Clinical Insights: August 10, 2021

    Welcome to RxStrategies’ Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy marketplace. Contact us to learn more.

    New Drug Approval

    Nexviazyme® (avalglucosidase alfa-ngpt) Intravenous Infusion – New Orphan Drug Approval – August 6, 2021 – The U.S. Food and Drug Administration approved Genzyme’s Nexviazyme® (avalglucosidase alfa-ngpt) for intravenous infusion to treat patients 1 year of age and older with late-onset Pompe disease. Patients with Pompe disease have an enzyme deficiency that leads to the accumulation of a complex sugar, called glycogen, in skeletal and heart muscles, which cause muscle weakness and premature death from respiratory or heart failure. Normally, glycogen—the stored form of glucose—breaks down to release glucose into the bloodstream to be used as fuel for the cells. <Read More>

    Saphnelo™ (anifrolumab-fnia) Injection – New Drug Approval – August 2, 2021 – AstraZeneca’s Saphnelo™ (anifrolumab-fnia) has been approved in the US for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy. The approval by the Food and Drug Administration (FDA) was based on efficacy and safety data from the Saphnelo™ clinical development programme, including two TULIP Phase III trials and the MUSE Phase II trial. In these trials, more patients treated with Saphnelo™ experienced a reduction in overall disease activity across organ systems, including skin and joints, and achieved sustained reduction in oral corticosteroid (OCS) use compared to placebo, with both groups receiving standard therapy. <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    No new update.

    New/Updated Drug Shortage

    August 09, 2021

    August 06, 2021

    August 05, 2021

    August 04, 2021

    August 03, 2021

    August 02, 2021

    New Drug Recall and Safety Alerts

    Atovaquone Oral Suspension, USP 750 mg/5mL by KVK Tech Inc. – New Voluntary Drug Recall – August 6, 2021 – KVK Tech, Inc., is voluntarily recalling two lots of Atovaquone Oral Suspension, USP 750 mg/5mLto the consumer level. The recall is based on customer complaints of unusual grittiness in the product, which KVK has determined was most probably caused by prolonged exposure of these product lots to extremely cold weather during shipment. Exposure of Atovaquone Oral Suspension to extremely low temperatures, during shipment (the product is required to be protected from freezing temperatures), may result in changes to the effectiveness, appearance, taste and thickness of the liquid. <Read More>

    New Generic/Biosimilar Approval and Launch

    Duexis® (ibuprofen and famotidine) Tablets – New Generic Launch – August 4, 2021 – Alkem Laboratories Ltd. (Alkem) announced the launch of Ibuprofen and Famotidine Tablets (800 mg/26.6 mg) in the United States, following an approval from the United States Food and Drug Administration (US FDA). Ibuprofen and Famotidine Tablets is AB-rated generic therapeutic equivalent version of Horizon Medicines LLC’s Duexis® Tablets, 800 mg/26.6 mg. This is the first generic approval of Duexis® Tablets, 800 mg/26.6 mg by the US FDA. The launch is a subject of ongoing litigation. <Read More>

    Clinical and Pharmacy News

    Laws for Prescription Drug Brokers Could Soon Have Teeth – August 9, 2021 – Buoyed by a major, unanimous U.S. Supreme Court ruling, some states are pressing ahead with efforts to rein in one of the most obscure—but also most potent—players in the prescription drug supply chain. Pharmacy benefit managers, known as PBMs, are the companies that administer the prescription drug programs of health insurance plans. Since appearing in the 1980s, they have grown in influence. Policymakers say PBMs now play an outsize role in determining not only what medications patients can access but also how much patients, pharmacies and health plans pay for those drugs. Many critics insist PBMs are adding substantial costs to the health care system rather than saving it money. And some studies back that assertion up: Ohio, Massachusetts and Michigan have determined that PBMs cost their Medicaid enrollees and state employee health programs hundreds of millions of dollars more than the acquisition costs of medicines. <Read More>

