40 States Sue Generic Drug Makers for Collusion

The heat is growing on the pharmaceutical industry after more than 40 US states filed a lawsuit accusing generic drug makers of engaging in a massive price-fixing scheme.

The lawsuit accuses 20 companies of conspiring to fix prices of more than 100 generic drugs, including some that are used to treat cancer and diabetes. The defendants include the largest producer of generic medicine in the world: Teva Pharmaceuticals.

The new lawsuit comes after a five-year investigation that uncovered a scheme through which “coordinated price hikes on identical generic drugs became almost routine,” according to an investigative report by the Washington Post. The suit covers the period from July 2013 to January 2015.

The companies and executives would “routinely communicate with one another directly, divvy up customers to create an artificial equilibrium in the market” to keep generic drug prices artificially high, the lawsuit says.

The scale of the alleged collusion was summed up by Joseph Nielsen, an assistant attorney general and antitrust investigator in Connecticut, whose office has taken the lead in the investigation: “This is most likely the largest cartel in the history of the United States,” he told the Washington Post last December.

In announcing the recent lawsuit, he cited e-mails, text messages, telephone records and testimony from former company executives that indicate a “multi-year conspiracy to fix prices and divide market share for huge numbers of generic drugs.”

This is not the only litigation. Pharmacies and other businesses have filed their own lawsuits against the generic drug makers. One such suit documents huge price hikes – like a 3,400% increase in the price of an anti-asthma medication – and investigators believe that generic drug producers colluded to raise prices in tandem or not make their products available in some markets or through specific pharmacy chains.

Significance of the states’ suit

The multi-state lawsuit is important because generics account for 90% of pharmaceutical spending in the U.S. Despite that, they only account for 23% of the total drug spend in the country, according to the Association for Accessible Medicines.

With so many prescriptions being written, the savings to consumers could be huge if the drug makers are found to have fixed pricing and they subsequently change their ways. What’s not clear, though, is whether it would actually spur changes in pricing by the companies.

According to the lawsuit, the drug companies allegedly conspired to manipulate prices on dozens of medicines between July 2013 and January 2015.

It accuses Teva and others of “embarking on one of the most egregious and damaging price-fixing conspiracies in the history of the United States.”

Connecticut Attorney General William Tong, who filed the suit, said the investigation had exposed why the cost of health care and prescription drugs was so high in the U.S.

Congress, Administration Serious About Tackling Health Care Costs

As more people struggle with their medical bills, Congress has been introducing a raft of new legislation aimed at cutting costs and making pricing more transparent.

The multi-pronged, bipartisan effort targets the lack of transparency in pricing particularly for pharmaceuticals, as well as surprise medical bills that have left many Americans reeling, and there are also other efforts aimed at reducing the cost burden on payers: the general public and employers.

And since consumers are affected regardless of their political affiliation, congresspersons are reaching across the aisle to push through legislation to address this crushing problem.

There are several draft proposals, but word is a number of bills are expected to be introduced soon.

Surprise medical bills

One of the top priorities seems to be surprise medical bills, which are in the administration’s crosshairs. President Trump in January 2019 hosted a roundtable to air the problems people face when hit with what are often financially devastating surprise bills after they venture out of their network for medical services for both emergency and scheduled medical visits.

After the roundtable, he directed a bipartisan group of lawmakers to create legislation that would provide relief. The House Energy and Commerce Committee in May responded by introducing draft legislation that aims to ban surprise medical bills.

Also, Sen. Maggie Hassan (D-N.H.) and Sen. Bill Cassidy (R-La.) have said they hope to introduce legislation to end the practice of surprise bills. With the White House and both sides of the aisle talking the talk, observers say that there are a number of ways legislation could tackle these surprise bills. That could include:

  • Setting caps on how much hospitals and service providers can charge, or
  • Requiring hospitals and service providers to turn to the insurance company (and not the patient) when they are seeking additional reimbursement.
  • Requiring the insurer to share more of the cost burden for the out-of-network services.

At this point legislation is still being formulated, but chances are good that we could see a bipartisan push to fix this problem. The biggest issue will be how to calculate what are “reasonable” costs for out-of-network services.

Pharmaceutical costs, transparency

The Trump administration has also made it a priority to reduce the costs of medications and tackle pricing transparency in the system.

