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Final Individual Coverage HRA Rule Released

By: Andrew Silverio, Esq.

Recently, the Trump administration released a finalized rule establishing the conditions under which employers can utilize HRAs to subsidize their employees’ purchase of individual coverage, including coverage on the Exchange.

Under the rule, employers are able to provide enrollees with a fixed dollar amount, tax exempt, which can be used to buy individual coverage.  While the rule doesn’t relieve the employer’s obligations to provide group coverage, if applicable, participation in the individual coverage HRA is conditional upon having individual coverage, which includes Medicare.  This requirement is applicable for the employee and any dependents.  Additionally, the individual coverage must satisfy certain requirements to qualify under the rule, allowing an individual to utilize the ICHRA, and individuals must attest that they have suitable individual coverage.

Notably, the model notice and attestation (available at https://www.cms.gov/CCIIO/Programs-and-Initiatives/Health-Insurance-Market-Reforms/Downloads/HRA-Model-Notice-PDF.pdf and https://www.cms.gov/CCIIO/Programs-and-Initiatives/Health-Insurance-Market-Reforms/Downloads/HRA-Model-Attestations-PDF.pdf) provided by the administration contain no disclosure or explanation that certain coverage, such as certain limited-benefit plans or health sharing ministries, would not satisfy the rule’s requirements relating to the suitability of other coverage.

Critics of the rule have pointed to a few plausible factors in arguing that it will raise the price of individual coverage in the exchanges, both by incentivizing sicker employees within a workforce and employers with sicker employee populations overall to feed high risk lives into the individual markets.  Additionally, it has been noted that older participants may not benefit sufficiently from the ICHRAs, because the limitations on how much the contribution amounts can differ based on age will be insufficient to compensate for the naturally disproportionate premiums those participants will encounter in the individual market.

Finally, the content of the rule aside, the quick turnaround time of a 01/01/2020 effective date is leaving state marketplaces scrambling, with many saying it will be simply impossible to implement sufficient changes in just a few months to be equipped to manage enrollment accurately under the new rule.

This is a significant development, with implications in the ACA, tax code, employment law, and other fields.  Court challenges are likely, but as of now the rule stands to go “live” in just a few months.  Reach out to The Phia Group at PGCReferral@phiagroup.com with any questions or for more detailed information on any of the rule’s contents.


The Conscience Rule’s Effective Date is Delayed

 

By: Erin M. Hussey, Esq.

On May 21, 2019, Health and Human Services (“HHS”) published the Final Conscience Rule with an effective date of July 22, 2019, which allows the denial of certain health care services for religious reasons. This rule protects providers, individuals, and other health care entities from having to provide, pay, or refer services such as abortion, sterilization, or assisted suicide. The rule also protects those providers, individuals, and other health care entities from discrimination on the basis of their exercise of conscience in HHS-funded programs. The intent of this rule is to protect religious and moral objections from having to conduct or pay for these services.

This rule also details compliance obligations such as non-retaliation requirements. The Director of HHS’s Office of Civil Rights (“OCR”), Roger Severino, stated the following on that matter:

“This rule ensures that healthcare entities and professionals won’t be bullied out of the health care field because they decline to participate in actions that violate their conscience, including the taking of human life. Protecting conscience and religious freedom not only fosters greater diversity in healthcare, it’s the law.”

Following the publication of the Final Conscience Rule, many lawsuits were filed, including one brought by 23 Democratic states and one brought by the city of San Francisco, and both of those lawsuits essentially argue that the Final Conscience Rule is unconstitutional. As a result of those lawsuits, HHS has now delayed the effective date of the rule until November 22, 2019. With regards to the delayed effective date, the city attorney of San Francisco, Dennis J. Herrera, stated the following:

“We have won this battle – and it was an important one – but the fight is not over. The Trump administration is trying to systematically limit access to critical medical care for women, the LGBTQ community, and other vulnerable patients. We're not going to let that happen. We will continue to stand up for what's right. Hospitals are no place to put personal beliefs above patient care. Refusing treatment to vulnerable patients should not leave anyone with a clear conscience.”

