YEAR-END REPORT - 2020 Published 21-Dec-2020 HPTS Issue Brief 12-21-20.34 Health Policy Tracking Service - Issue Briefs Pharmaceuticals and Medical Devices Cost Savings This Issue Brief was written by David J. Steiner, J.D., a contributing writer and member of the Ohio bar. 12/21/2020 I. Introduction California Governor Gavin Newsom recently announced that he has signed legislation intended to bring down the cost of prescription drugs for taxpayers, employers, and consumers in California. In September, Pennsylvania State Senator Tom Killion (R-Chester and Delaware) introduced legislation intended to substantially lower the cost of prescription medications for Pennsylvania residents. The U.S. Department of Health and Human Services and the U.S. Food and Drug Administration recently announced a final rule that is intended to “help provide safe, effective, and more affordable drugs to American patients as part of the Safe Importation Action Plan, fulfilling the aspect of the July Executive Order on drug pricing to complete the rulemaking to allow states to import certain prescription drugs from Canada.” Pennsylvania state senator Tom Killion (R-Chester/Delaware) recently introduced legislation aimed to substantially lower the cost of prescription medications for Pennsylvania residents. The Department of Health and Human Services (HHS), the Department of Labor, and the Department of the Treasury recently released the Transparency in Coverage final rule. This final rule is intended to help place health care price information in the hands of consumers and other stakeholders. Immediate, a financial wellness company, recently announced a new partnership with ScriptSave WellRx to provide discounts on prescriptions directly from the ImmediatePay app. II. General cost saving news Center for American Progress supports Lower Drug Costs Now Act The Center for American Progress recently applauded the U.S. House of Representatives for passing H.R. 3, the Lower Drug Costs Now Act. This legislation is intended to lower the cost of prescription drugs, and enable Medicare to negotiate prescription drug prices, extend these lower prices to consumers in the commercial market, and reinvest $358 billion of savings into strengthening the Medicare benefit package to include dental, vision, and hearing coverage. Neera Tanden, president and CEO of the Center for American Progress, released the following statement on the bill's passage: We applaud the U.S. House for passing the most transformative legislation to lower drug prices in a generation and delivering on a major promise to the American people. This bill would produce significant savings for millions of Americans with chronic conditions such as diabetes, who, as our analysis shows, could save more than $700 a year. In addition to lower drug costs and insurance premiums, by reinvesting the bill's savings into strengthening Medicare's benefit package, H.R. 3 would save seniors hundreds of dollars every year on traditionally uncovered out-of-pocket expenses. With his opposition to H.R. 3, President Donald Trump has broken his promise to allow Medicare to negotiate drug prices. This broken promise comes at a real cost to the financial well-being and health of the American people?and his refusal to stand up to Big Pharma speaks volumes about who he is fighting for. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -1- The Center for American Progress defines itself as “an independent nonpartisan policy institute that is dedicated to improving the lives of all Americans, through bold, progressive ideas, as well as strong leadership and concerted action. Our aim is not just to change the [FN2] conversation, but to change the country.” Recent analysis by the Center for American Progress estimates that, as a result of the H.R. 3 negotiation process, some diabetics could save more than $700 on an annual supply of certain types of insulin. Negotiation of prescription drug prices could also reduce the net price for other types of drugs (including costly treatments for cancer and multiple sclerosis) by thousands of dollars per month. The Center contends that the public “overwhelmingly” believes that the government should negotiate with pharmaceutical companies, and that 85 percent of Americans support this tactic. The Trump administration, however, opposes H.R. 3, which is the only current bill that includes drug price negotiation Under the procedure set forth in the bill, the secretary of health and human services would negotiate as many as 250 drugs each year. The negotiation process would prioritize drugs with the greatest savings potential, which are defined by those that rank highest by spending, have no generic or biosimilar competitor, and have a large pricing gap between the United States and peer nations. Manufacturers of drugs subject to negotiation would agree to a price no higher than 120 percent of the average price in other industrialized countries. When international comparison data were unavailable, the H.R. 3 negotiation process would cap drug prices at 85 percent of the U.S. average manufacturer price. The Congressional Budget Office (CBO) has estimated that H.R. 3 negotiations would result in an average discount of nearly 55 percent on current Medicare Part D net prices for the first group of drugs to undergo negotiations and a discount of 40 to 50 percent for drugs negotiated in subsequent years. H.R. 3 would also potentially lead to lower, negotiated prices available beyond Medicare to payers in the commercial market. Any drug manufacturers who refused to participate in negotiations or abide by the resulting maximum fair price would be subject to increasing financial penalties. The legislation also attempts to crack down on companies that increase a drug's Medicare price above the rate of inflation by subjecting those drugs to excise taxes. The CBO estimates that these changes would save the federal government approximately $500 billion over the next 10 years, which would be reinvested to bolster Medicare benefits, increase funding for the National Institutes of Health and the Food and Drug Administration, and make other public health investments. The Center for American Progress concluded by noting that, “By allowing Medicare to negotiate with drug companies and giving more consumers access to those negotiated prices, H.R. 3 has taken a strong first step toward lowering excessive drug prices. Without meaningful reforms including negotiation, the rising price of prescription drugs will continue to take a toll on families' finances and, in the worst cases, cost lives. Three years ago, then-candidate Trump promised to support Medicare negotiations. His administration is [FN3] breaking that promise by opposing H.R. 3.” Paper on reference pricing finds lower prices paid by employers and lower cost sharing by employees; also finds time lag in prescribing habits by physicians A recently published paper in JAMA addresses reference pricing in employment-based health insurance. Researchers looked into whether such reference pricing is associated with the prescribing of lower-priced drugs, and whether this prescribing practice is associated with reductions in cost sharing by patients. After an economic evaluation of 3.3 million drug insurance claims, researchers found that, after implementation of reference pricing, physicians increased the prescription of the low-cost drugs within each therapeutic class. This increase was, in fact, associated with a reduction of prices paid by employers and cost sharing paid by employees. Ultimately, according to the researchers, these findings mean that, “Reference pricing may shift the mix of drugs dispensed from those offering the highest rebates to the pharmacy benefit manager to those offering the lowest prices to the employer and employee.” Reference pricing has reduced drug spending in Europe and has been adopted by some employers and labor unions in the United States. Its association with patient cost sharing depends on whether, and how quickly, prescribing doctors adjust their prescribing patterns to favor the least costly alternatives within each therapeutic class. Reference pricing encourages physicians to prescribe and patients to use the least costly medications within therapeutic classes that feature multiple alternatives. In reference pricing situations, the employer's or insurer's payment is limited to the price of the least costly product in each therapeutic class. Patients using higher-priced drugs within the class must pay the full difference themselves, unless the prescribing physician requests an exemption on clinical grounds. This reference pricing approach is intended to create incentives for physicians to switch their prescriptions to lower-priced products on behalf of their patients, thereby generating savings for the employer or insurer. Reference pricing has been applied only recently and in limited contexts in the United States. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -2- The objective of the study was to, “examine whether the implementation of reference pricing is associated with physicians and patients shifting to lower-cost drugs, thereby reducing consumer cost sharing and the prices paid by employers.” The economic evaluation in the study included employees of Catholic organizations who purchased health insurance through the Reta Trust, as well as a random sample of employees of public sector organizations who purchased insurance through the California Public Employees' Retirement System (CalPERS) as a comparison group between July 1, 2010, and December 31, 2017. Researchers performed data analysis between January 1, 2019, and September 1, 2019. The Reta Trust had implemented reference pricing in July 2013, while CalPERS did not adopt reference pricing during the relevant study period. During the study period, a total of 1.2 million prescriptions were submitted by 34,319 individuals covered by Reta Trust. Furthermore, 2.1 million prescriptions were submitted by 738,159 individuals covered by CalPERS. In the first 2.5 years after implementation of reference pricing, the percentage of prescriptions made for the low-priced drug within each therapeutic class increased by 5.1 percentage points (95% CI, 1.8 to 8.4 percentage points), patient cost sharing increased by 10.3% (95% CI, -1.6% to - 23.6%; this difference was not statistically significant), and prices paid decreased by 19.1% (95% CI, -30.2% to -6.2%) for Reta Trust patients compared with CalPERS patients. During the subsequent two-year postimplementation period, the percentage of prescriptions made for the low-priced drug increased an additional 6.2 percentage points (95% CI, 2.3 to 10.1 percentage points), patient cost sharing decreased by 21.3% (95% CI, -31.2% to -9.9%), and prices paid increased by 7.2% (95% CI, -12.6% to 31.4%; this difference was not statistically significant). Relative to the change experienced by the CalPERS population, during the study period, the share of prescriptions for lower-priced drugs increased by 6.3 percentage points (8.9% relative increase), the mean prescription drug price decreased by $9.5 (12.1% relative decrease), and the mean patient cost sharing decreased by $1.8 (4.3% relative decrease). Researchers involved in the study concluded that “reference pricing was associated with a combination of lower prices paid by [FN4] employers and lower cost sharing by employees but with a time lag in prescribing habits by physicians.” Research conducted for health insurance groups finds that Medicaid managed care plans are saving taxpayers billions of dollars each year Recently published research from The Menges Group, conducted on behalf of America's Health Insurance Plans (AHIP), found that Medicaid managed care plans are saving taxpayers billions of dollars each year and consistently providing Medicaid enrollees with prescription drugs at lower costs than traditional Medicaid fee-for-service programs. Approximately one in five Americans are covered by Medicaid, including millions of children, older adults, people with disabilities, and two million veterans. Two-thirds of Medicaid enrollees, which amounts to over 56 million people, are served by Medicaid managed