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The Hill
Like most Americans, I’ve closely followed press briefings by the White House on the national response to COVID-19, looking for hints of public health expertise. What caught my attention most were comments from Ambassador-at-Large, Deborah L. Birx, coordinator of the U.S. Government Activities to Combat HIV/AIDS, and now a leading voice on the White House COVID-19 taskforce. Rightly so, Ambassador Birx has earned a leadership role during this critical time, given her extensive leadership role in our global HIV prevention and treatment strategy. Her most astute comment, I believe, highlighted how “communities are at the center of this,” and that the virus should be stopped “at the community level.” Providing COVID-19 screening access to the American people across all geographic and socioeconomic areas is critical, particularly given our collective and shared knowledge that exposure to COVID-19, like the flu, does not discriminate. Hospitals and urgent care clinics are apparent sites for screening. In Westchester County, N.Y., drive-up screening for residents greatly improved access to screening and now similar drive-ups are being implemented in other states. But in places like Harlem, where I live, and neighborhoods like South Bronx and East New York-Brooklyn, as well as the vast non-urban areas across New York State and the nation, going to the hospital for a test may not be the most viable strategy. They definitely should not be emphasized as our only community-reaching frontline effort. While drive-up screening aligns with the concept of social distancing, it is not accessible or practical for Americans living in densely populated urban centers, regardless of social, economic level, due to the high likelihood of gridlock. As we conceptualize a comprehensive community COVID-19 strategy that gives all Americans access to screening services, I believe we must prioritize attention on increasing the number and types of screening access points. Simple math would tell us that with more access points and greater geographic distribution, the higher the ability for social distancing. What has not been mentioned and exists in plain sight is the expanded public health role for pharmacies, which includes independent small business and minority-owned pharmacies. Many of us are familiar with pharmacies extending their practice beyond filling prescriptions to include blood pressure screening, flu vaccinations, and even co-located primary care clinicians. A successful pharmacy practice innovation that arose out of the HIV epidemic and included a large proportion of independent, small minority-owned pharmacy businesses, were on-site HIV screening services in high risk, lower-income communities. The research revealed strong evidence of such practical and feasible screening services being able to reach those systematically disconnected from traditional healthcare access points. Pharmacies are frequented by all segments of the population and typically located within 5 miles for 95 percent of all Americans. They usually have flexible hours and capacity to properly store and dispense all forms of pharmaceuticals, provide medication counseling and medical advice, and are known for their strong ties in their communities, particularly independently-owned pharmacies. Taking this idea a step further, the rationale for pharmacy-based COVID-19 screening also supports the capacity for pharmacists to create linkage to treatments readily available and forthcoming, which are likely to arrive much sooner than a vaccine. Currently available COVID-19 treatment includes fever reducers, supplemental oxygen, and respirators – all of which are safely stored in pharmacies and could easily be scaled up. While “big box” corporate chain pharmacies are being considered for a frontline role as suggested, it is critical to place more (or at least equal) attention on supporting the part of the independent, small business-owned pharmacies, who are frankly being overlooked. Independent pharmacies represent 36 percent of all U.S. retail pharmacies, with over 22,000 locations. These pharmacies are typically located in geographic areas where large chains are absent, including rural and lower-income urban areas across the U.S. At a time when the administration is taking unprecedented actions to remove bureaucratic barriers and support small businesses in general, legislation should prioritize economic support for independently-owned pharmacies to purchase pharmaceuticals and supplies related to administering COVID-19 screening services. The White House should also prioritize policy that gives small pharmacy business owners access to high-cost medications that are exclusive to large corporate conglomerates. Falling short in our public health response will not only extend the mounting fear, and disruption of American life, but will essentially weaken the positive impact of critical public health efforts employed thus far such as travel restrictions, school, and college closings, bars and restaurant closings, bans on crowded events, and social distancing. We must think innovatively about COVID-19 screening access at the community level. The more viable and practical screening and treatment access points we put in place, the higher the likelihood of minimized chaos, crowded waiting lines, and an expedited return the social freedoms that we all took for granted will become possible again. Crystal Fuller Lewis Ph.D. is an infectious disease epidemiology from Johns Hopkins Bloomberg School of Public Health and is currently an associate professor at NYU School of Medicine, Department of Psychiatry. Lewis has spent two decades conducting NIH funded research to expand access to HIV prevention and related social and medical services to high-risk communities.