We will be watching to see if the Final Conscience Rule goes into effect on November 22, 2019. This final rule coupled with the proposed rule on Section 1557, which was discussed in our previous blog, will have a major impact on different classes of vulnerable patients.

For more information on the Final Conscience Rule, please see HHS’s fact sheet found here: https://www.hhs.gov/sites/default/files/final-conscience-rule-factsheet.pdf.


The Government Shutdown's Impact on the Texas v. U.S. Case

By: Erin M. Hussey, Esq.

By now, most Americans, especially those in the healthcare industry and proponents of the ACA, are aware of the December 14, 2018 decision in Texas v. United States by Judge O’Connor of the Northern District Court of Texas. This decision shook the self-funded healthcare industry as it ruled that the individual mandate was unconstitutional and not severable from the rest of the Affordable Care Act (“ACA”), thus concluding that the ACA itself is unconstitutional.

More recently on January 3, 2019, the House filed a motion to intervene, and detailed that they have a “unique institutional interest in participating in this litigation to defend the ACA.” This motion was to intervene in separate claims that were made by the plaintiff states which were not ruled on in the December 14th decision. However, on January 7, 2019, the House filed a second motion to intervene which, if granted, would allow the House to defend the ACA alongside the intervenor states. The House argues that they have the right to defend the constitutionality of federal laws when the Attorney General or the Department of Justice (“DOJ”) do not.

However, this process will be slowed down as the government shutdown continues. The shutdown, which began on December 22, 2018, is interfering with the DOJ’s ability to meet the deadline to file their opposition to the House's motion. As a result, the DOJ asked the Fifth Circuit to pause all briefings since they will be unable to prepare their motion as Justice attorneys cannot work during the shutdown. On January 11, 2019, the Fifth Circuit issued an order, signed by Judge Leslie Southwick, granting the DOJ’s request to temporarily pause the case. While this shouldn't have a deep impact on the case, it presents just one example of many of how the government shutdown is impacting the country.


EEOC Vacates ADA and GINA Wellness Incentive Rules

By: Erin M. Hussey, Esq.

On the verge of a potential government shutdown, the Equal Employment Opportunity Commission (“EEOC”) was quick to issue final rules December 19th on the Americans with Disabilities Act (“ADA”) and the Genetic Information Nondiscrimination Act (“GINA”). Issuing final rules at the end of the year is not a new trend, but the unique situation is that the final rules are vacating current provisions on wellness program incentives. With an effective date of January 1, 2019, we are left with less guidance than we had on December 18th.

By way of background, in 2016 the American Association of Retired Persons (“AARP”) sued the EEOC claiming that the EEOC’s wellness incentive rules, for wellness programs that implicate the ADA and GINA, were coercive and not truly voluntary. A wellness program would implicate the ADA if medical examinations or disability-related inquiries were involved (i.e., biometric screenings), and a wellness program would implicate GINA if there were inquiries about genetic information. Before recent events, the EEOC’s ADA and GINA rules capped the wellness program incentive at 30%.

In a 2017 opinion, the judge determined that the EEOC had never defined the term voluntary thus the court found that the EEOC "failed to adequately explain" the 30% maximum and how a plan can still be considered voluntary with that incentive. The EEOC was directed to re-write their workplace wellness rules related to incentives for an effective date of January 1, 2019 or the old rules would be vacated. Obviously the EEOC did not re-write the ADA and GINA incentive-related rules as they have now been vacated effective January 1, 2019. However, the EEOC had indicated at their Fall 2018 Unified Agenda of Federal Regulatory and Deregulatory Actions, that they intend to issue new regulations in June 2019.

In order to ensure compliance until new rules are issued, the quick solutions are to remove medical testing, questions about genetics, and lower the amount of the incentive (though it is unclear what amount will truly be considered voluntary). While frustrating to say the least, this limbo situation for employers and plans is more of the same uncertainty that we have been dealing with for the past eight years. Employers that choose not to make changes should be aware of the compliance risks they may face due to the lack of rules.

*Please note: the above-mentioned EEOC wellness rules are separate from the Health Insurance Portability and Accountability Act (“HIPAA”) and the Affordable Care Act (“ACA”) wellness rules and the above ruling has no effect on these rules.


