• Compliance Perspectives

  • By: SCCE
  • Podcast
Compliance Perspectives By cover art

Compliance Perspectives

By: SCCE
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  • Summary

  • An SCCE Podcast
    Society of Corporate Compliance & Ethics
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Episodes
  • Jason Reddish and Mark Ogunsusi on 340B Drug Pricing Program Compliance [Podcast]

    Jason Reddish and Mark Ogunsusi on 340B Drug Pricing Program Compliance [Podcast]
    May 2 2024
    By Adam Turteltaub The 340B Drug Pricing Program was created to protect safety net hospitals from rising drug prices. It allows them to purchase outpatient drugs, and pharma companies to sell those drugs, at a discount. In this podcast, Jason Reddish (LinkedIn), Principal and Mark Ogunsusi (LinkedIn), Associate, at Powers Pyles Sutter & Verville provide an overview of the program and the compliance requirements. They are also two of the authors of the chapter “Pharmacy: 340B Drug Pricing Program” in the Complete Healthcare Compliance Manual. The 340B program helps hospitals that are the last line of defense for underserved communities, including those with a large percentage of Medicaid patients. Often, they are the only hospital around in rural areas. Also helped by the program are federal grantees such as Ryan White clinics and those providing treatment for STDs. The program dictates which entities can buy discounted drugs and have very specific requirements including two very important ones. First, the drugs cannot be resold or transferred to anyone who is not a patient of the covered entity. Second, double billing of Medicaid is prohibited and must be monitored for. There are a number of typical compliance problem areas, but the good news is that there has been a decline in non-compliance. Listen in to learn more about what covered entities are doing right, and what you should be on the lookout for.
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    13 mins
  • Laura Ann Smith and Judy Mayo on SEC Climate Disclosure Requirements [Podcast]

    Laura Ann Smith and Judy Mayo on SEC Climate Disclosure Requirements [Podcast]
    Apr 30 2024
    By Adam Turteltaub Currently on hold due to pending court challenges, the SEC’s rules to standardize climate-related disclosures created a fire storm of controversy and comments when first proposed. The final rules (assuming the courts sides with the SEC), explains Laura Ann Smith and Judy Mayo of the communications firm Labrador (LinkedIn), reflected strong industry pushback, easing the burden on some 4000 filers. Nonetheless, there are serious demands on industry. To quote from the SEC press release, registrants will be required to disclose: Climate-related risks that have had or are reasonably likely to have a material impact on the registrant’s business strategy, results of operations, or financial condition; The actual and potential material impacts of any identified climate-related risks on the registrant’s strategy, business model, and outlook; If, as part of its strategy, a registrant has undertaken activities to mitigate or adapt to a material climate-related risk, a quantitative and qualitative description of material expenditures incurred and material impacts on financial estimates and assumptions that directly result from such mitigation or adaptation activities; Specified disclosures regarding a registrant’s activities, if any, to mitigate or adapt to a material climate-related risk including the use, if any, of transition plans, scenario analysis, or internal carbon prices; Any oversight by the board of directors of climate-related risks and any role by management in assessing and managing the registrant’s material climate-related risks; Any processes the registrant has for identifying, assessing, and managing material climate-related risks and, if the registrant is managing those risks, whether and how any such processes are integrated into the registrant’s overall risk management system or processes; Information about a registrant’s climate-related targets or goals, if any, that have materially affected or are reasonably likely to materially affect the registrant’s business, results of operations, or financial condition. Disclosures would include material expenditures and material impacts on financial estimates and assumptions as a direct result of the target or goal or actions taken to make progress toward meeting such target or goal; For large accelerated filers (LAFs) and accelerated filers (AFs) that are not otherwise exempted, information about material Scope 1 emissions and/or Scope 2 emissions; For those required to disclose Scope 1 and/or Scope 2 emissions, an assurance report at the limited assurance level, which, for an LAF, following an additional transition period, will be at the reasonable assurance level; The capitalized costs, expenditures expensed, charges, and losses incurred as a result of severe weather events and other natural conditions, such as hurricanes, tornadoes, flooding, drought, wildfires, extreme temperatures, and sea level rise, subject to applicable one percent and de minimis disclosure thresholds, disclosed in a note to the financial statements; The capitalized costs, expenditures expensed, and losses related to carbon offsets and renewable energy credits or certificates (RECs) if used as a material component of a registrant’s plans to achieve its disclosed climate-related targets or goals, disclosed in a note to the financial statements; and If the estimates and assumptions a registrant uses to produce the financial statements were materially impacted by risks and uncertainties associated with severe weather events and other natural conditions or any disclosed climate-related targets or transition plans, a qualitative description of how the development of such estimates and assumptions was impacted, disclosed in a note to the financial statements. Even with all these requirements, Smith and Mayo recommend that companies realize that this is just a baseline. For those with operations in Europe there are requirements to meet as...
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    13 mins
  • Eddie Green on Electronic Messaging [Podcast]

    Eddie Green on Electronic Messaging [Podcast]
    Apr 25 2024
    By Adam Turteltaub It used to be that tracking email usage was considered tough. These days the workforce is also communicating via text, WeChat, Slack and countless other channels both internally and externally. That can be a total nightmare since prosecutors want access to all those conversations. What makes things harder is that employees may be resistant, feeling that the communications they have on their phone, especially in organizations with a Bring Your Own Device (BYOD) policy, is private. The employee owns the phone, not the company. Eddie Green (LinkedIn), CEO of SnippetSentry advises companies get their heads around this problem. Digital compliance is broadening out from the investment community to pharma and elsewhere. To manage the issue, some companies are now scrapping BYOD policies and making it clear that all work communications need to go on work-owned devices. They are also looking for solutions which enable employees to communicate in familiar ways, but with the tracking that logs all those communications. Listen in to understand the challenge and how to approach it more effectively.
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    7 mins
Management Economics
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