Will Humble Climate Change, Wills Blog

EPA Proposing Fuel Efficiency Standard Rollback

The EPA & National Highway Traffic Safety Administration are proposing a roll back of the existing vehicle fleet fuel efficiency standards, which require automakers to gradually increase the average fuel efficiency of their new fleets.  

Under the existing regulations, new cars, trucks, and SUVs fleets will need to average about 50 miles per gallon by 2025. The new EPA & NTHSA proposed rule will stop the progression of standards in 2021.  Rather that requiring a fleet average of 50 mpg by 2025, the new standard will stop at 38 mpg.  Last year, the average fleet fuel efficiency was about 25 mpg.  The current average fuel efficiency of all vehicles on the road is about 21 mpg.

Fuel efficiency standards are an important driver that pushes vehicle manufacturers to discover new ways of improving fuel efficiency and are an important strategy toward reducing greenhouse gas emissions.  The transportation sector is the largest contributor to atmospheric CO2 emissions.

You can submit comments directly to the EPA and NTHSA at this web portal (it’s Docket EPA-HQ-OAR-2018-0283).  The deadline to comment is October 23, 2018. There are only 138 comments in the system so far.  I have this on my to-do list.  Hopefully some of our members will weigh in as well

Will Humble Climate Change, Wills Blog

EPA Proposing Looser Methane Leak Regulations

The USEPA has proposed a new rule that will relax the regulation of methane emissions at oil and gas facilities.  Methane is a very powerful greenhouse gas.  A mole of CH4 emitted today lasts about 10 years  in the atmosphere on average, which is much less time than CO2.  But, because CH4 absorbs much more energy than CO2 (CH4 is 30 times more potent as a greenhouse gas than CO2) it has an outsize impact on climate change (but for a shorter time period).  

The plan announced today by EPA will roll back key provisions of the current methane regulations.  The new proposal reduces the frequency of emissions monitoring at oil and natural gas wells from twice a year to once a year or even every other year.  Facilities that compress gas for transport through pipelines will have their monitoring frequencies cut in half from 4 times a year to just twice.  It will also extend the time that companies will have to repair leaks of this potent greenhouse gas from 30 days to 60 days.  Here’s the proposal summary: https://www.epa.gov/sites/production/files/2018-09/documents/frnoilgasreconsideration2060-at54nprm20180910.pdf

At least it won’t let companies completely off the hook, but then that’s looking through rose-colored glasses I guess.

This new rollback hasn’t been published in the UA Administrative Register yet, and comments are not yet open.  The 60-day comment period will begin once it’s published in the Register.  The Docket ID number will be EPA-HQ-OAR-2017-0483 with comments at www.regulations.gov.

Will Humble Affordable Care Act, Health Insurance, Medicaid, Public Health Law, Wills Blog

Health Insurance for People w Pre-existing Conditions in Jeopardy Again

A main driver for passing and implementing the Affordable Care Act was to ensure that people with pre-existing health conditions could buy health insurance.  Prior to the ACA- people with pre-existing medical conditions like diabetes faced real challenges getting health insurance.

Indeed, one of the most consistently popular parts of the ACA are the provisions that help people get  coverage regardless of health status.  The ACA prevents health insurance companies from denying someone a policy because they have a preexisting condition (called the “guaranteed issue” requirement), refusing to cover services that people need to treat a pre-existing condition (called “preexisting condition exclusions”), or charging a higher premium based on a person’s health status (called the “community rating” provision).   

You can think of pre-existing conditions exclusions, guarantee issue, and community rating as the three legs of the ACA stool.  Despite these largely popular provisions, there are people that want to knock over the stool.  Back in February, 20 states (including Arizona) filed a lawsuit in Texas federal court seeking to invalidate the 3 legs of the stool: preexisting condition exclusions, community rating, and guaranteed issue.

This most recent legal attack argues that the removal of the individual mandate penalty by the most recent federal tax cut legislation makes the ACA unconstitutional (the US Supreme Court upheld the ACA several years ago, in part, because the tax penalty provision provided a statutory hook for the ACA to rest on).  The lawsuit argues that because the mandate is an essential feature of the ACA, the rest of the law must be struck down too.  If the lawsuit eventually succeeds these central provisions of the ACA would go away and an estimated 17 million people could become uninsured again.

During the Obama Administration, the federal government defended the ACA from lawsuits like these.  Those days are over.  A couple of months ago, the U.S. Department of Justice announced that they agree with the plaintiff States that the ACA’s individual mandate is unconstitutional. The administration urged the court to strike down the law’s guaranteed issue, preexisting condition exclusion, and community rating provisions.

Prior to the ACA, standards to protect people with preexisting conditions were primarily determined at the state level.  Most states including AZ had very limited protections. Before the ACA, many insurers maintained lists of up to 400 different conditions that disqualified applicants from insurance or resulted in higher premiums.  35% of people who tried to buy insurance on their own were either turned down by an insurer, charged a higher premium, or had a benefit excluded from coverage because of their preexisting health problem.

If the Federal courts (ultimately the US Supreme Court probably) rule in favor of the plaintiffs, States could still play as a regulator of insurance, as they could enact and enforce their own laws to protect residents from discrimination due to preexisting conditions.  In fact, several states already have their own laws to incorporate some or all of the ACA’s protections (Arizona does not). 

Oral arguments have been scheduled for next week in the Texas lawsuit. Arguments are scheduled to take place next Monday before Judge Reed O’Connor.  Whatever the Federal TX Court rules, the result will likely be appealed to the UA Appellate Court and eventually probably the US Supreme Court.

