Insurance Coverage and Medical Care

Merck v. Albrecht is a simple issue contained in a long story.

In 2009 in Wyeth v. Levine the Supreme Court held that federal law preempts state law failure to warn claims that a drug manufacturer failed to change a drug label if there is “clear evidence” the Food and Drug Administration (FDA) would not have approved the label change. In Merck v. Albrecht a unanimous Supreme Court held that a judge rather than a jury determines if the FDA would have approved the change.

The federal Food, Drug, and Cosmetic Act (FDCA) provides no federal remedy for unsafe and ineffective drugs but state law may in the form of a failure to warn claim. The FDA allows manufacturers to change warnings on drug labels when newer drug safety information becomes available. The Supreme Court has held if the FDA would not have approved a drug label change, which a state failure to warn law would have required, the FDCA preempts the state law claim.

CSG Midwest
When a health consumer receives care outside of an insurer’s network of providers, he or she may receive a surprisingly high medical bill, and face the prospects of paying unexpectedly high out-of-pocket costs. 
These situations are not uncommon, and often not the fault of the health consumer — for example, he or she requires immediate emergency care, or an out-of-network provider is part of a larger team of physicians providing complex medical treatment.
As evidenced in recent polling data and new state laws, “surprise billing” has become a widespread concern among health care consumers and policymakers alike. In a poll conducted last year by the Kaiser Family Foundation, two-thirds of Americans said they were either “very worried” or “somewhat worried” about being able to afford their own or a family member’s unexpected medical bills.
The Commonwealth Fund, meanwhile, has been tracking the spread of laws to protect individuals from certain types of “surprise billing.” By the end of 2018, the number of states with such laws had reached 25: nine with comprehensive laws (including Illinois in the Midwest) and 16 with “partial protections” (including Indiana, Iowa and Minnesota).

In December 2018 a federal district court declared the Affordable Care Act (ACA) individual mandate unconstitutional. It also declared the remaining provisions of the act “inseverable,” meaning also invalid. The court didn’t issue a nationwide injunction which would have had the effect of immediately ceasing all aspects of law.

In the district court litigation the Department of Justice (DOJ) didn’t defend the individual mandate. But it did argue that other provisions of the ACA, excluding the guaranteed-issue and community-rating requirements, which were intended to provide affordable health insurance for those with pre-existing conditions, were severable. Now DOJ has informed the Fifth Circuit that it has changed course and agrees with the lower court that the entire ACA was properly invalidated.

At the same time the federal government has announced a new emphasis on reviewing how well states enforce Medicaid eligibility rules, it has offered a new tool to help states improve accuracy and speed up the eligibility determination process.
In June 2018, the Trump administration announced new initiatives to increase Medicaid program integrity. These initiatives include assuring that states effectively enforce Medicaid beneficiary eligibility rules. The Government Accountability Office (GAO) estimates that improper Medicaid payments totaling $11.3 billion were made in 2017 because of state errors in eligibility determinations.

By
Guest

In March, ADAPT Pharma, a subsidiary of Emergent BioSolutions and CSG Associate, announced the expansion of its program offering free NARCAN Nasal Spray – the leading community use naloxone – to U.S. high schools and eligible colleges and universities. NARCAN Nasal Spray 4mg is the only FDA-approved, needle-free formulation of naloxone for the emergency treatment of a known or suspected opioid overdose. As part of this effort, ADAPT Pharma will:

• Expand free NARCAN Nasal Spray availability by eliminating the prior 20,000 cartons cap for eligible colleges and universities
• Double the allocation to high schools from one free carton (two 4mg doses) to two free cartons (four 4mg doses)
• Extend the term of the free NARCAN Nasal Spray offer until it is in every high school and eligible college and university in the United States

CSG Midwest
In October, the Trump Administration adopted new rules for short-term (or “skinny”) health insurance plans. Since then, some states have weighed in by adopting new rules of their own, while also reminding insurers that they must still comply with state-level regulations.

While a federal district court struck down the Affordable Care Act as unconstitutional on December 14, the Act and the litigation will continue. The judge didn’t issue a nationwide injunction which would have had the effect of immediately ceasing all aspects of law.

Unsurprisingly, the states defending the law have stated they will appeal this ruling to the Eleventh Circuit. Particularly if the Eleventh Circuit agrees with the lower court the Supreme Court is likely to hear this case though not until its next term beginning October 2019.

The Affordable Care Act individual mandate required uninsured who didn’t purchase health insurance to pay a so-called shared-responsibility payment. In 2012 the Supreme Court held the individual mandate is a constitutional “exercise of Congress’s Tax Power because it triggered a tax.” The Tax Cuts and Jobs Act of 2017 reduced the tax to $0 as of January 1, 2019.

CSG Midwest
Wisconsin has received federal approval of changes to its Medicaid program that include requiring work for some enrollees and charging higher premiums based on the results of a health risk assessment. The approved waiver centers on childless adults applying for and receiving coverage through the public health insurance program. According to The Washington Post, Wisconsin also had originally sought to become the first state in the nation to impose drug tests on some of its Medicaid population. This requirement did not receive federal approval.

Ballot measures to expand Medicaid eligibility in Idaho, Nebraska and Utah passed in the mid-term elections. Montana voters rejected a measure to continue the expansion in their state.

On Oct. 22, the federal government issued new draft regulations concerning 1332 waivers. In a call to CSG from the Centers for Medicare and Medicaid Services (CMS), officials explained the new regulations would provide more flexibility to states, revising the “guardrails” set in the 2012 regulations. Plans previously considered non-ACA compliant could be sold on the marketplaces and could qualify for federal subsidies. 

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