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The Telegraph
Legislation to cut out the role of pharmacy benefit managers in handling Medicaid prescription drug claims won final passage in the Kentucky legislature Wednesday. The Senate voted 30-1 to send the measure to Gov. Andy Beshear after it accepted changes made by the House. The bill would require the state's Medicaid program to pay pharmacies directly for prescription drugs, bypassing pharmacy benefit managers. Lawmakers took action on stacks of bills amid uncertainty about how much longer this year's session will last because of the coronavirus outbreak. Wednesday was day 48 in the 60-day session scheduled to end in mid-April. Senate President Robert Stivers said Tuesday that the goal is for lawmakers to finish their business “as quickly and expeditiously as possible, and then go home.” The biggest job for the Republican-led legislature is to finish work on a new two-year state budget. The bill dealing with pharmacy benefit managers is among proposals being considered to shake up some inner workings of Kentucky's Medicaid program. Republican Sen. Max Wise, the bill's lead sponsor, has said the current system funnels hundreds of millions in taxpayer money to companies to handle prescription claims. Drugstores, especially in rural areas, have been hurt by the pricing and reimbursement practices of pharmacy benefit managers, or PBMs, he has said. The bill's opponents include CVS Health, a national player in pharmacy benefit management. It says the measure is based on a “flawed analysis” and would be a “costly step backwards" for Kentucky. In other action Wednesday, the House passed a bill to allow Kentucky consumers to have spirits, wine or beer shipped directly to their homes. The measure passed 52-33 and now goes to the Senate. The bill would apply to producers only. It would also allow Kentucky bourbon distillers to ship their products directly to consumers outside Kentucky, if their states allow such shipments. The same would apply to the state's beer and wine producers. The bill's supporters include the Kentucky Distillers' Association, which represents many of the state's bourbon producers. Kentucky produces about 95% of the world's bourbon. “This important measure creates a model framework for the responsible shipping of alcohol that will allow our signature bourbon industry to market their products globally, creating more jobs, investment and local revenue for communities all across Kentucky,” KDA President Eric Gregory said in a statement. Under the measure, consumers receiving direct shipments would pay the same taxes and fees that retailers face in their state. It also would put monthly limits on amounts of direct shipments — 10 cases of wine, 10 cases of beer and 10 liters of distilled spirits. The bill is the product of lengthy discussions among alcohol producers, wholesalers and retailers. Mississippi Business Journal
A bill that says it is designed to level the playing field for independent pharmacies overwhelmingly passed the Mississippi House of Representatives and has been sent to the state Senate. House Bill 708, which would be known as the Pharmacy Benefits Prompt Pay Act, was approved by the House 115-3. It would cut the time allowed for Pharmacy Benefit Managers (PBMs) to reimburse pharmacies to seven days, down from the current 15. “PBMs are paid by their clients as soon as the pharmacy fills the subscription,” the Mississippi Independent Pharmacy Association stated in a “talking points” release, and PBMs “hold” all these reimbursements “until they are forced to pay the pharmacies.” The PBMs are making money off the pharmacies’ money by holding the reimbursement in an interest-bearing account, association argues. “If the Mississippi Division of Medicaid can reimburse the pharmacies in 7 days, why can’t a major multibillion-dollar corporation pay in 7 days?” Legislation that went into effect on July 1, 2006 reduced the turnaround to 15 days. Many reimbursements had taken 30 to 60 days, according to Robert Dozier, executive director of the association. HB 708 also seeks to bring clarity on how Pharmacy Benefit Managers (PBMs) establish maximum level reimbursement to pharmacies, Dozier said. Pharmacies pay drug wholesalers for what they charge for prescription medicine. But in some cases, PBMs reimburse less than the pharmacies paid, putting them at a deficit, according to Dozier. “There is no state or federal law that tells how to set a reimbursement,” Dozier said of PBMs in an interview. “If the reimbursement if below the pharmacy’s acquisition cost, we want to know how they arrived at the reimbursement,” Dozier said. “All we want is a little transparency,” he said. But the scenario is not little guy versus big guy, or the chains, he said. “The chains are in the same boat.” However, according to at least one calculation, the number of independent pharmacies is sinking. The number of independents in Mississippi has fallen to about 385, according to the