21st Century Cures Clears Senate, President Expected to Sign into Law but Some Issues Remain

Today, the Senate voted overwhelmingly – 94-5 – to pass sweeping medical innovation legislation clearing the way for President Obama to sign it into law when it reaches his desk later this week. The 21st Century Cures Act, (Cures), a rare bipartisan major piece of healthcare legislation, provides $6.3 billion for research, streamlined approvals for drugs and devices as well as funding to improve the Food and Drug Administration’s (FDA)  ability to hire top quality scientific talent by increasing pay and improving the hiring process.  The House of Representatives recently passed Cures by a similarly wide bipartisan margin of 392-26.  The Senate vote marks a milestone victory for Cures champions including outgoing Energy and Commerce Committee Chairman Fred Upton (R-MI), Representative Diana DeGette (D-CO) and Senate Health, Education, Labor and Pensions Committee Chairman Lamar Alexander (R-TN). Continue reading

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FDA hits the brakes on LDT draft guidance

Last week the Food and Drug Administration (FDA) decided to delay finalizing draft guidance for Laboratory Developed Tests (LDT).  First issued in July of 2014, the draft guidance would give FDA regulatory oversight of LDTs.  This guidance marked a significant shift in the regulation of LDT as FDA has chosen not to exercise regulatory oversight or enforcement over LDTs.  Continue reading

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Pharmaceutical Reps Now Required to be Licensed in the City of Chicago; Includes Code of Ethics & Potential Transparency Reporting

Earlier this week, the Chicago City Council joined other government agencies in imposing licensure and marketing requirements on pharmaceutical representatives when it unanimously approved licensing requirements for pharmaceutical representatives in the City of Chicago. Individuals who conduct business in the City of Chicago as a pharmaceutical representative for 15 or more days per year must obtain a license, which includes completing an educational course determined by the Commissioner of Public Health (Commissioner), submitting a registration form to the Department, and paying a $750 licensure fee. Renewal applicants will be required to complete at least 5 hours of continuing education in the areas of ethics, pharmacology, laws and regulations applicable to pharmaceutical marketing, and other areas that the Commissioner may designate by rule. Training courses may not be provided by the pharmaceutical representative’s employer. The ordinance takes effect on July 1, 2017.

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Filed under Industry Codes, Sales & Marketing, State Marketing & Disclosure Laws

OIG Issues 2017 Work Plan – PAMA, Open Payments, Drug Manufacturer Rebates Among Areas of New Focus

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued today its 2017 Work Plan. This annual publication summarizes new and ongoing reviews and activities by the OIG related to various HHS programs. For example:

  • There are at least three new areas of review related to each skilled nursing facilities and hospice.
  • OIG will conduct a review of Medicare payments for certain clinical diagnostic laboratory tests, as mandated by section 216 of the Protecting Access to Medicare Act of 2014 (PAMA).
  • OIG will conduct a review of the data reported to Open Payments under the Physician Payments Sunshine Act. Among other things, OIG intends to determine the volume and total dollar amount for drugs, devices and medical equipment ordered by physicians under Medicare Parts B and D who are contained in the Open Payments reports.
  • OIG will conduct an analysis to determine the amount the federal government could potentially collect from pharmaceutical manufacturers if inflation-indexed rebates were required under Medicare Part B. This analysis builds on prior OIG analyses.
  • OIG also will conduct an analysis to determine the amount the federal government could potentially save if pharmaceutical manufacturers paid rebates for drugs dispensed through the Medicare Part D program at 340B covered entities and contract pharmacies.

Pharmaceutical and medical device companies, clinical laboratories and other health care entities should carefully review the OIG 2017 Work Plan to determine areas of government focus. The Work Plan often serves as a useful resource for companies planning and prioritizing compliance activities for the upcoming year, including training, auditing and monitoring. Additionally, reports issued by the OIG after a review are a valuable resource regarding the OIG’s current analysis of industry activities.

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CMS Issues Final MACRA Physician Payment Rule

On Friday, October 14th, the Center for Medicare & Medicaid Services (CMS) released the long-anticipated final rule with 60-day comment period (Rule) for the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) Quality Payment Program (QPP). The QPP provides incentive payments for participation in Advanced Alternative Payment Models (Advanced APM).  The provisions of the 2,400 page Rule take effect January 1, 2017.  When fully implemented, the Rule will generally transition providers from the current fee-for-service payment system into new value-based payment models.  Continue reading

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Filed under Health Care, Medicare, Telehealth, Telemedicine, Uncategorized

GAO Criticizes HHS In Health Information Cybersecurity Report

On Monday, the Government Accountability Office (“GAO”) released a report (the “Report”) criticizing the U.S. Department of Health and Human Services (“HHS”) security and privacy guidance and oversight in protecting electronic protected health information (“ePHI”) from cybersecurity attacks.  The Report noted that HHS does not adequately address cybersecurity elements outlined by other agencies in published guidance and fails to address how key National Institute of Standards and Technology (“NIST”) cybersecurity framework  (“Cybersecurity Framework”) can be implemented in the operations of covered entities and business associates.  The GAO claims that the lack of adequate guidance by HHS, leaves health information vulnerable to cybersecurity attacks.

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Filed under Health Information Privacy, Health IT, HIPAA, HITECH Act

FDA Announces Critical Off-Label Forum for Drugs and Devices

A notice was published today in the Federal Register regarding a two day public hearing that will be held on November 9-10, 2016 by the U.S. Food and Drug Administration (FDA) to obtain input from a wide range of stakeholders regarding communications by industry related to unapproved uses of FDA-regulated drugs, biological products and medical devices (collectively, “Medical Products”). The announcement noted that FDA has been engaged in a comprehensive review of its regulations and policies related to off-label communications of approved or cleared Medical Products since 2014, and input from the meeting will further inform FDA’s policy development.

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