By Drew Kohlmeier

Stop the Clock: Implications of Switching Time Zones

April 20th, 2019 in Analysis, Federal Legislation, State Legislation

The holiday season is joyous for many reasons; from family, friends, and food, there is ample joy and merriment to go around. There is one aspect of the season that doesn’t match these factors; especially in New England – darkness. At the outset of winter, on December 21st each year, the sun sets in Boston at 4:11pm. There are many negative effects of darkness setting in before the end of the workday – with increased crime, traffic accidents, and seasonal depression being one of the most paramount. Boston’s sunset is not the earliest in the area, with municipalities in Maine experiencing sunsets earlier than 4pm; but it is the earliest of the major cities, beating out Buffalo, NY despite being further south.

Early sunsets do not become apparent in New England until clocks fall back in line with the change from Daylight Savings Time. Daylight Savings is a federal program instituted during World War II that the country has become accustomed to; the federal legislation only permits states to opt out of the program, but it does not allow states to make the program permanent, which would keep the clocks from falling back an hour. Hawaii and Arizona have opted out of the program – made available through the US Energy Policy Act of 2005, allowing any state that lies entirely within one time zone to opt out.

New England states, primarily Massachusetts and Maine at this point, have been considering a change to the Atlantic Time Zone

The Sacred Cod and House Clock
Massachusetts House Chamber

in order to increase the number of waking hours with sunlight. With a change to Atlantic Time, and subsequent opting out daylight savings, New England would be out of sync with the rest of the Eastern Time Zone from November to March, or the period in which clocks “fall back” in line with daylight savings in the Eastern Time Zone. A transfer to Atlantic Standard Time – which includes Puerto Rico, the Virgin Islands and eastern Canada – would mean jumping an hour ahead of the Eastern time zone from November to February. The time zones would align from March to October.

While the benefits of having an extended amount of light in the evening hours are readily apparent, there are several drawbacks that accompany a change. Early risers in particular, who are likely accustomed to the sun being out while they start their days have reason to complain. School aged children may be leaving to their schools in darkness in the morning, and businesses that transact on financial markets may be put out of sync with the markets they depend on.

If New England were to change to Atlantic time, there would be a two-step process. First, the interested states would have to decide to leave. Second, the states would have to consult the US Department of Transportation, the cabinet agency that regulates time zones. States, municipalities, business interests, and others would have the opportunity to weigh in during both steps.

There could be major issues with “commerce, trade, interstate transportation and broadcasting” if one state moves ahead one hour while its neighboring states remain in the Eastern Time Zone. It seems to be a requirement of widespread support and agreement for any change in this area to take effect. Lawmakers in Maine might support the change – in May 2017, Maine’s Senate passed a bill that would move the state to the Atlantic Time Zone — if approved by residents in a state-wide referendum. Maine conditioned the change, subject to their approval, on Massachusetts and New Hampshire.

Some states seem to have considered the idea and decided against it, with the New Hampshire Senate voting against a bill that would move the state to the Atlantic Time Zone by a 16 to 7 vote; at the same time, the bill passed the house with a voice vote. While there has yet to be an affirmative move, the proponents of the change are enlivened by the action around the issue and are hopeful for the future.

Massachusetts established a commission to study the issue. In a neutral report neither supporting or disavowing the change, the commission stated its findings that “People tend to shop, dine out, and engage in other commercial activities more in after-work daylight,”. . . “Year-round DST could also increase the state’s (competitiveness) in attracting and retaining a talented workforce by mitigating the negative effects of Massachusetts’ dark winters and improving quality-of-life.” More daylight could also reduce street crime, on-the-job injuries and traffic fatalities, and boost overall public health, the commission found.

States in the Northeast seem intrigued by the change, but alterations of the particulars of their citizen’s days are deeply personal to their citizens may be a drastic change to take without widespread public support. In Arizona, the effects of their non-adherence to daylights savings time are apparent when the state is out of sync with the rest of the surrounding states – constant clarification of what time is in effect, setting different meeting times, etc. Results on an individual basis are a mixed bag, with businesses that are purely local and that thrive in the daylight being supporters of the longer day due to increased business, and those who constantly run up against timing differences by virtue of dealing with other regions.

It will be interesting to observe if public support for a time zone change increases as people in New England become aware that doing so is a possibility to increase their daylight hours in the depths of winter. In any case, it is clear that the states’ legislatures have identified it as a possible issue.

 

Drew Kohlmeier is a student in the Boston University School of Law Class of 2020 and is a native of Manhattan, KS, graduating with a degree in Biology from Kansas State University in 2016. Drew decided on Boston for law school due to his interest in health care and life sciences, and will be practicing in the emerging companies space focused on the life sciences industry following his graduation from BU.

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Raising the Blinds – Gaining Meaningful Insight into Pharmaceutical Pricing through Legislation

February 7th, 2019 in Analysis, Federal Legislation, Legislation in Court, Lobbying

Rising healthcare costs are a growing concern across the United States; in 2016 U.S. health care spending was $10,348 per person – or 17.9 % of the nation’s Gross Domestic Product (GDP). To counter this alarming rise in healthcare costs, states are addressing one of the largest factors in rising healthcare costs – high drug prices. 