Take Two Premiums and Call Me in the Morning...

By: Ron E. Peck, Esq.

A friend and ally in the health benefits industry recently asked me if I had an up to date listing of the most costly health care expenses paid by health plans in 2018.  I didn’t; so on a whim I brought up my handy dandy search engine and typed in: “the most costly health care expenses paid by health plans in 2018.”  You know what the top results were?  “Cost of Employer Health Coverage to Rise in 2019” … “Health Insurance: Premiums and Increases” … “How to Find Affordable Health Insurance in 2018” … and other, similar articles focused on what individuals will pay in premium (and in some instances, even dissecting co-pays, deductibles, and co-insurance).  The common thread?  They are all about participant out-of-pocket expenses.  I didn’t ask how much it costs to obtain insurance.  I asked how much it costs to obtain an appendectomy!

This is just a most recent example of an issue that sticks in my craw like no other, and reminds me of something I wrote years ago.  Check this article out: https://moneyinc.com/affordable-health-insurance-is-not-affordable-health-care/.

“… too many people are confusing the term ‘health care’ with ‘health insurance.’ … Health care – meaning the actual act of caring for someone’s health – is necessary for survival. Health insurance – meaning a method by which we pay for health care – is just that; merely a means to pay for health care. Yet, a few years ago (2009 to be precise), a report posted by the American Journal of Public Health indicated that nearly 45,000 deaths are annually associated with a ‘lack of health insurance’ and that uninsured, working-age Americans have a forty percent higher risk of death than those with private insurance.  The knee-jerk reaction to this news is likely (and likely was) to rush to provide health insurance to as many people as possible. Indeed, according to this report, health insurance saves lives. Furthermore, one could argue, if saving lives is health care, and health insurance saves lives, then health insurance is health care, and your author has proven himself wrong.… As stated before, however, health insurance is a method by which we pay for health care. It stands to reason, therefore, that it is not a lack of health insurance that kills people, but rather, it is a lack of means by which to pay for health care that kills people. This, then, leads us to a logical conclusion; the problem is not that we don’t have insurance … the problem is that we can’t pay for health care without insurance. This, then, leads to the next logical thought: why is health care so expensive?”

Go back and re-read the first paragraph of this blog post.  Sadly, I fear my words published two years ago apply as much today as ever.  Enjoy this blast from the past for Throwback Thursday, and let me know if you think we’ve advanced at all since then.


HHS Proposes Drug Transparency Rules for TV Advertisements

By: Patrick Ouellette, Esq.

In a move geared toward making drug prices more visible to consumers, the Department of Health and Human Services (HHS) recently released a proposed regulation that would force drug companies to include prices in their television advertisements of prescription drugs and biological products. HHS focused the proposal on drugs in 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.

There are some drug price components of WAC to note, as WAC is generally the manufacturer’s price for drugs before the supplier of the product offers any rebates, discounts, allowances or other price concessions. True pricing involves a number of other variables to determine what the final drug costs are to patients beyond the WAC, such as what their insurance covers or whether their deductible has been met. These proposed regulations are also limited only to drugs covered under Medicare or Medicaid. However, it will be instructive in the long-term to see whether the inclusion of pricing in advertisements will actually lower final drug payments for patients. Similar to CMS requiring (starting in 2019) hospitals to make public a list of their standard charges via the Internet in a machine-readable format, there are no assurances that patients armed with new information will reduce final costs.

If these regulations prove to be successful, it will be interesting to see whether HHS would extend them to drugs payable by private insurers. In particular, HHS regulations could affect pharmacy benefit manager (PBM) rebates in the self-funded health plan space:

Because the list price of a drug does not reflect manufacturer rebates paid to a PBM, insurer, health plan, or government program, obscuring these discounts can shift costs to consumers in commercial health plans and Medicare beneficiaries. Many incentives in the current system reward higher list prices, all participants in the chain of distribution, e.g., manufacturers, wholesalers, pharmacy benefit managers, and even private insurers, gain as the list price of any given drug increases. These financial gains come at the expense of increased costs to patients and public payors, such as Medicare and Medicaid, which ultimately fall on the backs of American taxpayers.

