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Report Finds Link Between Pharmacy Reimbursement and Flu Vaccination Rates for Medicaid-Covered Adults The Global Healthy Living Foundation (GHLF) and the IQVIA Institute for Human Data Science recently co-released a report that found a link between pharmacy reimbursement and flu vaccination rates among Medicaid-covered adults in the United States. GHLF and IQVIA Institute for Human Data Science commissioned the report to better understand the correlation between equitable compensation for pharmacists and enhanced vaccination rates for the adult Medicaid population. The report notes that adult Medicaid beneficiaries tend to face “significant disparities in vaccination rates” when compared to individuals with Medicare or commercial insurance coverage. Prior studies have found an 8-11% gap in flu vaccination rates between Medicaid and commercial insurance populations and a nearly 30% difference between Medicaid and Medicare populations. This may be due in part to the fact that, as the report notes, “Medicare payments to vaccine providers are uniformly higher than Medicaid payments.” According to a 2023 survey published in Health Affairs, Medicare reimbursement for flu vaccines administered by physicians was $30, but 38 state Medicaid programs paid physicians less than $15 for administering the same adult flu vaccine. The report pulled state-level provider reimbursement data for flu vaccine supply and administration for Medicaid fee-for-service populations as well as state-level flu vaccination rates in those patient populations, and then reviewed the relationship between the two variables. Additionally, the total reimbursement amount was estimated for each state for office-based physicians and for pharmacies, using publicly available materials related to Medicaid coverage and reimbursement policies for influenza vaccines for adults in all 50 states, plus the District of Columbia. The total reimbursement amount consists of a fee for the vaccine supply as well as a fee for the vaccine administration. For office-based providers, vaccine reimbursement may also include a fee for a billable office visit. The estimated cost of the vaccine was subtracted from the total fees to calculate the estimated total reimbursement amount. Overall, the report found that the state level Medicaid fee-for-service Influenza Vaccination Rate generally ranges from 10% to 30%, with a few outlier exceptions. The estimated total reimbursement amount for physicians and pharmacies varies across states. In the case of pharmacies, this ranges from a reimbursement amount that is lower than the cost of the vaccine supply to a total reimbursement amount of roughly $25. The average reimbursement amount for pharmacies across states is roughly $12. For office-based physicians, the average is around $22.50. The report also found that the estimated total reimbursement amount for pharmacies is significantly and positively associated with the proportion of Medicaid fee-for-service population that received the flu vaccination for the 2022–2023 flu season at a state level, after controlling for other factors such as state per capita income, state education, and total reimbursement amount for providers. Additionally, a $13 increase in Medicaid fee-for-service total pharmacy reimbursement amount for adult influenza vaccination supply and administration was associated with a 5.6% increase in the state vaccination rate for adult Medicaid fee-for-service population. For physician offices, however, total reimbursement amount was not significantly associated with influenza vaccine uptake in adults. Similar results were found when restricting the analysis to only male or only female populations; when restricting the analysis to urban populations (not with rural populations, though); and for Hispanic, White, and Black populations (results not significant for Asian populations). “Pharmacists play a crucial role in immunization efforts in the U.S. and globally; now is the time to ensure state policies adequately compensate pharmacies for vaccine administration,” said study co-author Robert Popovian, PharmD, Chief Science Policy Offer at the Global Healthy Living Foundation (GHLF). “These actions can be a crucial step toward improving vaccination rates for Medicaid enrollees.” “The improved reimbursement for pharmacists to administer the flu vaccine for Medicaid patients is an essential step in addressing health disparities as it pertains to low-income communities where pharmacies are far more accessible than physician offices and where racial and ethnic minorities are overrepresented,” said Dr. Popovian.