While both Republicans and Democrats have decried the skyrocketing costs of prescription medications, the inflation for which is outpacing all other forms of medical care, so far there has been only one piece of legislation introduced tackling transparency.

Unfortunately, it’s part of a larger bill that aims to preserve the Affordable Care Act and reverse some recent policy decisions by the Trump administration, so the chances of that measure going anywhere in the Senate are slim to none.

The good news is that members from both parties have been talking about cooperating on legislation, and political observers say the chances are good some type of measure will be introduced this summer.

Other costs

Sen. Ron Wyden (D-Ore.) in February introduced legislation that would require insurers to tell people what they would have to pay out of pocket for any in-network treatment or prescription drug.

On top of that, the Senate Health Committee will soon introduce a number of bills aimed at reducing frictional costs in the system.

In addition, the Senate Finance and Judiciary committees are both in the process of formulating measures aimed at reducing health care costs, as well as prescription drug prices.

Insurers Will Pay Record Amount of Rebates to Small Group Plans

While most businesses rarely get rebate checks from their group health insurer, this year may be different as insurance companies are expected to pay back record excess premiums, as required by the Affordable Care Act.

The landmark insurance law requires that insurers spend at least 80% of their premium income on medical care and medications, but expected payouts in 2018 came in way below expectations. That means they have to pay out rebates for the overcharge.

Analysts expect that insurers will pay out $1.4 billion in rebates, $600 million of which would be paid to small and large group health plans, according to a report by the Kaiser Family Foundation.

The reason for the sizeable expected rebate is that insurers raised rates substantially for 2018, which was right after Congress had passed a law that eliminated the individual mandate penalty, as well as uncertainty about the law after the Trump administration introduced regulations to expand the use of short-term health plans and association plans.

As mentioned, plans must spend 80% of premiums they collect on medical claims or quality improvements if they are in the individual or small group market. The threshold is 85% in the large group market. The rest can be spent on claims administration, marketing and other overhead, as well as set aside for profit.

Rebates to small group plan and large group plan members have typically overshadowed rebates to those who purchase plans individually on government-run exchanges. In 2017, according to the Centers for Medicare and Medicaid Services, insurers paid out nearly $707 million in ACA rebates, as follows:

  • $132.5 million to individual market enrollees.
  • $309.4 million to small group market enrollees.
  • $264.8 million to large group market enrollees.

But this year, rebates to the individual market are expected to be $800 million, while the remaining $600 million would be paid to enrollees in group plans.

The premium increases that many insurers pushed through led to much higher rates – benchmark premiums were up 34% going into 2018 – because of market uncertainties, such as:

  • In October 2017, the Trump administration ceased payments for cost-sharing subsidies, which led some insurers to exit the market or request larger premium increases than they would have otherwise.
  • The administration reduced funding for advertising and outreach.
  • Congress repealed the individual mandate penalty, effective for 2019.
  • The administration introduced regulations extending the time people could be on short-term plans, and also introduced association health plans as an alternative for the small group market.

But the insurers’ fears didn’t materialize. Despite payments per enrollee growing 26% to $559 in 2017 on exchanges, per person claims increased only 7% to $392 year over year.

Also, the repeal of the penalties and increased premiums did not drive younger, healthier consumers out of the marketplace as had been expected.

How to disburse rebates

If you are one of the employers whose health plan gets to receive a rebate, the big question that always comes up is “how do you distribute the funds?”

ACA regulations require insurers to pay rebates directly to the group health plan policyholder, who will be responsible for ensuring that employees benefit from the rebates to the extent they contributed to the cost of coverage.  

But remember, since you as the employer also contributed to the premiums, you are entitled to your portion of the rebate. Your take should be in the same proportion as the premium you pay compared to your employees.

The way that you disburse the rebate is up to you, but whatever you do, it must be in accordance with ERISA’s general standards of fiduciary conduct.

Typically, if the rebate works out to be small for each participant, it would likely not be worth your time to cut each employee a check.

The preferred method in most cases is to provide the rebate in the form of a premium reduction or discount to all employees participating in the plan at the time the rebate is distributed.

DOJ Files Brief Asking Court to Throw Out ACA

The stakes for the future of the Affordable Care Act just got higher after the U.S. Department of Justice filed a brief with a federal appeals court to strike down every facet of the landmark legislation.

