Health & Welfare Plans Newsletter

October 16, 2018

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[Official Guidance]

Text of CMS Proposed Regs: Medicare and Medicaid Programs -- Drug Pricing Transparency

45 pages. "This proposed rule would ... [amend] the Medicare Parts A, B, C and D programs, as well as the Medicaid program, to require direct-to-consumer (DTC) television advertisements of prescription drugs and biological products for which payment is available through or under Medicare or Medicaid to include the Wholesale Acquisition Cost (WAC, or 'list price') of that drug or biological product.... [CMS seeks] comment on [1] [W]hether Wholesale Acquisition Cost is the amount that best reflects the 'list price' for the stated purposes of price transparency and comparison shopping under this proposed regulation.... [2] [W]hether 30-day supply and typical course of treatment are appropriate metrics for a consumer to gauge the cost of the drug.... [3] [H]ow to treat an advertised drug that must be used in combination with another non-advertised drug or device.... [4] [W]hether the cost threshold of $35 to be exempt from compliance with this rule is the appropriate level and metric for such an exemption." Centers for Medicare & Medicaid Services [CMS], U.S. Department of Health and Human Services [HHS]

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[Guidance Overview]

HHS Fact Sheet: What You Need to Know about Putting Drug Prices in TV Ads

"The 10 most commonly advertised drugs have list prices ranging from $535 to $11,000 per month or usual course of therapy.... 47 percent of Americans have high-deductible health plans, under which they often pay the list price of a drug until their insurance kicks in.... List prices are also what patients pay if a drug is not on their insurance formulary, and list prices help determine insurance plans' placement of drugs on their formulary." U.S. Department of Health and Human Services [HHS]

[Guidance Overview]

CMS Proposes Requirement that Manufacturers Disclose Drug Prices in Television Ads

"[T]he posting would take the form of a legible textual statement at the end of the ad. The HHS Secretary would maintain a public list of drugs that were advertised in violation of this rule. CMS would provide an exception to the requirement to post prices for prescription drugs with list prices of less than $35 per month." Centers for Medicare & Medicaid Services [CMS], U.S. Department of Health and Human Services [HHS]

[Guidance Overview]

Editor's Pick 2018 Welfare Plan Participant Disclosure Checklist (PDF)

6 pages. Designed for use during open enrollment as well as during the plan year. Bass, Berry & Sims

TV Ads Must Trumpet Drug Prices, Trump Administration Says; Pharma Tries a Plan B

"If approved, the proposed rule has no government enforcement mechanism that would force the companies to comply. Rather, it depends on shaming, noting that federal regulators would post a list of companies violating the rule. It would depend on the private sector to police itself with litigation." Kaiser Health News

Opioid Bill Expands Secondary Payer Reporting for Group Health Plans

"The legislation expands Medicare secondary payer reporting requirements for group health plans, which must submit data on prescription drug coverage. The purpose is to identify situations where the employer plan -- rather than Medicare -- should be the primary payer for Part D (drug) benefits. The final agreement leaves out an earlier House provision that would have extended the period during which employer-sponsored health plans are primary payers for people with end-stage renal disease." Willis Towers Watson

Employee Benefits After Divorce

"Plans that identify ineligible individuals on their plans will want to review claims incurred by the individual after they lost eligibility.... in some cases (particularly where a plan is funded through a trust), the plan administrator may need to restore any incorrectly paid funds to the plan to rectify a potential breach of fiduciary duty.... [P]lans must approach these situations consistently so as to avoid potentially singling out certain employees[.]" HUB International

Business and Operational Issues Associated with Forming an AHP: Engaging an Insurance Carrier

"An association which is starting a new AHP will typically require a lot of assistance and expertise from its prospective insurance company partner. This means diversion of time and precious resources without immediate compensation; the carrier's reward will only arrive if the AHP is successful and the member firms generate profitable revenue to the carrier. In most cases, it takes years for a startup AHP to build up to a sustainable level, and there's no guarantee of success.... So why would a carrier ever partner with an AHP? To a large extent, it's often a defensive measure." Benefits BCLP

HHS Adjusts Penalties for HIPAA Violations

"HHS has announced its annual inflation-related adjustments to civil monetary penalties for violations of the HIPAA Privacy and Security Rules. These penalties reflect a 2.041 percent increase over the prior amounts and are effective as of October 11, 2018.... The new amounts apply only to penalties assessed on or after October 11, 2018, for violations occurring on or after November 2, 2015."
Buck

Anthem Pays OCR $16 Million in Record HIPAA Settlement Following Largest U.S. Health Data Breach in History

"The $16 million settlement eclipses the previous high of $5.55 million paid to OCR in 2016.... This breach affected electronic protected health information (ePHI) that Anthem, Inc. maintained for its affiliated health plans and any other covered entity health plans." U.S. Department of Health and Human Services [HHS]

How to Avoid a $16 Million Settlement with HHS

"While you may not have PHI of 79 million individuals, even a single violation of HIPAA can lead to the $1.5 million cap per violation very quickly (as HHS has the authority to penalize a covered entity up to $50,000 per violation per individual impacted). This breach all began with employees receiving phishing emails. At least one Anthem employee responded to the phishing email, which opened the door to the cyber-attackers obtaining personally identifiable information of approximately 79 million individuals." Graydon

CMS Releases Additional 2019 Coverage Data; Another Insurer Wins CSR Case

"[CMS] released new data showing average premiums for 2019 marketplace plans in the 39 states that use HealthCare.gov. The report includes national and state-specific average monthly premiums for the second-lowest-cost silver plan and the lowest-cost plan from 2016 to 2019.... [Also,] Judge Elaine D. Kaplan of the Court of Federal Claims ordered the federal government to pay about $360,000 in unpaid CSR payments to Sanford Health Plan. This is believed to be the second decision on whether insurers are owed unpaid CSRs following the Trump administration's abrupt decision to stop making the payments last year." Katie Keith, in Health Affairs

Benefits in General

[Official Guidance]

Text of IRS Disaster Relief Announcement VA-2018-02, for Victims of Hurricane Florence in Virginia

"Individuals who reside or have a business in Henry, King and Queen, Lancaster, Nelson, Patrick, Pittsylvania, and Russell counties and the Independent Cities of Newport News, Richmond, and Williamsburg may qualify for tax relief.... [C]ertain deadlines falling on or after Sept. 8, 2018 and before Jan. 31, 2019, are granted additional time to file through Jan. 31, 2019." Internal Revenue Service [IRS]

IRS Extends Deadlines for Additional Areas in Florida, Georgia, North Carolina, South Carolina and Virginia Affected by Hurricanes Florence and Michael

"After additional disaster declarations by FEMA, the IRS has added more counties that are eligible for individual and public assistance in areas of Florida and Georgia affected by Hurricane Michael .... In addition, the IRS has also extended these deadlines for additional Hurricane Florence victims covered under FEMA public assistance declarations. This includes taxpayers in a number of counties in North Carolina, South Carolina and Virginia."
Internal Revenue Service [IRS]

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Lois Baker, J.D., President
David Rhett Baker, J.D., Editor and Publisher
Holly Horton, Business Manager

BenefitsLink Health & Welfare Plans Newsletter, ISSN no. 1536-9595. Copyright 2018 BenefitsLink.com, Inc. All materials contained in this newsletter are protected by United States copyright law and may not be reproduced, distributed, transmitted, displayed, published or broadcast without the prior written permission of BenefitsLink.com, Inc., or in the case of third party materials, the owner of those materials. You may not alter or remove any trademark, copyright or other notices from copies of the content.

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