Health Law Advisor

Thought Leaders On Laws And Regulations Affecting Health Care And Life Sciences

HRSA Issues Interpretive Rule on 340b Orphan Drug in Response to Court Vacating Final Rule

LinkedIn Tweet Like Email Comment

By Constance Wilkinson, Alan Arville, and Jonathan Hoerner

On July 23, 2014, the Health Resources and Services Administration (“HRSA”) issued an “interpretive rule” entitled “Implementation of the Exclusion of Orphan Drugs for Certain Covered Entities under the 340B Program” (the “Interpretive Rule”).[1] The Interpretive Rule follows the ruling by the U.S. District Court for the District of Columbia on May 23, 2014, that vacated the final rule previously released by HRSA on the treatment of orphan drugs under the 340B program (the “Final Rule”).[2]

By way of background, the 340B program, created in 1992 and administered by HRSA, requires drug manufacturers to give discounts to entities covered under the law—known as “Covered Entities”—in order to have their drugs covered by Medicaid. The Affordable Care Act, along with the Medicare and Medicaid Extenders Act of 2010, expanded the definition of Covered Entities to include critical access hospitals, free-standing cancer hospitals, rural referral centers, and sole community hospitals. For these categories of Covered Entities only, drugs designated by the Food and Drug Administration as drugs “for a rare disease or condition” (“Orphan Drugs”) are excluded from covered outpatient drugs subject to mandatory 340B pricing requirements (the “340B Orphan Drug Exclusion”).[3] Other Covered Entities, such as disproportionate share hospitals, are not subject to the Orphan Drug Exclusion.

Interpretive Rule on Orphan Drugs in the 340B Drug Pricing Program

Consistent with the now vacated Final Rule, the Interpretive Rule states that the 340B Orphan Drug Exclusion only excludes Orphan Drugs when those drugs are “transferred, prescribed, sold, or otherwise used for the rare condition or disease,” for which the drug was designated orphan status. For example, even though Prozac (fluoxetine) is an Orphan Drug for the treatment of autism, under HRSA’s interpretation of the 340B Orphan Drug Exclusion, a Covered Entity subject to the 340B Orphan Drug Exclusion may purchase Prozac for its eligible patients at the 340B discount price when it is prescribed for depression, a non-orphan condition.[4] To support its position, HRSA states that its interpretation is consistent with the FDA’s interpretation of the orphan drug provisions in the Federal Food, Drug, and Cosmetic Act, including the FDA’s application of incentives for the development of orphan drugs (e.g., market exclusivity, tax credit, user fee exemption) to only the use of the drug intended to treat the rare disease or condition and not non-orphan drug indications.

The Interpretive Rule also discusses Section 340B’s requirement that prohibits certain hospitals, including free-standing cancer hospitals subject to the 340B Orphan Drug Exclusion, from purchasing covered outpatient drugs through a group purchasing organization (“GPO”). As with the Final Rule, the Interpretive Rule states that this prohibition does not apply to Orphan Drugs when they are used for the orphan designated rare condition or disease. Therefore, free-standing cancer hospitals can use a GPO to purchase an Orphan Drug for such rare condition or disease but cannot use a GPO when the drug is being used for other non-orphan purposes.

In order to facilitate the identification of drugs with an orphan designation for 340B Program purposes, the Interpretive Rule states that on the first day of the month prior to the end of the calendar quarter, HRSA will publish a listing of orphan drug designations, providing the name of the drug and the designated indication. HRSA also repeats its position in the Final Rule that a Covered Entity cannot purchase Orphan Drugs through the 340B program if the Covered Entity does not have the ability to track the indication for drug use. Notably, the Interpretive Rule does not include the requirement of the Final Rule that Covered Entities must notify HRSA if they cannot or do not wish to maintain auditable records sufficient to demonstrate compliance with the 340B Orphan Drug Exclusion.[5]

Previous Court Decision

After HRSA issued the Final Rule in July 2013, the Pharmaceutical Research and Manufacturers of America (“PhRMA”) brought suit against HRSA claiming that the rule was invalid because it contravened the plain language of the statute.[6] First, the court determined that the Final Rule was a legislative rule, a rule which carries the force of law. Next, the court concluded that HRSA lacked the statutory authority to promulgate the Final Rule as a legislative rule.