care plans. These plans are designed to provide savings through patient-centered care coordination programs, high-quality and accessible provider networks, increased utilization of generic prescription drugs, and other effective solutions like programs focused on routine and preventive care. The study found that Medicaid managed care plans' net costs per prescription (which factor in rebates) were approximately 27% below the net costs in the traditional Medicaid fee for service program. The lower costs yielded approximately $6.5 billion in net savings for states and taxpayers during fiscal year 2018. Other conclusions from the study include: • Medicaid managed care plans consistently control prescription drug costs more effectively than traditional Medicaid. Over the 5-year period from 2013 to 2018, net costs per prescription increased 13% faster in FFS settings than in Medicaid managed care plans. • States continue to recognize the value and advantages of Medicaid managed care plans in delivering affordable health care and program savings. Medicaid enrollment in managed care plans more than doubled from 25.6 million people in 2010 (51% of Medicaid enrollees) to 56.5 million people (77% of enrollees) in 2018, and this trend is expected to continue. • With states significantly expanding the role of Medicaid managed care in Medicaid, the number and percentage of Medicaid prescriptions covered nationwide by Medicaid managed care grew dramatically. More than 70% of all Medicaid prescriptions nationwide were delivered through Medicaid managed care plans in 2018, compared to only 28% in 2011. • States that used Medicaid managed care to deliver integrated drug benefits instead of prescription drug carve-outs realized big savings?with upwards of 25% lower net drug costs. A comparison of states with integrated drug coverage versus carve outs showed higher generic dispensing rates and much lower growth rates in net costs per prescription. The recent announcement is the first of several studies on the performance of Medicaid managed care plans conducted by The Menges Group for AHIP. Additional studies to be released throughout 2020 will examine key performance metrics, including quality performance and value, use of innovative programs, and technology. According to Matt Eyles, AHIP President and CEO, “Medicaid managed care plans ensure that the Americans who rely on this important health care safety net program have access to high-quality health care and prescription drug coverage.” © 2021 Thomson Reuters. No claim to original U.S. Government Works. -3- Mr. Eyles further noted that, “When states rely on Medicaid managed care plans to provide integrated drug benefits to enrollees, they do even better and deliver more savings for taxpayers every day. This study shows that when the private and public sectors work together for better health care, everyone wins.” AHIP is a national association whose members “provide coverage and health-related services that improve and protect the health and [FN5] financial security of consumers, families, businesses, communities and the nation.” Mako Medical Laboratories announces new pharmacy program using $25 flat monthly rate through network of independent pharmacies; 300 different medications on list Mako Medical Laboratories has announced a new pharmacy program intended for families struggling with the cost of medication. It is called MakoRx. MakoRx uses a proprietary cost/plus model and leverages a network of independent pharmacies around the country to dispense the medication. This new program allows families to pay only $25 per month, select from a list of 300 different medications, and receive them whenever they are needed at no additional cost. This allows families to budget as little as $25 per month to have access to medications like blood pressure, mental health, antibiotics, and other commonly prescribed medications. Under the system, when a patient has a prescription for any drug on the 300 list, there is no additional cost or co-pay. The patient simply walks into the pharmacy and receives the medicine for free. The only cost is the membership fee of $25 per month. MakoRx is also working on expanding the list from 300 to include over 500 different medications that could be selected at no additional cost. Through this model, MakoRx plans to leverage access to over 16,000 pharmacies around the country to dispense for this program. This new model will also likely be used by Accountable Care Organizations and large medical practices that are working to have their patients become compliant with their medications. Medications not listed on the 300 list could still be purchased through the pharmacy network at an additional cost with MakoRx's loyalty card. Savings are as high as 80% for medications that are not included on the card. MakoRx's new mobile app is scheduled to be released March 2020. According to Chad Price, President of Mako Medical, “We have worked really hard to put a program together that is easy, transparent, and will make an impact for families all over America.” Mako Medical also claims that “Mako Medical Laboratories and MakoRx are known for their extensive community service, hiring military [FN6] veterans and their propriety technology. Mako Medical has won awards for innovation, growth, and community service.” March survey finds 32 percent of U.S. families declined medical care (including medications) due to cost YouGov Plc recently conducted a survey on behalf of Bankrate that found that nearly one in three U.S. families (32 percent) decided not to seek medical care in the past twelve months because of cost. The survey's definition of “medical care” included medications and vaccinations, as well as doctor's visits, annual exams, vision checks and more. The implications of these findings could significantly affect the decision of some Americans from seeking testing and/or care for Covid-19, regardless of whether such testing or care is, in fact, covered by insurance or by the government. The total sample size of the survey was 2,596 adults, including 2,053 who reported having health care expenses in the past 12 months. The online survey was conducted between February 12-14, 2020. It used a non-probability-based sample using both quotas upfront during collection and then a weighting scheme on the back end designed to provide nationally representative results. Key findings of the survey include the following: • Six percent of respondents say the health care system is fine as-is; • Nearly 40 percent of Americans say Democrats are best prepared to offer health care solutions, compared with 27 percent who favor Republicans on this issue; • Millennials are more likely than those who are older to turn down medical care due to cost; and • Americans take on debt and borrow money from families to cover health care costs. Although Covid-19 is not preventable by a vaccine or antiviral treatment, health experts at the Centers for Disease Control (CDC) recommend receiving medical care to help relieve symptoms, and in more severe cases, support vital organ functioning. According to Stephen Zuckerman, senior fellow and vice president for health policy at the Urban Institute, “If people don't believe that the testing is going to be free, they could resist getting tested when they suspect that they may have the illness. Even if someone has mild symptoms, they could transmit it to someone who might end up having a more severe reaction.” Mark Hamrick, Bankrate's senior economic analyst, suggests that the overwhelming dislike of the health care system is largely because of affordability. Hamrick noted that, “Health care costs are causing injury to Americans' personal finances, which is why they're elevating the issue as an urgent political priority. The desire for change is one rare case where most are in agreement.” © 2021 Thomson Reuters. No claim to original U.S. Government Works. -4- Nearly two in five millennials (40 percent) said they avoided some medical care because of cost, which was the highest of any older age group. That total was 35 percent for Generation X and 24 percent for baby boomers. Zuckerman suggests that these figures are explained by the fact that millennials are newer in the workforce and earn less than older generations. Self-rationing of care was more common among those with lower incomes. Thirty-seven percent of those earning less than $40,000 each year declined health care due to cost. That figure was 29 percent among those who said they earn more than $80,000. Latinos were the most likely ethnic group to decline treatment, with 37 percent foregoing care because of affordability constraints. That figure was 30 percent for individuals who identified as white and 29 percent for those who identified as African-American. The poll also found that over two out of five families (43 percent) with children younger than 18 declined health care treatments, compared with 27 percent of those who had children older than 18 and 31 percent of those who were not a parent or guardian. According to the poll results, having insurance did not guarantee treatment. Families with privately purchased plans were more likely to have avoided medical care due to cost (44 percent) more so than the uninsured (33 percent), as well as those with insurance through an employer (34 percent) or through a government program such as Medicare or Medicaid (26 percent). The survey also found that half of all Americans who had a health care expense over the past twelve months said it ended up being more expensive, while 40 percent said it was about what they expected and ten percent found it to be cheaper than expected. Nearly one in ten (nine percent) of Americans had to take on substantial debt to pay for treatments, while eight percent had to borrow money from friends or family and seven percent had to use a part of their retirement savings. Some Americans (six percent) had to find another job, and five percent sold assets or personal belongings. Three percent borrowed money from their home's equity, and another [FN7] three percent sought debt consolidation or declared bankruptcy. Insulin manufacturers offer lower cost options to patients during COVID-19 pandemic Eli Lilly and Sanofi, two of the largest manufacturers of insulin products, are responding to the COVID-19 pandemic with programs intended to provide patients with continued access to insulin products. Sanofi has created two platforms for insulin patients. One is for patients with insurance and one is for those without. Those with insurance are eligible for the company's co-pay assistance programs, where most participants will pay $10 or less per month for their products, regardless of their income level. This program includes Adlyxin (lixisenatide) injection, Apidra (insulin glulisine injection) 100 Units/mL, Lantus (insulin glargine injection) 100 Units/mL, Toujeo (insulin glargine injection) 300 Units/mL, Soliqua 100/33 (insulin glargine, and lixisenatide injection) 100 Units/mL and 33 mcg/mL. For those with no health insurance, Sanofi created the Insulins Valyou Savings Program, where all uninsured patients (regardless of income level) can purchase one or multiple Sanofi insulins (Lantus, Toujeo, Admelog, and Apidra) for a fixed price of $99 per month. A statement from Sanofi noted that, “The intent of this program is to provide relief for those who currently pay the highest prices for their insulin due to lack of insurance coverage and do not qualify for other assistance programs.” Eli Lilly has also introduced the Lilly Insulin Value Program. This program allows anyone with or without insurance to fill their monthly prescription of Lilly insulin at a capped price of $35. The program covers most Lilly insulins including all Humalog (insulin lispro injection 100 units/mL) formulations. Diabetes patients who use Lilly products are encouraged to call the Lilly Diabetes Solution Center at (833) 808-1234. According to Mike Mason, president of Lilly Diabetes, ‘Too many people in the U.S. have lost their jobs because of the COVID-19 crisis, and we want to make sure no one goes without their Lilly insulin. We've been providing affordability solutions for a long time, but more is needed to help people during this unprecedented period. People with commercial insurance, as well as those without insurance at all, are eligible, and the process is quick and simple. We want people who need help to call us.” Novo Nordisk has also offered low-cost options for patients. The company said it is working with distributors to ensure that patients maintain an adequate supply of the medication during the pandemic. Novo Nordisk offers several options for patients, including its My $99Insulin program where, for $99, people with diabetes can obtain up to three vials or two packs of FlexPen/FlexTouch/PenFill pens, of any combination of Novo Nordisk Inc. insulins. According to the company, this volume amounts to a month's supply of insulin for many patients. Novo Nordisk' ReliOn human insulin is also available at Walmart for approximately $25 per vial and $44 per box of FlexPens. Similar offerings are available at CVS and other national pharmacies. According to the company, approximately 500,000 Americans are using Novo Nordisk human insulin through these retailers. Novo Nordisk also has cost-savings programs for patients with high out-of-pocket expenses for insulin, and the company offers a [FN8] patient assistance program. Drug costs related to COVID-19 to affect different people in different ways based on insurance status The Kaiser Family Foundation (KFF) recently published a review of the steps taken by states, Congress, the Trump Administration, and private insurance plans to address affordability issues relating to timely access to COVID-19 testing and treatment. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -5- KFF broke the issues down into testing, treatment, preventative care, inability to afford care, and the effects of potential economic downturns. Each issue addresses, to some degree, cost savings matters relating to drugs and COVID-19. Because of the Families First Coronavirus Response Act (FFCRA), most people should not incur costs for the COVID-19 test. Starting on March 18 and lasting for the duration of the public health emergency, all forms of public and private insurance, including self-funded plans, must now cover FDA-approved COVID-19 tests and costs associated with testing with no cost-sharing. This includes high- deductible health plans and grandfathered plans. Medicare also covers serology tests that can determine whether an individual has been infected with SARS-CoV-2, the virus that causes COVID-19, and developed antibodies to the virus. The FFCRA also included an option for states to cover testing for the uninsured through Medicaid with 100% federal financing. Furthermore, $2 billion was allocated to reimburse providers for testing-related costs for uninsured individuals through the COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing and Treatment of the Uninsured Program. The Centers for Medicare and Medicaid Services has announced that Medicare will reimburse providers up to $100 per test, depending on the test. Newer COVID-19 tests that give results more quickly may cost providers more than the early tests. Several private providers, including some that take no insurance, are charging substantially more than $100 for COVID-19 tests. The Coronavirus Aid, Relief, and Economic Security (CARES) Act also expanded protections by requiring private plans to fully cover out-of-network tests. The CARES Act, however, does not prohibit out-of-network providers from billing patients directly for the COVID-19 test. This fact could deter some patients from obtaining a test. Unlike federal laws relating to testing, there has not yet been comprehensive federal legislation to limit cost-sharing for treatment of COVID-19, such as hospitalization and related prescription drugs for patients who become very ill with the disease. Most major insurers have voluntarily waived some or all treatment costs. For self-funded plans, employers ultimately decide whether treatment costs will be covered, and the degree to which they will be covered. Although there is currently no approved vaccine to prevent COVID-19, the coronavirus funding package passed on March 6, 2020 noted that, if a vaccine is developed, it should be priced “fairly and reasonably.” If a vaccine for COVID-19 is approved, recommended, and made widely available, it will likely be covered for nearly all insured people without cost-sharing. The Affordable Care Act includes a requirement that federally-recommended preventative care be covered without cost-sharing for anyone enrolled in private insurance, Medicare, or in the Medicaid expansion. Insurers are generally given at least one year to implement these recommendations, but the CARES Act requires plans to cover any coronavirus-related preventative care without cost-sharing within 15 days of a recommendation from the USPSTF and ACIP. Under the FFCRA, states must cover COVID-19 vaccine costs for all Medicaid enrollees without cost sharing to be eligible for the enhanced matching funds available through the public health emergency. Covering the costs of the vaccine for uninsured individuals has yet to be addressed by the federal government. The CARES Act expedites the process for designating a coronavirus vaccine and testing as federally-recommended preventative care to be covered in private insurance without cost-sharing. This Act also provides for coverage of any eventual coronavirus vaccine under Medicare Part B with no cost-sharing. This requirement applies to beneficiaries in both traditional Medicare and Medicare Advantage plans. Because of the economic crisis related to COVID-19, more people are likely to qualify and enroll in Medicaid. In states that adopted the Medicaid expansion, adults (both parents and childless adults) with incomes up to 138% FPL could be eligible for Medicaid. In states that have not adopted the expansion, eligibility for parents is generally well below poverty level and childless adults are not eligible for coverage (except in Wisconsin). Children in unemployed families will likely be newly eligible for Medicaid or the Children's Health Insurance Program (CHIP), which is open to children with family income at or well above 200% of FPL in nearly all states. Unlike coverage in the Marketplace, there is no open-enrollment period for Medicaid, and individuals can apply at any time. Medicaid eligibility is based on current monthly income. State unemployment benefits are counted as income for Medicaid eligibility, but new [FN9] federal supplemental unemployment benefits are excluded from income for purposes of determining Medicaid eligibility. Survey finds 12% of respondents missed doses of mental health medications due to COVID-19 fears A recent survey conducted by RxSaver by RetailMeNot, in partnership with Kelton Research, looked into the impact of the COVID-19 crisis on mental health in America. Many survey respondents reported that the COVID-19 pandemic has made it more challenging to obtain mental health care than before. Approximately 12% of Americans surveyed had been able to have a virtual doctor's appointment for treatment for mental health symptoms. Over one-third reported missing a health appointment due to a COVID-19-related difficulty. Moreover, 12% of survey respondents stated that they have missed doses of a prescribed medication. A motivating factor of this non- adherence was attributed to fear of the prescription running out or being unable to obtain a refill because of the pandemic. Younger © 2021 Thomson Reuters. No claim to original U.S. Government Works. -6- respondents aged 18 to 55 were more than twice as likely to report having skipped a medication dose compared to those in the baby boomer generation. RxSaver claims that it will use this data to better serve Americans as they manage both mental health and financial strain during the [FN10] pandemic, and the company offers free prescription coupons on its website. Study finds small percentage of Americans obtain drugs from outside U.S. A recent study investigated the question of, “How many U.S. adults buy or import drugs to save money, and what factors are associated with their purchase of medications outside the US?” Researchers found that, in the cross-sectional study of 61,238 US adults taking prescription medication, 1.5% reported medication purchases from countries outside the US. At this point, little is known about the current use of imported drugs and the factors associated with individual purchases of medications outside the U.S. Researchers involved in the study wanted to “evaluate the proportion of the U.S. adult population that purchases medications in other countries and the patient factors associated with the behavior.” The retrospective cross-sectional study used data from the 2015-2017 National Health Interview Survey. The study sample included 61,238 individuals 18 years or older who reported use of prescribed medication by a physician or other practitioner. Data analysis was performed in November 2019. The study found that, among 61,238 US adults taking prescription medications, the estimated prevalence of purchasing of medication outside the US was 1.5%. Those who purchased medications outside the US were more likely to be older than 64, to be from Hispanic or immigrant populations, and to have higher educational attainment, lower family income, and lack health insurance. The study also found that online health information?seeking behavior or use of an online pharmacy was associated with a greater likelihood of medication purchases outside the U.S. Individuals who skipped medications or delayed filling a prescription also had greater odds of purchasing medication outside the U.S. The researchers' findings suggest that patients are not using prescription purchases outside the U.S. to meet their medication needs. Despite these findings, according to the researchers, we should continue to promote safe administration of medications imported into the United States. This retrospective, cross-sectional study used aggregated data from the 2015-2017 National Health Interview Survey (NHIS). The NHIS is a nationally representative survey of the civilian, noninstitutionalized US population with a mean response rate of 80% that is conducted annually by the National Center for Health Statistics to track health status and health services use in the US. The NHIS is the country's largest in-person household health survey that has been used extensively in health services research to address medication-related issues of cost and nonadherence. Researchers involved in the study analyzed data for survey respondents 18 years or older who reported taking medication prescribed by a physician or other health care professional in the past 12 months. They excluded respondents who had missing information on socioeconomic variables, health insurance status, and health information use. Researchers measured Internet use behaviors for health care with three factors: (1) searching for health information on the internet; (2) using online chat groups to learn about health topics; and (3) filling a prescription online during the past 12 months. They constructed binary variables of each item (yes vs no). Survey respondents were also asked whether they (1) skipped medication doses; (2) delayed filling a prescription; or (3) used alternative therapies to save money in the past 12 months. Researchers in the study noted the following aspects of each respondent: age, sex, race/ethnicity, immigration status, marital status, employment status, educational level, family income, census region, health insurance status, self-reported general health status, and the number of comorbidities. Comorbidities included reports of physician-diagnosed hypertension, diabetes, cardiovascular disease (including coronary heart diseases, angina, myocardial infarction, and other heart diseases), stroke, emphysema, asthma, chronic obstructive pulmonary disease, ulcer, chronic pain (neck, back, or joint), problems with vision or hearing, or any type of cancer. They also found that having more comorbidities was not associated with medication purchases outside the U.S. as a means of saving costs. Patients with multiple conditions are likely to be older and receiving