    Amber Specialty Pharmacy Selected by Kadmon to Dispense Rezurock™ (belumosudil) Tablets for Chronic Graft-Versus-Host Disease Patients – August 9, 2021 – Amber Specialty Pharmacy announces that it will begin dispensing Rezurock™ (belumosudil) tablets for chronic graft-versus-host disease (cGVHD) to patients throughout the United States. Rezurock™  is manufactured by Kadmon, headquartered in New York City, New York, and is the first and only FDA-approved small molecule inhibitor of ROCK2, a signaling pathway that modulates inflammatory responses and fibrotic processes. Rezurock™  was approved by the U.S. Food and Drug Administration (FDA) on July 16, 2021, for the treatment of adult and pediatric patients 12 years and older with cGVHD after failure of at least two prior lines of systemic therapy. <Read More>

    Pharmacy Times® Expands Strategic Alliance Partnership Program with the Addition of the American Association of Pharmacy Technicians – August 9, 2021 – Pharmacy Times®, the leading media resource for pharmacists, is delighted to announce that it has added the American Association of Pharmacy Technicians (AAPT) to its Strategic Alliance Partnership program. “We are very grateful for the opportunity to join forces with the first-ever pharmacy technician association,” said Gil Hernandez, vice president of Pharmacy & Healthcare Communications, LLC, publisher of Pharmacy Times®. “As our partnership grows, we look forward to helping AAPT provide leadership, networking opportunities, and continuing education to pharmacy technicians across the United States.” <Read More>

    Experts Say Delta Variant Changing Everything – August 8, 2021 – In mid-June, the 1,100-bed UAB Hospital in Birmingham, Ala., had three active COVID-19 cases. Today, the staff is caring for more than 60 patients with COVID-19, according to Ricardo Franco, MD, an assistant professor of medicine at the University of Alabama at Birmingham. “About 89% of our COVID-19 samples sequenced at the UAB lab are the delta variant, and unvaccinated people account for 97% of COVID hospitalizations at UAB,” Dr. Franco said at a press briefing sponsored by the Infectious Diseases Society of America. <Read More>

    Digital Health Literacy: An Increasingly Important Skill for Both Patients and Providers – August 6, 2021 – Although telemedicine has existed for years, the COVID-19 pandemic has certainly proliferated its use and has brought on more innovative uses of telemedicine to safely provide optimal care. Telemedicine visits with a clinical pharmacist offer many advantages, such as social distancing, flexible scheduling, and the ability to use nonverbal cues to convey understanding—a major limitation of phone visits. Telemedicine also has the ability to help narrow current gaps in health disparities among various populations, including those most financially vulnerable. <Read More>

    New CDC Study: Vaccination Offers Higher Protection than Previous COVID-19 Infection – August 6, 2021 – A study of COVID-19 infections in Kentucky among people who were previously infected with SAR-CoV-2 shows that unvaccinated individuals are more than twice as likely to be reinfected with COVID-19 than those who were fully vaccinated after initially contracting the virus. These data further indicate that COVID-19 vaccines offer better protection than natural immunity alone and that vaccines, even after prior infection, help prevent reinfections. “If you have had COVID-19 before, please still get vaccinated,” said CDC Director Dr. Rochelle Walensky. “This study shows you are twice as likely to get infected again if you are unvaccinated. Getting the vaccine is the best way to protect yourself and others around you, especially as the more contagious Delta variant spreads around the country.” <Read More>

    NIH-Convened Expert Panel Proposes Standardized Definition of Placental SARS-Cov-2 Infection – August 6, 2021 – A panel of experts convened by the National Institutes of Health has recommended standardized criteria to define infection of the placenta with SARS-CoV-2, the virus that causes COVID-19. The panel also offers guidance for the best methods to evaluate placental SARS-CoV-2 infection for research and clinical applications. Their recommendations aim to help streamline research on SARS-CoV-2 infection during pregnancy and ultimately optimize clinical care. <Read More>

    Pharmacies Facing More Payment Denials During Pandemic’s Virtual Audits – August 6, 2021 – Already marred from COVID-19 burnout and years of financial threats, independent pharmacies’ latest woe is pharmacy benefits managers’ shift to virtual audits during the pandemic. Independent pharmacies say the new process allows for significantly more claims to be denied and allege the practice is predatory, Kaiser Health News reported Aug. 6. The number of pharmacy audits conducted in 2020 actually decreased by nearly 14 percent from the previous year, but the overall number of prescriptions reviewed increased by 40 percent, according to data from pharmacy audit assistance service PAAS National. The data showed the number of prescriptions reviewed in September and October increased fourfold from what PAAS reported in previous years. <Read More>