In addition to arguing that it had the requisite authority to issue a legislative rule, HRSA also took the alternative position that the Final Rule was not a legislative rule and should be viewed and upheld as an interpretive rule. As opposed to a legislative rule, an interpretive rule provides clarifications or explanations of a statute and does not create a new law, modify an existing law, or create an enforceable right. Even though an interpretive rule does not carry the force of law like a legislative rule, courts will generally give deference to an agency’s interpretive rule.

Calling HRSA’s argument “half-hearted,” the court noted that the Final Rule underwent notice and comment rulemaking and had a “legal effect” on the parties, two components of the D.C. Circuit’s test for a legislative rule. However, the court concluded that it lacked sufficient information to decide if the Final Rule could be considered a valid interpretive rule. HRSA declined the opportunity to make additional arguments on this issue and instead chose to separately promulgate the rule as the Interpretive Rule.

Future Implications

Immediately after HRSA released the Interpretive Rule, PhRMA filed a court document arguing that HRSA’s Interpretive Rule was an attempt to “evade the Court’s holding” that HRSA did not have authority to issue this rule.[7] Thus, it is likely that litigation will continue over the scope of HRSA’s ability to engage in rulemaking, which will likely impact HRSA’s issuance of the proposed 340B “mega-rule.” The “mega-rule” would address multiple key components of the 340B program including the definition of an eligible patient, compliance requirements for contract pharmacy arrangements, and hospital eligibility including criteria for off-site facilities. HRSA had planned to release the “mega-rule” as early as June 2014, but given the questions surrounding HRSA’s authority to engage in rule-making, the “mega-rule” will likely continue to be delayed.

In the absence of a grant of general rulemaking authority in the 340B statute, HRSA’s custom has been to administer the 340B program through a series of Notices issued through the Federal Register, as well as other sub-regulatory guidance. Whether HRSA reverts to this practice as a result of, or in the absence of, a judicial determination regarding its rulemaking authority remains to be seen.


ENDNOTES

[1] HHS HRSA, Interpretive Rule: Implementation of the Exclusion of Orphan Drugs for Certain Covered Entities Under the 340B Program, (July 21, 2014), http://www.hrsa.gov/opa/programrequirements/interpretiverule/.

[2] 340 Drug Pricing Program, 42 C.F.R. pt. 10 (2014).

[3] Public Health Service Act § 340B(e), 42 U.S.C. 256b(a) (2012).

[4] Pharm. Research & Mfrs. of Am. v. United States HHS, No. 13-1501, 2014 U.S. Dist. LEXIS 70894, at *2 (D.D.C. May 23, 2014).

[5] 340 Drug Pricing Program, 42 C.F.R. § 10.21(c)(3).

[6] Pharm. Research & Mfrs. of Am. v. United States HHS, No. 13-1501, 2014 U.S. Dist. LEXIS 70894 (D.D.C. May 23, 2014).

[7] Supplemental Memorandum in Support of PhRMA’s Motion for Miscellaneous Relief, ECF No. 52.

How Big Is Halbig? The Viability of the ACA’s Employer Mandate Hangs in the Balance

LinkedIn Tweet Like Email Comment

By: Adam C. SolanderKara M. Maciel, Mark M. Trapp, and Stuart M. Gerson

Yesterday, the U.S. Court of Appeals for the District of Columbia and the U.S. Court of Appeals for the Fourth Circuit sent shockwaves through the country when they issued conflicting opinions on a key aspect of the ACA.  The cases are Halbig v. Burwell, D.C. Cir., No. 14-508 and King v. Burwell, 4th Cir., No. 14-1158.  The question at issue in both cases was whether the IRS has the authority to administer subsidies in federally facilitated exchanges when the statute itself specifically authorizes subsides only in state exchanges.

