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Compliance Policies/ Document Sharing Project OUR GOAL: to make 1,000 documents available to members THE INDIVIDUAL THAT SUBMITS THE MOST DOCUMENTS TO THE LIBRARY EACH MONTH, RECEIVES ONE OF 12 IPOD NANOS OR AN HCCA AUDIO CONFERENCE! Contribute a document and enter the iPod/Audio Conference Giveaway! Contribute the most compliance-related documents to the SCCE Document Library and receive an iPod Nano or an SCCE Audio conference. Each month, an iPod Nano or an HCCA Audio conference is given away beginning in July 2008. Giveaways will be held on a monthly basis through June 2009, so there are many opportunities for YOU to contribute. E-mail your document(s) to Caroline Lee Bivona at caroline.leebivona@hcca-info.org October 2008 56 With 2,300 lawyers in 30 locations, Jones Day One Firm Worldwide is a proud law firm sponsor of this giveaway! www.jonesday.com Health Care Compliance Association • 888-580-8373 • www.hcca-info.org www.hcca-info.org | 888-580-8373
SEC Disclosure: Managing information at FDA-regulated companies. ...continued from page 53 information that a company may need to disclose, particularly if the company has previously disclosed information regarding a clinical investigation or trial. Significant changes or results from investigations previously discussed with the public will likely warrant prompt and accurate disclosure. Again, in order to accomplish this efficiently, the creation and implementation of an SOP regarding clinical investigation developments may be beneficial. For each ongoing clinical investigation, create a distribution list which includes at least one member from the regulatory affairs department, the General Counsel’s office and the corporate communications or investor relations department. Use this distribution list to promptly communicate any new and significant developments so that people outside the clinical investigation group are not only informed of the new information, but can make an assessment regarding whether or not disclosure is necessary. Consider including as part of this SOP a procedure for calling meetings among the distribution list on short notice, thus allowing for discussion about the new information across various segments of the company. SEC filings Creating SOPs for the drafting, review, and filing of any SEC filings is also an important component for disclosure policies and procedures. For each periodic filing on Form 10-K or 10-Q, implement an SOP that not only sets forth the timeline for drafting the filing, but also includes the necessary sign-offs for each section. Of particular importance for many FDA-regulated companies, including medical device developers and manufacturers, is a section appearing in each periodic report called management’s discussion and analysis of financial conditions and results of operations (MD&A). This section requires management to discuss information that may cause the current financial condition to not be indicative of future financial condition. For medical device companies, this may include indications from the FDA regarding status of a pending application or events from a clinical investigation. Consequently, an SOP regarding the drafting and review of periodic filings needs to allow for review by members of the regulatory affairs and clinical investigation divisions to ensure that information pertinent to those divisions is included and accurately described. Similarly, SOPs for Forms 8-K and registration statements can be drafted to allow for review by relevant divisions at the company. These SOPs, however, may need to be streamlined because often time is of the essence when filing a disclosure on Form 8-K or a registration statement for an equity offering. In August 2004, revisions for the filing of Forms 8-K became effective, requiring that companies file disclosures regarding specified information within four business days. And, although registration statements can integrate prior filings, a company must still ensure that it describes “any and all material changes in the registrant’s affairs” that were not previously reported on a Form 10-Q or 8-K. Regulation Fair Disclosure Finally, because many FDA regulated companies are frequently communicating with the investing public, particularly institutional investors, developing an SOP that covers Regulation Fair Disclosure (Reg FD) may be useful. Under Reg FD, companies are prohibited from selectively disclosing material nonpublic information to certain parties, such as securities market professionals, institutional investors, and investment companies. If material nonpublic information is disclosed to a select party, Reg FD requires that the information be simultaneously disclosed to the public or if the disclosure is inadvertent, the information must be disclosed to the public as soon as practicable after discovering the disclosure. SOPs regarding communications with the investment community can be a valuable way to prevent running afoul of Reg FD. For example, an SOP to assist with Reg FD compliance might require that: n All staff who interact with the investment community complete regular training about FD. n All communication with investors be logged into a central system, which includes the date of the communication and a description of the information provided to the investor. n All “road show” materials be reviewed and approved by specified personnel. Conclusion SEC disclosure requirements may not always be given the necessary attention at developing public companies that are regulated by the FDA. However, the cooperation between the FDA and the SEC, as well as the risk of civil suits, suggest that FDA-regulated companies need to take care when disclosing information to the investing public because the potential damage from making inaccurate disclosures can be significant. Using SOPs, a familiar format of control at FDA-regulated companies, is one possible way to make disclosure policies and procedures functional for these dynamic companies. n 1 See “SEC and FDA Take Steps to Enhance Inter-Agency Cooperation,” SEC Press Rel. 2004-13 (Feb. 5, 2004) and “FDA and SEC Work to Enhance Public’s Protection from False and Misleading Statements,” P04-15 (Feb. 5, 2004). 2 See SEC v. Shashikant C. Shah, Lit. Rel. No. 20034 (March 8, 2007) (“The staff acknowledges the assistance and cooperation of . . . the FDA in the investigation of this matter”). 3 See Backmun v. Polaroid Corp., 910 F. 2d 10, 13 (1st Cir. 1990) (en banc). Health Care Compliance Association • 888-580-8373 • www.hcca-info.org 57 October 2008
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Volume Ten Number Ten October 2008
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INSIDE Publisher: Health Care Compl
Page 5 and 6: which ensures that the understandin
Page 7 and 8: Table 1: 14 CLAS Standards U.S. Dep
Page 9 and 10: Scholarship Recipients The Four Dua
Page 11 and 12: and need emergency care (e.g., an i
Page 13 and 14: Court analyzes first case under Sta
Page 15 and 16: It was established in 1969 in respo
Page 17 and 18: and get linked up with e-newsletter
Page 19 and 20: Social networking Many compliance p
Page 21 and 22: Focus on Organizational Compliance
Page 23 and 24: Medicare’s medical necessity crit
Page 25 and 26: Is no notice enough notice Legal pr
Page 27 and 28: Exploring the question: Does this r
Page 29 and 30: “Does this really make a complian
Page 31 and 32: Certification - the recognized mark
Page 33 and 34: suffice. This potential error can b
Page 35 and 36: Introducing Compliance & Ethics Soc
Page 37 and 38: who typically sell multiple plans o
Page 39 and 40: n State OIG that fight Medicaid fra
Page 41 and 42: Coordinating external requests for
Page 43 and 44: The what, why and how of Medicare C
Page 45 and 46: The what, why and how of Medicare C
Page 47 and 48: to hear the message first. Educatin
Page 49 and 50: COMPLIANCE ACADEMIES February 2-5 S
Page 51 and 52: or whistleblower lawsuit. Moreover,
Page 53 and 54: SEC Disclosure: Managing informatio
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Page 67 and 68: PHI under false pretenses, that per
Page 69 and 70: Improving competitiveness and compl
Page 71 and 72: Speakers Sharon Anolik Blue Cross B
Page 73 and 74: commitment to overhaul deficient co
Page 75 and 76: e g i s t e r n o w f o r HCCA’s
Page 77 and 78: New principles can help advance ind
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Page 81 and 82: When to use a monitor Although some
Page 83 and 84: ASKLEADERSHIP John asks the leaders
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Page 89 and 90: “I am a compliance professional a
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Page 94: 600 U.S. BANK PLAZA SOUTH 220 SOUTH
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