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ONC Issues Final Rule on Health Data Technology Updates Recently, the Office of the National Coordinator for Health Information Technology (ONC) Department of Health and Human Services (HHS) published a final rule, Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing. The final rule implements the Electronic Health Record (EHR) Reporting Program provision of the 21st Century Cures Act by establishing new Conditions and Maintenance of Certification requirements for health information technology developers under the ONC Health IT Certification Program and makes updates to certification criteria and standards recognized by the Program. Additionally, the final rule provides enhancements to support information sharing under the information blocking regulations and updates technical standards in the Program to advance interoperability, enhance health IT certification, and reduce burden and costs for health IT developers and users of health IT. The final rule also promotes the responsible development and use of artificial intelligence through transparency and improves patient care through policies that advance standards-based interoperability and electronic health information (EHI) exchange. ONC Health IT Certification Program Updates As noted above, the final rule implements the EHR Reporting Program through new Conditions and Maintenance of Certification requirements for developers of certified health IT, which will provide transparency into the use and benefits of certified health IT. This final rule revises several Program certification criteria, including criteria related to decision support, electronic case reporting, and standards-based application programming interfaces (APIs). One notable change to the Health IT Certification Program is that ONC will no longer maintain an edition naming convention for the health IT certification criteria. The last new edition was released in 2020, which was an update of the 2015 Edition certification criteria. Without editions, all certification criteria within the Health IT Certification Program are renamed to “ONC Certification Criteria for Health IT.” Additionally, ONC may now update individual certification criterion through notice and comment rulemaking. ONC hopes that the adoption of new and revised standards and criteria in this final rule will facilitate interoperability through standardized health information and functionality, which will ultimately lead to better care and health outcomes for patients, all while reducing burden and costs. ONC also hopes that it will make it easier for certified health IT developers to maintain product certification over time. Information Blocking The final rule also implements certain provisions of the Cures Act to improve information sharing—and address information blocking—by providing refined definitions of statutory terms and further identifying practices that are reasonable and necessary and, therefore, do not constitute information blocking. ONC noted that generally, commentors on the draft guidance were supportive of the proposed enhancements and for updating the regulations as time goes on to improve clarity and/or reduce burdens, all while continuing to encourage interoperable access, exchange, and use of electronic health information to the fullest extent allowed. The final rule became effective on February 8, 2024.  Related Stories• View comments • Track comments •
Bipartisan Group of Attorneys General Send Letter to Congress, Urging PBM Reform Recently, the National Association of Attorneys General (NAAG) sent a letter to Congressional leaders, urging the United States Senate and House of Representatives to engage in a meaningful debate and ultimately reform the current practices of pharmacy benefit managers (PBMs). The bipartisan letter notes the urgent need for legislative action to target potential abuses within the PBM industry, with specific focus on three bills currently pending before Congress. The three bills – the DRUG Act (S1542/HR6283), Protecting Patients Against PBM Abuses Act (HR2880), and the Lower Costs, More Transparency Act (HR5378) – are together meant to limit PBMs from excessively increasing drug prices and to mandate steps that would increase the transparency of their practices. The attorneys general believe that the legislation would allow health plans to negotiate more advantageous agreements with PBMs and allow regulators to hold PBMs accountable for their actions. The letter notes that while the original purpose of PBMs was to “protect and negotiate on behalf of employers and consumers after pharmaceutical manufacturers were criticized for overpricing medications,” they have “only made the pharmaceutical market more opaque and have been a cause of rising drug prices.” The attorneys general note that it’s a small number of PBMs that hold a significant portion of the market and “are reaping abundant profits at the expense of the patients, employers, and government payors” that the PBMs were originally intended to help. The letter cites to state legislation that has targeted PBMs, specifically in Ohio and Arkansas, which both passed legislation that prohibits