According to the statutory text of the ACA, the penalties under the employer mandate are triggered only if an employee receives a subsidy to purchase coverage “through an Exchange established by the State under section 1311” of the ACA.  If a state elected not to establish an exchange or was unable to establish an operational exchange by January 1, 2014, the Secretary of HHS was required to establish a federal exchange under section 1321 of the ACA.

In 2012, the IRS promulgated regulations making subsidies available in both federally facilitated exchanges and state-run exchanges.  In those regulations, the IRS asserted that “the statutory language … and other provisions” of the ACA “support the interpretation” that credits are available to taxpayers who obtain coverage through both state and federally facilitated exchanges.

The individuals who brought the suits live in states that did not establish their own exchanges. They argue that the text of the ACA is clear and unambiguous: the IRS does not have the authority to administer subsidies in their states because the exchanges were not “established by the State.”

The D.C. Circuit, in a 2-1 decision, in Halbig v. Burwell agreed with the appellants and vacated the IRS regulation.  The court focused heavily on the plain meaning of the statutory text and concluded “that the ACA unambiguously restricts the … subsidy to insurance purchased on Exchanges established by the state.”  In an opinion issued only hours later, the 4th Circuit, in a 3-0 decision, in King v. Burwell agreed with the IRS that the statutory language was not plain, but ambiguous. Accordingly, the court upheld the subsidies “as a permissive exercise of the agency’s discretion.”

Given the circuit court split, many commenters believe that Supreme Court review is necessary to resolve this issue.  However, while it is certainly possible, perhaps even likely, that the Supreme Court will review this issue, it may not be a foregone conclusion.  The Obama administration has already indicated it will seek en banc review of the Halbig decision by the entire D.C. Circuit.  If the full D.C. Circuit reverses the Halbig panel decision, the existing “circuit split” would be resolved, potentially making Supreme Court review less likely.  It should be noted that there are similar cases pending in district courts in the 10th and 7th Circuits, that if decided in favor of the challengers could create a circuit split even if the full D.C. Circuit reverses Halbig.

On the other hand, given the tremendous importance of this issue to the operation of the ACA, and the fact that under the plain meaning of the statute, the IRS regulation allows billions of dollars in tax credits without the authorization of Congress, the Supreme Court may accept review to fully settle this important question of federal law, regardless of whether there are conflicting decisions from the circuit courts. The Supreme Court has long operated under the “rule of four,” a convention under which a grant of certiorari requires the approval of only four justices. Given the fact that the availability of the subsidies is an issue of national importance, and that two years ago four justices voted to strike down the ACA altogether, Supreme Court review of this issue appears likely. Ultimately, however, whether the Supreme Court will accept the case is a matter of speculation.

For employers, the most significant issue may be the potential impact the Halbig ruling could have on the Employer Mandate.  As noted above, the employer mandate penalties are only triggered by an employee going to the exchanges and purchasing subsidized health care.  Accordingly, if none of its employees receives a subsidy, then no penalties would be triggered against an employer.  Thus, for employers with employees in the 36 states with a federally facilitated exchange, the question arises how the Halbig decision impacts their decision and strategy to provide health coverage to their employees when the Employer Mandate takes effect in 2015 (or 2016 for employers with 50-99 employees).

Additionally, considering that the Employer Mandate and its penalty provisions have been extended twice before, this legal development could provide employers and trade associations with an opportunity to ask the Obama Administration to delay the Employer Mandate again until the Supreme Court has a chance to review the case, or even to scrap it altogether.

While more questions may be raised by the two conflicting court decisions, what is clear at this point is that yesterday’s decisions are certainly not the final word on this issue.

 

OIG’s Permissive Exclusion Criteria: Comment Before Sept. 9, 2014

LinkedIn Tweet Like Email Comment

The Office of the Inspector General (“OIG”) of the U.S. Department of Health and Human Services (“HHS”) is soliciting comments, recommendations, and other suggestions on the non-binding criteria used by OIG in assessing whether to impose a permissive exclusion, which were first published in 1997 (https://oig.hhs.gov/authorities/docs/2014/2014-16222.pdf).  The OIG’s permissive exclusion criteria currently are organized into four general categories, including: (1) the circumstances and seriousness of the underlying misconduct; (2) the defendant’s response to the allegations or determination of wrongdoing; (3) the likelihood of a future violation; and (4) the defendant’s financial ability to provide quality health care services.  Over the last two decades, OIG has used these criteria to evaluate whether to impose a permissive exclusion or release this authority in exchange for the execution of an Integrity Agreement with OIG.

