The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from August 17 – August 23.  Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.

NON-CORONAVIRUS LEGISLATIVE UPDATE

Senate 

  • The Senate is currently scheduled to return to DC after Labor Day.

House

  • On August 16, Speaker Nancy Pelosi (D-CA) called House members to return to DC to vote on the Delivering for America Act on August 22, which would fund postal services during COVID-19 and prohibit the U.S. Postal Service (USPS) from implementing any changes to operations or level of service it had in place on January 1, 2020. There is some concern that a lack of support for the USPS may impact mail-order prescription drugs, a delivery method that has increased during COVID-19 and that veterans and rural communities disproportionately rely on; however, industry leaders have not seen delays. On August 18, Postmaster General Louis DeJoy delayed pending changes and USPS initiatives until after the November election.

  • On August 17, Energy & Commerce Chairman Pallone, Health Subcommittee Chairwoman Anna Eshoo (D-CA), and Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO) launched an investigation regarding delays in mail-order medications. The Energy & Commerce chairs requested information from CVS Health, Express Scripts, the National Association of Chain Drug Stores, OptumRx, the Pharmaceutical Care Management Association, Rite Aid, and Walgreens. On August 19, Sens. Elizabeth Warren (D-MA) and Bob Casey (D-PA) announced a similar investigation and requested information from some of the same companies plus Cigna, Humana, UnitedHealth, and OptumHealth. On August 20, Kaiser Family Foundation (KFF) released a report estimates that 14 million Medicare Part D enrollees and large employer plans relied on mail-order pharmacies for at least one prescription in 2018. 

NON-CORONAVIRUS REGULATORY UPDATE

  • On August 17, Centers for Medicare & Medicaid Services (CMS) resumed Medicare Administrative Contractor (MAC) fee-for-service medical review activities and State Survey Agencies safety and survey inspections, including onsite revisit surveys, nonimmediate jeopardy complaint surveys and annual recertification surveys. Reviews and inspections were put on hold due to the COVID-19 Public Health Emergency (PHE). MACs will resume post-payment reviews of items/services provided before March 1, 2020. 

  • On August 17, CMS updated the Toolkit on State Actions to Mitigate COVID-19 Prevalence in Nursing Homes to assist nursing homes in meeting the needs of nursing home residents during COVID-19 PHE. This includes actions and best practices by organizations, state governments nationwide, and U.S. territories.

  • On August 17, National Institute of Allergy and Infectious Diseases launched the Keep Up The Rates campaign to encourage Americans to receive recommended vaccines that may have been delayed during COVID-19. 

  • On August 18, CMS released updated frequently asked questions for the Medicare Diabetes Prevention Program Expanded Model PHE flexibilities. 

  • On August 18, the Department of Justice filed a False Claims Act complaint against Teva Pharmaceuticals for illegally paying Medicare co-pays for their multiple sclerosis treatment, Copaxone, in violation of the Anti-Kickback Statute. 

  • On August 18, the U.S. Department of Health and Human Services (HHS) announced a 10-year plan to address public health priorities and challenges entitled Healthy People 2030. The plan includes 355 objectives addressing a variety of health conditions and behaviors, populations, settings and systems, and social determinants of health. 

  • On August 18, the Food and Drug Administration (FDA) released guidance entitled Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank: Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff. The goal of this guidance is to increase transparency for clinical trials by enforcing fines of up to $10,000 for failing to register studies, not reporting results to a government database, submitting false information, and other measures. 

  • On August 19, HHS issued an amendment to the Declaration under the Public Readiness and Emergency Preparedness (PREP) Act to increase access to vaccines and decrease the risk of vaccine-preventable disease for children, due to the drop of vaccination rates for children during the COVID-19 PHE. This temporary emergency directive lifts current restrictions and allows pharmacists and supervised interns to vaccinate children. 

  • On August 19, HHS announced that the FDA will not require laboratory developed tests to be reviewed before they are released for market use. HHS determined that the FDA lacks authority to regulate lab-developed tests for any condition, including COVID-19. Lab-developed tests that do not receive FDA approval are not eligible for PREP Act coverage. On August 20, Chairman Pallone released a statement expressing concern that the lack of FDA regulation will lead to inaccurate testing, undermining overall COVID-19 testing efforts. 

  • On August 19, the FDA released industry guidance entitled Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers. This document addresses questions about regulatory and policy issues, including inspections, pending drug applications, and changes in manufacturing facilities for approved pharmaceutical products.

