On November 30, 2018, the Department for Health and Human Services (“HHS”) Health Resources and Services Administration (“HRSA”) will publish its final rule to change the effective date for its 340B Drug Pricing Program ceiling price and manufacturer civil monetary penalty final rule to January 1, 2019.

After two years of proposed rulemaking, HHS published a final rule on January 5, 2017 outlining requirements of manufacturers to calculate the 340B ceiling price for a covered outpatient drug and the process by which HRSA can levy civil monetary penalties on drug manufacturers for knowingly and intentionally charging beyond the statutory ceiling price. This final rule was initially announced to be effective March 6, 2017 but was delayed on several instances. HHS’s most recent delay was announced on June 5, 2018, when HHS published a second final rule delaying the regulation’s effective date until July 1, 2019 so it could develop “comprehensive policies to address the rising costs of prescription drugs.” HHS then issued a proposed rule on November 2, 2018 soliciting comments on potentially changing the effective date from July 1, 2019 to January 1, 2019 to eliminate further delay. HHS’s latest announcement solidifies the effective date as January 1, 2019.

HHS maintains that finalizing the 340B ceiling price and civil monetary penalty rule will not interfere with its plan to develop separate drug pricing policies. Commenters expressed concern that HHS has not established adequate guidance to implement the rule appropriately, responded to public questions, or provided adequate rationale for its change of view on the need for additional rulemaking. HHS addressed these concerns by explaining that issuing additional guidance is unnecessary to implement the rule and that it would be more efficient for the rule to go into effect sooner and to “assess the need for further rulemaking and guidance after the rule is in effect.” Other commenters feared that they would be unable to achieve compliance in time for a January 1, 2019 effective date. HHS responded that, since HHS published the initial final rule in January 2017, these stakeholders have had “sufficient time” to adjust their systems and update their policies and procedures.

After January 1, 2019, drug manufacturers must calculate the 340B ceiling price for covered drugs on a quarterly basis consistent with the January 5, 2017 final rule. Most significantly, drug manufacturers will newly be subject to financial sanctions for knowingly and intentionally overcharging a covered entity, although HRSA anticipates using such penalties in “rare situations.”   For additional information about the issues discussed above, please contact one of the authors or the Epstein Becker Green attorney who regularly handles your legal matters.

On October 15, 2018, the Centers for Medicare and Medicaid Services (CMS) unveiled its proposed rule requiring direct-to-consumer television advertisements for prescription drug and biological products to contain the list price (defined as the Wholesale Acquisition Cost) if the product is reimbursable by Medicare or Medicaid. Medical devices are not included in the proposed rule, although CMS seeks comment on how advertised drugs should be treated if used in combination with a non-advertised device. If finalized, the requirement will be sweeping and only purports to exclude products costing under $35 per month for a 30-day supply or a typical course of treatment.

CMS prescribes specific language for manufacturers to use at the end of an advertisement:

The list price for a [30-day supply of ] [typical course of treatment with] [name of prescription drug or biological product] is [insert list price]. If you have health insurance that covers drugs, your cost may be different.

The list price is determined “on the first day of the quarter during which the advertisement is being aired or otherwise broadcast.” This pricing statement must be legible, “placed appropriately against a contrasting background for sufficient duration,” and must be in an easily read font and size. Manufacturers are permitted under the proposed rule, “[t]o the extent permissible under current laws,” to include a competitor’s current product list price, so long as the disclosure is done in a “truthful, non-misleading way.”

CMS proposes that drug and biological products in violation of the proposed rule would be publically listed on its website. Although CMS acknowledged that it was proposing no other HHS-specific enforcement mechanisms, CMS anticipates an influx in private actions under the Lanham Act as the primary enforcement mechanism if the proposed rule is finalized.

Health and Human Services Secretary Alex Azar emphasized the proposed rule’s intent to mitigate consumer out-of-pocket costs and reduce unnecessary Medicare and Medicaid expenditures. Interested stakeholders can submit comments online to the regulations.gov docket or by mail until December 17, 2018.

In 2016, the populist trend in American politics was an undeniable factor behind Trump’s election victory as well as the ascendancy of Bernie Sanders and Elizabeth Warren within the Democratic Party.  During upcoming months, industry observers will be looking for signs as to whether drug pricing is an area in which both parties can agree on instituting significant legislative action at the state and federal levels.  The nature and shape of any such reforms will be highly consequential for the U.S. pharmaceutical industry, which has served as a prime source of innovation in medicine.  The question going forward is whether cool-headed reform that facilitates patient access to drugs without stymying pharmaceutical R&D investment can be achieved in an era of fervent populism and discontent over rising healthcare costs.