In support of its decision to consider revising the criteria, OIG indicated that “updated guidance could better reflect the state of the health care industry today.”  OIG also noted that issues currently under consideration include, but are not limited to: (1) whether there should be differences in the criteria for individuals and entities, and (2) whether and how to consider a defendant’s existing compliance program.

We encourage all interested parties to weigh on in the existing criteria, which can be found here (https://oig.hhs.gov/exclusions/files/criteria_b7.pdf.).  Comments are due by September 9, 2014.

Please reach out to George Breen, Jonah Retzinger, or Marshall E. Jackson, Jr. for assistance with the preparation and submission of comments.

 

Medicare’s Proposed Home Health Rule for 2015: Face-to-Face Encounter Documentation Requirements

LinkedIn Tweet Like Email Comment

Our colleagues at Epstein Becker Green released a client alert: “Medicare’s Proposed Home Health Rule for 2015: CMS Suggests Only Limited Relief to the Face-to-Face Encounter Documentation Requirements but Continued Compliance Burdens on Home Health Agencies,” by Emily E. Bajcsi and Serra J. Schlanger.

Following is an excerpt:

On July 7, 2014, the Centers for Medicare & Medicaid Services (“CMS”) published proposed changes to the Medicare Home Health Prospective Payment System (“HH PPS”) for calendar year 2015 (“Proposed Rule”). The Proposed Rule would update the HH PPS payment rates effective January 1, 2015, including continued implementation of the rebasing adjustments as required by the Affordable Care Act (“ACA”). CMS projects that these proposed payment rate changes would result in overall payment reductions to home health agencies (“HHAs”) of $58 million, or 0.30 percent. CMS proposes a number of additional changes, including recalibration of the home health case-mix weights and changes to the home health quality reporting program requirements that would establish a minimum submission threshold for the percentage of OASIS assessments that an HHA must submit each reporting period. CMS is also asking for comments on a home health value-based purchasing model that it is considering testing in certain states beginning in 2016.

The Proposed Rule would also make significant changes to the physician face-to-face encounter requirements for HHA reimbursement. CMS claims that the changes would “simplify” the face-to-face encounter documentation requirements through elimination of the physician narrative requirement; however, CMS will expect the information formerly contained in the physician narrative to be documented in the medical record of the certifying physician or the discharging facility. To incentivize physicians to supply sufficient documentation, CMS proposes to deny the physician’s claim for certification or re-certification if the HHA claim is denied due to insufficient documentation to support beneficiary ineligibility. Yet, the Proposed Rule fails to provide any clarity as to what will constitute “sufficient” documentation. As a result, even with these proposed changes, HHAs will continue to bear both the risk of financial loss from denied claims and the burden of assuring that the certifying physician “sufficiently” documents the beneficiary’s eligibility to receive services under the Medicare home health benefit. Public comments to the Proposed Rule are due by September 2, 2014.

Read the full alert here.

 

The ACA Still Has Its Day in Court, Now Over Subsidies, in Law360

LinkedIn Tweet Like Email Comment

Our colleagues Kara Maciel, a Member of the Firm in the Labor and Employment, Litigation, and Health Care and Life Sciences practices, in the Washington, DC, office, Mark Trapp, a Member of the Firm in the Labor and Employment and Litigation practices, in the Chicago office, and Adam Solander, an Associate in the Health Care and Life Sciences practice, in the Washington, DC, office, wrote an article titled “The ACA Still Has Its Day in Court, Now Over Subsidies.” (Read the full version – subscription required.)

Following is an excerpt:

Challenges to the government’s health care reform implementation continue to make their way through federal courts, with rulings expected shortly. Employers are especially advised to monitor challenges to the federal regulations that authorized the federally facilitated exchanges (“FFEs”) to distribute tax credits and copayment subsidies (collectively, subsidies) to eligible persons.