Furthermore, consumers who have not met their deductible or are subject to coinsurance, pay based on the pharmacy list price, which is not reduced by the substantial drug manufacturer rebates paid to PBMs and health plans. As a result, the growth in list prices, and the widening gap between list and net prices, markedly increases consumer out-of-pocket spending, particularly for high-cost drugs not subject to negotiation.

Though the proposed regulations only affect companies in which their drugs covered by public payers, Medicare and Medicaid, all payers across healthcare should keep track of this initiative. The Pharmaceutical Research and Manufacturers of America (PhRMA) has already argued that such rules would violate the First Amendment and not affect patient costs.


Has the Life Expectancy of Drug Rebates Been Reduced?

By: Kelly Dempsey, Esq.

That’s a pretty big question as we learn more about the Trump Administration’s attempt to reduce drug costs.

We all know drug prices are off the charts and several attempts to control pricing have failed to get up and running. As you may recall, President Trump indicated during his campaigning that he would develop a plan to lower prescription medicine costs. The U.S. health secretary (Azar) is making some moves and has indicated that eliminating drug rebates may help reduce costs.

Cost containment is key to self-funding and high drug costs have caused employers and plans to explore options to keep plan costs down, including utilizing vendor programs that obtain drugs from outside the U.S. and/or build certain rebate programs into the customized plan design. While there’s still a lot that must be worked through before changes are implemented, these four key takeaways may give plans, employers, brokers, PBMs, and other vendors some heart burn:

  1. In July 2017 the Department of Health and Human Services proposed regulations that reduce the protections for rebate programs – without these protections, these programs could be found to be illegal under federal ant-kickback laws.
  2. The PBM industry has contested the proposed rules indicating that Congress would need to modify a federal statute (instead of HHS just issuing rules).
  3. The FDA released a plan to increase the use of biosimilars (lower cost versions of biotech medicines).
  4. Health Secretary Azar directed the FDA to explore importation of drugs from other counties to combat high prices in the U.S.

Plans and vendors that utilize these types of programs should be on the look-out for rule changes to ensure continued health plan compliance. 


Patient Assistance Programs: Friend or Foe?

By: Brady Bizarro, Esq.

Prescription drugs are some of the most costly benefits for any health plan, especially for those plans that are self-funded. In 2017, total spending on prescription drugs in the U.S. reached $453 billion. Specialty drugs are particularly culpable, accounting for more than one third of all drug expenditures in 2016 despite making up less than one percent of all written prescriptions. In May, the Trump administration released a forty-four-page blueprint for executive action on prescription drug prices, entitled “American Patients First.” The document contained many strategies for combating rising drug costs; but it also focused in on the use of patient assistance programs (“PAPs”) and considered whether they might be driving up list prices by limiting the transparency of the true cost of drugs to patients.

Plan sponsors originally utilized the typical tools available to them to try to offset the cost of specialty drugs: higher copayments, coinsurance, and deductibles. In an effort to mitigate the impact on patients, several pharmaceutical manufacturers developed PAPs to help offset patients’ out-of-pocket drug costs. Some of these programs are very generous. For example, a PAP run by Enbrel offers up to $660 per month toward the cost of a specialty drug for members who would not otherwise qualify for financial assistance.

Assistance programs are marketed as a kind of altruism for patients, which has great public relations benefits. They can also increase the demand for specialty drugs, even when generic alternatives are available. This results in a huge cost to the patient’s health plan. Consider the following scenario: a specialty drug’s list price is $10,000. A generic alternative is available that has a list price of $2,000. The health plan imposes a $500 copay for specialty drugs when generics are available and a $100 copay for generics. In this case, however, the specialty drug manufacturer offers the patient a $450 copay card. For the patient, the out-of-pocket cost for the specialty drug is $50 cheaper than the copay for the generic alternative. The patient chooses the specialty drug, and the health plan pays $9,500. Had the patient selected the generic alternative, the plan would have only paid $1,900.