Mississippi Board of Pharmacy. Between 2009 and 2019, 189 independents and 158 chain pharmacies closed in Mississippi, the board says. Nationally, there were 21,909 indies as of 2017, down from 23,106 in 2011, according to the National Community Pharmacists Association. Chris Paddington of A.T. Kearney, a global management firm, stated in an interview with another publication: “Many independent operators are older and looking for an exit, while younger pharmacists are less attracted to the risk and return of ownership.” However, Greg Lopes, assistant vice president for strategic communications for the Pharmaceutical Care Management Association, provided a study by that organization that was released this month that indicates an actual increase in the number of independents between 2010 and 2019 of more than 2,600 stores (12.9 percent), whereas chains lost around 80 stores (0.2percent) on average. Lopes said in an email to the Mississippi Business Journal: “Pharmacy benefit managers, PBMs, are advocating on behalf of Mississippians to reduce prescription drug costs and improve health outcomes. The legislation [HB 708] risks the health and safety of Mississippi’s patients, especially for those with chronic conditions taking specialty medications. In addition, HB 708 does nothing to lower drug costs, in fact, it will result in higher costs for patients.” The Pharmaceutical Care Management Association website states that PBMs were established by health plans more than two decades ago and now “administer prescription drug plans for more than 266 million Americans who have health insurance from a variety of sponsors. PBMs will save health plan sponsors and consumers more than $1 trillion on prescription drugs this decade.” In another email, Lopes stated: “We firmly believe there’s a patient safety issue with the legislation . . . . It’s not at all uncommon for independent pharmacies to seek higher reimbursement levels, which almost always would come at the expense of higher drug costs to patients.” Further, Lopes said: “The majority of independent drugstores hire Pharmacy Service Administrative Organizations to collectively bargain with PBMs and other payers on reimbursement rates, payment terms and pharmacy audits. These are very large organizations, with huge market scale; many of these PSAOs also serve as wholesalers to pharmacies and sell them the medications they dispense.” Nevertheless, the Mississippi Independent Pharmacists Association maintains that a standard and “transparent” maximum allowable cost list is necessary to assure pharmacies they are getting “a fair reimbursement from the PBMs.” WBGZ Radio / Alton Daily News
Illinois lawmakers are making an attempt to block drug companies from unnecessarily raising drug costs for patients. Earlier in the week, State Senator Andy Manar (D-Bunker) unveiled a sweeping package of legislation aimed at establishing a system of checks on the pricing power of pharmacy benefit managers and ultimately lowering the cost of prescription medications. According to an analysis by CBS News, during the first half of 2019, there were price increases for over 3,400 prescription drugs. Of those, the average price hike was nearly 10.5%, which currently sits at 5 times the standard rate of inflation. Manar says “ The current system is a result of drug monopolies and PBMs having unrestrained power to set and manipulate prices.” For a full list of all items included in Manar’s legislation, visit this story at AltonDailyNews.com. Manar’s package of legislation includes:
CVS Health issued a statement late Monday (March 16) in response to the story: CVS Health has a proven track record of lowering drug costs and helping improve health outcomes in Illinois. At a time when drug manufacturers are increasing list prices at a record rate, the several bills introduced by Senator Andy Manar will increase drug costs across Illinois by limiting the ability of PBMs to negotiate and deliver savings for patients, health plan sponsors and taxpayers. By making prescriptions more expensive, drug manufacturers benefit—not patients. PBMs are estimated to save over $21 billion in Illinois in the next 10 years through their work to negotiate lower prices from drug manufacturers and reducing costs for patients across the state. In Medicaid, carving out pharmacy benefits would significantly impact the health of the hundreds of thousands of Illinoisans who rely on Medicaid for the prescription drugs they need, and would jeopardize the $2.1 billion in savings that PBMs will generate for Illinois Medicaid over the next decade. Going forward, we look forward to working with lawmakers to promote high-value, effective care in Illinois by preserving the tools that PBMs use to deliver lower costs for patients. Bloomberg Business