By way of background, it was nearly two years ago when the U.S. Supreme Court ruled that the individual mandate at the heart of the Affordable Care Act could be construed as a tax, despite violating the Commerce Clause of the Constitution.

Read the full article here (subscription required).

DC Circuit Strongly Reaffirms the Applicability of the Attorney-Client Privilege to Internal Compliance Investigations

LinkedIn Tweet Like Email Comment

Our colleagues at Epstein Becker Green released a client alert: “DC Circuit Strongly Reaffirms the Applicability of the Attorney-Client Privilege to Internal Compliance Investigations,” by George B. Breen, Jonah D. Retzinger, Marshall E. Jackson Jr., and Stuart M. Gerson.

Following is an excerpt:

Especially in the District of Columbia Circuit, the home base for many fraud cases in which the government is opposed to health care providers and defense contractors, there had been considerable doubt that the attorney-client privilege attached to internal compliance investigations, particularly those investigations conducted on governmental mandate by company internal counsel. In a recent victory for companies and effective compliance, the United States Court of Appeals for the DC Circuit squarely removed that doubt in support of the application of privilege.

Reversing the controversial District Court decision in United States ex rel. Barko v. Halliburton Co., 2014 U.S. Dist. LEXIS 36490, 2-3 (D.D.C. Mar. 6, 2014), on June 27, 2014, the DC Circuit handed down its opinion in In re Kellogg Brown & Root, 2014 U.S. App. LEXIS 12115 (D.C. Cir. 2014). The DC Circuit’s holding reinforces the protections established by the Supreme Court 30 years ago in Upjohn Co. v. United States, 449 U.S. 383 (1981), that afford privilege to confidential employee communications made during a corporation’s internal investigation led by company lawyers.

Read the full alert here.

 

Third Circuit Deepens Circuit Split in Adopting “Nuanced” Standard for FCA Claims

LinkedIn Tweet Like Email Comment

By Daniel C. Fundakowski

                   I.            Background

On June 6, 2014, in Foglia v. Renal Ventures Management, LLC the Third Circuit revived a dismissed False Claims Act (“FCA”) lawsuit, holding that the New Jersey District Court applied Federal Rule of Civil Procedure 9(b) too rigorously when granting Renal’s 12(b)(6) motion to dismiss.  Under Rule 9(b), an FCA whistleblower must allege “with particularity the circumstances constituting fraud or mistake.”

Foglia was hired in 2007 as a registered nurse for Renal Ventures Management, a dialysis provider, and was terminated in 2008.  Foglia alleged in his second amended complaint that Renal violated the FCA by falsely certifying to Medicare that it was in compliance with state regulations regarding quality of care, falsely submitting claims for reimbursement for the vitamin D drug Zemplar, and by reusing the remainder of single-use Zemplar vials while charging Medicare for the full content of the vial.  Foglia’s allegations derived from Renal’s inventory logs.  Based on the number of patients seen throughout a given month, Foglia alleged that Renal would have needed 50 vials of Zemplar per day (assuming Renal was not reusing vials).  Because Renal was only using 29 to 35 vials per day, Foglia alleged that Renal was reusing vials and overcharging Medicare because the vials are reimbursed for the full content of the vial, regardless of how much is used.

The district court held that Foglia’s complaint failed to satisfy Rule 9(b)’s “particularity” requirement because it failed to provide a “representative sample” or “identify representative examples of specific false claims made to the Government.”  The United States did not intervene in the litigation.

                II.            Circuit Split on Applying Rule 9(b) in FCA Context

Circuit Courts of Appeal are split on the proper application of Rule 9(b)’s “particularity” requirement in the FCA context.  In a unanimous decision, the Third Circuit panel aligned itself with the First, Fifth, and Ninth Circuits, which endorse a more lenient approach to how precisely whistleblowers must plead FCA claims.  In these circuits, it is generally sufficient to allege “particular details of a scheme to submit false claims paired with reliable indicia that lead to a strong inference that claims were actually submitted.”  On the other hand, the Fourth, Sixth, Eighth, and Eleventh Circuits are known for a stricter application of Rule 9(b), often requiring whistleblower complaints to include “representative samples of the alleged fraudulent conduct, specifying the time, place, and content of the acts and the identity of the actors.”