The DOJ’s filing in the case states that the law is unconstitutional in its entirety and should be struck down. The filing concerns a case that had been brought by Texas and other Republican-led states that challenged the constitutionality of the law.

The trial judge in the case had ruled the entire law had been nullified after Congress in December 2017 passed legislation that jettisoned the individual penalties for not securing health coverage.

A group of 21 Democratic-led states, headed by California, immediately appealed the judge’s ruling. The appeal will be heard by the Fifth Circuit Court of Appeals in New Orleans. The DOJ’s brief urges the Fifth Circuit to uphold the trial judge’s ruling.

U.S. District Judge Reed O’Connor of the Northern District of Texas ruled in December 2018 that a congressional tax law passed in 2017 – which zeroed out the penalty imposed by the ACA’s individual mandate – rendered the entire health care law unconstitutional. The ACA remains in effect pending the outcome of the appeal.

Most legal pundits expect that the lower court’s ruling will be overturned. The decision not to appeal the ruling by the Trump administration had been foreshadowed, but still had many legal observers surprised that the DOJ would choose not to defend the law of the land.

Others have pointed out that if Congress’s intent had been to nullify the ACA when it got rid of the penalties for individuals who don’t abide by the individual mandate, it would have written that into the legislation. But the only part of the ACA that was addressed in the tax bill was the individual mandate penalty, and not any other parts of the law.

So what’s likely to happen?

It’s too early to know how this will all shake out. But even if the Fifth Circuit upholds the lower court verdict, the ruling would be appealed to the Supreme Court. If the Fifth Circuit overturns the lower court’s ruling, the Supreme Court may not even take up the case since it has already ruled twice before in favor of the ACA.

There are also widespread concerns over any sudden overturning the law. The effects would be widespread, especially in the individual market, and uncertain for many employees who now get coverage from their jobs thanks to the employer mandate portion of the law.

Judge Shoots Down Association Plans

A federal judge has rejected the Trump administration’s rules for association plans, saying they are an attempt to allow employers to skirt their obligations under the Affordable Care Act.

The rules that the Department of Labor finalized last year allow employers to band together as “associations” for no other purpose than to purchase health insurance for their employees.

And under those rules, the plans do not have to comply with many of the ACA’s provisions, including providing plans that are “affordable” and offer a set of minimum essential benefits.

Judge John Bates of the U.S. District Court for the District of Columbia wrote in his decision that the DOL’s final rule goes beyond the department’s authority under the Employee Retirement Income Security Act (ERISA) of 1974.

The judge particularly homed in on the fact that the associations would become the de facto employer for members to allow them to band together for the sole purpose of having access to lower rates.

To date, about 30 association plans have been formed around the country in response to the regulations, which took effect last year. The association plans are reportedly not up and running, but have been gearing up to start Jan. 1, 2020.

Under the rule, employers in the same industry can form a plan across state lines, as can any businesses in a specific geographic area. Sole proprietors can also join, along with small businesses, and obtain coverage for themselves and their families.

By banding together to form a pool with more than 100 workers, the employers would be considered a “large” employer under the ACA. While employee health plans for companies with fewer than 100 workers must abide by all of the ACA’s provisions, including covering 10 essential benefits, large plans do not have the same constraints.

This means that sole proprietors who may be purchasing their health plans on a state exchange would suddenly have the purchasing power of a large employer in the health insurance market.

The judge homed in on the part of the regulation that adopted a new definition of “employer” under ERISA, for purposes of determining when employers can join together to form an association health plan that is treated as a group health plan under that law. The new definition of employer includes sole proprietors with no employees.

The judge did not issue a stay on the start of these plans, but the ruling could create difficulties for those that have already been formed and are ready to launch in 2020.

The Trump administration is likely to appeal the ruling, but the judge has made it difficult since he struck down the linchpin of the regulation, which had changed the definition of what constitutes an employer and employee (“the association has become the employer and sole proprietors the association’s employees for the purpose of purchasing coverage at large group rates.”)

Existing association plans

Interestingly, the fears that many observers had expressed about association health plans have not come to bear. Many had predicted that these plans would be stripped-down health plans devoid of many of the protections offered by the ACA, particularly being able to keep your children on your plan until they are 26 as well as coverage of 10 essential benefits.

