A project of the George Washington University's Hirsh Health Law and Policy Program and the Robert Wood Johnson Foundation

Rulemaking, Rules, and Guidance

IRS releases employer mandate draft forms

Posted on July 25, 2014

The Internal Revenue Services (IRS) released two draft forms for employers required to adhere to the employer shared responsibility payment, or employer mandate, under the Affordable Care Act (ACA).  Beginning in 2015, employers with 100 or more employees will be required to provide health insurance to their employees pursuant to the ACA, and employers with more than 50 employees will be expected to comply with the mandate beginning in 2016.  The new draft forms are currently available for comment.

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HRSA removes orphan drug exemption under 340B

Posted on July 22, 2014

A rule released yesterday by the Health Resources and Services Administration (HRSA) clarifies a portion of the 340B program, which requires drug manufacturers to offer their pharmaceuticals at a discounted rate to covered entities.  Under 340B, a covered entity typically refers to healthcare providers treating medically vulnerable populations, such as Ryan White Clinics or Disproportionate Share Hospitals.  The new rule specifically removes the discount exemption for orphan drugs sold for off-label usage.  A recent lawsuit led to the promulgation of this interpretative rule,  as many orphan drugs are used to treat conditions other than the rare conditions for which the drugs were created.

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CMS releases 2015 Medicare payment rules

Posted on July 4, 2014

The Centers for Medicare and Medicaid Services (CMS) issued several rules concerning Medicare payments for 2015.  First, CMS released the 2015 physician fee schedule.  Pursuant to the “doc fix” legislation recently passed, this proposal holds physician payments for the first quarter of next year.  The rule also bolsters the Physician Payment Sunshine Act by requiring providers to report payments received from speaking at continuous education events.  Additionally, the proposal revises the quality scoring methodology so that accountable care organizations (ACOs) are better able to exemplify the improvements they make in quality measures.  The number of metrics will increase from 33 to 37.

Yesterday, CMS also updated the payment scheme for outpatient services by 2.1% for 2015.  Biologics and non-pass-through drugs are still expected to be paid at average sales price plus 6%.  Payments are anticipated to increase by $5.2 billion compared to 2014.

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Rule finalizes 90-day waiting limit

Posted on June 20, 2014

Today, the US Department of Health and Human Services (HHS), the Internal Revenue Service (IRS) and the Employee Benefits Security Administration (EBSA) released a final rule concerning the 90-day waiting period limitation. The final rule states that group health insurance plans cannot apply a waiting period that exceeds 90 days after the employee has been approved for coverage. The rule further states that small group plan orientation periods, the time it takes from hire to when the plan deems the employee is eligible for coverage, cannot exceed one month.

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IRS Q&A clarifies employer payment plans

Posted on May 27, 2014

According to a Q&A document recently released by the Internal Revenue Service (IRS), employers that do not offer health insurance but reimburse premiums for employees that purchase private insurance may be hit with a financial penalty. The Q&A states that employers utilizing this approach are effectively creating employer payment plans, which are beholden to the same rules and requirements as other group health plans under the Affordable Care Act (ACA). The IRS states that this arrangement does not comply with the ACA market reforms, and offering this option to employees may result in a $100/day excise tax per applicable employee for the employer.

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CMS issues Medicare Advantage and Part D final rule for 2015

Posted on May 21, 2014

The Centers for Medicare and Medicaid Services (CMS) issued the final rule for Medicare Advantage (Part C) and the Medicare prescription drug benefit program (Part D) for contract year 2015. The rule aims to clarify program provisions, enact statute requirements, and improve payment accuracy. One specific provision provided in the rule said CMS will not open up preferred networks to permit any willing pharmacy to offer preferred cost-sharing. CMS indicated they would continue to study preferred cost-sharing practices to address stakeholder reactions and concerns to the proposed policy.

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HHS releases final Marketplace rule

Posted on May 16, 2014

The US Department of Health and Human Services (HHS) issued a final rule entitled Patient Protection and Affordable Care Act; Exchange and Insurance Market Standards for 2015 and Beyond. Some specific provisions in the rule include:

  • Raising the administrative costs and profits ceiling under the risk corridor formula by 2%.
  • Providing information on how to include ICD-10 costs under the medical loss ratio (MLR).
  • Requiring qualified health plans (QHP) on the ACA Marketplace to have a more efficient and effective method for enrollees to acquire medications not covered on the plan. This specifically applies to enrollees on a course of treatment in which absence of the medication would substantially impact the individual’s life and health.
  • Requiring insurers to annually report plan changes to beneficiaries.
  • Beginning in 2016, Marketplaces will have to display quality data on all plans for public viewing. The data will be based on a five-star system and enrollee satisfaction surveys.
  • Enumerating state requirements that may prohibit Navigators or other assistors from performing their roles. For example, Navigators may go door-to-door for enrollment assistance and outreach. They may not, however, provide gifts to entice enrollment.
  • Delaying the “employee choice” option in the small business health options program (SHOP) to 2016.

The final rule is largely unchanged from the proposed version. An FAQ addressing market reforms and Marketplace standards can also be accessed here.

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New CMS rule reduces burden and promotes efficiency

Posted on May 8, 2014

A final rule released by the Centers for Medicare and Medicaid Services (CMS) is designed to loosen policies that could save hospitals up to $3.2 billion over the next five years. One policy addressed removes the requirement that a physician must be present at a rural health center every two weeks, which was implemented to help combat the shortage of rural health providers. The rule also relaxes supervision requirements for some providers, such as dieticians. Easing regulations under this rule follows suit with the administration’s “regulatory lookback” that began in 2012.

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Administration releases more ACA guidance

Posted on May 5, 2014

Last Friday, the Centers for Medicare and Medicaid Services (CMS) posted a new bulletin on special enrollment periods and hardship exemptions under the Affordable Care Act (ACA). The bulletin provides information on how federally-facilitated Marketplaces (FFM) should address coverage for individuals that fall into the following four categories: hardship exemptions for individuals that obtained coverage effective May 1st, special enrollment periods for individuals eligible for or enrolled in COBRA, special enrollment periods for individuals whose plans are renewing outside of open enrollment, and special enrollment periods for AmeriCorps/VISTA/National Civilian Community Corps Members. The bulletin suggests that state-based Marketplaces (SBM) use these guidelines to help individuals that fall into these categories.

The administration also released a new FAQ set regarding ACA implementation. This FAQ, prepared jointly by the US Department of Treasury, the US Department of Health and Human Services, and the US Department of Labor, addresses questions concerning a myriad of health reform topics. Several of the issues addressed include updated Department of Labor Model Notices for COBRA, out-of-network and out-of-pocket charges, and Summaries of Benefits and Coverage (SBC).

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CMS releases payment rules

Posted on May 1, 2014

A final rule released on Tuesday indicates that federally qualified health centers (FQHCs) may receive a 32% payment boost under Medicare’s new payment system. Effective October 1st of this year, Medicare will pay FQHCs a per member per day fee of $158.85, which will be adjusted for geographic differences in healthcare costs. The Centers for Medicare and Medicaid Services (CMS) currently does not adjust payments for FQHC patients.

Another rule released by CMS discusses inpatient payment regulations for 2015. Per the Hospital Readmission Reduction Program, Medicare payments to physicians with poor readmission rates could be reduced by as much as 3%. Hospitals with poor performance regarding hospital acquired conditions may face an additional penalty.

Other payment rules released by CMS include skilled nursing facilities, rehabilitation facilities, and psychiatric facilities, which all call for payment increases of 2%, 2.2%, and 2.1% respectively.

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