HRI regulatory center

HRI regulatory center

HRI regulatory spotlight: Quality reporting hits the ACA exchanges in 2016
HRI regulatory spotlight: Quality reporting hits the ACA exchanges in 2016
Starting in 2016, state and federal marketplace websites must display a new “star” rating system developed by HHS.
HRI regulatory spotlight: CMS proposes ‘two-midnight’ hospital payment compromise
HRI regulatory spotlight: New 340b guidance adds oversight to drug discounts
New federal guidance aims to clarify the eligibility of health systems for drug discounts received through the federal 340b Drug Pricing Program.
HRI regulatory spotlight: CMS proposes ‘two-midnight’ hospital payment compromise
HRI regulatory spotlight: CMS proposes ‘two-midnight’ hospital payment compromise
New regulations proposed by the Medicare program will give hospitals flexibility to determine the medical appropriateness of a patient’s inpatient stay by relying more on physician judgment.
HRI regulatory spotlight:CMS final rule establishes flexibility for Medicare ACOs
HRI regulatory spotlight: CMS final rule establishes flexibility for Medicare ACOs
Medicare Accountable Care Organizations (ACOs) now have more flexibility in administrative requirements, additional choices around shared savings options, and new performance and quality metrics that they must meet as part of a final rule effective August 3, 2015.
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The Affordable Care Act has entered its most pivotal year since being signed into law in 2010. About 20 million Americans gained coverage during the ACA’s inaugural open enrollment period, and hospitals and physicians are beginning to reorient how they deliver care to align with new payment models. It’s now more important than ever to stay atop the regulatory environment, as federal agencies provide the guideposts to an emerging new health economy. But that’s just the starting point. As consumers shoulder more of the costs for care, prepare to see dynamic changes as the industry shifts to compete for the newly insured.

Learn more about the healthcare regulatory environment through the following resources:

Week of 10/05/2015

  • Meaningful Use Stage 3, interoperability guidelines released
  • Agreement reached on biologics exclusivity in trade deal
  • ACA risk corridors program falls short on payouts
  • New Health Economy trends fuel new jobs
  • PCORI funds $83 million for new round of comparative outcome research

Week of 09/28/2015

  • CMS looks to avoid misfiled claims under new October 1st ICD-10 process
  • Biosimilar user fee program up for review
  • Medicare aims to change how it pays labs
  • Hospitals that treat the poor hit hardest by readmission penalties
  • Fourth ACA CO-OP folds
  • New HRI Closer Look: Healthcare’s Alternative Payment Landscape

Week of 09/21/2015

  • Federal judge sides with hospitals on “two-midnight” rule
  • Uninsured rate decreases as employer coverage holds steady
  • Economic assessment seeks to put fair price on drug value
  • States consider reform tweaks with innovation waivers
  • FDA integrating patient views into device approvals process
  • New HRI Spotlight: Quality reporting hits the ACA exchanges in 2016

Week of 09/14/2015

  • President Obama to nominate new FDA commissioner with industry experience
  • Major updates proposed to clinical research oversight rule
  • House gets go-ahead to move forward with ACA lawsuit
  • Hospitals, physicians take aim at new Medicare payment rules

Week of 09/07/2015

  • Federal officials eye new round of HIPAA audits
  • Long-awaited 340B omnibus guidance released
  • ‘Navigators’ receive $67 million in new CMS grants
  • First biosimilar hits the market at 15% lower price than competitor

Week of 08/24/2015

  • FDA on track for a record year for drug and device approvals
  • Court rules third-party administrators subject to mental health parity requirements
  • Healthcare channels shift ten years after Katrina
  • 2016 exchange rates slowly finalize as states reconsider Medicaid expansion plans
  • New Risk Assurance report: Healthcare needs to up its risk management game
  • HRI as we see it will not publish the week of 08/31/15

Week of 08/10/2015

  • Survey: Physicians lag hospitals and insurers for ICD-10 readiness
  • FDA data security capacity panned by Congress
  • Federal exchange struggles with eligibility determinations
  • Data analytics seen as key to managing ER ‘super users’
  • HRI as we see it will not publish the week of 08/17/15

Week of 08/03/2015

  • FDA approves new drug using special voucher
  • Increased competition puts downward pressure on exchange premiums
  • Most hospitals in line for a slight Medicare pay increase
  • FDA issues cybersecurity warning
  • New HRI Spotlight: CMS proposes ‘two-midnight’ hospital payment compromise

February 25, 2014

Final rules on ACA's employer mandate include new transition relief

The IRS issued final regulations providing guidance on the Affordable Care Act's employer shared responsibility provisions, sometimes called the 'employer mandate' or the 'pay or play' rules. The regulations apply for periods after December 31, 2014 to applicable large employers who fail to offer coverage to their full-time employees. The regulations extend earlier transition rules and provide new ones to help employers comply with the requirements.

Highlights of the final regulations include:

  • an extended transition period for employers with between 50 and 99 full-time equivalent employees, so they won't be subject to penalties until 2016
  • a temporary rule for employers with 100 or more full-time employees, so the largest penalty will not apply for 2015 if the employer offers coverage to at least 70% of its full-time employees (rather than 95% as will be required after 2015)
  • final rules for determining full-time employee status reflect the proposed regulations, including the optional look-back measurement period and stability period, with numerous clarifications and new definitions
  • additional guidance for the monthly method of determining full-time status
  • rules for determining full-time status for special categories of employment, including a new definition of seasonal employees
  • an additional year for employers who do not now offer coverage to their employees' dependents to comply, as long as coverage is offered to the children of employees by the 2016 plan year
  • safe harbors for determining if employer-provided coverage is affordable for employees for purposes of the employer penalties
  • The Treasury Department and the IRS plan to issue final regulations soon intended to simplify and streamline the associated employer reporting requirements.

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