more medications, which is associated with health care spending increases and low medication adherence. The researchers stated the following conclusion: The current study provides, to our knowledge, the first national benchmark estimates on the prevalence of purchasing of prescription medications by US adults in another country to save money. Among US adults taking prescription medications, 1.5% (representing 2.3 million US individuals) reported that they purchased their medications from countries outside the US to save money. Financial constraints on refilling prescription, along with inadequate coverage and internet use for health care, were significantly associated with medication purchase outside the US. Given the expected changes in prescription drug importation rules, continued monitoring appears to be needed to examine the patterns of medication purchase behaviors and factors that facilitate or impede the use of imported drugs. Future research regarding the economic evaluation of changing drug importation rules in the US health care system is also warranted. [FN11] © 2021 Thomson Reuters. No claim to original U.S. Government Works. -7- CEO of Gilead Sciences pens open letter explaining company's pricing of remdesivir during COVID-19 pandemic Remdesivir, drug maker Gilead Sciences' investigational treatment for COVID-19, is the first antiviral to have demonstrated patient improvement in clinical trials for the disease. Daniel O'Day, Chairman and CEO of the company, recently released a letter explaining the company's pricing decision on the drug and how it reached that decision. Remdesivir is an antiviral product that is being studied in several clinical trials on COVID-19 patients. The approval status of remdesivir varies by country, and in countries where remdesivir has not been approved by the regional health authority, it is considered an investigational drug. Remdesivir has not been approved by the U.S. Food and Drug Administration (FDA) for any use. In the United States, the FDA granted remdesivir an Emergency Use Authorization (EUA) for the treatment of hospitalized patients with severe COVID-19. This authorization is temporary, may be revoked, and does not take the place of the formal new drug application submission, review, and approval process. Mr. O'Day first noted that, “As with all our actions on remdesivir, we approached this with the aim of helping as many patients as possible, as quickly as possible and in the most responsible way. This has been our compass point throughout, from collaborating to find rapid answers on safety and efficacy, to scaling up manufacturing and donating our supply of remdesivir through the end of June. In each case, we recognized the need to do things differently to reflect the exceptional circumstances of the pandemic. Now, as we transition beyond the donation period and set a price for remdesivir, the same principle applies.” He then stated that, in normal circumstances, the company would price a drug according to the value it provides, and that the first results from the NIAID study in hospitalized patients with COVID-19 showed that remdesivir reduced time to recovery by an average of four days. In the United States, earlier hospital discharges would result in hospital savings of approximately $12,000 per patient. He then set forth the pricing structure, stating that, “We have decided to price remdesivir well below this value. To ensure broad and equitable access at a time of urgent global need, we have set a price for governments of developed countries of $390 per vial. Based on current treatment patterns, the vast majority of patients are expected to receive a 5-day treatment course using 6 vials of remdesivir, which equates to $2,340 per patient.” In the United States, the same government price of $390 per vial will apply, and the price for private insurance companies will be $520 per vial. O'Day also stated that, “At the level we have priced remdesivir and with government programs in place, along with additional Gilead assistance as needed, we believe all patients will have access.” The company has also entered into agreements with generic manufacturers to deliver treatment at a “substantially lower cost” in [FN12] developing countries so as to “ensure that all countries in the world can provide access to treatment.” PBM Capital Rx announces partnership with Walmart on Clearinghouse Model for specialty and mail order prescriptions Pharmacy benefit manager (PBM) Capital Rx recently announced that it is partnering with Walmart to help bring transparency of unit prices across specialty and mail order prescriptions through its Clearinghouse ModelSM in an attempt to combat the rising costs of prescription drugs. Capital Rx's Clearinghouse Model is a new technology-driven pricing framework that eliminates arbitrary drug costs by connecting buyers (plan sponsors) and sellers (pharmacies), and providing real time pricing for all drugs. Capital Rx and Walmart are the first to offer employers a unit price for all prescriptions across retail, mail, and specialty. Capital Rx is a PBM that claims it is “redefining the way prescriptions are priced and administered in the U.S.” Its Clearinghouse ModelSM is an attempt to unlock the pharmacy supply chain and reduce prescription costs for employer groups. The company noted in a statement that, “By establishing a competitive marketplace for drug pricing, Capital Rx focuses its resources on deploying actionable strategies that improve plan performance and patient outcomes. The company's commitment to innovation, technology, and service is why Capital Rx is the fastest-growing pharmacy benefit manager in America.” According to AJ Loiacono, founder and CEO at Capital Rx, “The extension of the Clearinghouse Model beyond retail to include specialty and mail order prescriptions furthers our commitment to eliminating artificial price inflation and variability for prescription drugs.” Loiacono further noted that, “Capital Rx offers employers a guaranteed price for each prescription. We're providing cost certainty on every transaction, not a constantly fluctuating price driven by PBM profitability. While this approach sounds simple, it is actually a transformational new model for an industry that has been plagued by price manipulation.” Capital Rx's Clearinghouse Model is an industry first pricing model that connects buyers and sellers and rebuilds trust across the supply chain. The Clearinghouse Model contains a cloud-native technology platform that provides plan sponsors with full visibility to the unit price for all drugs in real time. Through this new pricing framework, Capital Rx hopes to eliminate arbitrary price variability for patients and employers. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -8- Walmart Specialty Pharmacy is a URAC accredited provider with a focus on patient-centered care, helping patients manage specialty medication therapies for a wide variety of complex and chronic diseases. Walmart Specialty Pharmacy coordinates care between patients, caregivers, and insurance companies to ensure that patients receive necessary medications and supplies whenever and wherever they are needed. Luke Kleyn, Vice President, Walmart Health and Wellness, commented on the collaboration, stating that, ““Everyday low price' has been a guiding principle at Walmart. We take pride in providing affordable prices to more than 160 million customers who shop Walmart each week. Working with Capital Rx will allow us to do the same for prescription drugs. Capital Rx is making great strides in redefining the way prescription drugs are priced and administered in the United States. We could not be more thrilled to work alongside such a forward-thinking team who shares our mission and will help Walmart's everyday low prices reach the marketplace.” CEO Loiacono also stated that, “Through our collaboration with Walmart, Capital Rx brings the purchasing experience of an efficient market to specialty and mail drugs,” said Loiacono. “Given that specialty medications are the highest cost and fastest growing expense for employers, we have an incredible opportunity to deliver significant savings to both plan sponsors and patients nationwide. Most importantly, all employers receive the same price on prescriptions. There is no more price disparity between larger and smaller [FN13] employers, enlightened and uninformed buyers, everyone receives the same, everyday low price.” Drug trade group opposes Trump “Buy American” Executive Order The Pharmaceutical Research and Manufacturers of America (PhRMA) released a statement in response to President Trump's recent “Buy American” Executive Order. The statement noted that, “At a time when our nation's priority should be to beat COVID-19, President Trump today signed yet another executive order that creates even more barriers to ongoing biopharmaceutical manufacturing and innovation. Companies are working around the clock to research and develop treatments and a vaccine for COVID-19. At the same time, they are working to ensure they have the capacity to manufacture the treatments and vaccines once approved so that every patient that needs them has access to them. These efforts are all hands on deck for the biopharmaceutical industry but each executive order issued by the administration adds another roadblock, making it harder to fight this pandemic.” It also stated that, “The administration is forcing biopharmaceutical companies to shift their critical attention and resources away from COVID-19 work to focus on making substantial changes to their business models necessary to comply with this and other recent executive orders. Increasing U.S. manufacturing of medicines is a laudable goal, but it cannot happen overnight and should not come at [FN14] the expense of medical innovation or Americans' access to the medicines they need.” Financial wellness company Immediate announces a new partnership with ScriptSave WellRx to provide discounts on prescriptions directly from new app Immediate, a financial wellness company, recently announced a new partnership with ScriptSave WellRx to provide discounts on prescriptions directly from the ImmediatePay app. The functionality of the app is a new money saving offering within the suite of financial wellness tools Immediate provides, including earned wage access, budgeting tools, and more. Users will be able to access savings from the prescription drug discount program by presenting their member card within the app upon checkout at any participating pharmacy. ScriptSave WellRx negotiates discounts on drug prices with pharmacies nationwide, providing reduced prices on thousands of prescription drugs, including pet medications. Immediate users can access these discounted prices by showing their member card within the ImmediatePay app when checking out at the pharmacy counter. ScriptSave WellRx is accepted nationwide at more than 65,000 pharmacies, with an average savings of 60% and in some cases 80% off the retail drug price. According to Marcus Sredzinski, PharmD, executive vice president and chief operating officer, ‘We admire what Immediate is doing to advance financial wellness for employees across the U.S. The economic challenges that people may be facing due to the pandemic has made it more important than ever to give them opportunities to save money on the things they need and purchase regularly. We're proud to offer our savings directly to Immediate users from within the ImmediatePay app.’ Debbie Payne vice president, sales and account management at ScriptSave WellRx, noted that, “For employees with limited insurance or no prescription coverage, we can help significantly reduce out-of-pocket costs. And for those with health insurance, be it Medicare or a high deductible health plan, we can reduce the cost of medications not covered by their insurance, or even help them find a lower price than their insurance copay.' While individual cost savings will vary by each prescription drug, Immediate users will be able to instantly access a lower price drug price at the checkout counter. ScriptSave WellRx contends that it has saved consumers more than $10 billion dollars in prescription costs over the last 25 years. Matt Pierce, Immediate founder and CEO, stated that, ‘As a financial wellness company our focus is to help customers make better financial choices. Healthcare costs can make up significant ongoing expenditures. It's important to us to provide our users with tools that will help them focus on making healthy financial decisions, and ScriptSave WellRx does exactly that. We evaluated different © 2021 Thomson Reuters. No claim to original U.S. Government Works. -9- competitors in the market and ScriptSave's robust platform and competitive discounted price offerings were clearly the best choice. [FN15] We're very excited for this partnership and the ability to offer these savings to our users.’ HHS Secretary praises Trump in speech to industry group Alex M. Azar, Secretary of the Department of Health and Human Services, recently gave a keynote speech to a generic and biosimilar drug industry group. In the speech, he praised outgoing President Donald Trump's policies and executive orders intended to reduce prescription drug costs. Secretary Azar also noted that accelerated approvals of biosimilars and generic drugs, combined with growing market competition since 2017, have contributed to a “plateau” in drug price inflation the past several years. The speech was given to the Association for Accessible Medicine (AAM) GRx+Biosims virtual conference. Azar credited this alleged trend to market dynamics and drug policies promoted by Trump. Azar stated that, “Since we released the president's drug pricing “blueprint' in May 2018, the official government measurement of drug price inflation has been flat. That measure saw the largest drop in nearly 50 years from June 2018 to June 2019. Now, I don't think that's because of the goodness of drug companies' hearts. In fact, I worked at a drug company myself, and I can more or less assure you it's not. In significant part, it's because of the market discipline that your companies provide.” He also noted that. “I believe we've seen more efforts to promote competition in prescription drug markets from HHS and our colleagues at FDA than we've seen since the passage of Hatch-Waxman in the 1980s.” Azar further stated that, “We've set records for approvals of generic drugs in 2017 [937], 2018 [971], and 2019 [1171], while also [FN16] accelerating approvals of biosimilars. The savings that these drugs deliver are massive.” III. Legislation, regulation, and legal actions President, HHS, and FDA announce notice of proposed rulemaking addressing importation of prescription drugs from Canada President Trump, the U.S. Department of Health and Human Services (HHS), and the U.S. Food and Drug Administration recently issued a notice of proposed rulemaking (NPRM) that would allow for the importation of certain prescription drugs from Canada. The Administration is also announcing the availability of a new draft guidance for industry that describes procedures drug manufacturers can follow to facilitate importation of prescription drugs (including biological products) that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country. According to HHS, the recently issued NPRM issued “is the first step in implementing a provision of federal law that would allow for the importation of certain prescription drugs from Canada under specific conditions that ensure the importation poses no additional risk to the public's health and safety while achieving a significant reduction in the cost of covered products to the American consumer.” The draft guidance describes procedures for a drug manufacturer to submit documentation that demonstrates that the product offered for import from any foreign country is an FDA-approved drug product, including that it is manufactured in accordance with the FDA- approved application. HHS Secretary Alex Azar commented on the proposed rule, stating that, “Today's announcement outlines two pathways for the safe importation of certain prescription drugs to help provide safe, effective, more affordable drugs to American patients. These are historic actions by HHS and the FDA, and they represent the bold nature of President Trump's agenda for lowering drug costs. The President has recognized the opportunity to lower costs for American patients through safe importation, and we at HHS and FDA are delivering on that possibility through a safe, commonsense approach.” The NPRM would allow states and certain other non-federal government entities to submit importation program proposals to the FDA for review and authorization. An importation program could be co-sponsored by a pharmacist, a wholesaler, or another state or non- federal governmental entity. Referred to as “Section 804 Importation Programs,” these programs would be authorized by the FDA to manage the importation of certain prescription drugs that are approved in Canada and also meet the conditions in an FDA-approved drug application. Eligible prescription drugs would have to be relabeled with the required U.S. labeling before importation and undergo testing for authenticity, degradation, and to ensure that the drugs meet established specifications and standards. These programs would also have to demonstrate significant cost reductions to the American consumer. According to Assistant Secretary for Health, Brett Giroir, “The FDA continues to assess and act on multiple opportunities to promote competition that can, in turn, help reduce drug prices and improve access to medicines for Americans. The proposed rule and draft guidance include procedures intended to protect the public's health and safety. We look forward to receiving public comment on these draft policies, and we will take timely comments into account as we work to finalize the rule and guidance. Our ultimate goal is to provide a robust program that clearly lays out procedures to import drugs that could provide lower prices while also maintaining the high quality Americans expect.” © 2021 Thomson Reuters. No claim to original U.S. Government Works. -10- The draft guidance describes procedures drug manufacturers could follow to obtain an additional National Drug Code (NDC) for certain FDA-approved prescription drugs, including biological products, that were originally manufactured, and intended to be marketed, in a foreign country. The use of an additional NDC is intended to allow greater flexibility for drug companies to offer these products at a lower price than what their current distribution contracts require. The draft guidance also recommends that the drug manufacturer include a statement on the product's label and in the prescribing information to assist pharmacists to accurately identify, dispense and bill for these products. Prescription drugs, including biological products, imported under the pathway described in the draft guidance could be available to patients in a variety of settings, including hospitals, health care providers' offices, or licensed U.S. pharmacies, and would include the FDA-approved labeling (including prescribing information). Comments on the NPRM are being accepted for 75 days after publication in the Federal Register and comments on the draft guidance [FN17] are being accepted for 60 days after publication in the Federal Register. Oklahoma lawmaker introduces bill to replace third-party PBMs with a direct-to-pharmacy payment system for state employees; law intended to save insureds money on medications Oklahoma state senator Paul Scott, R-Duncan, has filed Senate Bill 1901 to replace the state's third-party pharmacy benefit managers (PBMs) with a direct-to-pharmacy payment system According to Senator Scott, this move could save the state millions and help significantly lower prescription drug prices for state employees. A PBM is a third-party administrator of prescription drug programs for state and federal government employee plans, self-insured employer plans, commercial health plans and Medicare Part D plans. By utilizing preferring formularies and exclusion lists, PBMs decide which drugs consumers can receive from their plan without facing additional out-of-pocket costs. They develop and maintain the list of medicines that can be used in a particular health system or under a particular health insurance policy. Senator Scott noted that, “States started using Pharmacy Benefit Managers because of their promised cost savings but now many are realizing that instead of cutting prescription costs and saving states money, PBMs are putting the rebates and savings in their own pockets. Drug costs are skyrocketing, and Oklahomans need help. No one should have to choose between their prescriptions and eating or paying utility bills but that has become the norm for many. It's time we cut out the middleman and get our citizens the savings they desperately need.” SB 1901 would direct the Oklahoma Employees Insurance and Benefits Board to collaborate with the Oklahoma Health Care Authority (OHCA) to make the change. By July 1, 2021, the two entities would establish pricing to lower prescription drug prices for all enrollees of any health insurance plans offered under the Oklahoma Employee Insurance and Benefits Act. Scott said OHCA is already doing this for SoonerCare recipients and his proposal would allow them to do the same for all state employees. There are currently five healthcare programs for Oklahoma state employees, and each has their own PBM. They are HealthChoice ? Caremark, Blue Cross/Blue Shield - Prime Therapeutics LLC, CommunityCare ? CVS, GlobalHealth ? Magellan, and Humana - [FN18] Humana Pharmacy Solutions. New Mexico passes law addressing cost of insulin New Mexico Governor Michelle Lujan Grisham recently signed into law a bill intended to reduce the high cost of prescription drugs. House Bill 292 caps co-pays and out-of-pocket expenses for insulin at $25 per prescription for a 30-day supply, making them the lowest in the country. A press release from Governor Grisham notes that the list prices of common types of insulin have tripled over the last decade, and approximately one quarter of American adults with diabetes say that price has affected their insulin use, according to the American Diabetes Association. According to Governor Lujan Grisham, “This law ends an unacceptable dilemma for thousands of New Mexicans with diabetes forced to choose between life-saving insulin and other expenses.” Rep. Micaela Cadena, a sponsor of the bill, stated that, “I am proud to have sponsored House Bill 292 making sure all New Mexicans can afford the medicine they need to survive and thrive. Capping insulin copays is an effort to bring much-needed relief to families [FN19] facing unconscionably high drug prices.” Utah law allows insurers to send patients to Mexico to obtain discounted prescription drugs A health insurance company in Utah is attempting reduce prescription drug costs by flying state employees to Mexico to obtain prescription medications at a major discount compared to the cost of the drugs in the United States. The program involves approximately ten state employees, and the cost savings to the insurer are so large that the insurance company can pay for each patient's flight, give them a $500-per-trip bonus, and still save tens of thousands of dollars. Ann Lovell, a 62-year-old teacher, participates in the program and stated that she had saved as much as $2,400 by travelling from Salt Lake City to San Diego and then crossing the border. She makes the trip to refill a prescription for arthritis medication. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -11- Ms. Lovell noted that, “This is the drug that keeps me functioning, working—I think if I wasn't on this drug ... I'd be on disability rather than living my normal life.” The Utah program began under a 2018 law called “right to shop”. It lists 12 medications, though only 400 of the state's 160,000 public employees are eligible to participate in the program. To protect counterfeiting, Utah officials track the medications from manufacturer to pharmacy to patient. A representative from a specialty pharmacy called Provide Rx escorts patients across the border. [FN20] Utah estimates the program has saved the state approximately $225,000 in a year. Virginia Congresswoman advocates for elimination of copays for TRICARE benefits for veterans during COVID-19 pandemic and sponsors similar legislation to that effect Congresswoman Elaine Luria recently led a bipartisan effort calling on Congressional leadership to temporarily eliminate copays on mail order prescription drugs for TRICARE beneficiaries during the COVID-19 pandemic in the next relief package. This initiative earned the support of over 50 members of Congress, in addition to thirteen veterans service organizations (VSOs). According to Congresswoman Luria, “During this unprecedented health crisis, it is vital to practice social distancing and protect military families and mission critical personnel at military treatment facilities. By temporarily eliminating the copay on mail order prescriptions, we can ensure that TRICARE beneficiaries can access their medicine without endangering themselves or others. I urge Congressional Leadership to include this commonsense provision in future coronavirus relief legislation.” Section 702 of the Fiscal Year 2018 National Defense Authorization Act adjusted pharmacy copayments for 2018 through 2027. In 2020, the copay for a 90-day supply of a generic drug is $10, while the copay for name brand drugs is $29. Beneficiaries who pick up their prescriptions at a Military Treatment Facility (MTF) do not pay a copay. In response to the COVID-19 pandemic, some installation commanders suspended installation access for retirees and survivors to protect mission critical personnel from infection. As a result of these decisions, many TRICARE beneficiaries can no longer access MTF pharmacies and must transfer their prescriptions to mail order or retail pharmacies which require copays. Temporarily eliminating the copay on mail order prescription drugs is intended to ease any unexpected financial burden on veterans and their families. Several veterans-related organizations have endorsed Congresswoman Luria's proposal, including: Air Force Sergeants Association, Association of Military Surgeons of the United States, Blinded Veterans Association, Commissioned Officers Association of the US Public Health Service, EANGUS: Enlisted Association of the National Guard of the United States, Fleet Reserve Association, Gold Star Wives of America, Military Officers Association of America, National Military Family Association, Service Women's Action Network, [FN21] Tragedy Assistance Program For Survivors, TREA: The Enlisted Association, and Wounded Warrior Project. Congresswoman Luria then joined Congresswoman Lisa Blunt Rochester in leading efforts to introduce a bill to eliminate copays for TRICARE participants during the COVID-19 pandemic. Luria noted that, “It is critical that we protect those who have fought and served our country. The Help Our Heroes Access Medicine Act would give the Secretary of Defense the authority to waive TRICARE copays on prescription drugs during a public health emergency or national emergency.” Congresswoman Liuria further stated that, “I urge Congress to quickly pass this important bill that would protect military retirees' and families' access to prescription drugs while keeping them and mission critical personnel safe.” Congresswoman Luria represents Virginia's 2nd Congressional District. She serves on the House Armed Services Committee, where she is the Vice Chair of the Seapower and Projection Forces Subcommittee, and on the House Committee on Veterans' Affairs, where [FN22] she serves as Chair of the Disability Assistance and Memorial Affairs Subcommittee. Jill Lynch, speaking on behalf of Veterans of Foreign Wars, commented on the proposed legislation, stating that, “Passing this bill will not only benefit applicable veterans, their families, and those eligible here in Tidewater and across the Commonwealth of Virginia, but across the country at large. So we thank you whole-heartedly for your support on this and we look forward to having this bill get [FN23] passed.' Utah Legislative Auditor General releases report on prescription costs in Utah Medicaid system The Legislative Auditor General of the State of Utah recently released an audit reviewing prescription costs incurred by Utah Medicaid. The review included findings and agency recommendations relating to better oversight on many fronts, including contract compliance between Accountability Care Organizations and their Pharmacy Benefit Managers. The Utah Department of Health Division of Medicaid and Health Financing (DOH, DOH Medicaid, or Utah Medicaid) is tasked with providing pharmacy benefits for Utah's Medicaid population. The Legislative Auditor General was asked by the Legislative Audit Subcommittee to audit the pricing structures of Medicaid's pharmacy costs and the oversight provided by Medicaid. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -12- Pharmacy benefits are administered to Medicaid recipients in two ways: through four separate Medicaid Accountable Care Organizations (ACOs), or directly through the DOH Medicaid program known as fee-for-service or FFS. While three of the ACOs contract with pharmacy benefit managers (PBMs), Select Health, an ACO, contracts directly with manufacturers for prescription benefits. FFS receives primary rebates for prescription benefits that are established by the Centers for Medicare & Medicaid Services (CMS). FFS also contracts directly with manufacturers for supplemental rebates for prescription benefits from Medicaid's preferred drug list. The Auditor General reviewed the relationship between the PBMs and the ACOs that contract with PBMs and how PBMs affect ACOs prescription costs, as well as FFS direct relationships with manufacturers. The audit examined how Medicaid has been controlling the increasing costs of prescription drugs. This audit also reviewed the oversight Medicaid provides to its Accountable Care Organizations (ACOs). Findings of the audit included: • Medicaid has access to protected rebate information; utilization of this information could save the Medicaid program millions of dollars; • Medicaid contractor Change Healthcare ensures that the price paid at the pharmacy is the lowest of six different indices, however DOH does not have a formal process of ensuring that the lowest price is being selected; and • Medicaid relies on the actuarial company Milliman to set capitated rates and uses these capitated rates as means to control spending but does not conduct other oversight activities of ACOs. The Auditor General made the following recommendations: • Agency Action: We recommend the Department of Health research and provide a report to the Social Services Appropriations Subcommittee and any other pertinent legislative committees regarding the potential savings, benefits, and costs from creating a statewide preferred drug list; • Agency Action: We recommend the Department of Health create a process to review lesser-of logic to ensure pricing is correct; • Agency Action: We recommend the Department of Health create a process to review claim-level rebate information to ensure rebates are processed correctly; • Agency Action: We recommend the Department of Health take steps to provide better oversight of the Accountable Care Organizations and review cost trends and contract changes; and • Agency Action: We recommend the Department of Health provide oversight of contract compliance between Accountability Care [FN24] Organizations and their Pharmacy Benefit Managers. Senators Cornyn and Bennet introduce biosimilars bill aimed at lowering costs for seniors U.S. Senators John Cornyn (R-TX) and Michael Bennet (D-CO) recently introduced the Increasing Access to Biosimilars Act, which would address the high cost of prescription drugs for seniors by promoting competition, increasing access to biosimilar medications, and encouraging physicians to prescribe biosimilars with lower out-of-pocket costs. Senator Cornyn noted that, “Seniors have been hit hard by skyrocketing costs for the prescription drugs they need. This legislation would encourage competition by promoting the use of biosimilars, which have a lower out-of-pocket cost but provide the same potentially lifesaving benefits.” According to Senator Bennet, “Prescription drug costs have drastically increased in recent years, placing a major financial burden on seniors, minority communities, and millions of Americans living on fixed incomes who require their prescribed medication to live their life. This bipartisan legislation would share lower-cost biosimilars with patients, saving them and our health care system billions of dollars.” The Increasing Access to Biosimilars Act would direct the Department of Health and Human Services to create a shared savings demonstration program for biosimilar drugs in the Medicare program. This program is intended to help increase competition and expand access to biosimilars. It is also intended to encourage physicians to prescribe less-expensive biosimilars in order to lower out-of-pocket costs to seniors. [FN25] The bill is supported by the Biosimilars Forum and by drug maker Mylan. President Trump signs four Executive Orders relating to prescription drug costs, including one addressing importation of prescription drugs President Trump recently signed four Executive Orders intended to lower prescription drug costs and increase Americans' access to life-saving medications, including insulin. The first Order directs federally qualified health centers to pass along discounts on insulin and epinephrine received from drug companies to certain low-income Americans. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -13- The second Order will allow State plans for safe importation of certain drugs, authorize the re-importation of insulin products made in the United States, and create a pathway for widespread use of personal importation waivers at authorized pharmacies in the United States. The third Order will prohibit secret deals between drug manufacturers and pharmacy benefit manager middlemen. This order is intended to ensure that patients directly benefit from available discounts at the pharmacy counter. The fourth and final Order ensures that the United States pays the lowest price available in economically comparable countries for Medicare Part B drugs. The White House contends that The United States often pays 80% more for these drugs than other developed countries. According to a press release from the White House, “It's time to reduce the price Americans pay for these costly Part B medications, and absent successful negotiations with drug company executives this Order will be implemented on August 24.” The White House press release also stated that, “The Trump Administration has approved generic drugs at historic rates, saving patients $26 billion in the first 19 months of the President's first term alone. In May, the Administration announced the Part D Senior Savings Model that will provide Medicare patients options to access a broad set of insulins at a maximum $35 copay per month. President Trump also signed legislation ending gag clauses that prevented pharmacists from informing patients about the best prices [FN26] for the medications they need.” Pharmaceutical trade group actively opposes Trump's Executive Orders and decries “socialism” The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country's leading innovative biopharmaceutical research companies. PhRMA's President and CEO, Stephen J. Ubl, recently made the following statement in response to the President's executive orders, citing “socialism” and accusing the President of going back on past promises. Mr. Ubl's statement noted that, “In his 2020 State of the Union Address, President Trump declared that “we will never let socialism destroy American health care.” However, according to Ubl, “Yet, in the middle of a global pandemic, when nearly 145,000 Americans have lost their lives and millions of others have suffered untold economic hardships, this administration has decided to pursue a radical and dangerous policy to set prices based on rates paid in countries that he has labeled as socialist, which will harm patients today and into the future.” PhRMA's Ubl further noted that, “The research-based biopharmaceutical industry has been working around the clock to develop therapeutics and vaccines