Health care regulatory services

As the future of health takes hold, health plans are playing a new role in helping new populations access care in new ways. With increased regulatory disruption both enabling and governing the pace of change, our team works side-by-side with health plans to identify solutions that can help them address pertinent issues.

Typical organizations we serve include:

• National health plans and pharmacy benefit managers (PBM)
  
• Regional health plans
• Provider-sponsored plans
• Emerging health funding organizations

Current issues we see include:

• Interoperability and price transparencyRisk adjustment challenges
• Government audit needs
• Emerging payment models and provider networks

The COVID-19 pandemic is fostering disruption across post-acute care and senior living. Organizations are facing compounding revenue pressures, continued emphasis and reliance on federal reimbursement, and increased regulatory scrutiny. Our team of industry specialists can help organizations develop practical, tech-forward solutions to address regulatory and operational risks.

Typical organizations we serve include:

• Skilled nursing facilities
• Home health agencies
• Hospice and palliative care organizations
• Senior living (independent living, assisted living, memory care) organizations
• Physiotherapy providers

Current issues we see include:

• CARES Act compliance and reporting
• Quality and safety
• M&A transactions: Regulatory compliance due diligence
• Revenue cycle
• Regulatory risk strategies
• Pre-and post-billing audits
• Legal matters
• Compliance program operations

As US prescription drug costs continue to grow (largely due to the advent of specialty drugs and treatment plans) pharmacy-related costs continue to be top of mind for legislators, health care providers, and consumers. With increased regulatory scrutiny and emergence of nonprovider organizations entering the pharmacy market spaces, our team is able to work side by side with pharmacy organizations to identify solutions that can help mitigate compliance concerns. We help organizations develop leading strategies to compete in a market space that now includes technology companies looking to disrupt the status quo.

Typical organizations we serve include:

• Retail health clinics
  
• Retail pharmacies
• Long-term care pharmacies
• Specialty pharmacies
• Specialty infusion service providers
• Suppliers of durable medical equipment, prosthetics, orthotics, and supplies
• Respiratory therapy product and service companies

Current issues we see include:

• Interoperability and price transparency
• 340B program assistance and guidance
• Billing and dispensing practices
• Specialty pharmacy guidance
• PBM audit needs
• Controlled substance and prevention of diversion practices

As an increasing proportion of the population enrolls in federal health care programs, physicians and other outpatient care providers have experienced reimbursement and core operational compliance shifts that affect day-to-day business. No longer is it enough to simply "treat the patient." More and more, phyisicans and other clinicians are scrutinized by federal programs based on their adherence to standards and practices established by regulators. In order to help meet these standards, create opportunities within federal programs, or mitigate and remediate compliance concerns, our team can help physicians and other health services strategize around the rules and leading practices created by regulatory change.

Typical organizations we serve include:

• Physician practices
  
• Ambulatory surgical centers
• Laboratories
• Medical transport companies
• Opioid treatment programs
• Behavioral health providers
• Student health programs

Current issues we see include:

• Interoperability and price transparency
• Billing and coding
• Value-based care and Medicare Access and CHIP reauthorization Act (MACRA)
• Stark Law and Anti-Kickback Statute

Amid uncertainty and ever-changing industry dynamics, hospitals and health systems are challenged to be innovative and proactive in response to the regulatory environment. Our practice helps clients in their efforts to become sustainable, adaptable, and transformative across the continuum of care.

Typical organizations we serve include:

• Health systems
• Academic medical centers
• Acute care hospitals
• Cancer care centers
• Inpatient rehabilitation facilities
• Critical access hospitals
• Federally qualified health centers
• Long-term care hospitals

Current issues we see include:

• CARES Act compliance and reporting
• Revenue cycle leading practices
• Compliance program operations
• Billing audits

Our Health Care Regulatory Support team works with law firms to provide regulatory operation insights and support services for corporate or government investigations, litigation, and other matters involving health care compliance.

Typical organizations we serve include:

• National and regional law firms
• In-house counsel

Current issues we see include:

• Billing/coding compliance assessments
• Compliance program and billing/coding due diligence and post-merger remediation
• Investigations
• Knowledgeable testimony or support services in litigation matters

Deloitte Health Care Regulatory Support team works with health care investors to provide additional regulatory insight for transactions, strategy, and other matters where more extensive review of business records is required.

Typical organizations we serve include:

• Private equity firms
• Commercial organizations pursuing mergers, acquisitions or divestitures

Current issues we see include:

• Billing/coding compliance assessments as a component of quality of earnings due diligence
• Emerging health policy impacts on strategy and revenue
• Compliance program and billing/coding due diligence and post-merger remediation

The economic burden of kidney failure in the United States ranks among the highest in the world with a significant portion reimbursed by compliance-driven government programs. Our team is experienced in helping dialysis and renal care providers with navigating the associated risks and opportunities in this specialized, highly regulated sector.

Typical organizations we serve include:

• Dialysis providers and suppliers (outpatient and home)
• Emergency and hospital-based dialysis providers
• Dialysis vascular access care centers

Current issues we see include:

• CARES Act compliance and reporting
• M&A transactions: Regulatory compliance due diligence
• Regulatory risk strategies
• Interoperability and information blocking
• Clinical documentation improvement and quality
• Medical records and billing compliance audits
• Compliance program operations