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 01/19/2015

  • Obama pivots from reform to medicine in SOTU
  • Exchange enrollment forges ahead
  • FDA clarifies its oversight of mHealth
  • Clinical trial data sharing gets boost
  • States urged to consider pharmacist scope-of-practice expansion
  • California opens the door to new entrants in 2016 exchanges

Week of 01/12/2015

  • First US biosimilar approval within sight
  • Final rule clarifies tax-exempt hospital status
  • Employer coverage steady post-ACA
  • FDA lays out 2015 regulatory agenda
  • ‘Dual eligible’ demographics detailed in new report

Week of 01/05/2015

  • Providers brace for lower payments in 2015 as penalties kick in
  • FDA approved 41 new drugs in 2014
  • HHS releases draft rules revamping benefit summaries
  • CMS touts ACOs as Medicare spending growth slows
  • Track-and-trace requirements delayed

Special edition: Week of 01/05/2015

  • The future of ACA subsidies: King v. Burwell Supreme Court case
  • Finishing old business: Medicare payments, SGR, and ICD-10
  • Medical device tax: Repeal gains momentum
  • Health insurance in the workplace: Defining the work week and facing the “Cadillac tax”
  • 2015 spending bill hits ACA insurance risk corridors
  • Congress focuses on innovation agenda: Modernizing the FDA

Week of 12/15/2014

  • Year 2 of exchange enrollment reaches first deadline
  • Medical debt continues to haunt millions of consumers
  • Learning from the Ebola outbreak
  • GAO finds concentrated health insurance market pre-exchanges
  • HRI as we see it will not publish the weeks of December 22 and December 29

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

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