The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from September 21 - September 27. 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
House
On September 21, House Democrats released H.R. 8337, a continuing resolution (CR), to extend government spending until December 11. After initially delaying the vote and further negotiating for the inclusion of trade relief for farmers and nutrition-related provisions, the House passed the bill by a bipartisan vote of 359 to 57. Notably, the estimated $1.6 trillion bill would delay repayment requirements for the Medicare Accelerated and Advance Payment programs emergency loans from The Coronavirus Aid, Relief, and Economic Security Act for one year and give providers 29 months to repay the full amount. The bill would gradually phase in these repayments and reduce the interest on unpaid amounts. The bill also freezes the 2021 Medicare Part B monthly premium at the 2020 amount, plus 25% of the difference between the 2020 amount and the preliminary monthly actuarial rate for 2021. The Senate is scheduled to vote on the spending bill on September 29.
On September 21, the House passed H.R. 1418, the Competitive Health Insurance Reform Act, that would allow federal antitrust enforcement against insurers. The bill was referred to the Senate Judiciary Committee.
On September 21, the House passed 10 health care bills by voice vote, including:
H.R. 4866, the National Centers of Excellence in Continuous Pharmaceutical Manufacturing (NCEs) Act of 2019, to direct the NCE, the Food and Drug Administration (FDA), and the pharmaceutical industry to create a national framework for continuous manufacturing implementation, including supporting additional research and development of this technology, workforce development, standardization and collaborating with manufacturers to support adoption of continuous manufacturing. The bill authorizes $80 million each year from Fiscal Year (FY) 2021 through FY 2025;
H.R. 7574, the Strengthening America’s Strategic National Stockpile Act of 2020, to make improvements to the Strategic National Stockpile (SNS);
H.R. 2271, the Scarlett’s Sunshine on Unexpected Death Act, to require the Centers for Disease Control and Prevention (CDC) to revise the Sudden Unexplained Infant Death Investigation Reporting Form, authorize CDC to award grants to improve the completion of comprehensive death scene investigations for sudden unexplained infant death (SUID) and sudden unexplained death in children (SUDC), to increase the rate of comprehensive, standardized autopsies in cases of SUID and SUDC, and to train medical examiners, coroners, death scene investigators, law enforcement, and health professionals on standard death scene investigation protocols;
H.R. 4995, the Maternal Health Quality Improvement Act of 2019, to create new programs to improve maternal health, including programs to strengthen maternal health quality and access to care in rural areas, programs to address racial and ethnic disparities in maternal health outcomes, and grants to implement best practices in maternal health care and strengthen training programs;
H.R. 3935, the Protecting Patients Transportation to Care Act, to include non-emergency medical transportation in the list of mandatory Medicaid benefits;
H.R. 1646, the Helping Emergency Responders Overcome Act of 2019, to create a CDC data system to capture public safety officer suicide incidences, study successful interventions, authorize grants for peer support behavioral health and wellness programs, and require the development of best practices for addressing post-traumatic stress disorder in public safety officers and educational materials;
H.R. 4564, the Suicide Prevention Lifeline Improvement Act of 2019, to increase funding for the National Suicide Prevention Lifeline program to $50 million each year, from FY 2020 through FY 2022. The bill also directs Health and Human Services (HHS) to establish a plan for maintaining the program and includes a pilot program to research, analyze, and employ various innovative technologies and platforms for suicide prevention;
H.R. 4585, the Campaign to Prevent Suicide Act to direct HHS, in coordination with CDC and the Substance Abuse and Mental Health Services Administration (SAMHSA), to carry out a national suicide prevention media campaign to advertise the new 9-8-8 number, when it becomes effective, raise awareness for suicide prevention resources, and cultivate a more effective discourse on how to prevent suicide. The bill would also provide guidance to TV and social media companies on how to talk about suicide by creating a best practices toolkit;
H.R. 5619, the Suicide Prevention Act to establish two grant programs to prevent self-harm and suicide through expanding surveillance of self-harm and awarding grants to hospital emergency departments for programs to prevent self-harm and suicide attempts among patients after discharge; and
H.R. 5663, the Safeguarding Therapeutics Act to extend the FDA’s administrative destruction authority to medical devices, where the FDA believes such medical devices are adulterated, misbranded or unapproved and may pose a threat to public health.
On September 21, 29 bipartisan Representatives urged House leadership to modify the Qualifying Alternative Payment Models Participant thresholds for accountable care organizations (ACOs), voicing their concern that the thresholds for incentive payments will discourage participation in risk-based models.
On September 24, Speaker Nancy Pelosi (D-CA) proposed a $2.4 trillion COVID relief package, including funding for airlines, schools, unemployment benefits, stimulus checks, and additional funding for states. House leaders referenced that a vote could happen before the October recess.
