HRI regulatory center: Regulatory and legislative updates and analysis

HRI regulatory spotlight: Meaningful use rule more flexible yet providers remain concerned
HRI regulatory spotlight: Meaningful use rule more flexible yet providers remain concerned
Providers work to comply with shifting meaningful use requirements.
HRI regulatory spotlight: Priority review vouchers: A shortcut in a drug’s race to market
HRI regulatory spotlight: Priority review vouchers: A shortcut in a drug’s race to market
Drug development is expensive and difficult, and companies have traditionally spent little to develop drugs for diseases with unlikely returns on investment.
HRI regulatory spotlight: Identification requirements for drugs, devices begin to ramp up
HRI regulatory spotlight: Identification requirements for drugs, devices begin to ramp up
New regulatory requirements are ramping up identity and labelling requirements for drugs and medical devices.
HRI regulatory spotlight: Quality reporting hits the ACA exchanges in 2016
HRI regulatory spotlight: Quality reporting hits the ACA exchanges in 2016
Starting in 2016, state and federal marketplace websites must display a new “star” rating system developed by HHS.
HRI regulatory spotlight: CMS proposes ‘two-midnight’ hospital payment compromise
HRI regulatory spotlight: New 340b guidance adds oversight to drug discounts
New federal guidance aims to clarify the eligibility of health systems for drug discounts received through the federal 340b Drug Pricing Program.
1 2 3 4 5

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

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 2/8/2016

  • President Obama’s budget tackles drug pricing, provider and payer reforms
  • FDA takes stronger stance on regulating opioid painkillers
  • CMS releases 2016 open enrollment data
  • New FDA guidance for medical device makers on prevention of user error
  • Health systems continue to expand care into the community
  • New HRI Spotlight: Major shift ahead in how FDA regulates drug quality
  • New HRI Spotlight: ACA marketplaces: Modest premium growth, fewer options, continued competition

Week of 2/2/2016

  • FDA unveils list of 2016 drug policy priorities
  • Government report finds generic drug prices are mostly steady
  • Medicare eyes new ways to gauge ACO performance, lessen risk
  • CMS proposes rule to package and sell Medicare claims data
  • Pharmacy boards add latest obstacle for telemedicine
  • White House launches “moonshot” to fight cancer

Week of 1/25/2016

  • CMS finalizes Medicaid drug rebate regulation
  • New CMS guidance eases hardship exceptions for meaningful use
  • The FDA issues new recommendations on device interoperability
  • Narrow networks on the rise in ACA marketplaces
  • New HRI Spotlight: CMS releases final meaningful use rule, hints at changes to come
  • New HRI Spotlight: Priority review vouchers – A shortcut in a drug's race to market

Week of 1/18/2016

  • FDA issues new draft medical device cybersecurity requirements
  • MedPAC calls for reduced 340B payments, Medicare Advantage changes
  • CMS tightens reins on ACA special enrollment periods
  • GAO report finds gaps in FDA’s post-market surveillance programs

Week of 1/11/2016

  • Louisiana expands Medicaid; Obama proposes additional money to get others on board
  • Eyeing consumer privacy, HHS updates HIPAA guidance
  • IRS sees “housing improvements” as a community benefit
  • FDA revamps, elevates dietary supplement regulatory division
  • New PwC report - 2016 Tax Policy Outlook: Setting priorities in an election year

Week of 1/3/2016

  • FDA lays out FY2016 regulatory priorities for devices
  • MACRA proposal aims to close gaps in quality measurement
  • Health plans in federal marketplaces receive guidance for 2017
  • CMS eyes RACs for Medicare Advantage oversight
  • Regulators invite patient groups to develop drug development insights

Special Edition

Top regulatory and policy issues for 2016

  • Insurers grapple with risk programs, question stability of exchange markets
  • Exchange plans get ready for first-time audits with end of safe harbor
  • Details emerge on new physician payment system
  • Meaningful Use and market consolidation still top provider concerns
  • Quiet changes to have big effect on drug and device approval processes
  • Unjamming the 21st Century Cures roadblock
  • Big health policy issues move to the states

Week of 12/14/2015

  • Medical device, ‘Cadillac,’ and insurer taxes delayed under major Congressional deal
  • HealthCare.gov sees boost in activity as first deadline hits
  • Hundreds of hospitals penalized by Medicare for poor performance
  • FDA drug approvals near all-time high
  • HRI as we see it will not publish during the weeks of Dec. 21 and Dec. 28

Week of 12/7/2015

  • Generic drug labeling regulation delayed
  • Ratings group forecasts stability for US hospitals
  • PPOs on ACA marketplaces reducing coverage
  • HHS OIG reports shortcomings in Office of Civil Rights’ HIPAA compliance program
  • New HRI report: Top health industry issues of 2016