    GoodRx, Surescripts Partner for Drug Price Transparency EHR Integration – August 5, 2021 – GoodRx has partnered with Surescripts to create a clinical decision support EHR integration that enhances prescription drug price transparency. The Surescripts Real-Time Prescription Benefit EHR integration will allow prescribers to provide uninsured patients with drug discount pricing from GoodRx. Patients for whom price information isn’t already available from their pharmacy benefit manager (PBM) or health plan will also be eligible for GoodRx’s discounted prescription drug pricing of up to 80 percent off of pharmacy retail prices. <Read More>

    CHEST Releases New Clinical Guidelines for Management of Venous Thromboembolism – August 5, 2021 – The American College of Chest Physicians (CHEST) recently released new clinical guidelines for venous thromboembolism (VTE) management, “Antithrombotic Therapy for VTE Disease: Second Update of the CHEST Guideline and Expert Panel,” that provides 29 recommendations on 17 Patients, Interventions, Comparators, Outcomes (PICO) questions, four of which have not been addressed previously. This is the second update to the ninth edition of these guidelines. The last full edition of the guideline, “Antithrombotic Therapy and Prevention of Thrombosis 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines,” or “AT9,” was published in 2012 and was last updated in 2016. <Read More>

    Erenumab Monotherapy Shows Sustained Long-Term Efficacy in Patients With Episodic Migraine – August 5, 2021 – In patients with episodic migraine who did not successfully respond to 2 to 4 prior preventive treatments, erenumab (Aimovig®; Amgen, Novartis) was found to have a sustained efficacy as a monotherapy treatment during a period of up to 64 weeks, according to results from the LIBERTY study. Additionally, the investigators observed that the safety of erenumab was consistent with the safety profile found during previous clinical trials. During the study, investigators enrolled 240 patients with episodic migraine who had previously completed the double-blind treatment trial phase (DBTP). In DBTP, patients received either a placebo or erenumab at 140 mg as a monotherapy administered through subcutaneous injections every 4 weeks. <Read More>

    CVS Stops Giving J&J Shot at Most Locations – August 5, 2021 – CVS spokesperson Mike DeAngelis told The Hill Aug. 4 the retail pharmacy chain stopped offering Johnson & Johnson’s COVID-19 shot at most of its pharmacies several weeks ago, and the change “helps us manage our vaccine supply across the chain, both in our pharmacies and clinics.” It’s still offering the shot at almost 1,000 of its MinuteClinic locations in 25 states and Washington D.C., Mr. DeAngelis confirmed to Becker’s, adding the decision to stop offering the shot at most locations is “how we’ve chosen to most efficiently handle the vaccines between our pharmacies and clinics.” CVS is still offering Moderna and Pfizer vaccines. <Read More>

    A Review of FDA-Approved Medications for Chronic Weight Management  – August 5, 2021 – Obesity is a worldwide major public health concern. In the US, approximately 74% of adults are either overweight (BMI 25-29.9 kg/m2) or obese (BMI > 30 kg/m2). Obesity is associated with serious health complications including type 2 diabetes, hypertension, dyslipidemia, and cardiovascular disease. As such, obesity is considered a multi-faceted chronic disease that requires appropriate management. According to the American Association of Clinical Endocrinologists and the American College of Endocrinology, lifestyle modification, consisting of a reduced-calorie diet and physical activity, is the first-line management strategy for overweight and obesity.2 Pharmacotherapy is recommended as an adjunct to lifestyle modifications in patients with a BMI > 30 kg/m2 or in patients with a BMI > 27 kg/m2 in the presence of weight-related comorbidities, such as diabetes, hypertension, and dyslipidemia.2 The recent FDA approval of semaglutide for weight management presents an important advancement in the pharmacotherapy options available to the practitioner as well as to the patient. The aim of this article is to provide a brief overview of the agents that are FDA-approved for chronic weight management. <Read More>

