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Part 2 Global Med Device Investigation Highlights Importance

of Managing Risk Alongside Innovation

Cures Act Provides cures for serious diseases continue to pursue partnerships with ven- not rendered but billed. But the expanse of
World of Opportunity that are not only devastat- dors who can provide innovative ways to the FCA has been considerable since its
for Healthcare ing to patients, but also enhance patient treatment and satisfac- inception.
Innovation but Requires add up to a significant tion, they should do so with a healthy dose Under the cybersecurity lens, if an
Providers to Read the share of the total cost of of cautious optimism. With a proliferation organization bills for services rendered but
healthcare nationally. of new opportunities to expedite innova- the quality of those services is non-com-
Fine Print It also continues to war- tion, not all vendors will have appropriate pliant with security requirements—or if it
Main Points: rant special attention policies, procedures and internal controls is aware of a potential vulnerability but
• On Dec. 13, President where compliance is con- in place to ensure compliance with the fails to disclose it—the organization might
Obama signed the 21st cerned, and providers CMS and state regulations, and, most be deemed non-compliant with the FCA.
Century Cures Act (the should closely monitor importantly, patient safety. For an FDA-regulated medical device
Cures Act) into law, boost- and address certain com- manufacturer, consequences could also
ing healthcare research dol- ponents more than others. Today’s BDO Pulse Check include a costly device recall and having to
lars, streamlining the Food BY VENSON WALLIN, In the context of patient In this environment of technology infil- resubmit the device for FDA approval.
and Drug Administration CPA care innovation, these tration and faster innovation, health When it comes down to it, the consumer
(FDA)’s drug and medical include: organizations—private and public alike— is the epicenter of all concern. Medical
device approvals processes, and advancing • Expedited FDA approvals: While share the responsibilities of improving the devices alone were linked to almost 83,000
mental health and addiction treatments. Cures opened new (and quicker) avenues quality of outcomes, bringing down care deaths and 1.7 million injuries in the last
• The Cures Act included $500 million to secure drug and medical device costs and collaborating within and beyond 10 years, the ICIJ found. The ultimate cost
in funding to the FDA to: approvals—and knocked down the regula- their traditional supply chains. of non-compliance—and the goal of
• modernize clinical trials and the ways tory obstacle to quicker medical innova- But they must not forget the importance improving innovation while still maintain-
safety and efficacy data is analyzed tion—it also left greater risk for product of managing risk, and protecting patient ing the proper level of risk management—
• streamline regulations so the process discrepancies to slip through the cracks. safety, in the process. is patient safety.
for securing approvals on medical devices, • Cybersecurity: With new types of risk With no warning system to communi-
technologies, vaccines and regenerative to medical devices stemming from cyber- cate health alerts and recalls to patients and Venson Wallin, CPA, is Managing Director
medicine therapies is more efficient and security and greater regulatory scrutiny health providers across national borders, and National Healthcare Compliance and
• provide the FDA with greater flexibil- under the False Claims Act, providers due diligence is a critical step when part- Regulatory Leader, at BDO Consulting, LLC.
ity in reviewing and approving medical should put internal controls in place to nering with vendors to identify new inno-
devices if they provide first-of-a-kind tech- adequately assess the quality of drugs and vative techniques and devices to pursue. Learn more about how to manage compli-
nologies. devices before prescribing them to Looking into approval processes for new ance and regulatory risk while keeping up
• It also allocated resources aimed at patients. Because the law requires the FDA products, quality control management and with innovation.
improving the interoperability of electron- to consider real-world evidence in making process for securing FDA approvals are key.
ic health records (EHR) systems and approval decisions, providers should They must also take a closer look at their Contact:
improving providers’ education on the lat- incorporate this data into their internal internal compliance controls, paying close Alfredo Cepero, Managing Partner
est medical technologies. controls and choose their partners accord- attention to potential FCA and cybersecu- 305-420-8006/ acepero@bdo.com
ingly. The new law promotes innovation in rity scrutiny. Typical examples of false
BDO’s Diagnosis the medical device area, and thus, the claims include improper billings, paying Angelo Pirozzi, Partner
The law underlined the government’s industry will see a significant increase in physicians for referrals or kickbacks, ghost 646-520-2870 / apirozzi@bdo.com
focus on expediting the development of
new vendors. While organizations should patients, up-coding of services and services

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