Acknowledging this as a “close case,” the Third Circuit articulated several reasons for ultimately adopting a more “nuanced” and lenient standard for evaluating the sufficiency of FCA complaints.  First, the court found a stringent approach to be textually inconsistent with the FCA—asserting that “it is hard to reconcile the text of the FCA, which does not require that the exact content of the false claims in question be shown, with the ‘representative samples’ standard favored by the Fourth, Sixth, Eighth, and Eleventh Circuit.”  Second, the court cited the recent amicus curiae brief filed by Solicitor General Donald Verrilli, Jr. in connection with the writ of certiorari in U.S. ex rel. Nathan v. Takeda PharmaceuticalsSee 707 F.3d 451 (4th Cir. 2013), cert. denied, 81 U.S.L.W. 3650 (Mar. 31, 2014) (No. 12-1349).  In that case, the Solicitor General asserted that the “heightened or ‘rigid’ pleading standard required by the Fourth, Sixth, Eighth, and Eleventh Circuits is ‘unsupported by Rule 9(b)’” and “undermines the FCA’s effectiveness as a tool to combat fraud against the United States.”

             III.            Impact of the Foglia Decision

It is unclear what impact this opinion will have on other courts and lawmakers, especially because it appears subtly at odds with several key tenets that are trending in other circuits.  For example, Foglia downplays the rigorous Rule 9(b) pleading standard by stating that “the purpose of Rule 9(b) is to ‘provide[] defendants with fair notice of the plaintiffs’ claims’” and holding that Foglia’s complaint met the Rule 9(b) standard because it “suffice[d] to give Renal notice of the charges against it, as is required by Rule 9(b).” (emphasis added).  While notice is indeed one objective of Rule 9(b), perhaps the more prominent objective is discouraging frivolous and speculative lawsuits—not simply apprising the defendant of the plaintiff’s claims.

Further, the panel’s reversal of the district court’s decision revived allegations that included violations of conditions of participation.  Conditions of participation are quality of care standards directed towards an entity’s continued ability to participate in federal health care programs, rather than prerequisites to government reimbursement.  On the other hand, conditions of payment are requirements that must be satisfied before the government will reimburse a claim.  Unlike a condition of participation, noncompliance with a condition of payment may properly support an FCA suit under the theory that the government should not have paid a claim that failed to comply with one or more prerequisites to payment.

Here, Foglia’s allegation about the practice of reusing Zemplar vials was permissible if certain HHS conditions were followed to ensure patient safety.  Foglia alleged that these conditions were conditions of payment, notwithstanding how they related to quality of care—a hallmark of conditions of participation.  The district court held that even if Foglia met the Rule 9(b) requirements, his complaint “provided no authority under an express or implied false certification theory that the claims submitted . . . violated a rule or statute establishing compliance as a condition of payment.”  On appeal, the Third Circuit held that, though it was “highly doubtful” that the HHS safety conditions were conditions of payment, “we must accept as true the allegations in the complaint” and “that Renal did not, in fact, comply with the required recommendations by HHS for the safe re-use of Zemplar vials.”

Consistent with judicial reluctance to expand the FCA into an all-purpose statute that polices all forms of regulatory noncompliance, courts are increasingly holding that legally false claims must allege conduct that would violate a condition of payment, not merely a condition of participation.  The Third Circuit balking at dismissing Foglia’s condition of participation claim may undermine the persuasiveness of this opinion on other courts where Rule 9(b) particularity may be an issue of first impression.

             IV.            Conclusion

This opinion is a victory for whistleblowers pleading FCA violations in the Third Circuit.  Though the Third Circuit clearly aligns itself with the First, Fifth, and Ninth Circuits endorsing a more relaxed interpretation of Rule 9(b), the subtle yet contentious findings in the opinion make it unclear whether it will have a durable impact.