Many factors contribute to the high price of healthcare in our country, some of which are natural to an aging populace due to the baby boom of the 1950’s as the proportion of the population that is 65 and over is projected to experience a large increase in the coming years. An increase in costs is natural with a larger number of consumers – addressing this change is an important, but avoidable, challenge to overcome.

One avoidable factor of increasing healthcare costs is rapidly increasing pharmaceutical prices. Variance in drug prices may be geographic; based on where the drug is sold , or whom the drug is being sold to (pharmacy v. government). Many factors contribute to price differences, but an important factor are Pharmacy Benefit Managers (PBMs) as an intermediate in the market. States have been working to roll back the PBM layer of the market for  the pharmaceutical industry.

Pharmaceutical pricing has long been the target of legislators, but with a lot of talk and a surprising lack of action. Drug pricing is  discussed in both major party’s campaign platforms of the major parties and has been featured prominently in speeches by President Trump, and has featured in initiatives by previous administrations. There has been an uptick of legislation passed in the past decade, at all levels of government, with state action against pharmacy benefit managers and President Trump’s signing the Know the Lowest Price Act and the Patient Right to Know Drug Prices Act.  A common thread in the legislation is increased transparency because a big factor in the high drug prices — and medical care generally—is the lack of information for consumers and purchasers. Since 2015, California, Oregon, Louisiana, Nevada, Vermont, Connecticut, and Maryland imposed reporting requirements on pharmaceutical manufacturers who increase prices over an established threshold in a set time period. For example, California requires reporting when a drug that costs more than $40 and its wholesale acquisition cost (WAC) increases by more than 16% over two calendar years.  The WAC is similar to a “list” price for pharmaceuticals to wholesalers and direct purchasers. The WAC, however, does not include discounts or rebates offered by pharmacy benefit managers.

The new transparency offers insight to price increases; if there are no legitimate reason for the increase other than higher profits due to market control, state officials, drug customers and the public can take action.

The states with transparency statutes have imposed different methodologies with manufacturers reporting to different government officials such as the Department of Health and Human Services, creation of new departments, or to the state’s Attorney General.

Oregon currently requires the most detailed reporting; manufacturers must report to the Department of Consumer and Business Services the following:

  1. Name, price of drug and net increase in price (in %) over previous calendar year
  2. Length of time on market
  3. Factors contributing to price increase
  4. Name(s) of any generic version(s) of the drug
  5. Research & Develop Costs from Public Funds
  6. Direct costs to Manufacturer
  7. Total sales revenue for drug over prev. calendar year
  8. Profit from drug over previous calendar year
  9. Drug's price at release and yearly increases over the past 5 years
  10. 10 highest prices paid for the drug during past year outside of the US
  11. Any other info relevant to price increase
  12. Supporting documentation

In contrast, California’s requirements provide for advance notice of price increases and unearthing the reasoning for the increase. The California law requires manufacturers to report (A) Date of increase, current WAC, and future increase in WAC (in dollar amounts); and (B) The change or improvement, if any, that necessitates the price increase. Purchasers then have notice of any forthcoming price changes and if the increase is warranted.  California also requires a report for new drugs if its price exceed $670—the 2017 Medicare Part D threshold.  California’s reporting scheme has been a model for other states.

Maryland’s approach was more severe, with a provision banning “price gouging” of generic drugs. An “unconscionable price increase” of any “essential off-patent or generic drug” is illegal and  Maryland can levy a fine and take action to reverse the price change. The state did not include any limitation of the law to drugs that have come into or passed through Maryland.

The generic drug lobby, the Association for Accessible Medicines, challenged the law and the Fourth Circuit Court of Appeals struck down the law as an unconstitutional regulation of interstate commerce. Maryland has petitioned the Supreme Court to revisit the case.

The Pharmaceutical Research and Manufacturers (PhRMA), one of the largest pharmaceutical lobbying groups, has sued California alleging the law, like Maryland’s, is unconstitutional. Because California’s law is informational—and does not allow forced price changes—it is likely constitutional. In fact, PhRMA’s initial complaint was dismissed, and subsequently filed an amended complaint on Sept. 18, 2018.

It will be imperative for states seeking to regulate pharmaceutical manufacturers to observe where courts determine the extent of reporting they may require when they go after a manufacturer for increasing the price of their drug. For the time being, it appears that information-gathering may be the easiest available avenue for states seeking to curtail increases in drug prices. Seeking justifications and reasoning for large increases in drug prices may create a barrier for pharmacuetical companies seeking to impose unsubstantiated increases in drugs. Going further towards affirmative control of pricing appears to be off limits to states going as far as Maryland, but more careful structuring of the controls to the specific state may be permissible.

 

Drew Kohlmeier is a student in the Boston University School of Law Class of 2020 and is a native of Manhattan, KS, graduating with a degree in Biology from Kansas State University in 2016. Drew decided on Boston for law school due to his interest in health care and life sciences, and will be practicing in the emerging companies space focused on the life sciences industry following his graduation from BU.

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