    Persistent COVID-19 Infections in Immunocompromised People May Give Rise to Variants of Concern – August 5, 2021 – In an article in the New England Journal of Medicine, scientists from Fred Hutchinson Cancer Research Center, Johns Hopkins Bloomberg School of Medicine, the U.S. Military HIV Research Program and the Institute for Global Health and Infectious Diseases at the University of North Carolina urged increased attention to persistent COVID-19 infections in immunocompromised people. “The medical community needs to develop more precise guidelines for monitoring, treating and preventing COVID-19 infections in immunosuppressed patients to reduce both the risk to these patients and the potential emergence of variants of concern,” said Dr. Larry Corey, virologist at Fred Hutch, leader of the COVID-19 Prevention Network and corresponding author of the article. <Read More>

    Medication Can be an Expensive Barrier to Care. At Charitable Pharmacies, It’s Free. – August 5, 2021 – In the U.S., those who can’t afford their medications often go without them. Most pharmacies charge for prescription drugs and, unlike hospital emergency rooms, “if you don’t have the money, you get turned away,” said Rusty Curington, the Director of Pharmacy at St. Vincent de Paul Charitable Pharmacy (SVDP) in Cincinnati, Ohio. For some patients, “It’s the choice between I’m going to pay my rent…or I’m going to take my drugs,” he said. Curington works at one of a few hundred charitable pharmacies across the U.S. These pharmacies, which are members of the National Association of Free and Charitable Clinics, provide medication for free to patients who are low-income or uninsured. “I have people who drive an hour to pick up their meds because it’s cheaper than paying for the pharmacy that’s within five minutes,” he said. <Read More>

    New Guidelines for Bacterial Vaginosis Diagnosis and Treatment – August 4, 2021 – The Centers for Disease Control and Prevention (CDC) recently updated their diagnosis and treatment guidelines for sexually transmitted infections (STIs). The updated guidelines included new information regarding the diagnosis and treatment of bacterial vaginosis (BV) in pregnant and nonpregnant women. According to the CDC, BV can be diagnosed via Amsel’s diagnostic criteria or by determining the Nugent score from a vaginal Gram stain. Vaginal Gram stain is the reference standard method for BV diagnosis. It is used to determine the relative concentration of lactobacilli, small gram-negative and gram-variable rods (i.e., G. vaginalis or Bateroides), and curved gram-negative rods (i.e., Mobiluncus) characteristic of BV. <Read More>

    Time to Revamp CDC’s Problematic 2016 Opioid Rx Guideline – August 4, 2021 – The AMA is urging the Centers for Disease Control and Prevention (CDC) Injury Center to revise the CDC’s problematic guideline on opioid prescriptions that has proved devastating for patients with pain. The AMA comments mirror those of a CDC Opioid Workgroup, which was established for the purpose of reviewing draft revisions to the CDC’s 2016 guideline for prescribing opioids. The resulting Opioid Workgroup report outlines the foreseeable misapplication of the guidelines and points to more productive ways to move forward. The report was recently presented to the Board of Scientific Counselors, which voted to endorse it with few amendments. The CDC should remove arbitrary thresholds, restore balance and support comprehensive, compassionate care as it revises the guideline. In comments to the CDC Injury Center’s Board of Scientific Counselors, AMA Board of Trustees Chair Bobby Mukkamala, MD, pointed out that the opioid epidemic is becoming more lethal due to illicitly manufactured fentanyl, fentanyl analogs, heroin, methamphetamine and cocaine. <Read More>

    Angiotensin Receptor Blockers Equally Effective as ACE Inhibitors For Treating Hypertension, May Result in Fewer Adverse Events – August 4, 2021 – Angiotensin receptor blockers (ARBs) and angiotensin-converting enzyme (ACE) inhibitors are equally effective in the treatment of hypertension, but ARBs may be less likely to result in adverse events (AEs), according to a study published in Hypertension. ACE inhibitors are currently prescribed more commonly than ARBs as a first-time blood pressure control medicine despite this difference in AEs, the study authors noted. “In professional guidelines, several classes of medications are equally recommended as first-line therapies. With so many medicines to choose from, we felt we could help provide some clarity and guidance to patients and health care professionals,” said RuiJun Chen, MD, MA, assistant professor in translational data science and informatics at Geisinger Medical Center, in a press release. <Read More>