  • On August 20, CMS released preliminary Medicaid and Children's Health Insurance Program enrollment data for May. The data shows that most states saw increases in enrollment and, overall, enrollment in these programs has increased by 2 million since the beginning of the COVID-19 PHE. 

  • On August 21, the Federal Emergency Management Agency (FEMA) will cut funding to 75% for National Guard COVID-19 response activities in most states, leaving the states to fund the remaining 25% until the end of 2020. Florida and Texas are exceptions, with FEMA continuing to provide 100% funding for National Guard activities through 2020. ArizonaCalifornia, and Connecticut received exemptions to funding cuts on a shorter timeline, with FEMA continuing to provide 100% funding for National Guard activities through September 30.

  • CMS updated the Appropriate Use Criteria (AUC) Program and announced that the Educational and Operations Testing Period has been extended through CY2021. CMS also announced that there will be no payment consequences associated with the AUC program during CY2020 and CY2021.

  • HHS is rumored to announce the Modernizing Public Health Reporting and Surveillance Project, a multi-year pilot program to improve public health data reporting for state and local health departments. This program focuses on automating the collection and reporting of public health data. Cost projections for this project have not yet been released. 

  • HHS Chief Information Officer Jose Arrieta will be stepping down from his position at the Agency early next month, where he has worked since April 2019. HHS has not announced who will take over this position.

CORONAVIRUS UPDATE  

Legislative

  • On August 17, Reps. Lauren Underwood (D-IL), Kim Schrier (D-WA), Kathy Castor (D-FL), and Ann McLane Kuster (D-NH) introduced H.R. 8061, Community Immunity During COVID-19 Act, which would direct HHS to issue grants to state and local health departments to increase recommended immunizations, including a potential COVID-19 vaccine. The bill includes $560 million for health departments to conduct campaigns and outreach.

  • On August 17, 61 Democratic House members called for a national vaccination distribution plan and asked how HHS will target high-risk populations, raising concerns of health equity. 

  • On August 18, Senate Majority Leader Mitch McConnell (R-KY) introduced the Delivering Immediate Relief to America’s Families, Schools and Small Businesses Acta $500 billion COVID-19 relief bill similar to the previously introduced Health, Economic Assistance, Liability Protection and Schools (HEALS) Act. This new package includes funding for unemployment benefits, the Paycheck Protection Program, USPS, education, the provider relief fund, and testing and liability protections. However, Majority Leader McConnell has expressed doubt on whether a relief package would pass at all. Speaker Pelosi indicated House Democrats would be willing to reduce the $3 trillion H.R. 6800 Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act in order to get a relief package passed and then revisit additional aid after the funding deadline in January. Some House Democrats, including the Blue Dog Coalition, are calling to vote on pandemic relief measures August 22, when the House returns to vote on funding for the USPS, but Speaker Pelosi indicated there would not be a relief vote this weekend. Sen. Tim Kaine (D-VA) predicted that the Senate will work towards a pandemic relief deal after the Republican National Convention.

  • On August 18, Democrats from the House Budget Committee highlighted how state and local government revenues have been negatively affected by COVID-19 and the additional expenses they have incurred. The letter pushes for more state and local aid and for the passage of the HEROES Act. 

  • On August 19, House Energy & Commerce Chair Pallone, Health Subcommittee Chair Eshoo, and Oversight and Investigations Chair DeGette requested that the Government Accountability Office review the changes to COVID-19 hospital reporting systems and data, including the transition from reporting to the Centers for Disease Control and Prevention (CDC) to reporting to HHS. 

  • On August 19, Sens. Warren, Tina Smith (D-MN) and Chris Murphy (D-CT) requested information from HHS and the CDC regarding guidance on collecting and reporting COVID-19 data for universities and identifying what mitigation strategies work.

White House

  • On August 19, White House Coronavirus Task Force coordinator Deborah Birx recommended that universities do entrance COVID-19 testing and set up “surge” testing to reduce community spread. 

  • On August 22, President Trump tweeted at FDA Chief Stephen Hahn that the FDA was making it “very difficult” for drug manufacturers to enroll patients in clinical trials for COVID-19 vaccines and therapies as part of a “deep state” conspiracy to hinder his re-election prospects: “The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!”

  • On August 23, President Trump held a press conference announcing that the FDA has issued an EUA for the use of blood plasma as a possible COVID-19 treatment.  The announcement comes less than a week after officials at the National Institutes of Health intervened to stop the FDA from issuing the EUA, due to insufficient evidence. 