On September 24, 161 House members sent a bipartisan letter to the Centers for Medicare & Medicaid Services (CMS) and HHS, urging the agencies to continue pay increases for primary care and other office-based specialties and delay or mitigate cuts to the Physician Fee Schedule, while allowing the scheduled increases to go into effect.
On September 29, the House is expected to consider a number of public health bills, including:
H.R. 7496 the COVID PREPARE Act of 2020, to require federal agencies to submit to Congress plans for responding to any resurgence of COVID-19;
H.R. 4764 the TRANSPLANT Act of 2019, to reauthorize the Stem Cell Therapeutic and Research Act of 2005; and
H.R. 2519 the Improving Mental Health Access from the Emergency Department Act of 2020, to Authorize SAMHSA to award grants to qualifying emergency departments for the purpose of supporting mental health services and support follow up services to those with mental health episodes.
The House will remain in session until a relief package is passed, with lawmakers remaining “on call” for a return to Washington.
Senate
On September 22, Sens. Michael Bennet (D-CO) and Susan Collins (R-ME) introduced the Medication Access and Training Expansion Act. This bill would require prescribers of federally controlled substances to complete a training on how to treat and manage patients with opioid and other substance use disorders. Reps. Lori Trahan (D-MA) and Jack Bergman (R-MI) previously introduced a companion bill in the House.
On September 25, Sens. Pat Toomey (R-PA) and Joe Manchin (D-WV) and Reps. Harley Rouda (D-CA) and Markwayne Mullin (R-OK) proposed the Improving Medicaid Programs’ Response to Overdose Victims and Enhancing Addiction Care Act, to mandate states to use the drug utilization review programs to alert prescribers to those who have previously had nonfatal opioid overdoses and better track opioid-related fatalities. The bill would also connect patients who have had an opioid-related overdose within the last five years with treatment options. A summary of the legislation is available here.
The Senate may leave for recess after passing the CR, with lawmakers on call for a possible Supreme Court Justice nomination vote.
The Senate Judiciary Committee will begin its confirmation hearings for Judge Amy Coney Barrett on October 12, with plans for a full Senate vote by October 26. Democratic Leader Chuck Schumer (D-NY) suggested his members focus on the potential striking down of the Affordable Care Act, which the Supreme Court will consider later this year, as the Democrats make their case against Judge Barrett.
NON-CORONAVIRUS REGULATORY UPDATE
On September 21, CMS submitted to the Office of Management and Budget (OMB) the notice entitled Advance Notice of Methodological Changes for Calendar Year (CY) 2022 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies – Part II.
On September 21, CMS concluded a notice for proposed rulemaking entitled Implementation of Executive Order (EO) 13937, “EO on Access to Affordable Lifesaving Medications.”
On September 22, CMS announced the expansion of the Repetitive, Scheduled Non-Emergent Ambulance Transport (RSNAT) Prior Authorization Model nationwide. CMS also released the model’s Second Interim Evaluation Report, finding that the model was successful in reducing RSNAT services and total Medicare spending while maintaining overall quality of and access to care levels.
On September 22, the FDA released a proposed rule entitled Regulations Regarding “Intended Uses” that would reverse a prior FDA rule that required companies to seek new labeling for known unapproved uses. The proposed rule clarifies that if a drug or medical device company is aware of an unapproved use of a product, it is not automatically required to pursue new labeling or additional FDA approval. Comments are due October 22.
On September 22, the FDA launched the Digital Health Center of Excellence as part of the effort to advance digital health technology.
On September 23, HHS announced $2.7 million for four awards under Leading Edge Acceleration Projects in Health Information Technology, to address challenges in interoperable health information technology and advance opportunities for the adoption and use of health IT standards across health care.
On September 23, CMS announced $165 million in supplemental funding to 33 states currently operating Money Follows the Person (MFP) demonstration programs, enabling state Medicaid programs to transition individuals with disabilities and older adults from institutions and nursing facilities to home and community-based settings. Each eligible state may receive up to $5 million in supplemental funding for planning and capacity building activities to accelerate long-term care system transformation design and implementation and to expand Home & Community-based Services capacity. Supplemental budget requests will be accepted through June 30, 2021.
On September 23, CMS released preliminary Medicaid and Children’s Health Insurance Program (CHIP) data, revealing that rates for vaccinations, primary, and preventive services among children in Medicaid and CHIP have steeply declined during the COVID-19 public health emergency. CMS warned that this decline may have significant impacts on long-term health outcomes for this population and called for action to make services more readily available. A fact sheet on the data is available here.