As the scenario above reveals, PAPs can incentivize patients to choose specialty drugs even when cheaper, generic alternatives are available. For most patients, the only price they are aware of is the amount they pay at the register. The cost to their health plan remains hidden to them, although they eventually feel the effects downstream. In other words, PAPs can save patients money on the front end while driving up the cost to patients on the back end through increased premiums and cost-sharing. With PAPs now in the crosshairs of both plan sponsors and the Trump administration, we should expect new regulations on their use in the coming months.


Know when to fold ‘em

By: Chris Aguiar, Esq.

Last week, I teased this blog post on Linkedin with vague commentary about effective cost containment not being just about recovering as much money as possible, but also about being knowledgeable and understanding when its best to cut losses.  One of the attorneys in our office is currently working on a file where a benefit plan may be ill-advisedly pushing the limits of the law.  You see, in subrogation and reimbursement cases, there is a rule called the “Made Whole Rule”.  This rule is one of equity that operates to eliminate a plan’s recovery rights when a plan participant does not recover the full amount of their damages (i.e. they weren’t “made whole”).  Now, those of us with private self-funded plans that enjoy the benefit of state law preemption can point to our plan terms and the current state of Federal law which holds that clear and unambiguous language that disclaims application of this rule and others like it will control and allow plans to recover regardless of whether the participant was made whole.

This plan, however, is unfortunately governed by state law as it is not a private self-funded benefit plan; preemption does not operate in its favor.  The participant had $800,000.00 in medical damages, alone, and received a $1,000,000.00 settlement.  Those numbers alone may indicate to some that the participant was, indeed, made whole.  However, the damages discussed above are ONLY the medical damages.  We have yet to discuss any other damages, including but not limited to:  1) lost wages (present and future) 2) pain and suffering 3) future care, etc.  The list of damages in serious accidents such as this can be extensive, and all of those categories hold considerable value and are compensable in the eyes of the law.  The particular jurisdiction in which this plan sits happens to have one of the most aggressive made whole rules in the country, and the judges there tend to be very pro participant.  Accordingly, it’s a safe assumption that given the participant will really only receive about $600,000.00 after fees and costs of pursuit – it’s quite easy to see that the participant will not likely be considered to have been “made whole” in the eyes of the court.

Despite that, The Phia Group’s attorney has been able to negotiate for a reimbursement of approximately 20% the Plan’s interest.  Should the Plan decide to try to enforce a right of full reimbursement, and the court apply the made whole rule, the Plan will receive no recovery at all and will have endured the extra time, expense, and possibly even media fallout for ‘dragging its participant through this ordeal’, of protracted litigation.

Plans, and we as their advisors, must be cognizant of the rules of the jurisdictions in which we operate and realize when a good outcome is unlikely.  Sometimes, even if one has a good case and can win and recover its entire interest, the cost of doing so paired with the inability to obtain reimbursement of the costs of pursuit can render the action moot, because the cost can in many instances outweigh the interest.  This is even more true, of course, in situations where the Plan is likely to lose.

Effective cost containment is about looking at the situation and determining the most cost effective approach – winning does not always equate to the best outcome.


FDA Approves Marijuana-Derived Drug for Seizures

By: Corrie Cripps

In June, the US Food and Drug Administration (FDA) issued the nation’s first approval for a drug derived from marijuana-based compounds. The drug’s name is Epidiolex, and is used to treat patients with forms of severe epilepsy (Dravet syndrome and Lennox-Gastaut syndrome).

The drug uses CBD, or cannabidiol, which is an oil that comes from resin glands on cannabis buds and flowers.

Prior to the FDA marketing Epidiolex, the Drug Enforcement Administration (DEA) must reclassify CBD, since it is currently listed as a Schedule I drug. Schedule I drugs are considered to have “no currently accepted medical use and a high potential for abuse.” The DEA is expected to make this change for CBD, but will likely leave cannabis itself at Schedule I.

Currently CBD is legal to purchase in only some states.  In the states where medicinal or recreational marijuana is legal, CBD is legal. In 17 other states, there are specific laws about what CBD products can be used by whom and for what.

If the DEA reclassifies CBD so that it is no longer a Schedule I drug, thus making CBD legal at the federal level, plan sponsors will need to determine if/how they want to address this in their plans (i.e., if they want to specifically exclude or cover it). Plan sponsors will need to determine how this change will impact their plans, including stop loss.