Regulatory

  • On August 17, the FDA announced equipment and software issues with Thermo Fisher’s TaqPath genetic test for COVID-19 that results in false positives. This test is used for COVID-19 screening globally. The FDA advised that labs better adhere to testing instructions and required Thermo Fisher to update the testing platform. 

  • On August 17, CMS updated the COVID-19 Policies for Inpatient Prospective Payment System (IPPS) Hospitals, Long-Term Care Hospitals (LTCHs), and Inpatient Rehabilitation Facilities (IRFs) due to Provisions of the CARES Act so that IPPS hospitals address potential Medicare program integrity risks, effective September 1, 2020. The guidance requires a positive COVID-19 test to be documented in the patient’s medical record to receive the 20% increase in hospital payment rates for COVID-19 patients, as mandated by the CARES Act.  The guidance also includes a warning that CMS may conduct post-payment medical review to confirm a positive COVID-19 test on record and additional payments will be recouped if a patient’s medical record does not include a test. 

  • On August 18, HHS Assistant Secretary for Health Brett Giroir announced 3,600 antigen test machines have been distributed to nursing homes. HHS predicts that every U.S. nursing home will receive an antigen test machine by mid- to late-September.

  • On August 18, the FDA granted an Emergency Use Authorization (EUA) for LumiraDx UK Ltd.’s point-of-care COVID-19 antigen test. 

  • On August 20, the Health Resources and Services Administration awarded over $35 million to 59 organizations as part of the fiscal year 2020 Rural Health Communities Awards to increase access to high quality care in rural communities. This funding will go towards expanding telehealth, strengthening the health care workforce in rural areas, supporting rural hospitals, and other initiatives. 

  • On August 20, HHS Office for Civil Rights (OCR) reached a resolution over Utah’s crisis standards of care guidelines to protect against age and disability discrimination. The resolution concluded that Utah hospitals and providers cannot set blanket “do not resuscitate” orders because of limited resources. This is OCR's seventh resolution with a state regarding discrimination concerns during COVID-19.

  • On August 20, HHS applied priority rated orders via the Defense Production Act for contracts with Becton Dickinson and Quidel Corporation to acquire COVID-19 testing diagnostic systems and assays and expedite shipments to nursing homes. 

  • CMS is rumored to issue a mandate for hospitals to report certain data to HHS in the coming weeks. This rule aims to improve COVID-19 data reporting in order to better respond to community and hospital needs. Hospitals currently submit certain information to the HHS Project or to their state health department to inform supplies distribution and other federal action, but it is not a federal requirement. 

  • The FDA will hold its first coronavirus vaccine advisory meeting on October 22.

  • COVID-19 information released by CMS is posted here; specific waivers are available here.

Other

  • On August 17, the Committee for a Responsible Federal Budget released a website to track federal COVID-19 funding. 

  • On August 17, Novavax, Inc. began Phase 2b clinical trial of the company’s COVID-19 vaccine candidate, NVX-CoV2373, in South Africa. The Bill & Melinda Gates Foundation awarded Novavax a $15 million grant for this trial. Novavax intends to begin Phase II trials in the U.S. and Australia. 

  • On August 18, the Federation of American Hospitals called on Congressional leadership to delay CMS recoupment of payments received under the Medicare Accelerated and Advance Payment Programs to no earlier than April 2021. The letter also requests that Congress and CMS reduce the amount of repayment taken from each Medicare claim during repayment from 100% to 25% and waive or limit the interest rate on the loans. 

  • On August 18, the World Health Organization called for wealthier countries to not hoard COVID-19 vaccines and personal protective equipment (PPE) for their own citizens and prevent “vaccine nationalism” through “appropriate and fair” global vaccination distribution. 

  • On August 19, Roche and Regeneron announced a partnership to develop, manufacture, and distribute Regeneron’s COVID-19 antiviral antibody treatment, REGN-COV2. The partnership is expected to increase supply of the treatment to at least three and a half times the current capacity. REGN-COV2 is currently in two Phase II/III clinical trials for the treatment of COVID-19 and a Phase III trial for the prevention of COVID-19. Regeneron will be responsible for distribution inside the U.S and Roche will be responsible for distribution outside the U.S. 

  • On August 20, Massachusetts General Mucosal Immunology and Biology Research Center published a study in the Journal of Pediatrics concluding that children can carry high viral load levels of COVID-19 even if they present milder or a lack of symptoms. 

