Department of Health and Human Services
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.
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.
Posted on June 26, 2014
A new proposed rule issued today by the Center for Consumer Information and Insurance Oversight (CCIIO) discussed annual eligibility redetermination under the Affordable Care Act (ACA) and several other enrollment standards for ACA Marketplace. CCIIO stated that nearly all of those currently enrolled in an ACA Marketplace plan will be re-enrolled unless they choose a new plan in the next open enrollment period or the plan in which they are currently enrolled is terminated. The rule proposes three methods for ACA Marketplaces to conduct annual redeterminations for enrollment. The rule also proposes standards to redetermine eligibility within a plan year and when an individual’s plan in the ACA Marketplace is not available for re-enrollment for the next plan year.
Additional guidance includes:
- Guidance on Annual Redeterminations for Coverage for 2015
- Draft Standard Notices When Discontinuing or Renewing a Product in the Small Group or Individual Market
- Instructions for Draft Standard Notices for Product Discontinuation and Renewal
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.
Posted on June 18, 2014
A new report by the US Department of Health and Human Services (HHS) describes how premiums vary among the 36 states operating federally-facilitated Marketplaces under the Affordable Care Act (ACA). The report, released by the Office of the Assistant Secretary for Planning and Evaluation (ASPE) within HHS, found the average premium payment by an individual receiving subsidies to be $82, with the subsidized average for the silver plan metal tier being $69. Average subsidized premiums ranged from $23/month in Mississippi to $148/month in New Jersey. The report does not capture the corresponding data for the state-based Marketplaces.
Posted on June 13, 2014
The Centers for Medicare and Medicaid Services (CMS) issued a rule to change the payment adjustment for low-volume hospitals and Medicare-dependent hospitals. The changes would be issued under the hospital inpatient prospective payment systems (IPPS) for the second half of fiscal-year 2014. According to the rule, a hospital is considered low-volume if it is more than 15 miles from another hospital and has less than 1600 discharges of individuals entitled to or enrolled in Medicare Part A.
Posted on June 12, 2014
A new FAQ released by the Center for Consumer Information and Insurance Oversight (CCIIO) addresses questions insurance issuers may have concerning Essential Community Providers (ECPs). The Affordable Care Act (ACA) requires issuers to contract with a sufficient number of ECPs, or providers that generally treat low-income and medically underserved patients. The FAQ describes specifics of the ECP requirements, how issuers can access the non-exhaustive ECP list, and how ECPs can actively pursue inclusion in insurance planes. A similar FAQ addressing the same ECP issues was released in May of 2013.
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.
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.
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).