spread pricing – when a PBM charges payors (such as Medicare) more than the PBM pays to the pharmacies that supply the medication and the PBM pockets the difference. While the United States House of Representatives recently passed legislation prohibiting spread pricing, the legislation is still pending a vote in the Senate. The letter goes on to note the importance of federal legislation on the issue, as PBMs often argue that “federal jurisdiction and preemption limit states’ authority to regulate PBMs.” One way the attorneys general believe that PBMs can be reigned in is by requiring PBMs to produce pricing data to health plans and federal and state regulators in a standardized format. They believe this would allow health plans to negotiate better deals with PBMs and would allow regulators to better hold PBMs accountable. The attorneys general also called on the Federal Trade Commission (FTC) to stop the ability of PBMs to “unreasonably raise the price of drugs” and to “require greater transparency.” The FTC has also announced an investigation into PBM practices, as have several Congressional committees (including the House Committee on Oversight and Accountability and the Senate Finance Committee).  Related Stories• View comments • Track comments •
Former Mazor Executive Convicted for Role in Insider Trading Scheme Doron “Ron” Tavlin, former vice president of business development at Mazor Robotics, was recently convicted for his involvement in an insider trading conspiracy involving nonpublic negotiations. According to evidence presented at his trial, Tavlin learned of material, non-public information about Medtronic, Inc.’s possible acquisition of his company, Mazor Robotics. Tavlin provided this information to his friend, Afshin Farahan, and told him to keep the information secret. Farahan knew that the acquisition of Mazor by Medtronic would likely result in an increase to Mazor’s stock price and therefore used the non-public information to quickly purchase more than $1 million of Mazor stock in August and September 2018. Then, on September 21, 2018, the morning after the acquisition was announced, Farahan sold all the stock he had purchased in recent weeks, resulting in a combined profit of more than $500,000 for himself and one other individual (discussed below). After Mazor was acquired by Medtronic, Tavlin learned that the Financial Industry Regulatory Authority (FINRA) was investigating trades of Mazor securities that were made prior to the publicly announced acquisition. Through that inquiry, FINRA asked Tavlin (and others) whether he knew any of the parties who traded in Mazor securities leading up to the public acquisition announcement. In January 2019, Tavlin responded by falsely saying he did not recognize any names on the list of persons who had purchased Mazor securities – including Farahan. Evidence presented at trial showed an agreement between Tavlin and Farahan that Farahan would pay Tavlin in exchange for the non-public information. In October 2019, Farahan gave $25,000 to Tavlin, in exchange for the information Tavlin provided about Mazor prior to the acquisition. Following a nine-day trial before United States District Judge Donovan W. Frank, Tavlin was found guilty on one count of conspiracy to commit insider trading and ten counts of securities fraud and aiding and abetting securities fraud. Farahan previously pled guilty to one count of conspiracy to engage in insider trading. Sentencing for both Tavlin and Farahan will take place at some point in the future. Third Individual – Not Found Guilty A third individual was involved as well, David Gantman. Gantman allegedly received the information from Farahan regarding the planned acquisition of Mazor and purchased substantial amounts of Mazor stock in anticipation of the acquisition. Gantman also allegedly sold all of his Mazor stock on September 21, 2018, and saw a profit from his actions. He was found not guilty on one count of conspiracy to commit insider trading and six counts of securities fraud.  Related Stories• View comments • Track comments •
Endo Reaches $465 Million Bankruptcy Settlement with United States Recently, it was announced that Endo Health Solutions, Inc. will pay up to $465 million to settle the United States’ law enforcement, tax, and health care cost claims, over the course of ten years. The settlement resolves criminal and civil settlements over its sales and marketing practices for its opioid drug, Opana ER with INTAC. Endo International and several of its affiliates (including Endo Health Solutions, Inc) started Chapter 11 bankruptcy proceedings in August 2022. One critical component to the resolution is that Endo would cease to function in its current form and would not emerge from the bankruptcy. Additionally, Endo’s affiliates have agreed to a Voluntary Operating Injunction that restricts opioid marketing and sales and would require Endo to turn over millions of documents connected to its role in the opioid crisis for publication in a public online archive. The settlements are subject to the approval of the United States Bankruptcy Court in the Southern District of New York. Criminal Plea One part of the settlement involves an plea