HRI regulatory center

HRI regulatory center



HRI regulatory spotlight: Managing antimicrobial resistance: More than just medicine
HRI regulatory spotlight: Managing antimicrobial resistance: More than just medicine

Antimicrobial resistance is a threat to the nation’s health and security. To help reduce this threat, President Obama recently proposed a $1.2 billion investment for research and development of new antibiotics.
HRI regulatory spotlight: States use rate approval authority to manage individual health insurance premium prices for 2015
HRI regulatory spotlight: States use rate approval authority to manage individual health insurance premium prices for 2015

The individual health insurance market has received much attention as consumers enroll in plans for 2015. In the months leading up to the 2015 open enrollment period, PwC’s Health Research Institute (HRI) analyzed insurers’ rate filings and found that premium increases over 2014 varied widely from state to state.
HRI regulatory spotlight: FDA sheds light on social media use for life-sciences sector
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
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
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
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.
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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 02/16/2015

  • New FDA guidance on drug compounding released
  • As the number of newly insured increases, so does opportunity
  • Providers leery of proposed Medicare shared-savings rule
  • New CMS program targets coordination among cancer patients
  • FDA urges consumer-friendly drug labels

Week of 02/09/2015

  • CMS amends final Medicare Advantage, drug benefit rule
  • Data breach highlights delicate balance between privacy and convenience
  • Regulators call for new privacy, security protections in era of mHealth
  • FDA streamlines application for experimental therapies
  • IRS attempts to ease ACA-related tax penalty
  • New HRI Spotlight: States use rate approval authority to manage insurance premiums

Week of 02/02/2015

  • President Obama’s budget outlines healthcare priorities
  • CMS proposes leeway as ‘interoperability’ deadline nears
  • Enrollment swells as states expand Medicaid
  • Congress provides details on medical innovation effort
  • New HRI Spotlight: Managing antimicrobial resistance: More than just medicine

Week of 01/26/2015

  • CMS sets goals, timeline for new Medicare payment models
  • Marketplace competition driving lower premiums, higher deductibles
  • Unique identification for devices moves forward
  • "Medicaid bump" increased access to care for low-income patients
  • For hospitals, Medicare penalties outweigh bonuses
  • New HRI Report: The FDA and industry: A recipe for collaborating in the New Health Economy

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

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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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