BDO Knows Healthcare Newsletter - Fall 2017

November 2017


Healthcare providers and investors, do you know where your cyber risk lives? 

Healthcare continues shifting to value-based reimbursement and pushing care outside traditional bricks-and-mortar care centers and into patient homes through avenues like telemedicine. The FDA's Software Precertification (PreCert) Pilot Program will only quicken that shift. Such changes present private equity funds with not only new opportunities, but also new risk—especially when it comes to cyber. The Fall 2017 BDO Knows Healthcare Newsletter outlines the PreCert Pilot Program and what providers—and their investors—need to know when it comes to cyber risk. 

Cybersecurity Deserves Increased Attention in Deal Negotiations

Healthcare’s transition to value-based reimbursement will quicken as key deadlines and requirements of Medicare’s Quality Payment Program take hold, unleashing a new wave of consolidation. As the due diligence process ensues for such deals, one costly risk is often pushed under the rug: cyber.

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Pilot Program Tests Easing FDA Regulatory Burdens for Lower Risk Medical Device Products

The FDA’s Software Precertification (PreCert) Pilot Program puts forth solutions to the healthcare industry’s burdensome medical device approval process. The working theory? If the FDA has a complete understanding of the company making a product, it could pre-certify that company so its low-risk software products bypass parts of the traditional 510(k) premarket submission process—with the potential to go straight to market. 

Healthcare's Cybersecurity Diagnosis: What Private Equity Needs to Know

Private equity funds have realized new opportunities amid the changing healthcare landscape, especially when it comes to behavioral health and long-term care. But investors must ensure costly cybersecurity risks do not go overlooked in the name of deal-making. 

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Why ASC 606 Elevates Risk for LTC Providers

The Department of Justice's largest-ever healthcare fraud enforcement action, announced in mid-July, sends a clear signal about the federal government's escalating efforts to eradicate and penalize fraud in healthcare: They're here to stay. Regardless of your organization's unique exposure to potential fraud, the new revenue recognition standard introduced by ASC 606, Revenue from Contracts with Customers, adds another significant layer of complexity to the equation, especially for long-term care providers.