agreement and admission from Endo that from April 2012 through May 2013, certain Endo Health Solutions sales representatives marketed Opana ER to prescribers by promoting the drug’s purported abuse deterrence, tamper resistance, and/or crush resistance, despite a lack of clinical data supporting those claims. The approved labeling for the drug did not provide adequate information for health care providers to safely prescribe Opana ER for use as an opioid that is abuse deterrent, and therefore, according to the plea agreement, Endo was responsible for the misbranding of Opana ER by marketing the drug with a label that failed to include adequate directions for its claimed abuse deterrence use, in violation of the Federal Food, Drug, and Cosmetic Act. Opana ER was withdrawn from the market voluntarily by Endo in 2017. Civil Settlement The civil settlement resolves allegations that from 2011 to 2017, Endo used a marketing scheme that targeted health care providers that the company knew were prescribing Opana ER for non-medically accepted indications. As less than 10% of all Opana ER prescribers wrote more than half of all Opana ER prescriptions, Endo allegedly focused its marketing on the health care providers who prescribed the highest levels of opioids and Opana ER. When certain Endo employees raised concerns about these tactics, Endo allegedly ignored or minimized the concerns and continued with their targeted marketing efforts. Additionally, Endo allegedly partnered with a consulting company to “drive incremental growth” of Opana ER prescriptions via a “sales force blitz,” in which 3,000 priority targets were added to its sales representatives’ call lists, with nearly all of those targets chosen for their high volume of opioid prescribing (or high volume of Opana ER prescribing). Endo allegedly used sales goals and contests to ensure sales representatives targeted these prescribers, which included some prescribers who were previously excluded from Endo’s call lists due to risks of abuse and diversion. Bankruptcy Settlement The bankruptcy settlement allows a group of Endo’s secured lenders to purchase Endo’s assets and operate the business under a new corporate structure. The new business will then pay the $364.9 million to the United States over the course of 10 years. It encompasses not only the claims from the criminal and civil settlements, but also tax claims and claims of various federal agencies (including the Defense Health Agency, the Office of Personnel Management, and the Department of Veterans Affairs). Under the settlement, the new company will not be permitted to acquire any unused tax credits or other beneficial tax attributes of Endo and the new company will also be required to fund voluntary trusts in settlement of opioid-related claims against Endo – including public trusts that will pay more than $450 million to state, local, and Tribal entities to fund programs to help solve problems created by the opioid crisis. Up to $450 million of those payments can be credited against the agreed-upon forfeiture amount. Tax Settlement The United States Internal Revenue Service (IRS) filed significant tax claims against Endo in the bankruptcy proceeding, based on ongoing audits. The audits included concerns about Endo’s valuation of assets that were transferred to foreign affiliates and its payment of a large loan pre-payment penalty to a foreign affiliate for which it sought a tax deduction. Federal Health Care Agencies Several federal health care agencies also asserted claims in the bankruptcy proceeding, including Centers for Medicare and Medicaid Services (CMS), Indian Health Service, and the Department of Veterans Affairs. These claims stemmed from medical care provided to individuals who used Opana ER and other opioids manufactured and sold by Endo that suffered from opioid-use disorder as a result. Statements “Chapter 11 is an important tool for businesses to preserve value for their stakeholders. Bankruptcy protections are not a free pass to evade responsibility for criminal misconduct, civil fraud, or taxes,” said U.S. Attorney Damian Williams for the Southern District of New York. “Today’s settlement ensures that Endo takes responsibility for its past misconduct, pays its federal debts, helps abate the nation’s opioid crisis by funding evidence-based treatment programs at the state and local level and distributes payments to individuals harmed by the opioid epidemic.” In a statement regarding the settlement, Endo notes that “Since 2013, Endo has proactively strengthened its U.S. compliance program, including by adopting new policies, enhancing others and developing additional training and risk management procedures. In addition, as part of its restructuring proceedings, the Company agreed to a Voluntary Operating Injunction in November 2022 that continues through August 2030. The Company remains committed to operating with integrity and maintaining a culture of compliance and ethics. The DOJ resolutions do not subject post-emergence purchaser entities to additional compliance-related or integrity obligations.”  Related Stories• View comments • Track comments •
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