperating with regulators.

The initial responses to investigation notices or document requests can be critical. Organizations will need to preserve relevant documents and data, and coordination among stakeholders will be needed to ensure a consistent approach. Hasty responses without legal guidance or preparation could limit an organization's ability to defend against enforcement actions.

When an organization receives requests for document production, it will need to gather the requested materials and determine whether objections can be made. While an organization will be required to cooperate with regulators, it may also need to take steps to protect confidential information. We can help healthcare businesses comply with these requests while protecting their interests.

We can also assist with settlement negotiations in certain cases. This may allow an investigation to be resolved by implementing corrective action plans or taking other steps to maintain compliance. Effective negotiation will require an understanding of the specific laws and regulations, the outcomes of similar cases, and the financial implications of corrective plans or other terms of a settlement.

CO Health Advisory represents healthcare organizations in regulatory investigations and enforcement proceedings. We can provide strategic counsel during an investigation, negotiate with regulators, and help an organization take steps to defend its interests.

Healthcare Fraud Risks

Accusations of healthcare fraud could lead to multiple types of penalties for an organization. Under the False Claims Act, an organization may be held liable for knowingly submitting false claims to government programs. Anti-kickback laws prohibit organizations from offering, paying, soliciting, or receiving remuneration to receive referrals for services covered by federal healthcare programs.

Arrangements with physicians for medical directorships, professional services, space or equipment rentals, or other relationships must be structured carefully to ensure that an organization complies with fraud and abuse laws. CO Health Advisory can provide guidance on the best ways to address concerns related to fraud and abuse. We can review financial arrangements with referral sources, make sure relationships are structured correctly, and work with organizations to respond to investigations or allegations of healthcare fraud.

Clinical Risk Management

Clinical risks involve potential harm to patients due to issues such as medical errors, diagnostic failures, treatment complications, adverse reactions to medications, hospital-acquired infections, and accidents such as falls. We work with organizations to implement risk management programs that will identify and mitigate these risks.

We can help organizations develop incident reporting systems that will gather information about adverse events, near misses, and safety concerns. Comprehensive reporting can help identify risks and their root causes, ensuring that they can be addressed correctly. We can also review insurance coverage and guidance on the best ways to respond to adverse events and malpractice claims.

Operational and Financial Risk Management

Healthcare organizations may face a variety of risks that may affect their financial sustainability. Contract disputes, staffing shortages, safety issues, or business interruptions due to disasters may lead to financial losses or operational concerns.

Comprehensive revenue cycle management can help address issues related to claim submissions, denials, appeals, and collections. Even small improvements in these areas can significantly impact a healthcare business's financial performance. Regular contract reviews and strategic negotiations can help improve a business's revenue streams. Workforce planning can address risks related to turnover, burnout, or workplace safety concerns. Business continuity planning can ensure that an organization will be prepared to respond to disasters, cyberattacks, pandemics, or other potential disruptions.

CO Health Advisory works with healthcare organizations to implement effective operational and financial risk management programs. We can review contracts to address potential risks, develop business continuity plans, and provide strategic counsel on the best ways to address operational challenges.

Cybersecurity and Technology Risks

Healthcare organizations may face threats such as ransomware attacks, phishing campaigns, and other technological issues that may affect data security and patient privacy. Cyberattacks can lead to the disclosure of protected patient information while disrupting a business's operations, damaging systems, and resulting in significant financial losses. Cybersecurity programs and effective incident response plans can help organizations protect against and respond to these types of attacks.

Our team can perform security assessments to identify vulnerabilities. We can help ensure that the proper security controls are put in place, including firewalls, encryption, intrusion detection, access controls, and multi-factor authentication. We can also address concerns related to vendor risk management, addressing security risks that may arise when third-party vendors access an organization's systems or data.

CO Health Advisory provides guidance for healthcare organizations on issues related to cybersecurity risk management. We can review vendor agreements, help ensure that the proper security systems and procedures are in place, develop incident response plans, and provide counsel on how to respond to breaches.

Contact Our New York City Healthcare Business Risk Management Advisors

CO Health Advisory provides comprehensive services to help healthcare organizations address concerns related to regulatory compliance while mitigating potential risks. Whether you need assistance developing compliance programs, responding to regulatory investigations, or addressing potential risks, we are ready to work closely with you to develop strategies that will help you manage these issues effectively. Contact our New York healthcare regulatory compliance advisors to set up a consultation.