Will Humble Public Health, Wills Blog

Center for Public Health Law & Policy

 

The Center for Public Health Law and Policy  is the cornerstone of the Sandra Day O’Connor College of Law’s nationally-ranked health law program. The Center brings together students, leading scholars, practitioners, and policymakers to address critical issues in law, ethics, policy, and the public’s health. The Center explores a wide range of issues, including national health care reform, communicable disease control, human subject research protection, emergency legal preparedness, obesity and injury prevention, health information privacy, and vaccination law and policy.

The Center for Public Health Law and Policy is also the home to the Western Region Office of the national Network for Public Health Law, funded in part by the Robert Wood Johnson Foundation. Led by Professor James G. Hodge, Jr., the Western Region Office provides technical assistance and other vital resources to public health practitioners, officials, attorneys, and advocates across 11 Western states and nationally. Since its inception in September of 2010, the Western Region Office has fulfilled nearly 3000 requests nationally, over 1000 of which directly aided requesters in the office’s home state of Arizona.

This fall the Network for Public Health Law is organizing the 2018 Public Health Law Conference, to be held October 4-6, in Phoenix, AZ. For more information, please visit: https://www.networkforphl.org/2018_conference/phlc18.

Will Humble Affordable Care Act, Behavioral Health, Federal Budget, Health Insurance, Medicaid, Wills Blog

State Action to Stem Rising Prescription Drug Costs

By Association for State and Territorial Health Officials Staff

The high cost of prescription drugs is a persistent problem in the United States, with about 10 percent of overall health spending attributed to prescription drugs. In recent years, there has been increased interest among states to address the rising cost of prescription drugs. Just this year, 24 states passed 37 bills to stem rising drug costs. In total, state legislatures have introduced 160 bills targeting prescription drug costs in 2018.

States have pursued a wide range of strategies to tackle the high cost of prescription drugs, including policies that address drug price transparency, rate setting requirements to prevent price gouging, drug importation programs, generic drugs companies, and pharmacy benefit manager transparency.

 

Drug Price Transparency

Controlling healthcare costs is one of the three elements of the Triple Aim, along with improving population health and patient care experience. As a first step toward controlling costs, states are seeking more price transparency requirements from drug manufacturers. In 2018, six states passed legislation addressing drug price transparency. Many of these laws adopt more stringent transparency policies requiring drug manufacturers to justify price increases over certain thresholds. For example, Connecticut requires drug manufacturers to justify price increases for specific drugs if the price increases by 20 percent or more in a year or 50 percent over three years.

 

Price-Gouging and Rate Setting Requirements

Anti-price gouging and rate setting requirements use information collected from transparency laws to allow states to impose penalties for excessive drug price increases. Currently, Maryland is the only state with an anti-price gouging law. The policy allows the state Medicaid agency to notify the state’s office of the attorney general when an essential off-patent brand name drug or generic medication has an excessive price increase.

Maryland’s attorney general can then request justification from manufacturers for the price increase. If the rationale of the price increase is deemed unjustified by “the cost of producing the drug, or the cost of appropriate expansion of access to the drug to promote public health,” the state can impose civil penalties or use other mechanisms to penalize the manufacturer. However, a lawsuit has since been filed in federal court by drug manufacturers asserting violations of Constitutional law as it relates to interstate commerce. To date, twelve other anti-price gouging bills have been introduced in states, although none have been enacted.

 

Drug Importation

Earlier this year, Vermont became the first state to pass a drug importation bill, allowing the state to import wholesale prescription drugs from Canada for use by all state residents. The law requires the designation of a state agency to become a licensed drug wholesaler, or to contract with a licensed drug wholesaler. Several steps remain before Vermont’s program can go into effect, including the state health department receiving federal approval from HHS by July 2019. In addition, although the Utah legislature failed to pass a bill that would have created a program for importing drugs from Canada, the legislature requested that the Utah Department of Health conduct a feasibility study associated with drug importation.

 

Generic Drugs

Recently, Maine passed a law requiring brand name manufacturers to make samples of drugs available to generic drug manufacturers, with the intention of promoting competition by increasing access of information for companies developing lower-cost generic drugs. The law states that, “In order for there to be competition in the prescription drug market, developers of generic drugs and biosimilar biological products must be able to obtain quantities of the reference listed drug or biological product with which the generic drug or biosimilar biological product is intended to compete.”

 

Pharmacy Benefit Managers

Several states have passed bills regarding pharmacy benefit managers (PBMs), which require increased transparency and disclosure of information on drug rebates and concessions. For example, Nevada passed a law in 2017 requiring PBMs to disclose the amount of rebates received from drugs used to treat diabetes. Connecticut’s drug price transparency law also requires PBMs to provide information on rebates and other price concessions received from drug companies. Mississippi passed a law preventing PBM gag clauses, which stop pharmacists from sharing information with patients on lower-cost drug options.

 

Other State Policies

In Montana, the legislature passed a bill establishing an interagency committee to study state drug pricing and spending trends, which will make recommendations to the state legislature on drug pricing policies in late 2018. In addition, New York implemented an annual cap on drug spending in its Medicaid program. Under the law, if spending projections extend beyond the cap, the state health department must identify the costliest drugs and attempt to negotiate additional rebates with manufacturers. This law also gives the state the authority to develop an independent panel that can penalize manufacturers through various mechanisms.

 

Future Opportunities

Emerging state legislation to address the rising cost of drug prices in demonstrates potential paths forward to address drug prices at the state level. The National Academy of State Health Policy (NASHP) has developed model legislation to address drug price transparency, drug importation, rate setting, and pharmacy benefit managers. The NASHP resource includes model legislation for states, bill text from states that have already passed legislation, and relevant briefing documents.

1 2