    Study: Drug Utilization Costs Health Industry $93B A Year, With Patients Bearing Most of the Cost – August 4, 2021 – Drug utilization management such as prior authorization and stricter formularies cost the healthcare industry $93 billion annually, with patients bearing the largest share of the cost, a new study found. The study, published Monday in the journal Health Affairs, found that intense use of drug utilization measures has led to patients spending $35.8 billion a year in cost sharing. “All stakeholders in the U.S. pharmaceutical system would benefit from a de-escalation of utilization management, combining lower drug prices with lower barriers of patient access,” the study said. It found that last year the three largest pharmacy benefit managers excluded 846 drugs from their formularies compared to 109 in 2014, and “one-third of large commercial payers now impose access restrictions on specialty drugs.” <Read More>

    The Effects of COVID-19 on Specialty Prescribing Habits – August 4, 2021 – The remote and virtual way of treating patients is becoming the new norm. Specialty providers have to adapt to provide the most streamlined solutions. COVID-19 has impacted many industries including health care. These impacts were seen in specialty and HUB operations early on, but it has become increasingly apparent that COVID-19’s effects are long-lasting. Patient service providers and specialty pharmacies are facing challenges to facilitate prescribing of specialty medications, knowing that prescribers are looking for new and easy ways to refer their patients for products and services. <Read More>

    How a Pharmacy-led Initiative Helped Texas Health Huguley Hospital Manage Practice Change in the ICU — 4 Takeaways – August 4, 2021 – Best-in-class glycemic management programs successfully manage change and foster continuous improvement which contributes to ongoing excellence. Every organization, however, takes a different approach to executing these programs. During a July webinar hosted by Becker’s Hospital Review and sponsored by Glytec, two experts on glycemic management discussed new technologies and how Fort Worth-based Texas Health Huguley Hospital shifted to a pharmacy-led approach to glycemic management: 1) Jordan Messler, MD, CMO, Glytec, 2) Angela Hodges, PharmD, manager, Diabetes Center of Excellence, Texas Health Huguley Hospital in Burleson. <Read More>

    Nevada to Require Out-of-State Pharmacists that Dispense or Compound for Nevada Patients to Hold a Nevada Pharmacist’s License – August 4, 2021 – If you are a Nevada licensed non-resident pharmacy, you will soon be receiving notification from the Nevada Board of Pharmacy (“Board”) stating that any pharmacist who dispenses or compounds prescriptions for a controlled substance or dangerous drug for a patient located in Nevada will need to be registered with the Board. In a July 22, 2021 opinion letter issued by the Board’s General Counsel, the Board now interprets NRS 639.100(1)(a) to provide that it is unlawful for any person to dispense or compound, or permit to be dispensed or compounded, any drug into the state unless the person “holds the appropriate certificate, license, or permit” required by applicable Nevada law. <Read More>   

    Is Reducing Opioids for Pain Patients Linked to Higher Rates of Overdose and Mental Health Crisis?  – August 3, 2021 – Opioid therapy is complex. In recent years, a rise in opioid-related deaths and changing prescribing guidelines and regulatory policies have led many physicians to reduce daily doses for patients prescribed stable opioid therapy for chronic pain. Some patients have reported that this dose reduction process – called tapering –has been difficult, sometimes involving worsened pain, symptoms of opioid withdrawal and depressed mood. In a study published Aug. 3 in JAMA, a team of UC Davis Health researchers examined the potential risks of opioid dose tapering. Their study found that patients on stable opioid therapy who had their doses tapered had significantly higher rates of overdose and mental health crisis, compared to patients without dose reductions. <Read More>

    CDC Opioid Prescribing Guideline Updates Are in the Works: Will the Changes be Enough? – August 3, 2021 – A look at initial feedback from the Opioid Workgroup on the updated CDC guideline and how some states are making their own opioid prescribing rules. Even before it was released five years ago, the CDC Guideline for Prescribing Opioids for Chronic Pain1 was at the center of controversy, with pain advocates and practitioners fearing that the recommendations would be misconstrued by policymakers as black and white rules with no room for individualized care and professional judgment. In the years since, these fears have often proven to be valid.2 Countless states legislatures and licensing boards have adopted portions of the guideline as law, as opposed to recommendations, and have typically done so in ways that ignore the nuance and flexibility of the underlying guideline in favor of strict dosage ceilings and duration limits never intended by the CDC. <Read More>

