Articles and Blogs

The Centers for Medicare & Medicaid Services (“CMS”) recently issued a proposed rule (“Proposed Rule”) that would require pharmaceutical manufacturers to disclose the list price for a typical course of treatment of prescription drugs and biologics covered by Medicare or Medicaid in direct-to-consumer television advertisements. This policy development comes just two months after the... READ MORE

NATIONAL Amazon adds to its list of HIPAA-eligible machine learning tools Leapfrog releases Fall 2018 safety grades showing medical errors, safety issues prevail in red and blue states Hospital CEOs Agree That Systemness Focus Drives Results Doctors as disruptors? AMA CEO says medicine’s future demands it 93% of MIPS-eligible clinicians to get positive payment... READ MORE

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

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

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

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

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

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

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

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