For more, see Politics, Populism, and the Future of Prescription Drug Pricing Reform in PharmaExec.com.

A recent article in Bloomberg BNA’s Health Insurance Report will be of interest: "ACA’s Employer ‘Pay or Play’ Mandate Delayed – What Now for Employers?" by Frank C. Morris, Jr., and Adam C. Solander, colleagues of ours, based in Epstein Becker Green’s Washington, DC, office. Following is an excerpt:

The past few weeks have changed the way that most employers will prepare for the employer ‘‘shared responsibility” provisions of the Affordable Care Act (ACA). Over the past year or so, employers have scrambled to understand their obligations with respect to the shared responsibility rules and implement system changes, oftentimes with imperfect information to guide their efforts to comply with ACA.

Understanding the difficulties that both employers and the health insurance exchanges or marketplaces would have, the Internal Revenue Service (IRS) on July 2 issued a press release stating it would delay the shared responsibility provisions and certain other reporting requirements for one year, until Jan. 1, 2015.

On July 9, the IRS published Notice 2013-45 (Notice), providing additional information on the one-year delay. Specifically, the following three ACA requirements are delayed:

  1. The employer shared responsibility provisions under Section 4980H of the Internal Revenue Code (Code), otherwise known as the employer mandate;
  2. Information reporting requirements under Section 6056 of the Code, which are linked to the employer mandate; and
  3. Information reporting requirements under Section 6055 of the Code, which apply to self-insuring employers, insurers, and certain other providers of ‘‘minimum essential coverage,” as defined by ACA.

The IRS notice clarifies that only the above three requirements are delayed. The notice does not affect the effective date or application of other ACA provisions, such as the premium tax credit or the individual mandate. Given the fact that the law itself is not delayed, the notice has raised significant issues for employers despite their being generally pleased with the mandate and penalty delay. This article will discuss the impact of the delay and some of the issues that employers should consider as a result of the delay.

Click here to download the full article in PDF format. The attached file is reproduced with permission from Health Insurance Report, 19 HPPR 28, 7/31/13. Copyright © 2013 by The Bureau of National Affairs, Inc. (800-372-1033) http://www.bna.com

I was recently quoted in an article titled “4th Circuit Upholds ACA’s Employer Mandate, Says Insurance Regulation Within Commerce,” by Mary Anne Pazanowski, in Bloomberg BNA’s Health Care Daily Report. Following is an excerpt:

A unanimous U.S. Court of Appeals for the Fourth Circuit July 11 declared the Affordable Care Act’s employer mandate a valid exercise of Congress’s power to regulate commerce under the U.S. Constitution’s Commerce Clause (Liberty University Inc. v. Lew, 4th Cir., No. 10-2347, 7/11/13).

In an opinion co-authored by Judges Diana Gribbon Motz, James A. Wynn Jr., and Andre M. Davis, the court held that the mandate is ”simply an example of Congress’s longstanding authority to regulate employee compensation offered and paid for by employers in interstate commerce.”

The ruling comes in a case filed by Liberty University Inc. and two individual plaintiffs that challenged both the individual and employer mandates. Treasury Secretary Jacob Lew has been substituted as a defendant in place of former Secretary Timothy Geithner.

Stuart Gerson, a former acting U.S. attorney general who is now an attorney with Epstein Becker Green in Washington, told BNA July 11 that ”there is considerable force to the Fourth Circuit’s view that health insurance decisions affect employment, which itself is a matter of interstate commerce.”

He predicted that, if the case returns to the Supreme Court—as seems likely based on a July 11 press release from the university’s attorneys—there would be four solid votes to uphold the Fourth Circuit’s ruling. But, he said, ”it is difficult to predict how the chief justice and the other four conservative justices come out on this point.” He added, though, that ”one must at least recognize that there is a difference between an individual’s decision not to engage in commerce and the clear commercial activity in which Liberty indisputably engages.”

Of course, Gerson said, if the conservatives on the high court vote to uphold Liberty’s challenge to the employer mandate, Chief Justice John G. Roberts Jr. ”could again perform the legerdemain and create a fifth vote for affirmance by holding that the employer man- date is supportable under the tax power as was the individual mandate in NFIB. The Fourth Circuit’s alternative reasoning allows for this result.”