  • On August 20, a report from IllumiCare found that average drug costs for hospitalized COVID-19 patients was $1,090 in July, a decrease from $3,011 in May, according to data from more than 50 hospitals. The report hypothesizes that this decrease is due to providers having more information on how to care for COVID-19 patients, EUAs for drugs that improve recovery time, and reduced use of ventilators. Some experts are concerned that costs will increase as the use and prices of remdesivir and tocilizumab, two drugs increasingly used for treating COVID-19, increase. 

  • On August 20, Pfizer and BioNTech released data from the company’s Phase I clinical trial indicating that their second COVID-19 vaccine, BNT162b2, generated a similar immune response to the company’s original vaccine, BNT162b1, but presented fewer side effects. Pfizer and BioNTech are currently conducting a Phase II/III clinical trial on BNT162b2. 

  • On August 20, KFF and the Peterson Center on Health Care published a brief entitled Cost-Sharing Waivers and Premium Relief by Private Plans in Response to COVID-19. The report estimates that across all individual and fully-insured group plans, 88% of enrollees are in a plan that has at some point during the pandemic waived out-of-pocket costs for COVID-19 treatments.  The report also estimates 11% of the individual market enrollees and 27% of fully-insured group market enrollees have insurers that offer premium payment relief. Many cost-sharing waivers expire in the coming months. This analysis does not include individuals with self-insured plans through their employers. 

  • On August 20, Janssen, a subsidiary of Johnson & Johnson (J&J), is expected to begin a Phase III COVID-19 clinical trial with 60,000 people in September. This will be the largest late-stage COVID-19 trial so far and Janssen anticipates that the vaccine, Ad26.COV2.S, will be available in early 2021. 

  • On August 20, HealthAffairs published a study entitled Severe Staffing And Personal Protective Equipment Shortages Faced By Nursing Homes During The COVID-19 Pandemic. This study found that more than one in five nursing homes report a severe shortage of PPE and any shortage of staff.  The study found no significant improvement in shortages from May to July. 

  • On August 20, the Gamaleya Research Institute announced that the Russian experimental COVID-19 vaccine, coined “Sputnik-V,” will begin a 40,000 person Phase III clinical trial. Data has not been released from previous trials. 

  • As of August 22, the U.S. had 5,645,697 US confirmed COVID-19 cases resulting in 175,817 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center

RULES AT THE WHITE HOUSE OMB

Pending Review

HHS-CMS

  • Conditions for Coverage for End-Stage Renal Disease Facilities-Third Party Payments (CMS-3337-P); Received 6/6/19

  • International Pricing Index Model for Medicare Part B Drugs (CMS-5528-P); Proposed Rule; Received 6/20/19

  • Medicaid & CHIP Managed Care (CMS-2408-F); Final Rule; Received 9/26/2019

  • Strengthening Oversight of Accrediting Organizations (AO) and Preventing AO Conflict of Interest, and Related Provisions (CMS-3367); Proposed Rule; Received 2/18/20

  • Specialty Care Models to Improve Quality of Care and Reduce Expenditures (CMS-5527); Proposed Rule; Received 3/10/20

  • Payment Policies for Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) (CMS-1738); Proposed Rule; Received 4/28/20

  • Advance Notice of Methodological Changes for CY2022 for Medicare Advantage Capitation Rates and Part C and Part D Payment Policies – Part I, CMS-HCC Risk Adjustment Model; Notice; Received 7/17/20

  • Modernizing and Clarifying the Physician Self-Referral Regulations (CMS-1720); Final Rule; Received 7/21/20

  • Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and fiscal year (FY) 2021 Rates (CMS-1735); Final Rule; Received 8/3/20

  • Clinical Laboratory Improvement Amendments and Patient Protection and Affordable Care Act; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (CMS-3401); Interim Final Rule; Received 8/10/20

HHS-FDA

  • Annual Summary Reporting Requirements Under the Right to Try Act; Proposed Rule; Received 3/31/20

HHS-OCR

  • HIPAA Privacy: Changes To Support, and Remove Barriers to, Coordinated Care and Individual Engagement; Received 7/31/20

HHS-OIG

  • Revisions to the Safe Harbors Under the Anti-Kickback Statute and Beneficiary Inducements Civil Monetary Penalties Rules Regarding Beneficiary Inducement; Final Rule; Received 7/21/20