to treat and prevent COVID-19. The administration's proposal today is a reckless distraction that impedes our ability to respond to the current pandemic ? and those we could face in the future. It jeopardizes American leadership that rewards risk-taking and innovation and threatens the hope of patients who need better treatments and cures.” Mr. Ubl concluded his statement by saying that, “The president's attempt to open our country up to socialized health care sets America, our economic recovery and scientific progress back at a time when we need them most.” PhRMA contends that, since 2000, its member companies have invested more than $900 billion in the search for new treatments and [FN27] cures, including an estimated $79.6 billion in 2018 alone. California Governor Newsom signs law intended to lower prescription drug prices for residents California Governor Gavin Newsom recently announced that he has signed legislation intended to bring down the cost of prescription drugs for taxpayers, employers, and consumers in California. Earlier in 2020, Governor Newsom announced a plan to lower the cost of prescription drugs by creating Cal Rx, which is a state- sponsored generic drug label. SB 852, sponsored by Senator Richard Pan (D-Sacramento) includes this initiative. Under the bill, the California Health and Human Services Agency (CHHS) will develop manufacturing partnerships to produce or distribute generic prescription drugs, making essential medications affordable and accessible to more patients. It is also intended to inject competition into markets that have driven up prices for consumers and help address critical drug shortages. According to Governor Newsom, “The cost of health care is way too high. Our bill will help inject competition back into the generic drug marketplace ? taking pricing power away from big pharmaceutical companies and returning it to consumers. California is using our market power and our moral power to demand fairer prices for prescription drugs. I am proud to sign this legislation affirming our ground-breaking leadership in breaking down market barriers to affordable prescription drugs.” Senator Pan noted that, “Prescription drugs don't work if people cannot afford to take them. I thank the Governor for his leadership to assure Californians will be able to have access to a reliable supply of affordable generic medications. With the signing of SB 852, California leads the country again in pursuing innovative ideas to increase health care access and affordability, this time for prescription drugs.” SB 852 advances the Governor's proposal in January to leverage California's purchasing power to increase generic drug manufacturing as one solution to the prescription drug affordability crisis. The state has already begun to identify potential target medications and develop a strategic plan to promote state-led generic drug purchasing and manufacturing. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -14- California is also transitioning all Medi-Cal pharmacy services from managed care to direct state payment in 2021, strengthening California's ability to negotiate better prices with drug manufacturers. The Governor has made addressing prescription drug pricing a priority for the Administration since he took office. Shortly after being sworn in, he signed an executive order to foster the creation of the nation's biggest single-purchaser system for prescription drugs. This system should ultimately allow all Californians and private employers to bargain with drug manufacturers when negotiating prescription drug prices. In 2019, Newsom signed legislation prohibiting pay-for-delay agreements between brand name and generic drug manufacturers by making them presumptively anticompetitive. Newsom contends that these anticompetitive deals hurt consumers and increase drug company profits by blocking the development of generic drug competition. Under SB 852, CHHS will target drugs for manufacture that could produce the largest cost savings, and will submit a report to the [FN28] Legislature by July 1, 2022 analyzing how its efforts have impacted competition, access, and costs for those drugs. Pennsylvania state senator introduces law tying state drug prices to Canadian prices In September, Pennsylvania State Senator Tom Killion (R-Chester and Delaware) introduced legislation intended to substantially lower the cost of prescription medications for Pennsylvania residents. Killion's Prescription Drug Cost Reduction Act, introduced as Senate Bill 1315, would tie prescription drug prices in Pennsylvania to the much lower prices charged to Canadian consumers. This proposal is based on model legislation unveiled in August by the National Academy for State Health Policy, a leading healthcare policy organizations. Killion has noted that the United States has the highest prescription drug prices in the world and that nearly 20 percent of the country's healthcare spending is directed toward prescription medications. Senator Killon stated that, “Pennsylvanians should never have to choose between their medication and paying their electric bill. They should never have to decide if they'll refill a prescription or put food on their table. Our drug prices are beyond excessive. My bill will change that.” Killion's legislation would require the state to create a list of the 250 most costly prescription drugs every year. Pennsylvania's Insurance Department would then establish a maximum rate paid by health insurance providers for each medication on the list based on Canadian pricing data. The legislation would also require that premium reductions resulting from lower medication costs paid by insurers be passed along to consumers, and fines would be levied against insurers for violations. Killion further commented on his proposal, noting that, “Pennsylvanians can't import drugs from Canada, but we can import their prices.” [FN29] FDA and HHS announce final rule relating to importing prescription drugs from Canada The U.S. Department of Health and Human Services and the U.S. Food and Drug Administration recently announced a final rule that is intended to “help provide safe, effective, and more affordable drugs to American patients as part of the Safe Importation Action Plan, fulfilling the aspect of the July Executive Order on drug pricing to complete the rulemaking to allow states to import certain prescription drugs from Canada.” The final rule implements a provision of federal law that allows FDA-authorized programs to import certain prescription drugs from Canada under specific conditions that ensure the importation poses no additional risk to the public's health and safety. The final rule also intends to reduce the cost of covered products to American consumers. The final guidance for industry describes procedures drug manufacturers can follow to facilitate importation of prescription drugs, including biological products, that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country. According to FDA Commissioner Stephen M. Hahn, M.D., “Today's action is an important part of FDA's priorities to promote choice and competition. The Safe Importation Action Plan aims to clearly describe procedures to import drugs that would lower prices and improve access while also maintaining the high quality and safety Americans expect and deserve. The FDA will continue to assess and act on opportunities to increase competition in the prescription drug market and help reduce the cost of medicines.” The rule allows states (including the District of Columbia and territories), Indian tribes and (in certain future circumstances) pharmacists and wholesalers, to submit importation program proposals to the FDA for review and authorization. An importation program can be co- sponsored by a state, Indian tribe, pharmacist, or wholesaler. These programs, referred to as Section 804 Importation Programs, will be managed by the respective sponsor and any co-sponsors and authorized by the FDA to facilitate the importation of certain prescription drugs that are approved in Canada and (with appropriate labeling) meet the conditions of an FDA-approved drug application. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -15- Eligible prescription drugs would have to be relabeled with the required U.S. labeling and undergo testing for authenticity, degradation and to ensure that the drugs meet established specifications and standards. These programs will also have to demonstrate significant cost reductions of the covered products to the American consumer. The final guidance issued describes procedures for a drug manufacturer to obtain a National Drug Code (NDC) for certain FDA- approved prescription drugs, including biological products and combination products, that were originally manufactured and intended for sale in that foreign country. The use of an additional NDC for these products may allow greater flexibility for drug companies to offer these products at a lower price than what their current distribution contracts require. Prescription drugs, including biological products, imported under the pathway described in the final guidance could be available to patients in a variety of settings, including hospitals, health care providers' offices or licensed pharmacies, and would include the FDA-approved labeling (including prescribing information). [FN30] Pennsylvania state senator introduces bill lowering state prescription costs to prices similar with Canada's Pennsylvania state senator Tom Killion (R-Chester/Delaware) recently introduced legislation aimed to substantially lower the cost of prescription medications for Pennsylvania residents. The Prescription Drug Cost Reduction Act (S.B. 1315) attempts to make drug prices in Pennsylvania similar to those prices charged in Canada. Senator Killion noted that, “Pennsylvanians should never have to choose between their medication and paying their electric bill. They should never have to decide if they'll refill a prescription or put food on their table. Our drug prices are beyond excessive. My bill will change that.” S.B. 1315 would require the state to create a list of the 250 most costly prescription drugs per year. Pennsylvania's Insurance Department would then establish a maximum rate paid by health insurance providers based on Canadian pricing information. Savings incurred by insurers under this program would be passed along to consumers. Trish Riley, executive director of the National Academy for State Health Policy, also commented on the proposed law. Ms. Riley stated that, “This legislation sets up a simple, low cost mechanism to assure purchasers in the state achieve the same savings as Canada on costly drugs, purchased from the same pharmacies consumers use today. Setting payment rates ? not prices ? is akin to how we pay [FN31] for all other health services and is designed to assure any legal challenges can be overcome.” HHS, DOL, and Treasury Department release Transparency in Coverage final rule, which also addresses prescription drugs The Department of Health and Human Services (HHS), the Department of Labor, and the Department of the Treasury recently released the Transparency in Coverage final rule. This final rule is intended to help place health care price information in the hands of consumers and other stakeholders. The requirements in this rule are intended to provide consumers the tools needed to access pricing information through their health plans. This rule builds upon previous actions the Trump Administration has taken to increase price transparency by giving patients access to hospital pricing information. The requirements in the Transparency in Coverage final rule intend to reduce the secrecy behind health care pricing with the goal of bringing greater competition to the private health care industry. This rule will require most group health plans, and health insurance issuers in the group and individual market, to disclose price and cost-sharing information to participants, beneficiaries, and enrollees. The Departments are finalizing a requirement to give consumers real-time, personalized access to cost-sharing information, including an estimate of their cost-sharing liability, through an internet based