A report by the trade publication Modern Healthcare found that association plans it had analyzed actually had not pared back benefits to enrollees. The analysis found that the plans it examined covered all of the 10 essential benefits as required by the ACA, and also at comparable costs, premiums, deductibles, and out-of-pocket requirements.

While the plans that have already been set up are slated to start on Jan. 1, 2020, for now, it’s likely they will continue planning for a 2020 start, but whether they actually get off the ground will depend on the courts going forward.

For the time being, employers that are interested in joining an association health plan may want to take a pause and consider other options if the appeals process drags on.

Proposed Rules Would Affect Prescription Drug Plans

The Centers for Medicare and Medicaid Services has floated proposed regulations that would affect drug benefits for group plans and association plans and attempt to reduce drug expenses for health plan enrollees and drug plans.

While the rules seem to be focused on individual plans sold on government-run exchanges, three of the changes would also affect small and mid-sized group plans.

Mid-year formulary changes

Under current regulations, health insurers are barred from making changes to their drug formularies mid-year. They can only introduce changes upon renewal.

The CMS says it wants to boost incentives for drug plans to use generic drugs, so it is proposing a new rule that would allow insurers to:

  • Add a generic drug that becomes available mid-year.
  • Remove the equivalent brand-name drug from the formulary, or
  • Remove the equivalent brand-name drug to a different tier in the formulary.

Under the rules, insurers would have to notify their affected enrollees at least 60 days before the change would take effect. They must also offer a process for an enrollee to appeal the decision.

This rule would affect insurers in the individual, small group, and large group markets.

Excluding certain brand-name drugs

Under existing regulations, all prescription medications covered under an insurance contract are considered an essential health benefit, including the requirements that aim to ensure that the drug coverage is comprehensive. Under the Affordable Care Act, health plans are required to cover 10 essential benefits, and that includes the medications that are required to treat them.

The CMS wants to change this by letting insurers exclude a brand-name pharmaceutical from “essential health benefits”, or EHBs, if there is a generic equivalent that is available and medically suitable.

As with the current rule, the proposal would only apply to plans in the individual and small group markets. That’s because large group and self-insured plans are not required to cover all 10 categories of EHBs.

The proposal would also permit insurers to count only the cost of the generic equivalent (and not the cost of the brand-name drug) toward the enrollee’s out-of-pocket limit. Also, insurers would be permitted to apply an annual and/or lifetime dollar maximum to the brand-name drug, since the prohibition against annual and lifetime dollar limits only applies to EHBs.

Manufacturers’ coupon-handling

Currently, some insurers will count manufacturer coupons for brand-name drugs in addition to what the enrollee pays in calculating their out-of-pocket outlays for deductible purposes. They may do so depending on laws in the various states in which they operate.

For example, take the scenario of a drug that costs $600, and the manufacturer provides a $400 coupon that can be used to reduce the cost of the drug and the enrollee pays $200 out of pocket. Currently, insurers will count the full $600 towards the deductible and out-of-pocket maximum.

The CMS’s proposed rule would allow insurers to only include the actual out-of-pocket expense for the enrollee when calculating how much of an out-of-pocket maximum has been satisfied.

What comes next

The comment period for the proposed regulations ended on Feb. 19, 2019, and the final rules could be out before summer. We will keep you posted once the new regulations are out.

Regulators Take Steps to Help Grandfathered Plans

Regulators are in the early stages of creating rules that make it easier for health plans that were grandfathered in before the Affordable Care Act took effect to continue providing coverage.

The number of workers enrolled in plans that were in effect before the ACA was enacted in 2010 has been shrinking, and as of 2018, some 16% of American workers who were enrolled in group health plans were in grandfathered plans.

Under the ACA, those plans do not have to abide by the same regulations as plans that took effect after the law’s implementation.

In February 2019, the Internal Revenue Service, the Employee Benefits Security Administration and the Health and Human Services Department issued a request for information from grandfathered plans. The goal is to determine whether there are opportunities for the regulators to assist plans to preserve their grandfathered status in ways that would benefit employers, employees, and their families.

While the effort will only affect a small amount of employer-sponsored plans, the move is significant as it looks like the ultimate goal is to further loosen rules for grandfathered plans.

A plan is considered grandfathered under the ACA if it has continuously provided coverage for someone (not necessarily the same person, but at all times at least one person) since March 23, 2010 and if it has not ceased to be a grandfathered plan during that time.