HHS-OS

  • COVID-19 Hoarding Prevention Under the Defense Production Act; Interim Final Rule; Received 6/23/20 

REPORTS     

HHS Office of Inspector General (OIG)

  • On August 17, OIG released a report entitled Opioid Use in Medicare Part D Continued To Decline in 2019, but Vigilance Is Needed as COVID-19 Raises New Concerns. OIG has been tracking opioid use in Medicare Part D since 2016. OIG found that about one in four Medicare Part D beneficiaries received opioids in 2019, a decrease from the previous three years, and spending on opioids was $2.8 billion, the lowest in the past 10 years. OIG also found that about 209,000 beneficiaries are receiving medication-assisted treatment for opioid use disorder, an increase of 20% from 2018, and the availability of naloxone has also increased. The report identified 140 prescribers ordered opioids for large numbers of these beneficiaries at serious risk of opioid misuse or overdose. OIG acknowledges that some 2020 reports indicate that overdose deaths are rising in some areas of the country. OIG recommends that CMS closely monitor opioid use and access to treatment. A summary of the report is available here

  • On August 17, OIG released a report entitled Medicare Part B Drug Payments: Impact of Price Substitutions Based on 2018 Average Sales Prices. OIG found that CMS lowered Part B reimbursement for 16 drugs in 2018 and the price-substitution policy saved $4.4 in 2018. OIG identifies that CMS could save an additional $1.7 million per year if CMS expanded the price substitution policy to allow the substitution for drugs that exceeded the five-percent threshold in a single quarter. OIG previously recommended that CMS expand the price-substitution criteria and continues to support this recommendation. CMS does not agree with the recommendation and it will consider further changes as necessary. A summary of the report is available here.

  • On August 17, OIG released a report entitled Comparison of Average Sales Prices and Average Manufacturer Prices: Results for the First Quarter of 2020. OIG found that eight drug codes met CMS’ price substitution criteria in the first quarter of 2020. OIG recommends that CMS determine whether to pursue price substitutions that would limit excessive payments for Part B drugs. A summary of the report is available here.

  • On August 18, OIG released a report entitled Nebraska Claimed Unallowable School-Based Administrative Costs Because of Improper Coding of Random Moment Timestudy (RMT) Responses. OIG found discrepancies in calculations and claims of school-based administrative (SBA) costs for Medicaid reimbursement resulting in $13.2 million in unallowable SBA costs claimed and received by the state during the audit period. OIG found improper oversight of contractors coding RMT responses and assigning participants. OIG recommends that Nebraska refund the improper SBA costs claims to the federal government and strengthen contractor oversight. A summary of the report is available here.

  • On August 18, OIG released a report entitled Medicare Home Health Agency Provider Compliance Audit: Mission Home Health of San Diego, Inc. OIG found that Mission Home Health did not comply with Medicare billing requirements and incorrectly billed Medicare for non-homebound beneficiaries, unnecessary skilled services, claims that were assigned incorrect payment codes, and claims with inadequate documentation. OIG found that Mission Home Health had inadequate procedures to prevent the incorrect billing, resulting in at least $5.9 million in overpayments for the audit period. OIG recommends that Mission Home Health refund overpayments to Medicare and strengthen billing procedures for Medicare claims. Mission Home Health disagreed with the findings and recommendations. OIG revised the original analysis and maintained the original recommendations. A summary of the report is available here

  • On August 19, OIG released a report entitled New Jersey Did Not Ensure That Incidents of Potential Abuse or Neglect of Medicaid Beneficiaries Residing in Nursing Facilities Were Always Properly Investigated and Reported. OIG found that New Jersey did not ensure that nursing facilities always investigated and reported incidents of potential abuse or neglect to the state and there were inconsistencies with documentation. OIG recommends that New Jersey reinforce guidance for nursing facilities abuse or neglect reporting and develop additional procedures for survey site visits. The summary of the report is available here

  • On August 21, OIG released a report entitled Rhode Island's Monitoring Did Not Ensure Child Care Provider Compliance With State Criminal Background Check Requirements at 18 of 30 Providers Reviewed. OIG found that Rhode Island's monitoring did not always ensure provider compliance with State requirements related to criminal background checks, potentially jeopardizing the safety of children. OIG recommends that Rhode Island conduct or renew required criminal background checks for identified individuals without valid background checks, determine whether it is feasible to develop a centralized process to monitor both family homes and child care centers, determine whether it is feasible to increase the ratio of State licensing inspectors to child care providers to meet industry standards, and require the State licensing agency to increase the number of current employees it reviews at all child care centers to ensure compliance with criminal background check requirements. Rhode Island partially agreed with the findings, addressed each recommendation, and identified the actions it has taken or planned to improve compliance. The summary of the report is available here