On September 23, the Justice Department announced that Gilead agreed to pay $97 million to resolve claims that the company paid kickbacks using a foundation as a conduit. The settlement determined that Gilead violated the False Claims Act by illegally paying the copays of thousands of Medicare patients taking Gilead’s pulmonary arterial hypertension drug, Letairis.
On September 23, the FDA updated the “Boxed Warnings” requirements to improve safe use of benzodiazepine drug class. The agency updated the requirements to address the risks of abuse, addiction, physical dependence, and withdrawal reactions of this class of drugs.
On September 23, the Health Resources and Services Administration questioned Eli Lilly’s decision to end 340B pricing for drugs obtained through contract pharmacies. HRSA also warned Eli Lilly that it could face potential litigation for violating the 340B program conditions.
On September 24, CMS announced that average 2021 premiums for MA plans are expected to decline 34.2% from 2017 and that many MA plans have expanded benefits. CMS also announced that through the Part D Senior Savings Model, beneficiaries will have over 1,600 MA and Part D prescription drug plans to choose from that will offer insulin at no more than $35 per month, beginning January 1, 2021. Medicare Open Enrollment begins on October 15, 2020, and ends on December 7, 2020.
On September 24, CMS released the Long-Term Care Hospital and Inpatient Rehabilitation Facility Provider Preview Reports and data.
On September 24, the FDA released a final rule entitled the Importation of Prescription Drugs. This rule allows the importation of certain prescription drugs from Canada and allows states, tribes, pharmacists, and wholesalers to submit 2-year plans to the FDA to import certain medications, provided that the importation program will not pose additional risk to the public’s health and safety.
On September 24, the FDA released final guidance entitled Importation of Certain FDA Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act. This guidance provides non-binding recommendations on procedures manufacturers can follow to facilitate importation of prescription drugs, including biologicals, that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country.
NON-CORONAVIRUS WHITE HOUSE UPDATE
On September 24, President Trump signed the EO on An America-First Healthcare Plan, calling to ensure those with pre-existing conditions can obtain health insurance and “maintain and build upon existing actions to expand access to and options for affordable healthcare” by directing the HHS Secretary to accelerate the approval of new generic and biosimilar drugs and facilitate the importation of prescription drugs from abroad. The EO also calls for Congress to pass legislation to end “surprise billing” by December 31, 2020 and if legislation is not passed, for the HHS Secretary to take administrative action to address surprise billing. The EO also calls for the HHS Secretary to promote medical innovations for treatments for COVID-19, Alzheimer’s disease, sickle cell disease, pediatric cancer, and other conditions. A summary of this EO is available here. A presentation of the plan is available here.
During the announcement for the EO, President Trump referenced a plan to send Medicare beneficiaries $200 discount cards for prescription drugs. According to the White House, funding for the discount cards, estimated to cost $6.6 billion, will be drawn from the Section 402 demonstration program and will be offset by future savings generated from the Most-Favored Nations models – that Trump directed by EO on September 13 and have not yet been implemented.
On September 26, President Trump nominated Judge Amy Coney Barrett to fill a vacancy on the U.S. Supreme Court created by the passing of Justice Ruth Bader Ginsburg.
CORONAVIRUS UPDATE
Legislative
On September 22, the Select Subcommittee on the Coronavirus Crisis found that four consultants working on Operation Warp Speed may have conflicts of interest through financial interests with companies supported by the program. The committee Chairman James Clyburn (D-SC) and Ranking Member Steve Scalise (R-LA) also sent a letter to HHS over delays in probes of the CDC and HHS regarding potential political interference in the agencies.
On September 22, nine senators, including Senate Finance Committee Ranking Member Ron Wyden (D-OR) and Senate Health, Education, Labor, & Pensions (HELP) Committee Ranking Member Patty Murray (D-WA), expressed their concerns regarding reports of health insurance companies ending comprehensive coverage of COVID-19 tests without cost-sharing requirements and asked CVS Health and other health insurance companies about their COVID-19 testing policies. Some states, including Tennessee, North Dakota, Oklahoma, Washington, and Georgia, have already taken action to cap costs or more narrowly define what insurers should pay for COVID-19 testing.
On September 23, the Energy & Commerce Health subcommittee held a hearing entitled Health Care Lifeline: The Affordable Care Act (ACA) and the COVID-19 Pandemic. Committee Chairman Frank Pallone (D-NJ) and Subcommittee Chair Anna Eshoo (D-CA) voiced their concern over the pending Supreme Court lawsuit against the ACA and the potential for the entire law to be deemed unconstitutional, leading to loss of health insurance coverage for many Americans. Witnesses included: Aviva Aron-Dine, Vice President for Health Policy, Center on Budget and Policy Priorities; Dean Cameron, Director, Idaho Department of Insurance; Douglas Holtz-Eakin, MD, President, American Action Forum; Peter Lee, Executive Director, Covered California; and Benjamin Sommers, MD, Huntley Quelch Professor of Health Care Economics, Professor of Health Policy & Economics, Professor of Medicine, Harvard T. H. Chan School of Public Health, Brigham & Women's Hospital.
