HRI regulatory center

HRI regulatory center

HRI regulatory spotlight:CMS final rule establishes flexibility for Medicare ACOs
HRI regulatory spotlight: CMS final rule establishes flexibility for Medicare ACOs
Medicare Accountable Care Organizations (ACOs) now have more flexibility in administrative requirements, additional choices around shared savings options, and new performance and quality metrics that they must meet as part of a final rule effective August 3, 2015.
HRI regulatory spotlight: New Medicare physician payment formula will reward risk, quality care
HRI regulatory spotlight: CMS draft rule revamps Medicaid managed care
Federal health officials are proposing to update decade old regulations, to better align rapidly growing Medicaid managed care programs with Medicare Advantage and private health insurance offerings.
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 07/20/2015

  • HHS sees mixed results in efforts to fight healthcare fraud
  • FDA finalizes drug shortage reporting rule
  • Slavitt nomination leads a year of change for agencies, associations
  • Ohio and California pass PBM reimbursement transparency laws
  • BCBS takes proactive approach to cyberattacks
  • Tax Research: Changes to high-deductible health plans, out-of-pocket maximums, on the horizon

Week of 07/13/2015

  • In the wake of King v. Burwell ruling, states reconsider exchange operations
  • CMS proposes bundled payment model for knee, hip replacements
  • White House releases draft guidance on protecting patient data
  • Medicaid expansion marches forward
  • New HRI Spotlight: CMS final rule establishes flexibility for Medicare ACOs

Week of 07/06/2015

  • Physicians see some relief under proposed ‘two-midnight’ rule changes
  • Medicare aims to pay for end-of-life consults
  • Pharmaceutical companies and providers had a $6.49 billion financial relationship in 2014
  • CMS adopts one-year ‘grace period’ for ICD-10 transition
  • CMS releases data on insurer risk payments
  • New HRI report: 21st Century Pharmaceutical Collaboration: The Value Convergence

Week of 06/22/2015

  • US Supreme Court upholds ACA subsidies in states using the federal exchange
  • FTC guidance expected to clarify role of state licensing boards
  • Biotech trade group: Embrace patient perspectives early in drug development
  • CMS: Home-based primary care drives savings
  • Group offers cancer drug value tool for comparing treatments
  • Covered California to launch patient data collection initiative
  • HRI as we see it will not publish the week of 06/29/15

Week of 06/15/2015

  • HHS releases rule finalizing changes for benefit summaries
  • AMA plans lobbying push to extend grace period of ICD-10 implementation
  • Double-digit increases not the case for all 2016 ACA marketplace premiums
  • PatientsLikeMe and FDA collaborate on post-market drug surveillance

Week of 06/08/2015

  • Final Medicare ACO rule gives providers more flexibility
  • CO-OPs’ proposed rate hikes could signal less price variation among ACA health plans
  • Pharmaceutical intellectual property rules discussed in Trans-Pacific Partnership
  • New HRI report: Medical Cost Trend: Behind the Numbers 2016
  • New HRI spotlight: CMS draft rule revamps Medicaid managed care

Week of 06/01/2015

  • Inspector General identifies new compliance targets for pharma, health systems
  • FDA priority review voucher sells for $245 million
  • Affordable Care Act faces new legal challenge
  • Community paramedicine seeks its place in the New Health Economy
  • Specialty drug Orkambi recommended for FDA approval

Week of 05/25/2015

  • Proposed rule increases state oversight of Medicaid managed care plans
  • Supreme Court decision may increase flexibility in product licensing
  • Hospitals leery of ‘Cures’ EHR provisions
  • States look ahead to 2016 as final results on 2015 ACA enrollment roll in
  • White House to hold summit on antibiotic resistance

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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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