Grandfathered plans have certain privileges that other group health plans that were created after that date do not have, as the latter are all required to comply with all of the rules under the ACA.

Under the ACA, grandfathered plans do not have to comply with certain provisions of the law.

These provisions include coverage of preventive health services and patient protections (for example, guaranteed access to OB-GYNs and pediatricians).

Other ACA provisions apply to grandfathered plans, such as the ACA’s waiting period limit.

Grandfathered status

Grandfathered health plans may make routine changes to their coverage and maintain their status.

However, plans lose their grandfathered status if they choose to make significant changes that reduce benefits or increase costs for participants.

Some of the questions that the three departments are asking plan administrators are:

  • What actions could the departments take to assist group health plan sponsors and group health insurance issuers to preserve the grandfathered status of a group health plan or coverage?
  • What challenges do health plans and sponsors face regarding retaining the grandfathered status of a plan or coverage?
  • What are your primary reasons for retaining grandfathered status?
  • What are the reasons for participants and beneficiaries remaining enrolled in grandfathered group health plans if alternatives are available?
  • What are the costs, benefits and other factors when considering whether to retain grandfathered status?
  • Is preserving grandfathered status important to group health plan participants and beneficiaries? If so, why?

Responses to the request for information are due by March 27.

DOJ Tells Court to Nullify ACA; What’s Next?

After a period of relative stability, the future of the Affordable Care Act has once again been thrown into uncertainty.

In a surprise move, the Department of Justice announced that it would not further pursue an appeal of a ruling by U.S. District Court Judge Reed O’Connor, and instead asked the 5th U.S. Circuit Court of Appeals to affirm the decision he made in December 2018.

O’Connor had ruled that Congress eliminating the penalty for not complying with the law’s individual mandate had in fact made the entire law invalid.

But, even though the DOJ won’t be pursuing defense of the law and challenging the ruling on appeal, a number of states’ attorneys general have stepped up to fight the ruling.

What this means for the future of the employer mandate is unclear, as the court process still has a long way to go. The ruling could be overturned on appeal and invariably whatever the 5th Circuit decides, the case will likely be appealed to the U.S. Supreme Court.

Already there has been fallout in the private health insurance market since the individual mandate penalty was eliminated, but the employer mandate, which requires that organizations with 50 or more full-time or full-time-equivalent workers offer health coverage to their employees, remains intact.

As the case winds on, it will be some time before anything changes. The 5th Circuit has not yet scheduled arguments. The DOJ has asked for a hearing date for July 8, and Democratic states’ attorneys general agreed.

Despite the DOJ’s announcement, the law stands and applicable large employers must continue complying with its requirements.

Analysis

The move was surprising because in the past President Trump had signaled that he wanted to keep parts of the ACA, particularly the barring of insurers from denying coverage based on pre-existing conditions. If the entire law is scrapped, so will that facet – as well as other popular provisions, like allowing adult children to stay on their parents’ policy until the age of 26.

Trump said his administration has a plan for something much better to replace the ACA.

Democrats have introduced some legislation to try to stabilize markets and improve on some ACA shortfalls. Their legislation aims to cut premiums for individuals buying on exchanges by expanding premium tax credits. Another bill would reaffirm the pre-existing condition protections, and restore enrollment outreach resources, which have been cut back under the Trump administration.

But with a divided Congress, the likelihood of anything reaching Trump’s desk are slim to none.

Meanwhile, the success of the ACA has been spotty. In some parts of the country, usually in areas with high population density, competition among plans ensures lower prices for people shopping on exchanges. But in smaller regions, cost increases are rampant.

A new analysis by the Urban Institute, a liberal-leaning think-tank, finds that more than half (271) of the country’s 498 rating regions have only one or two insurers participating in the ACA marketplace. Those regions are disproportionately in sparsely populated areas.

Regions with little competition tend to have much higher premiums. In a region with only one insurer, the median benchmark plan for a 40-year-old nonsmoker is $592 a month. That compares to $376 for the same consumer in a region with at least five plans.

Vision Benefits Help Workers, Who in Turn Help You

EVERY EMPLOYER benefits from a healthy workforce. But many employers do not know that an affordable way to achieve this is with voluntary vision benefits which are a win-win for both businesses and their employees.