The FDA is encouraging licensed pharmacists and physicians to create batches of hand sanitizer to cut back on spot shortages that, thanks to the new coronavirus, have pushed consumers to make their own. People are encouraged to wash their hands for at least 20 seconds, or use hand sanitizer with at least 60% alcohol in it to help fight the virus, but stores around the country have run out of hand sanitizer and the agency is worried home-made concoctions aren’t as safe to use. That’s why the agency said Saturday it won’t take any enforcement action against certain facilities or licensed professionals who make hand sanitizer for consumer use as long as they use high quality ingredients and follow a recipe laid out by the agency. That recipe includes suggested volumes of alcohol, glycerol, hydrogen peroxide, and sterile water. These pharmacists and doctors “are more familiar with standards and methods for producing drug products” than the standard “untrained” consumer, the agency said. New York State Senate
Senator James Skoufis (D-Hudson Valley) co-sponsored legislation that will help empower independent pharmacists during the Coronavirus pandemic and also ease the burden on the larger healthcare industry. He is calling for the immediate passage of this essential bill. Bill S5092 authorizes pharmacists as qualified health care professionals and allows them to complete the Clinical Laboratory Improvement Amendments (CLIA) waived testing under their own practice, removing a significant barrier that currently requires them to hire a medical director -- something that most local pharmacists can’t afford to do. CLIA waived testing allows for the screening and treatment process to be completed during a single encounter, improving access to care, counseling, and overall patient outcomes. “As we see our hospital beds fill up with people testing positive for Coronavirus, the capacity of our providers is going to be tested and we need to come up with innovative ways to ease that burden,” said Senator Skofuis. “This bill will give independent pharmacists the ability to test for the flu and other illnesses to help rule-out COVID-19 and ensure that hospital beds are reserved and resources are used for those who need them most.” Steve Moore, President of the Pharmacists Society of the State of New York said, "We thank the bill sponsors and Senator Skoufis for bringing attention to this incredibly timely bill. While CLIA waived tests may not be immediately available for COVID-19, existing CLIA waived tests could be used to confirm or rule out other conditions such as seasonal influenza and in turn, ease the burden of an already stressed healthcare system. As some of New York's most accessible healthcare professionals, pharmacists are a natural fit for CLIA waived testing privileges and we look forward to working with other stakeholders to bring these tests to our patients and communities." Senator Skoufis is dedicated to addressing this public health crisis in a timely and effective manner. Just this week, he signed onto a bill that would crack down on price gouging of consumer medical supplies during a public health emergency. Additionally, last week, the Legislature acted swiftly and approved $40 million in emergency funds for the Department of Health to hire additional staff, purchase equipment, and obtain additional resources to combat COVID-19. The New York State Department of Health has set up a 24 Hour Coronavirus Hotline Number: 1-888-364-3065 and website. Law 360
The federal government is urging the U.S. Supreme Court to undo the Eighth Circuit’s ruling that an Arkansas law regulating pharmacy benefit managers' drug reimbursement rates was trumped by ERISA, saying the finding stretched the federal law’s preemption provision too far. U.S. Solicitor General Noel J. Francisco told the high court in his amicus brief Monday that the Eighth Circuit wrongly found that Arkansas’ Act 900 had an impermissible reference to and connection with Employee Retirement Income Security Act plans, triggering preemption. The statute didn’t act immediately or exclusively on ERISA plans, and those plans weren’t essential to the operation of the law, the federal government said. And though Act 900 might have an indirect economic influence on ERISA plans, it didn’t force their administrators to choose any particular path, the solicitor general contended. “Indeed, the [Supreme] Court has cautioned that, if state laws that merely influenced the choices of ERISA plans were preempted, courts would 'scarcely see the end of ERISA’s preemptive reach,'” the government said. The Arkansas law at the center of the case was initially struck down by a federal court in March 2017 after the Pharmaceutical Care Management Association challenged the statute. The state took the case to the Supreme Court after the Eighth Circuit sided with the trade group on appeal. The solicitor general asked the Supreme Court in December to grant Arkansas’ petition to review the Pharmaceutical Care Management Association’s win at the appeals court, and the justices agreed to do so in January. Arkansas filed a brief defending its law the following month. In the brief Monday, the solicitor general also took