The June 6, 2014 opinion was vacated and amended on June 10, 2014 to correct a typographical error in articulating the circuit split.  The amended opinion is available by clicking here.

 

Stuart Gerson on the Supreme Court’s Harris and Hobby Lobby Decisions

LinkedIn Tweet Like Email Comment

Our colleague Stuart Gerson of Epstein Becker Green has a new post on the Supreme Court’s recent decisions: Divided Supreme Court Issues Decisions on Harris and Hobby Lobby.”

Following is an excerpt:

As expected, the last day of the Supreme Court’s term proved to be an incendiary one with the recent spirit of Court unanimity broken by two 5-4 decisions in highly-controversial cases. The media and various interest groups already are reporting the results and, as often is the case in cause-oriented litigation, they are not entirely accurate in their analyses of either opinion.

In Harris v. Quinn, the conservative majority of the Court, in an opinion written by Justice Alito, held that an Illinois regulatory program that required quasi-public health care workers to pay fees to a labor union to cover the costs of wage bargaining violated the First Amendment. The union entered into collective-bargaining agreements with the State that contained an agency-fee provision, which requires all bargaining unit members who do not wish to join the union to pay the union a fee for the cost of certain activities, including those tied to the collective-bargaining process. …

An even more controversial decision is the long-awaited holding in Burwell v. Hobby Lobby Stores, Inc. Headlines already are blasting out the breaking news that “Justices Say For-Profits Can Avoid ACA Contraception Mandate.” Well, not exactly. …

Both sides of the discussion are hailing Hobby Lobby as a landmark in the long standing public debate over abortion rights. It is not EBG’s role to enter that debate or here to render legal advice, but we respectfully suggest that the decision’s reach is already being overstated by both sides. In the first place, the decision does not allow very many employers to opt out of birth control coverage – only closely-held for-profit companies that have a good-faith ideological core, as clearly was the case for Hobby Lobby. That renders such companies functionally the same as non-profits that are exempted from the mandate by the government. Publicly-held companies are not affected by the decision (though some are likely to argue that Citizens United might require such an extension. Nor are privately-held companies that can’t demonstrate an ingrained belief system.

Read the full post here.

Complimentary Webinar to Focus on the Role of Patient Engagement Strategies

LinkedIn Tweet Like Email Comment

Epstein Becker Green and EBG Advisors, as part of their Thought Leaders in Population Health Speaker Series, will host a complimentary webinar in July on emerging trends in population health. The webinar—What Role Do Patient Engagement Strategies Play in Promoting Population Health?—will examine different approaches to target, engage, and modify individual behaviors to lead a healthier lifestyle. Key thought leaders in population health will share examples of ways to engage high-risk and chronically ill groups so as to achieve meaningful clinical and financial outcomes.

This webinar, scheduled for July 31, 2014, at 12:00 p.m. ET, will be led by Kathleen Ann Fraser, RN-BC, MSN, MHA, CCM, CRRN, President, Case Management Society of America (CMSA); and Ben Gardner, Founder and President, Linkwell Health, a leading technology-enabled content marketing company serving health plans. Linda Tiano, Member, Epstein Becker Green, will moderate the session. To register, click here.

During the webinar, the panelists will discuss:

  • Methods to promote better eating and exercise
  • Avenues to promote healthy behaviors and address chronic disease head-on
  • Ways to improve medication adherence
  • Approaches to optimize provider involvement in patient care over the continuum
  • Strategies to benchmark positive change in targeted populations and provide meaningful feedback loops to the patients

The summer webinars of the Thought Leaders in Population Health Speaker Series will focus on key aspects of the emerging population health paradigm, addressing big data and IT integration issues, patient engagement strategies, and population health strategies for employer-based coverage. The tenth session in the series will be held on August 26. The presentation, Population Health Strategies for Employer-Based Coverage, will assess how the Affordable Care Act is influencing population health management strategies for employer-based coverage.  To register, please click here.

“This webinar series attempts to find some common ground for health care professionals and other health care stakeholders by identifying best practices and creating a call to action for collaboration and outcomes improvement nationwide,” says Mark Lutes, Chair of Epstein Becker Green’s Board of Directors. “From the Affordable Care Act and data analytics to advancement in health IT systems, a number of factors are having a significant impact on the health care delivery system.”

