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Health Law News

Episode-Based Bundled Payment Models Poised to Make a Comeback

[11/16/18]

Posted on November 16, 2018 in Health Law News

Published by: Hall Render

Health and Human Services (“HHS”) Secretary Alex Azar announced on Thursday, November 8, 2018 that HHS intends to reconsider some of the episode-based payment models that it withdrew almost one year ago. According to Secretary Azar, HHS is exploring new and improved episode-based payment models, including a mandatory bundled payment model for radiation oncology.[1]... READ MORE

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CMS Finalizes Several Changes for Off-Campus Provider-Based Clinics

[11/12/18]

Posted on November 12, 2018 in Health Law News

Published by: Hall Render

On November 1, 2018, the Centers for Medicare & Medicaid Services (“CMS”) released its final rule for the Calendar Year (“CY”) 2019 Medicare Physician Fee Schedule (“MPFS Final Rule”). Among many other changes, CMS finalized maintaining payments for certain non-excepted (non-grandfathered) off-campus provider-based hospital departments (“PBDs”) at 40 percent of the Outpatient Prospective Payment... READ MORE

CMS Proposes Major Change to Medicare Part B Drug Payment System Introducing International Pricing Index Model

[11/09/18]

Posted on November 9, 2018 in Health Law News

Published by: Hall Render

The Centers for Medicare & Medicaid Services (“CMS”) Center for Medicare and Medicaid Innovation proposed to lower the cost of Medicare Part B outpatient prescription drugs by establishing their prices based on lower drug prices of other advanced industrial nations as compiled in an “international price index” (“IPI”) and changing the way the current drug... READ MORE

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Health Provider News – November 9, 2018

[11/09/18]

Posted on November 9, 2018 in Health Law News

Published by: Hall Render

NATIONAL DJO launches 1st outpatient arthroplasty risk assessment tool Hospitals slammed with $380M in CMS cuts, industry cries foul CMS finalizes site neutral payment rule AHA says payer consolidation, not hospital prices, raises healthcare costs 3 changes potentially coming to HIPAA OCR Announces Next Round of HIPAA Audits Will Focus on Enforcements CMS Publishes... READ MORE

CMS Letter to Clinicians – E/M Documentation Update

[11/09/18]

Posted on November 9, 2018 in Health Law News

Published by: Hall Render

On November 8, 2018, CMS released a letter to clinicians regarding E/M documentation and coding reform. This follows the CY 2019 Medicare Physician Fee Schedule Final Rule intentions to reduce burden on clinicians in furtherance of the agency’s “Patients Over Paperwork” initiative. Effective January 1, 2019, CMS will: Simplify the documentation of history and exam... READ MORE

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FDA Issues New Draft MOU for 503A Compounders Governing Cross-Border Dispensing and Comments Related to CGMP Compliance for Outsourcing Facilities

[11/02/18]

Posted on November 2, 2018 in Health Law News

Published by: Hall Render

On September 7, 2018, the United States Food and Drug Administration (“FDA”) issued a revised draft Memorandum of Understanding (“MOU”) that would govern interstate dispensing and distribution of “inordinate amounts” of compounded prescription drugs by certain compounding physicians and pharmacies. The concept of this MOU first appeared in the Compliance Policy Guidance issued by... READ MORE

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Health Provider News – November 2, 2018

[11/02/18]

Posted on November 2, 2018 in Health Law News

Published by: Hall Render

NATIONAL HHS secretary warns Big Pharma: Lower prices, or ‘you’ll get whatever comes at you’ Amazon’s health-care ambitions shouldn’t be underestimated, says industry veteran HHS Unveils New Plan for Prescription Prices for Medicare Part B Drugs 15 leaders on why hospitals should hire a chief wellness officer Lawmakers ask CMS to reconsider ACO MSSP... READ MORE

Department of Homeland Security and FDA Collaborate to Address Medical Device Cybersecurity

[11/02/18]

Posted on November 2, 2018 in Health Law News

Published by: Hall Render

On October 15, 2018, the National Protection and Programs Directorate (“NPPD”) of the U.S. Department of Homeland Security (“DHS”) and the U.S. Food and Drug Administration (“FDA”) entered into a Memorandum of Agreement (“MOA”) that formalizes a long-standing relationship between the agencies and implements a new framework for increased collaboration, information-sharing and coordination that... READ MORE

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Civil Monetary Penalties Inflation Adjustment for 2018

[10/26/18]

Posted on October 26, 2018 in Health Law News

Published by: Hall Render

The U.S. Department of Health and Human Services (“HHS”) published in the Federal Register the 2018 updated civil monetary penalties (“CMPs”) adjusted for inflation as required by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (§701 of Pub. Law 114-74) (the “Act”). The updated CMPs became effective on the date of... READ MORE

Newly Enacted Opioid Law: How Does It Impact Providers?

[10/26/18]

Posted on October 26, 2018 in Health Law News

Published by: Hall Render

On October 25, 2018, the president signed a wide-ranging bipartisan legislative package to address the opioid epidemic. The enactment of the Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, or the SUPPORT for Patients and Communities Act, (the “Act”) follows a lengthy process in both the Senate and... READ MORE

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