Congressional Budget Office (CBO)

  • On August 19, CBO released a report entitled An Evaluation of CBO’s Past Revenue Projections. This report is the analysis of annual federal revenue projections since 1982. The report finds that errors in the Administration’s budget-year projections of revenues are similar to CBO projections. CBO found that the agency and the Administration tended to slightly overestimate budget-year revenue projections compared with actual revenue collections, with an average error of 1.2% and 1.7%, respectively, and sixth-year projections, with an average error of 5.6% and 7.4%, respectively. A summary of the report is available here.

  • CBO will release An Update to the Budget Outlook: 2020 to 2030 on September 2, including the latest baseline budget projections. 

UPCOMING HEARINGS

Senate

  • None of note.

House

  • None of note.

OTHER HEALTH POLICY NEWS

  • On August 18, West Virginia Attorney General Patrick Morrisey filed lawsuits against Walmart and CVS for their alleged roles in the opioid epidemic in West Virginia. Morrisey accuses the companies of failing to monitor and report suspicious orders and supplying more opioids than market demand to retail pharmacies. West Virginia filed similar lawsuits against Rite-Aid and Walgreens in June. 

  • On August 18, Pennsylvania issued a standing order allowing community-based organizations to provide naloxone to residents by mail, due to restrictions people are facing with the COVID-19 PHE.

  • On August 19, J&J announced it will acquire Momenta Pharmaceuticals for $6.5 billion in cash. This acquisition will allow J&J’s subsidiary, Janssen Pharmaceutical, to expand into therapies for autoimmune diseases. 

  • On August 19, the Supreme Court released the calendar for November arguments. Notably, the court will consider California v. Texas on November 10, the lawsuit challenging the Affordable Care Act (ACA) minimum-coverage provision and the constitutionality of the entire ACA, one week after the November election. 

  • On August 19, the U.S. District Court of the New York Southern District rejected a motion to dismiss the Federal Trade Commission (FTC) lawsuit against Vyera Pharmaceuticals. The FTC accused Vyera of alleging an anticompetitive scheme to preserve a monopoly for Daraprim, a treatment for toxoplasmosis. 

  • On August 19, a MA insurance broker, MedicareAdvantage.com, published a report finding that more than $1.4 billion was spent on discarded units of drugs in 2017 and 2018. Medicare spent $725 million on discarded drugs in 2018, an increase from $695 million in 2017. The report found that most of this waste was from single-dose vials or containers of medications that include higher doses than are necessary to treat the average patient.

  • On August 20, Tennessee Gov. Bill Lee signed H.B. 8002 the Insurance, Health, Accident bill, which requires commercial insurers to reimburse for telehealth services at the same rate as in-person services and cover remote patient monitoring services covered by Medicare. A summary of the bill is available here

  • On August 20, Arizona Maricopa County Superior Court Judge Pamela Gates ruled that there are not enough valid signatures on the petitions to stop surprise billing and codify the ACA’s protections for preexisting conditions on the State's November ballot. Judge Gates ruled that more than 150,000 of the signatures were invalid for various reasons. 

  • The Democratic National Convention ran from August 17 to August 20. Presumptive Democrat Presidential candidate Joe Biden promised to strengthen the ACA and Medicare but did not mention plans of a public option. The Republican National Committee will run from August 24 to August 27. 

  • According to recent filings in Purdue Pharma’s bankruptcy filings, 49 states and DC claim a total of $2.2 trillion in damages for the company’s role in marketing prescription painkillers, such as OxyContin, while downplaying risks of abuse and overdose. States are also pursuing settlements of $21.14 billion from McKesson, AmerisourceBergen and Cardinal, and $5.28 billion from Johnson & Johnson for their alleged roles in the opioid crisis. 

  • Defense Secretary Mark Esper is rumored to propose $2.2 billion in cuts to the military health system over the next five years to eliminate inefficiencies. Other defense officials and Sen. Doug Jones (D-AL) raised concerns that the proposed cuts may negatively impact military personnel and their families, especially considering the impact of COVID-19. On August 18, President Trump tweeted that he rejected the proposed cuts.