Recent research shows that employers see average returns of $70 for every $10 invested in vision benefits. There are a few good reasons why benefits covering regular exams and eye wear are helpful to employers.

The cost of health care can go down

Even people with good vision should have an eye exam each year. Optometrists can identify the beginning stages of several other health problems during an exam.

Early signs of diabetes, brain tumors and high blood pressure can be detected. One of the most important of these points is diabetes. Although doctors may miss some of the earliest signs in a physical exam, optometrists can identify it by slightly blurred vision, which is one of the earliest signs.

Since diabetes is one of the most costly health problems, this is one of the most important preventative benefits of a regular eye exam. Diabetes can be easier to control when it is caught early.

Eye exams are also helpful in identifying the early stages of serious vision problems. Some examples of these problems include retinal detachment, macular degeneration, cataracts and glaucoma.

These conditions alone cost the system over $35 billion each year. Early detection is the key to reducing the long-term costs of these conditions.

Regular exams are also helpful for people who need corrective eye wear.

Prescription needs can change, and the eyes can become strained from wearing outdated contacts or glasses. Even those who have good vision should purchase quality preventative eye with 100% UV blockage to wear outdoors.

More productive employees

If employees cannot see properly, their work performance suffers.

For office workers, this could mean typographical errors on important accounting records or crucial documents. For laborers, this could mean mistakes on the job that lead to workplace injuries.

Employees with poor vision also get headaches and become fatigued faster. Research shows that even a slight vision problem can lead to a 20% reduction in work productivity. This is especially true for employees with astigmatic vision problems.

Higher job satisfaction

Employers know that satisfied employees work better and are less likely to quit. A good comprehensive vision plan is a great way for employers to increase satisfaction enough to keep employees working there.

Research shows that 80% of employees found the idea of workplace vision benefits very satisfying. In addition to this, researchers found that workers who are satisfied with their benefits are three times more likely to not quit their jobs.

Research has also shown that about three out of every four employees will enroll in vision plans offered by their employers. But, about one of every three of those enrolled will not use their benefits.

They also do not know what lens options are available to them. This shows that employers must make a greater effort to educate workers about what is included in their plans.

Workers understand that their vision is a precious gift, and they do not want to lose it.

The high cost of vision care is prohibitive for many to seek the care they need, so they need to understand just how much their plans save them and how often they should see an optometrist.

To learn more about what options are available, call us to discuss your options.

Employers More Confused about Coverage than Ever

One of the biggest challenges for employers who offer their workers health insurance benefits is that the majority of U.S. workers are really in the dark about how insurance works, according to a new survey.

Despite employers’ best efforts to provide as much education as possible to their workers before and during open enrollment, it seems the finer points are not sinking in, according to United Healthcare’s “Consumer Sentiment Survey.”

Here are the main findings:

  • A mere 7% of those surveyed had a full understanding of all four basic insurance concepts: plan premium, deductible, coinsurance and out-of-pocket maximum.
  • More than 60% of respondents could define plan premium and deductible.
  • 36% could define out-of-pocket maximum.
  • 32% could define coinsurance.

These deficiencies result in more people spending more on coverage than they may actually need to.

Another study, carried out earlier this year by the Kaiser Family Health Foundation, concluded that not having the correct information can lead to dissatisfaction when employees discover they’ve signed up for a plan that doesn’t meet their needs.

The Kaiser survey revealed that employees are most confused when it comes to understanding these factors:

  • How to calculate out-of-pocket costs once health insurance claims are processed.
  • The concept of providers who are in network vs. out of network at an in-network hospital.
  • Understanding deductibles and out-of-pocket annual limits for their plans.
  • What a health insurance formulary is (concerning prescription coverage amounts).

What you can do

So, as open enrollment nears, you may want to consider focusing on the foregoing areas to better educate your workers. Also, it’s recommended that you approach the education process with a multi-pronged approach employing technology, meetings and the offers of one-on-one time to cater to people’s different learning styles.

It’s important for your employee morale and their pocketbooks that they understand what their choices are and what they’re buying. The more light you can shine on the process and the more stress you can reduce, the better off your employees will be.

This is especially true in light of one other finding in the United Healthcare study: One-fourth of respondents said they would rather file their annual income taxes than select a health plan.

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