HRI regulatory center

HRI regulatory center

HRI regulatory spotlight: FDA sheds light on social media use for life-sciences sector
Consumers are increasingly turning to social media websites such as Twitter, Facebook and CaringBridge to better engage in health decisions. But when it comes to social media and healthcare, life-sciences companies have lagged behind.
HRI regulatory spotlight: Hospitals face compliance challenges under 'two-midnight' rule
Chief financial officers say they could lose millions of dollars in payments—and potentially change how and when patients are admitted for care—under a controversial Medicare rule that narrows hospital admission criteria.
HRI regulatory spotlight: Medicaid rule revamps home and community services
A final rule from CMS makes it easier for Medicaid beneficiaries to receive services in their homes and communities, and adds fuel to the rapidly growing long term care industry.
HRI regulatory spotlight: Medical device identifiers: Better outcomes through better tracking
Seven years after Congress instructed the FDA to create a system to enhance its tracking of medical devices the agency released a final rule this September fulfilling the requirement.
HRI Spotlight: FDA focuses on patient safety as medical devices go wireless
HRI regulatory spotlight: FDA focuses on patient safety as medical devices go wireless
As more medical devices include remote technology, the FDA is advising manufacturers to ensure their products remain safe and effective.
HRI's closer look
Health insurance premiums: Comparing ACA exchange rates to the employer-based market
In 2014 the premiums for state exchange based health plans are comparable to -- and in some cases lower than -- those being offered by employers. The data suggest the new exchanges are competitive with the current insurance market and may open doors for employers as they contemplate future benefits strategies.
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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 12/08/2014

  • Spending bill pushes health issues into 2015
  • FDA issues new guidance for generic drugs, delays another
  • The ACA’s newly insured
  • Devicemakers eye risk-based contracts

Week of 12/01/2014

  • As concerns mount, CMS offers ACOs fresh support
  • 2015 open enrollment: Two weeks down, 11 to go
  • New requirements proposed for Rx benefits in exchange plans
  • FDA releases menu labeling rules
  • PwC insight on tax treatment of generic drug litigation costs
  • New HRI report: Top health industry issues of 2015

Week of 11/17/2014

  • Health insurance marketplace 2015 season opener: so far, so good
  • Sunscreen Innovation Act lands on President Obama’s desk
  • MedPAC sees fewer hospital admissions, offers ‘2-Midnight’ options
  • Hospitals express interest in CMS appeals process
  • FDA launches two new studies on televised drug advertising
  • New HRI report released: Healthcare delivery of the future
  • HRI as we see it will not publish the week of November 24

Week of 11/03/2014

  • Parts of the ACA in play after GOP takes Senate majority
  • Final Medicare rules set payment, policy changes for 2015
  • FDA to assess impact of patient input on drug review process
  • Inspector General plans dozens of new reviews for Medicare, Medicaid, and ACA
  • New ‘super office’ streamlines FDA’s pharmaceutical quality controls

Week of 11/10/2014

  • Supreme Court to rule on federal subsidies case
  • Medicaid DSH cuts could hinder safety net care
  • “Right to try” laws gain momentum
  • Obama administration requests $6 billion in emergency Ebola funding
  • More companies make big investments in private exchange technology

Week of 10/27/2014

  • CMS addresses data breaches and federal subsidies in new health plan agreement
  • Low-income residents in three states view Medicaid as superior to private coverage
  • HHS unveils $840 million practice transformation initiative
  • Report: Access to cost, quality data drives down costs
  • Federal agency tells drugmakers to provide refunds

Week of 10/20/2014

  • US ramps up Ebola containment and vaccine development efforts
  • As Medicaid enrollment soars, states see slower spending growth
  • CMS announces new ACO model and funding incentive
  • FDA, Congress focus on generic drugs
  • Health Wearables: Early Days

Week of 10/13/2014

  • Final HIPAA disclosure rule delayed until 2015
  • Medicare Advantage and Part D will have fewer plans in 2015
  • New analysis reveals Rx trends in public exchanges
  • ACA “Cadillac” tax likely to have widespread impact on employers, health plans
  • FDA finalizes cybersecurity guidance for devices

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