self-service tool. This requirement will empower consumers to shop and compare costs between specific providers before receiving care. Through this final rule, plans and issuers will also be required to disclose on a public website their in-network negotiated rates, billed charges and allowed amounts paid for out-of-network providers, and the negotiated rate and historical net price for prescription drugs. Making this information available to the public is intended to drive innovation, support informed, price-conscious decision-making, and promote competition in the health care industry. This final rule includes two approaches to make health care price information accessible to consumers and other stakeholders, allowing for easy comparison-shopping. First, most non-grandfathered group health plans and health insurance issuers offering non-grandfathered health insurance coverage in the individual and group markets will be required to make available to participants, beneficiaries and enrollees (or their authorized representative) personalized out-of-pocket cost information, and the underlying negotiated rates, for all covered health care items and services, including prescription drugs, through an internet-based self-service tool and in paper form upon request. Most consumers will be able to receive real-time and accurate estimates of their cost-sharing liability for health care items and services from different providers in real time, allowing them to both understand how costs for covered health care items and services are determined by their plan, and also shop and compare health care costs before receiving care. An initial list of 500 shoppable services as determined by the Departments will be required to be available via the internet based self-service tool for plan years that begin on or © 2021 Thomson Reuters. No claim to original U.S. Government Works. -16- after January 1, 2023. The remainder of all items and services will be required for these self-service tools for plan years that begin on or after January 1, 2024. Furthermore, most non-grandfathered group health plans or health insurance issuers offering non-grandfathered health insurance coverage in the individual and group markets will be required to make available to the public, including stakeholders such as consumers, researchers, employers, and third-party developers, three separate machine-readable files that include detailed pricing information. The first file will show negotiated rates for all covered items and services between the plan or issuer and in-network providers. The second file will show both the historical payments to, and billed charges from, out-of-network providers. Historical payments must have a minimum of twenty entries in order to protect consumer privacy. The third file will detail the in-network negotiated rates and historical net prices for all covered prescription drugs by plan or issuer at the pharmacy location level. Plans and issuers will display these data files in a standardized format and will provide monthly updates. This data will provide opportunities for detailed research studies, data analysis, and offer third party developers and innovators the ability to create private sector solutions to help drive additional price comparison and consumerism in the health care market. These files are required to be made public for plan years that begin on or after January 1, 2022. HHS will also allow issuers that empower and incentivize consumers through plans that include provisions encouraging consumers to shop for services from lower-cost, higher-value providers, and that share the resulting savings with consumers, to take credit for such “shared savings” payments in their medical loss ratio (MLR) calculations. HHS will allow this to ensure that issuers would not be required to pay MLR rebates based on a plan design that would provide a benefit to consumers that is not currently captured in any existing MLR revenue or expense category. HHS believes this change will preserve the statutorily-required value that consumers receive for coverage under the MLR program, while encouraging issuers to offer new or different value-based plan designs that support [FN32] competition and consumer engagement in the healthcare market. © Copyright Thomson/West - NETSCAN's Health Policy Tracking Service [FN2] . “In Passing Bill to Lower Drug Prices, House Delivers on Major Promise to the American People, Says CAP's Neera Tanden,” December 12, 2019, available at: https://www.americanprogress.org/press/statement/2019/12/12/478696/statement-passing-bill-lower- drug-prices-house-delivers-major-promise-american-people-says-caps-neera-tanden/. [FN3] . “House Bill Could Lower Patients' Prescription Drug Spending by Thousands of Dollars,” Nicole Rapfogel, Maura Calsyn, and Emily Gee, December 9, 2019, available at: https://www.americanprogress.org/issues/healthcare/news/2019/12/09/478380/house-bill-lower- patients-prescription-drug-spending-thousands-dollars/. [FN4] . James C. Robinson, “Physician and Patient Adjustment to Reference Pricing for Drugs, JAMA, February 5, 2020, available at: https:// jamanetwork.com/journals/jamanetworkopen/fullarticle/2760028. [FN5] . “New Study: Medicaid Managed Care Saves Billions on Prescription Drugs for Taxpayers Every Year,” February 24, 2020, available at: https://www.ahip.org/new-study-medicaid-managed-care-saves-billions-on-prescription-drugs-for-taxpayers-every-year/. [FN6] . “Mako Medical Caps Pharmacy Cost for Over 300 Medications,” February 7, 2020, available at: https://www.newswire.com/news/ mako-medical-caps-pharmacy-cost-for-over-300-medications-21091870. [FN7] . Sarah Foster, “Survey: As coronavirus spreads, nearly 1 in 3 Americans admit to not seeking medical care due to cost,” March 12, 2020, available at: https://www.bankrate.com/surveys/health-care-costs/. [FN8] . Alex Keown, “Insulin Makers Eli Lilly, Novo Nordisk and Sanofi Provide Low-Cost Options for Patients During COVID-19 Outbreak,” Biospace.com, April 8, 2020, available at: https://www.biospace.com/article/eli-lilly-sanofi-offer-low-cost-insulin-assistance-programs-to- diabetes-patients-during-pandemic/. [FN9] © 2021 Thomson Reuters. No claim to original U.S. Government Works. -17- . Rachel Fehr, Cynthia Cox, Karen Pollitz, Jennifer Tolbert, Juliette Cubanski, “Five Things to Know about the Cost of COVID-19 Testing and Treatment,” May 26, 2020, available at: https://www.kff.org/coronavirus-covid-19/issue-brief/five-things-to-know-about-the- cost-of-covid-19-testing-and-treatment/. [FN10] . “RxSaver Finds Over Half of Americans' Mental Health Has Been Negatively Affected by COVID-19,” May 14, 2020, available at: https://starlocalmedia.com/news/state/rxsaver-finds-over-half-of-americans-mental-health-has-been-negatively-affected-by-covid-19/ article_c98159d2-40e9-538d-b2df-60725dc83081.html. [FN11] . Young-Rock Hong, PhD, MPH, “Socioeconomic and Demographic Characteristics of US Adults Who Purchase Prescription Drugs From Other Countries,” JAMA Netw Open, June 24, 2020, available at: https://jamanetwork.com/journals/jamanetworkopen/ fullarticle/2767592?resultClick=3. [FN12] . “An Open Letter from Daniel O'Day, Chairman & CEO, Gilead Sciences Daniel O'Day,” June 29, 2020, available at: https:// stories.gilead.com/articles/an-open-letter-from-daniel-oday-june-29. [FN13] . “Capital Rx Announces Collaboration with Walmart to Expand Prescription Drug Cost Savings.” July 7, 2020, available at: https:// www.businesswire.com/news/home/20200707005098/en/. [FN14] . “PhRMA Statement on the “Buy American” Executive Order,” August 6, 2020, available at: https://phrma.org/Press-Release/PhRMA- Statement-on-the-Buy-American-Executive-Order. [FN15] . “Immediate Announces New Partnership with Prescription Discount Program ScriptSave WellRx,” November 10, 2020, available at: https://www.prnewswire.com/news-releases/immediate-announces-new-partnership-with-prescription-discount-program-scriptsave- wellrx-301168738.html. [FN16] . Tony Hagen, “Azar Says Trump's Drug Price Shake-up Is Working,” November 11, 2020, available at: https:// www.centerforbiosimilars.com/view/azar-says-trump-s-drug-price-shake-up-is-working. [FN17] . “Trump Administration Takes Historic Steps to Lower U.S. Prescription Drug Prices,” December 18, 2019, available at: https:// www.hhs.gov/about/news/2019/12/18/trump-administration-takes-historic-steps-to-lower-us-prescription-drug-prices.html. [FN18] . “Bill to eliminate third-party pharmacy benefit managers could save state millions,” January 24, 2020, available at: http:// www.oksenate.gov/news/press_releases/press_releases_2020/pr20200124c.htm. [FN19] . “Governor signs priority public health bills into law,” March 4, 2020, available at: https://www.governor.state.nm.us/2020/03/04/ governor-signs-priority-public-health-bills-into-law/. [FN20] . Edward Helmore and agencies, “Utah cuts healthcare costs by flying employees to Mexico for prescriptions,” The Guardian, February 11, 2020, available at: https://www.theguardian.com/us-news/2020/feb/11/utah-cuts-healthcare-costs-flying-employees-mexico- prescription-drugs. [FN21] . “Congresswoman Elaine Luria Leads Bipartisan Effort to Reduce Prescription Drug Costs for Military Families and Retirees During COVID-19.” April 13, 2020, available at: https://luria.house.gov/media/press-releases/congresswoman-elaine-luria-leads-bipartisan- effort-reduce-prescription-drug. [FN22] © 2021 Thomson Reuters. No claim to original U.S. Government Works. -18- . “Congresswoman Elaine Luria Co-Leads Bill to Help Our Heroes Access Medicine,” April 28, 2020, available at: https:// luria.house.gov/media/press-releases/congresswoman-elaine-luria-co-leads-bill-help-our-heroes-access-medicine. [FN23] . “Luria looks to help military with lower prescription costs,” 13News Now, April 30, 2020, available at: https://www.13newsnow.com/ article/news/health/luria-looks-to-help-military-with-lower-prescription-costs/291-432c0cb0-8556-4843-a7af-19912752f620. [FN24] . “2020-02 | A Performance Audit of Medicaids Pharmacy Benefit Oversight,” May 2020, available at: https://olag.utah.gov/olag-web/# and https://olag.utah.gov/olag-doc/2020-02.pdf. [FN25] . “Cornyn, Bennet Introduce Bill to Address High Cost of Prescription Drugs for Seniors,” July 1, 2020, available at: https:// www.cornyn.senate.gov/content/news/cornyn-bennet-introduce-bill-address-high-cost-prescription-drugs-seniors. [FN26] . “President Donald J. Trump Is Taking Action to Lower Drug Costs and Ensure That Americans Have Access to Life-saving Medications,” July 24, 2020, available at: https://www.whitehouse.gov/briefings-statements/president-donald-j-trump-taking-action- lower-drug-costs-ensure-americans-access-life-saving-medications/. [FN27] . “PhRMA Statement on Drug Pricing Executive Orders,” July 24, 2020, available at: https://www.phrma.org/Press-Release/PhRMA- Statement-on-Drug-Pricing-Executive-Orders. [FN28] . “Governor Newsom Signs Legislation Advancing California's Fight to Lower Prescription Drug Prices,” September 28, 2020, available at: https://www.gov.ca.gov/2020/09/28/governor-newsom-signs-legislation-advancing-californias-fight-to-lower-prescription-drug-prices/. [FN29] . “Killion Proposes New Concept to Lower Prescription Drug Costs,” September 10, 2020, available at: https:// www.senatorkillion.com/2020/09/10/killion-proposes-new-concept-to-lower-prescription-drug-costs/. [FN30] . “FDA Takes Actions to Help Lower U.S. Prescription Drug Prices,” September 24, 2020, available at: https://www.fda.gov/news- events/press-announcements/fda-takes-actions-help-lower-us-prescription-drug-prices. [FN31] . Debra Flax, “Sen. Killion introduces legislation seeking to lower prescription drug costs,” Pennsylvania Business Report, September 16, 2020, available at: https://pennbizreport.com/news/17605-sen-killion-introduces-legislation-seeking-to-lower-prescription-drug- costs/. [FN32] . “Transparency in Coverage Final Rule Fact Sheet,” October 29, 2020, available at: https://www.cms.gov/newsroom/fact-sheets/ transparency-coverage-final-rule-fact-sheet-cms-9915-f. Produced by Thomson Reuters Accelus Regulatory Intelligence 14-Mar-2021 © 2021 Thomson Reuters. No claim to original U.S. Government Works. -19-