________________________

The Speakers

Kathleen Ann Fraser, RN-BC, MSN, MHA, CCM, CRRN, and President, CMSA

Ms. Fraser has an extensive background in hospital nursing, which includes emergency room and labor and delivery experience, and as a Director of Nursing.  She became a Case Manager 21 years ago, creating the first Case Management Department for a large national health care system.   For the past 19 years, she has specialized in workers’ compensation, and, for the past 14 years, she has been a Regional Director of Managed Care Case Management for Zurich Financial Services.

Ms. Fraser is the current President of the CMSA National Board of Directors and will serve in this position through June 2016. She is also on the Role Delineation and Expert Panel Committees of the American Nurses Association Certification Council for Case Management.  She is the current Immediate Past-President of the Houston/Gulf Coast Chapter of CMSA and, during the past 21 years, has served three previous chapter presidency terms in Houston. She has also served twice as Chair of her chapter’s Annual Educational Conference and is a past Houston/Gulf Coast CMSA Case Manager of the Year.

Ben Gardner, Founder and President, Linkwell Health

Mr. Gardner founded Linkwell Health in 2007 with the mission of developing simple, meaningful ways to engage and empower consumers to promote healthier lifestyles. His 20+ years of experience span both the health care and marketing services sectors, working primarily in startup and early stage businesses.

Mr. Gardener’s earlier career was focused on health care, working with such companies as Stryker Medical (medical devices) and HPR (clinical software). He graduated from Bentley University with a B.A. in Marketing.

Linda Tiano, Member, Epstein Becker Green

Session moderator Ms. Tiano is a member of Epstein Becker Green’s Health Care and Life Sciences practice, in the firm’s Washington, DC, and New York offices. She has more than 30 years of experience serving clients in the health care industry, in legal and executive capacities.

Ms. Tiano has published extensively in the health law area and is a regular speaker at industry conferences. She is also a former adjunct faculty member at the New York University Graduate School of Public Administration. In 2013, Ms. Tiano was selected as a “Leading Lawyer” in the Health Insurance category by The Legal 500 United States.

 

To learn more, log on to www.ebgadvisors.com or click here to register for any of these webinars. A Q&A period will follow the webinar, so don’t miss this unique opportunity for leading population health experts to answer your questions. To listen to the previous webinars from our Thought Leaders in Population Health Speaker Series, please click here.

 

Health Care Entities and the ADA: A Two-Part Webinar

LinkedIn Tweet Like Email Comment

Post-Acute Care in Transition:  Tackling the Legal/Regulatory Transformation of the Industry

Health Care Entities and the ADA:  Part 2 – Complex Issues in the Reasonable Accommodation of Patients, Residents & Guests with Disabilities

Wednesday, July 16, 2014, at 12:00 PM – 1:00 PM (EDT)

Presenters:
Andrea R. Calem, Epstein Becker Green
Frank C. Morris, Jr., Epstein Becker Green

In part two of the webinar series, Epstein Becker Green attorneys explain the laws, regulations, enforcement considerations and hot-button issues relating to the accommodation of individuals with disabilities (be they patients, customers, or members of the public).

Their discussion will focus on the public access provisions of the Americans with Disabilities Act, the Rehabilitation Act, and state statutes, which require health care entities and other public accommodations to make their goods and services fully accessible to individuals with disabilities. Some of the issues to be explored will include:

  • Must a health care provider incur construction costs to reconfigure its treatment rooms?
  • Can hospitals or post-acute care facilities be sued if their websites or online scheduling tools are not accessible to those with sight impairments?
  • Must health care facilities modify diagnostic equipment to make it more accessible to individuals using wheelchairs?
  • What are the required dimensions for accessible changing rooms?
  • Must a skilled nursing facility hire a sign language interpreter for hearing-impaired patients or companions?

We hope that you will join us as we explore these and other hot-button issues confronting post-acute care facilities and all other health care businesses today.

Registration Is Complimentary 

To register for this webinar, please click here.