aim at PCMA’s arguments for why the Arkansas statute was preempted by ERISA, saying that the trade group’s “concerns about the consequences of the Arkansas statute for nationally uniform plan administration are misplaced.” Ultimately, the statute only imposed obligations on PBMs, not ERISA plans, according to the federal government. Additionally, the court didn’t need to address whether the federal benefits law preempted the application of the Arkansas statute to ERISA plans managing prescription drug benefits themselves, since PCMA’s members weren’t plans, the solicitor general said. The federal government further noted that the language of ERISA and the context surrounding its passage didn’t suggest that Congress meant for the federal benefits law to overtake the states’ regulation of health care costs. “Holding that ERISA preempts Arkansas’s regulation of pharmacy reimbursement rates would thus stretch ERISA’s preemption provision beyond what history suggests Congress contemplated,” the solicitor general said. Arkansas received an outpouring of support at the Supreme Court on Monday, with amicus briefs from 46 attorneys general and several pharmacy groups, including the National Association of Specialty Pharmacies and National Community Pharmacists Association. The state was also backed by medical professional organizations, such as the American Medical Association and American Pharmacists Association. “Having such large bipartisan support from the public and private sectors shows the overwhelming need to regulate abusive PBM reimbursement practices,” Arkansas Attorney General Leslie Rutledge said in a statement Tuesday. “Abusive PBM reimbursement practices are harming Arkansas patients and community pharmacies nationwide, all the while lining the pockets of PBMs with billions of dollars.” But Michael B. Kimberly, an attorney for PCMA, told Law360 on Tuesday that they “don’t think that the amicus briefs filed yesterday paint a fair or accurate picture of the very important role that PBMs play in the health care market.” In a statement following Arkansas’ February brief, the PCMA said the association believes “everyone deserves access to quality, affordable health care services, no matter the state one lives in.” “Unique state laws governing the administration of pharmacy benefits are proliferating across the country, establishing vastly different standards,” PCMA said. “These inconsistent and often conflicting state policies eliminate flexibility for plan sponsors and create significant and costly administrative inefficiencies. This will result in increased premiums and prescription drug costs for patients and payers.” “The Employee Retirement Income Security Act has long enabled employers to provide consistent, nationwide health care benefits due to its preemption of state laws,” the association added. “Federal preemption is a vitally important issue to ensuring high-quality health care for patients.” Arkansas is represented by Nicholas Jacob Bronni, Leslie Rutledge and Shawn J. Johnson of the Arkansas Attorney General's Office. The Pharmaceutical Care Management Association is represented by Michael B. Kimberly, Andrew C. Liazos, Sarah P. Hogarth, Paul W. Hughes and Matthew Waring of McDermott Will & Emery LLP. The case is Rutledge v. Pharmaceutical Care Management Association, case number 18-540, in the Supreme Court of the United States. Chain Drug Review
The U.S. Supreme Court Will Hear The Case In April An amicus brief by the National Association of Chain Drug Stores (NACDS) urges the U.S. Supreme Court to stand by its precedents and uphold an Arkansas law that “prevents [pharmacy benefit managers] PBM contracts from reimbursing pharmacies at low rates that do not cover the costs of purchasing and dispensing expensive prescription medications, which presently results in pharmacies taking a loss for dispensed prescriptions.” NACDS said, “In addressing such losses, Arkansas’s legislature has chosen to ensure that pharmacies can keep their doors open to patients.” The U.S. Supreme Court is set to review the Eighth Circuit Court of Appeals’ decision against an Arkansas law that ensures pharmacy reimbursement rates cover pharmacies’ costs of purchasing drugs. The case that the U.S. Supreme Court will consider is Rutledge v. Pharmaceutical Care Management Association. The question is whether the Eighth Circuit erred in holding that Arkansas’s statue regulating PBMs’ drug-reimbursement rates, which is similar to laws enacted by about 40 other states, is preempted by the Employee Retirement Income Security Act (ERISA). NACDS argues, “Under a straightforward application of this Court’s precedents, Arkansas’s law is not preempted. It does not refer to ERISA plans, has only an attenuated connection to ERISA plans, and serves laudable policy goals unrelated to the purposes of ERISA. The Court should resolve this case narrowly and leave those precedents intact, rather than using this case as a vehicle to make broad changes to preemption