Our colleagues Kara Maciel, Frank C. Morris Jr., Elizabeth Bradley, and Adam Solander have posted a client advisory on the recent ACA employer mandate delay, exploring the ramifications and unresolved issues that employers should consider. Following is an excerpt:

In reaction to employers’ concerns about the many difficulties posed in efforts to comply with the Employer Mandate provisions of the Affordable Care Act ("ACA"), the Obama administration ("Administration") announced late yesterday that it is delaying the implementation of the penalty provisions and other aspects of the shared responsibility regulations until 2015. While the delay may have been to accommodate stakeholder requests, the delay also may have accommodated the Administration in connection with its readiness to implement the Employer Mandate. This delay could be a precursor to other implementation delays as the Administration seeks to make the ACA’s implementation successful, especially in light of intense scrutiny as to implementation and an inability to amend the law in Congress.

Read the full advisory: Employer Mandate Delayed—Employers Get Welcome Relief from Penalties Until 2015, but Many Questions Remain.

Greta RavitskyBy Greta Ravitsky

I wrote the January 2013 edition of Take 5: Views You Can Use, a newsletter published by the Labor and Employment practice of Epstein Becker Green.

In it, I summarize five actions that employers should consider taking in 2013 as the DOL steps up its audit efforts under the leadership of the reenergized Obama administration:

  1. Assess the Workforce
  2. Choose Whether to “Pay” or to “Play”
  3. Evaluate Existing Wellness Programs and/or Implement New Wellness Programs to Enhance Employees’ Health Profiles and to Avoid or Minimize the “Cadillac Tax”
  4. Understand and Be Ready to Comply with New Tax-Related Changes and Requirements
  5. Conduct Self-Audits to Ensure Compliance

The following is an excerpt:

With the U.S. presidential election behind us, it is clear that the Patient Protection and Affordable Care Act (“Affordable Care Act”) is likely here to stay, having survived a U.S. Supreme Court case challenge last June. While affected employers can avoid facing penalties until 2014 for not making health care coverage available to their workforce, the U.S. Department of Labor (“DOL”) has begun auditing employers’ group health plans for compliance with other requirements of the law that are already in effect. As the DOL steps up its audit efforts under the leadership of the reenergized Obama administration, below are five actions that employers should consider taking in 2013.

Read the full version on EBGlaw.com.

On Friday, November 30, Epstein Becker Green attorneys Frank C. Morris, Jr., and Adam C. Solander offered a one-hour webinar titled “The New Wellness Program Regulations, Part of a Webinar Series on the New ACA Implementation Regulations: Employer Impact.” The webinar discussed:

  • the proposed regulations and the impact these regulations could have on your overall wellness strategy
  • areas where employer comment is needed
  • recent wellness litigation trends
  • where EEOC fits in the picture

The audio recording and presentation slides for "The New Wellness Program Regulations" webinar are now available. Contact Elizabeth Gannon at 202/861-1850 or egannon@ebglaw.com, or Lisa Blackburn at 202/861-1887 or lblackburn@ebglaw.com, to obtain a password to download the files.

Epstein Becker Green is pleased to announce a webinar series for employers on the forthcoming rules and regulations implementing the Affordable Care Act ("ACA"). We expect the Administration to release a significant number of regulations in the near future which will directly impact employers.

EBG Health Care & Life Sciences and Labor & Employment practitioners, along with outside speakers, will provide in-depth analysis on proposed rules and regulations and how they will impact decisions that must be made by employers. The first webinar will take place on November 30.

Stay tuned for upcoming webinars on:

  • Wellness Programs
  • Exchange Implementation
  • Shared Responsibility
  • And others…

In addition to this blog, EBG’s HEAL blog will also post regulatory developments.

Click here to register for the November 30th Wellness Programs Webinar

For additional Information, please contact Elizabeth Gannon at 202/861-1850 or egannon@ebglaw.com, or Lisa Blackburn at 202/861-1887 or lblackburn@ebglaw.com.

by Jackie Selby and Jane L. Kuesel

As enacted in the Patient Protection and Affordable Care Act, states are required to have established operational health benefit exchanges by January 1, 2014, or the federal government will implement one for them. These exchanges will allow individuals and small businesses to buy health care coverage and are expected to add approximately 30 million currently uninsured persons to the health insurance market. Most of the health plans that will be offered on such exchanges will be managed care plans with networks of participating providers. Thus, the resulting new business will be covered by hospital, physician, and other provider participation agreements with such managed care plans.

Read the full alert here