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12 Jan 2017 FDA Issues Final Guidance on Postmarket Management of Cybersecurity in Medical Devices

  The Food and Drug Administration (FDA) recently issued a final guidance titled “Postmarket Management of Cybersecurity in Medical Devices.” The guidance applies to “(1) medical devices that contain software (including firmware) or programmable logic, and (2) software that is a medical device, including mobile medical applications.” In an expansion from the draft version, the final guidance also applies to devices that are part of an interoperable system and “legacy” devices, i.e., devices already on the market or in use.   Continue reading this Barnes…

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06 Jan 2017 FDA Finalizes Guidance on Benefit-Risk Factors to Consider Regarding Medical Device Availability, Compliance, and Enforcement

  The Food and Drug Administration (FDA) recently issued a final guidance titled “Factors to Consider Regarding Benefit-Risk in Medical Device Availability, Compliance, and Enforcement.” The guidance is largely unchanged from the draft version released in June.   More specifically, the guidance states that the FDA has the authority to limit the availability of violative medical devices and to pursue other compliance and enforcement actions related to violative medical devices. The agency recognizes, however, that to protect and promote public health, decisions regarding these actions…

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06 Oct 2016 Revenue Procedure 2016-44 Expands Management Contract Safe Harbor

  On August 22, the Internal Revenue Service released Revenue Procedure 2016-44, which changes the management contract safe harbors contained in Revenue Procedure 97-13 regarding private business use.   Rev. Proc. 2016-44 went into effect immediately and applies to management contracts entered into on or after August 22.  However, issuers and borrowers may apply the prior safe harbors set forth in Rev. Proc. 97-13 to any contract entered into before August 18, 2017, so long as the terms of the contract are not materially amended…

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25 Jul 2016 Watch Out for MACRA ‘Brain-Freeze’

  Shortly after the passage of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) in April 2015, Centers for Medicare & Medicaid Services’ (CMS) Chief Actuary Paul Spitalnic predicted that, starting in 2026, Medicare Part B payments under MACRA will reduce access to physicians and the quality of services they provide.   “While physician payment updates would be adequate for many years, there are a number of concerns about the specified updates in the long range,” Spitalnic said in a statement. “In particular,…

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07 Jul 2016 New Rule, New Requirements for Healthcare Providers OCR Extends Non-Discrimination Access and Notification Requirements for Healthcare Providers

Co-authored by Anne Compton-Brown and Kaitlyn Jakubowski. The U.S. Department of Health and Human Services (HHS) recently issued a rule describing precisely what healthcare providers (including hospitals and other entities that participate in Medicare, and physicians that participate in Medicaid) must do in order to fully comply with Section 1557, which is the nondiscrimination provision of the Affordable Care Act (ACA). Section 1557 prohibits discrimination in certain health programs or activities on the basis of race, color, national origin, age, disability or sex, including discrimination…

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17 Jun 2016 Supreme Court Preserves Implied Certification Theory in Closely Watched False Claims Act Case

In the much-anticipated ruling on Universal Health Services Inc. v. United States ex rel. Escobar, the United States Supreme Court today held that False Claims Act liability can be predicated on an implied certification theory of liability.  (For the factual background and procedural history of the case, see our earlier blog post about the court’s grant of certiorari.) The court also clarified the materiality threshold that must be satisfied to pursue actionable claims under this theory, finding that materiality can be established with or without…

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10 Jun 2016 Department of Health and Human Services Issues Its Semiannual Regulatory Agenda

The Department of Health and Human Services (HHS) issued its semiannual regulatory agenda on June 9. The agenda outlines the status of regulations currently under development and provides timelines for the agency’s actions on pending and new rules. The June 9 agenda highlights current activity by the Centers for Medicare and Medicaid Services (CMS) as well as the Food and Drug Administration.  Of particular note:   Comments are due June 27, 2016, on CMS’s notice of proposed rulemaking “Merit-Based Incentive Payment System and Alternative Payment…

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03 Jun 2016 Texas Narrowly Interprets Exception to Medical Peer Review Privilege

On May 27, the Texas Supreme Court found a trial court judge abused its discretion in ordering the disclosure of peer review files to a physician in a medical malpractice case, stating the trial court failed to conduct a sufficient review of the documents before ordering the hospital to disclose the file. Because a proper review was critical to evaluating the peer review privilege claim, the high court directed the lower court to determine whether the hospital’s peer review committee took some disciplinary action against the…

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23 May 2016 State Regulation of Telepharmacy

This article was previously published on Pharmacy Times.   State regulation of telepharmacy varies depending on the market-driven needs within each particular state. The first state to regulate telepharmacy was North Dakota. In 2001, the state’s Board of Pharmacy promulgated rules for a telepharmacy pilot program in an effort to combat the closure of pharmacies in rural areas. Under the program, pharmacies could operate remote sites without the physical presence of a pharmacist, so long as the pharmacy maintained a central site staffed by a…

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20 May 2016 Telehealth Expansion Initiatives Helping to Increase Patient Choice and Access

The United States boasts the largest market for the use of telehealth and telemedicine services, generating $14 billion in global business last year with a predicted increase of nearly $20 billion by as early as 2020. Despite its size, the U.S. telehealth industry faces issues with broadband connectivity, regulatory hurdles like provider licensing restrictions and limitations on prescription orders and concerns over its potential to cause even more overutilization of healthcare services.   At the simplest level, “telemedicine” or “telehealth” is all healthcare practiced at…

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