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

Rulemaking, Rules, and Guidance

HHS publishes rules on contraception coverage

Posted on August 25, 2014

The U.S. Department of Health and Human Services (HHS) published an interim final rule which provides an alternative process for an eligible organization to provide notice of its religious objections to providing contraceptive coverage.  It will allow qualifying organizations to notify HHS of their religious objections to providing coverage and the government will in turn contact their insurers, which are to provide contraceptive benefits to the employees without any cost sharing.  HHS additionally released a proposed rule which changes  the definition of an eligible organization that can avail itself of an accommodation with respect to coverage of certain preventive services. These rules come in response to recent decisions against the Affordable Care Act’s (ACA) birth control mandate from multiple federal courts. HHS also released a coinciding fact sheet on the rules.

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CMS announces updated training program for ACA navigators

Posted on August 15, 2014

The Centers for Medicare and Medicaid Services (CMS) released a bulletin updating the Navigator, non-Navigator assistance personnel, and certified application counselor training curriculum for the Federally-facilitated and State Partnership Marketplaces in preparation for the next Open Enrollment Period beginning November 15, 2014.  The expanded curriculum will include more information on immigration, household income calculations and help for specific populations, including victims of domestic abuse and college students.  All assisters, whether they are seeking recertification or initial certification, will be required to complete the new training program.

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CMS publishes Medicare pay final rule

Posted on August 5, 2014

The Centers for Medicare and Medicaid Services (CMS) issued a final rule revising the Medicare hospital inpatient prospective payment systems (IPPS). In adherence to the Affordable Care Act (ACA), part of the rule would effectively reduce payments to disproportionate share hospitals (DSH), which serve the most vulnerable patients. DSH payment reductions are a result of the expansion of Medicaid, however in states that chose not to expand, hospitals still risk losing some payment for uncompensated care.

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CMS issues regulations on premium payment

Posted on July 24, 2014

The Center for Consumer Information and Insurance Oversight (CCIIO) and the Centers for Medicare & Medicaid Services (CMS) issued Federal guidance which gives individuals a three-month grace period to pay a premium without losing coverage. However, the same guidance states that if individuals choose enroll in a new policy for 2015, insurance companies cannot apply new premiums to outstanding 2014 debt. Some have suggested that this inconsistency could allow consumers to avoid paying their December premiums. However, nothing bars an insurer from making a bona fide effort to collect any unpaid premiums, as the consumer would still owe this amount to the insurer.

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IRS releases final rules on tax credit and drug fee

Posted on July 24, 2014

The Internal Revenue Service (IRS) published a final rule clarifying its premium tax credit policy for those enrolling in health plans through Affordable Insurance Exchanges with complicated family and household situations. The rule clarifies that certain married individuals, including spouses in abusive relationships, and divorced or separated taxpayers, can be considered not married for the purposes of the Internal Revenue Code, under Section 7703(b).

The agency also released a final rule regarding the implementation of the Affordable Care Act’s (ACA) branded prescription drug fee. The rule  provides guidance on the annual fee imposed on covered entities engaged in the business of manufacturing or importing branded prescription drugs.

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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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