HRI regulatory center

HRI regulatory center

HRI regulatory spotlight: New Medicare physician payment formula will reward risk, quality care
HRI regulatory spotlight: New Medicare physician payment formula will reward risk, quality care
After 18 contentious years, Medicare’s sustainable growth rate formula—intended to determine yearly payment rate updates for doctors who care for Medicare patients—will be replaced by a series of new reimbursement models that more closely reflect broader healthcare trends, such as growing consumerism and rewards for high-quality, low-cost care.
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 05/11/2015

  • Drug makers fight for flexibility in off-label promotion
  • OIG: Providers paid $8.2 million so far this year in penalties for false claims
  • In Medicaid, a small number account for highest costs
  • Proposed 2016 marketplace premium rates trickle in
  • Survey: Consumers struggle with selecting health plans
  • New HRI Report: Money matters: Billing and payment for a New Health Economy
  • HRI as we see it will not publish the week of 05/18/15

Week of 05/04/2015

  • Medicare drug spending reaches $103 billion 2013
  • Funding concerns arise for ACA exchanges and risk corridors
  • Pioneer ACO program gets approval to expand
  • FDA helps device companies optimize foreign clinical data
  • Medicaid expansion efforts roll on

Week of 04/27/2015

  • FDA’s plan to regulate lab-developed tests sparks intense debate
  • Blue Cross and Blue Shield Plans announce private exchange for retirees
  • CMS expands mental health parity requirements to Medicaid and CHIP
  • Drop in health spending may be long-lasting, in part due to the ACA
  • FDA issues final biosimilar guidance: Learn more in HRI’s recent Spotlight
  • New PwC survey: An HR perspective – ACA reporting survey results

Week of 04/20/2015

  • Hospitals see a modest increase under inpatient payment rule
  • Five-star ratings prove elusive for most hospitals
  • FDA puts increased focus on drug quality
  • Proposed wellness rule provides some clarity, raises some concerns
  • HRI Spotlight: New Medicare physician payment formula will reward risk, quality care

Week of 04/13/2015

  • New Medicare law replaces SGR and includes risk-based payments
  • Drug spending growth reaches a 13-year high
  • Proposed rule eases EHR data collection and reporting efforts
  • Some states grant insurers flexibility in light of King v. Burwell uncertainty
  • FDA guidance may speed up device reviews

Week of 04/06/2015

  • CMS bumps up Medicare Advantage payments in final rule
  • MedPAC plan would replace short-stay hospital policy
  • FDA releases guidance to combat drug abuse
  • Federal insurance marketplace reopens as IRS extends filing period for some
  • Efforts to expand Medicaid heat up

Week of 03/30/2015

  • Hospitals get a reprieve on short-stay reviews
  • Drugmakers offer alternative to FDA labeling proposal
  • Medicare legislation builds on alternative payment models
  • New public-private initiative drives care coordination
  • President Obama lays out national action plan on antibiotic resistance

Week of 03/23/2015

  • ‘Meaningful Use’ requirements proposed as CMS eyes interoperability
  • HHS, DOJ crack down on healthcare fraud
  • Court decision may bolster biosimilars market
  • Latest Tenet deal highlights continued focus on outpatient care
  • FDA issues new drug safety report

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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.

Read more

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