Week of 11/30/2015

  • CMS proposed rule sets minimum network adequacy standards
  • CMS proposes changes to 3Rs in 2017 benefit and payment parameters
  • Obama signs new law extending marketing exclusivity periods for some drugs
  • Biosimilar regulatory process takes shape in new FDA guidance

Week of 11/16/2015

  • 2016 ACA enrollment off and running; states continue to eye Medicaid expansion
  • CMS works on Medicaid managed care final rule
  • Geisinger Health System offers money-back guarantee
  • Medical device approvals soar in 2015
  • New HRI report: Primary Care in the New Health Economy
  • HRI as we see it will not publish the week of November 23

Week of 11/09/2015

  • CMS acknowledges underpaying for dual-eligibles
  • Insurance commissioners plot path to broader provider networks
  • Federal regulations ease Stark law, increase False Claims fines
  • HHS publishes investigative plans for 2016
  • The top reasons medical device companies get into trouble with the FDA
  • New PwC report: Board governance in a transitioning health economy

Week of 11/02/2015

  • Two-midnight changes solidified under final payment rule
  • New CMS rules aim to bolster patient-centered care
  • Proposed rule modifies discharge process for hospitals
  • AMA responds to rise in telemedicine, begins developing standardized billing codes
  • CMS sets ground rules for biosimilar reimbursement

Week of 10/26/2015

  • Emerging budget deal impacts hospitals, pharma
  • ACA benchmark premiums hold steady with employer market over three years
  • ACA outreach groups prepare for exchange enrollment
  • FDA’s medical device division lays out priorities for 2016

Week of 10/19/2015

  • Third enrollment season on ACA exchanges looms
  • Inspector General alert puts providers, health IT sector, on notice
  • California places new limits on veterinary prescribing and rejects right to try legislation
  • Changes in physician training spurred by health reform and focus on quality
  • Device identification data to be included in electronic health records

Week of 10/12/2015

  • With start of open enrollment, seniors could face significant Medicare rate hikes
  • ACA’s small group market expansion repealed
  • FDA seeks to revamp consumer drug risk information
  • Primary care initiative shows promise, yet underscores challenges
  • New HRI Spotlight: Identification requirements for drugs, devices begin to ramp up

Week of 10/05/2015

  • Meaningful Use Stage 3, interoperability guidelines released
  • Agreement reached on biologics exclusivity in trade deal
  • ACA risk corridors program falls short on payouts
  • New Health Economy trends fuel new jobs
  • PCORI funds $83 million for new round of comparative outcome research

Week of 09/28/2015

  • CMS looks to avoid misfiled claims under new October 1st ICD-10 process
  • Biosimilar user fee program up for review
  • Medicare aims to change how it pays labs
  • Hospitals that treat the poor hit hardest by readmission penalties
  • Fourth ACA CO-OP folds
  • New HRI Closer Look: Healthcare’s Alternative Payment Landscape

Week of 09/21/2015

  • Federal judge sides with hospitals on “two-midnight” rule
  • Uninsured rate decreases as employer coverage holds steady
  • Economic assessment seeks to put fair price on drug value
  • States consider reform tweaks with innovation waivers
  • FDA integrating patient views into device approvals process
  • New HRI Spotlight: Quality reporting hits the ACA exchanges in 2016

Week of 09/14/2015

  • President Obama to nominate new FDA commissioner with industry experience
  • Major updates proposed to clinical research oversight rule
  • House gets go-ahead to move forward with ACA lawsuit
  • Hospitals, physicians take aim at new Medicare payment rules

Week of 09/07/2015

  • Federal officials eye new round of HIPAA audits
  • Long-awaited 340B omnibus guidance released
  • ‘Navigators’ receive $67 million in new CMS grants
  • First biosimilar hits the market at 15% lower price than competitor

Week of 08/24/2015

  • FDA on track for a record year for drug and device approvals
  • Court rules third-party administrators subject to mental health parity requirements
  • Healthcare channels shift ten years after Katrina
  • 2016 exchange rates slowly finalize as states reconsider Medicaid expansion plans
  • New Risk Assurance report: Healthcare needs to up its risk management game
  • HRI as we see it will not publish the week of 08/31/15

Week of 08/10/2015

  • Survey: Physicians lag hospitals and insurers for ICD-10 readiness
  • FDA data security capacity panned by Congress
  • Federal exchange struggles with eligibility determinations
  • Data analytics seen as key to managing ER ‘super users’
  • HRI as we see it will not publish the week of 08/17/15

Week of 08/03/2015

  • FDA approves new drug using special voucher
  • Increased competition puts downward pressure on exchange premiums
  • Most hospitals in line for a slight Medicare pay increase
  • FDA issues cybersecurity warning
  • New HRI Spotlight: CMS proposes ‘two-midnight’ hospital payment compromise


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