    Why Telehealth Visits Shouldn’t Mean Skipping BP Measurement – August 2, 2021 – The nation made gains on adults getting their blood pressure under control, but progress began backsliding a few years before COVID-19 hit and cardiovascular deaths were on the rise. The hard data isn’t in yet for exactly how the pandemic will impact those numbers, according to Kate Kirley, MD, the AMA’s director of chronic disease prevention. But, she told viewers of a recent AMA webinar, “Clinical Case Study: Telehealth for Hypertension,” it is known that patients during the second quarter of 2020—when visits were more likely to be via telehealth—were not having their blood pressure taken during visits as often as they would have in the second quarter of 2019 or 2018. <Read More>

    Telehealth, Enriching Residents During Pandemic – August 2, 2021 – Using video appointments to manage stem cell transplant patients and employing innovative approaches to ensure PGY-1 oncology residents get the most out of their rotations are among the strategies that pharmacists have used to counter challenges brought on by COVID-19. One positive change in health care accelerated by the COVID-19 pandemic that is expected to linger is a transition to telehealth, said Julianna Merten, PharmD, BCPS, BCOP, an ambulatory care pharmacist with Mayo Clinic in Rochester, Minn. <Read More>

    Thrombocytopenia Syndrome Rates Following AstraZeneca COVID-19 Vaccine Dose Comparable to Unvaccinated Population – August 2, 2021 – Rates of thrombosis with thrombocytopenia syndrome (TTS), a rare clotting disorder, following a second dose of AstraZeneca’s COVID-19 vaccine (Vaxzevria®) are comparable to the rate observed in the unvaccinated population, according to data published in The Lancet. The rates reported are 2.3 per million vaccinees after the second dose and 8.1 per million vaccinees after the first dose. The analysis used AstraZeneca’s global safety database, which contains all spontaneously reported adverse events from real-world use of its medicines and vaccines worldwide. The cases of TTS reported globally within 14 days of the first or second dose of the vaccine that were included in the study were up to the cut-off date of April 30. <Read More>

    Skilled Pharms Use Technology Tools to Ensure PN Order Safety – August 2, 2021 – Even with multiple steps in place to improve the safety of parenteral nutrition (PN) prescribing and order reviews, mistakes can occur. That’s why it’s crucial for health systems and long-term care facilities to have skilled pharmacists complete the order review and verification steps for this complex therapy, panelists said during the virtual ASPEN 2021 Nutrition Science and Practice Conference. In one of the largest published data samples on PN interventions, pharmacists who reviewed 37,634 PN prescriptions from 232 hospitals and other customers using Central Admixture Pharmacy Services (CAPS) found 248 PN prescriptions (0.66%) requiring at least one intervention. <Read More>

    340B in the News

    Class-Action Lawsuit Alleges 4 Drugmakers Colluded to Restrict Insulin Sales to 340B Contract Pharmacies – August 5, 2021 – Four major drugmakers colluded when they restricted sales to contract pharmacies of insulin discounted under the 340B program, a new class-action lawsuit alleges. The federal lawsuit filed late last week by Mosaic Health, a New York-based collection of 22 safety net clinics, is the latest legal action over the drugmakers’ moves to restrict 340B contract pharmacy sales. The Biden administration demanded drugmakers reverse the restrictions, but several have sued to continue them. The class-action lawsuit alleges that Sanofi, Eli Lilly, Novo Nordisk and AstraZeneca colluded in the summer of 2020 to restrict offering discounted products to 340B contract pharmacies. <Read More>

    CY 2022 HOPPS Proposed Rule: What Pharmaceutical Manufacturers Need to Know – August 5, 2021 – The Centers for Medicare & Medicaid Services (CMS) has issued its annual proposed rule related to the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems (HOPPS) (the Proposed Rule). Comments on the Proposed Rule are due no later than September 17, 2021… The United States Supreme Court has agreed to hear oral arguments in the case of American Hospital Association, et al. v. Becerra, in which the American Hospital Association has challenged CMS’ authority to issue rulemaking reducing Medicare Part B reimbursement when 340B drug stock is administered to Medicare patients. Depending on the Supreme Court’s ruling, the 340B payment policies addressed in the Proposed Rule could be short-lived. <Read More>