law.” In further summarizing the argument, the brief states: • “Under this [U.S. Supreme] Court’s precedents, any incidental effect Arkansas’s law will have on the relationship between PBMs and ERISA plans is insufficient to trigger ERISA preemption.” • “Arkansas’s statute also serves sound policy interests unrelated to the goal of ERISA preemption. The statute is designed to mitigate a healthcare crisis: the rampant closure of pharmacies…When a pharmacy closes in a rural area, local residents may have no alternative healthcare provider nearby, leading to the risk of noncompliance with medication regimens and poor health outcomes.” • “That is a laudable legislative goal – and it in no way undercuts the core purpose of ERISA preemption, which is to protect ERISA plans from inconsistent state administrative burdens.” The U.S. Supreme Court will hear the case on April 27, 2020. NBC News - KARK Arkansas
Attorney General Leslie Rutledge says, ‘the stranglehold PBMs have on drug prices is driving many local pharmacies out of business’ Arkansas Attorney General Leslie Rutledge has filed a brief with the United States Supreme Court in Arkansas’s pharmacy benefit manager (PBM) case. The Supreme Court will hear oral arguments in that case on April 27, 2020. In this case, Rutledge seeks to protect rural Arkansas’s small businesses and save community pharmacies from abusive PBM payment practices. “For many Arkansans, we interact most frequently with our local pharmacists, but the stranglehold PBMs have on drug prices is driving many local pharmacies out of business,” said Attorney General Rutledge. “It’s time we hold PBMs accountable for skyrocketing prescription drug prices and directly hurting Arkansan’s pocketbooks.” In 2015, the Arkansas General Assembly enacted Act 900 to regulate PBMs who play the role of intermediary, reimbursing pharmacists for prescription drugs dispensed to insurance beneficiaries. Before Act 900’s enactment, PBMs were found to reimburse pharmacies at less than a pharmacy’s cost to acquire a drug, causing more than 16 percent of rural pharmacies to close in recent years. In 2015, PCMA filed a lawsuit to block enforcement of Act 900. U.S. District Judge Brian Miller ruled Act 900 was preempted by the federal Employee Retirement Income Security Act, and in 2018 the Eighth Circuit Court of Appeals affirmed Judge Miller’s ruling Rutledge petitioned the U.S. Supreme Court in November 2018. Rutledge’s petition was supported by the U.S. Solicitor General and a bipartisan, 32-state coalition led by California. The case is Rutledge v. Pharmaceutical Care Management Association, No.18-540. NCPA.org News Release
Case seeks to clarify if states can regulate runaway corporate middlemen The National Community Pharmacists Association (NCPA) and the Arkansas Pharmacists Association (APA), along with the American Pharmacists Association (APhA) and the National Alliance of State Pharmacy Associations (NASPA), announced today they will file an amicus curiae brief with the Supreme Court of the United States in support of a case that pits pharmacy benefit managers (PBM) against neighborhood healthcare providers. "The PBMs have been hiding behind a vaguely worded section of a federal law that was never supposed to apply to them," said B. Douglas Hoey, CEO of NCPA, which represents 21,000 locally owned pharmacies nationwide. "They operate without meaningful regulation, and because of that they're able to stack the deck in their favor, and at the expense of community pharmacies and their patients." The case, Rutledge v. the Pharmaceutical Care Management Association, will be heard on April 27, 2020, the Court announced today. It originates from Arkansas, which passed a law in 2015 barring PBMs from reimbursing local pharmacies at a lower rate than what the pharmacies pay to fill the prescriptions. The PBM lobby, PCMA, challenged the law in court, which is when the APA and NCPA joined the effort to ensure the 2015 precedent stands. "For countless years, PBMs have tightened the noose on pharmacists and their ability to serve their communities and provide access to life-saving medications and essential counseling," said APA CEO and Executive Vice President John Vinson, Pharm.D. "Instead, PBMs have prioritized profits and stockholders by using anti-competitive practices, self-dealing, and monopoly-like business practices to create an environment where patients, pharmacists, and employers suffer the consequences — patients lose their choice, pharmacists lose their jobs, and employers lose their money." That case made its way to the federal 8th Circuit Court of Appeals, where the judge ruled in favor of the PBMs. When Arkansas appealed the ruling, the Supreme Court asked the US Solicitor General to recommend whether to take the case. Not only did he urge the Court to take the case, but he argued strongly that the 8th Circuit erred in its decision. Continue Reading the Full News Release HERE |
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