HRI regulatory center

HRI regulatory center



FDA announces landmark biosimilar approval
FDA announces landmark biosimilar approval

FDA’s first biosimilar approval – an event described as “historic” by agency leadership – marks an important step toward the drug cost savings intended by the ACA’s Biologics Price Competition and Innovation Act.
HRI regulatory spotlight: Regulatory action may strengthen telehealth take-off
HRI regulatory spotlight: Regulatory action may strengthen telehealth take-off

State and federal governments are playing a role in driving telehealth expansion. New York is the latest in over 20 states already mandating private insurer reimbursement, and more than 40 states have expanded Medicaid to cover telehealth.

For more information, click here to download HRI's overview presentation on telehealth.

 

HRI regulatory spotlight: Understanding the 3Rs – risk adjustment, risk corridors, and reinsurance
HRI regulatory spotlight: Understanding the 3Rs – risk adjustment, risk corridors, and reinsurance

The 3Rs were created to balance insurer risks in the insurance exchanges and incentivize health plans to participate in this new market.
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: 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 03/16/2015

  • SGR replacement unveiled as Congress moves toward repeal
  • FDA issues guidance on reusable devices
  • Payment recommendations reflect push for quality, cost control
  • Outcomes research ramping up
  • Successful enrollment season could bring financial challenges for Colorado CO-OP
  • New HRI Report: Healthcare Reform: Five trends to watch as the Affordable Care Act turns five

Week of 03/09/2015

  • New ACO model weighs more risk for return
  • FDA approves first biosimilar
  • Estimated ACA costs and “Cadillac” tax revenues fall
  • Hospital spending on charity care, community benefit documented
  • New Mexico explores leasing HealthCare.gov

Week of 03/02/2015

  • Supreme Court hears arguments in King v. Burwell
  • Few physician practice groups receive value-based bonus payments
  • FDA seeks to diversify drug, device trials
  • MedPAC readies “neutral site” payment recommendation
  • “Cadillac” tax inches closer
  • New HRI Spotlight: Regulatory action may strengthen telehealth take-off
  • New Health Industries Report: Global health's new entrants: Meeting the world's consumer

Week of 02/23/2015

  • CMS proposes lower Medicare Advantage payments
  • Medicare payments will account for cost of Hepatitis C drugs
  • 2015 open enrollment – not quite closed
  • CMS issues final benefit and payment parameters for 2016
  • Medical device surveillance system proposed
  • New PwC report on pharmaceutical, life sciences deals

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

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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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