On September 23, the HELP Committee held a hearing entitled COVID-19: An Update on the Federal Response.Chairman Lamar Alexander (R-TN) highlighted the FDA’s standards for COVID-19 vaccines of safety and efficacy and urged preparation for future pandemic. Ranking Member Murrary raised concern with political interference in the vaccine approval process. FDA Commissioner Stephen Hahn reiterated the safety and effectiveness of authorized COVID-19 vaccines. Witnesses included: Anthony Fauci, MD, Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health; Robert Redfield, MD, Director, CDC; Brett Giroir, MD, Assistant Secretary for Health, HHS; and Stephen Hahn, MD, FDA Commissioner.
On September 24, the National Academy of Sciences and National Academy of Medicine raised alarm with the politicization of science and warned of efforts to discredit science and public health. On September 25, a group of professors from Harvard, Yale, Johns Hopkins and other universities urged the FDA to be transparent regarding an Emergency Use Authorization (EUA) for COVID-19 vaccines and also warned of efforts to discredit science and politicization of the vaccine approval process.
Regulatory
On September 21, Government Accountability Office (GAO) released a report entitled COVID-19: Federal Efforts Could Be Strengthened by Timely and Concerted Actions. This report disclosed that the administration reallocated at least $6 billion allocated for the Strategic National Stockpile and the CDC to Operation Warp Speed.
On September 22, the CDC announced that states had to submit plans for distributing COVID-19 vaccines by October 16.
On September 22, the FDA drafted additional guidelines for COVID-19 vaccines EUA requirements, including tracking participants for a median of at least two months after receiving the second vaccine shot and data requirements similar to what is required for full FDA drug approval. This new guidance signals that the U.S. will likely not distribute COVID-19 vaccines before the election. President Trump called the stricter guidelines “a political move” and threatened to reject them. The guidance is currently stalled, with the White House asking for further justification from FDA for the need to issue them.
On September 22, Senate Democrats, led by Democratic Leader Schumer and HELP Committee Ranking Member Senator Murray, introduced the Science and Transparency Over Politics Act, to preserve and promote integrity in scientific decision making at HHS. The bill would create a task force to investigate potential interference in scientific work by the FDA and CDC.
On September 22, the CDC’s Advisory Committee on Immunization Practices delayed recommending priority of a COVID-19 vaccine until committee members are able to learn more about the individual vaccines. The committee agreed to hold an emergency meeting when the FDA authorizes a vaccine to determine vaccine distribution priority, specific to the vaccine and the FDA’s conditions of use. The next meeting is scheduled October 28 and 29. On September 23, Chair Hana El Sahly announced she will step down from the committee, due to potential conflict of interest, as a lead investigator for Moderna’s COVID-19 vaccine trial.
On September 22, HHS awarded Fresenius Kabi $35 million and Baxter Healthcare Corp. $29.9 million to resupply the Strategic National Stockpile with COVID-19 drugs and prepare for future emergencies.
On September 23, the CDC awarded $200 million for 64 state and local jurisdictions to assist in preparing for the COVID-19 vaccine. This is much lower than CDC Director Robert Redfield’s projection that $6 million would be needed to distribute and administer COVID-19 vaccines.
On September 23, the FDA updated summarized evidence in support of the emergency use of COVID-19 convalescent plasma as a treatment for COVID-19.
On September 23, the FDA issued an EUA for Assure’s antibody point-of-care COVID-19 test.
On September 24, CMS released draft guidance for hospitals reporting COVID-19 data including new reporting requirements for daily data on influenza cases. Hospitals risk termination of their Medicare provider agreement if they do not accurately submit data everyday, including weekends, to HHS Protect, the federal COVID-19 data collection system.
On September 24, Energy & Commerce Chairman Pallone, Health Subcommittee Chair Anna Eshoo (D-CA), and Oversight and Investigations Chair Diana DeGette (D-CO) requested that the HHS Office of Inspector General (OIG) open an investigation on potential political interference by the White House and political appointees in CDC work on COVID-19. On September 24, New York Gov. Andrew Cuomo and Michigan Gov. Gretchen Whitmer called for Congress to investigate the White House's response to COVID-19, specifically in HHS and USPS.
On September 25, CMS released new tools to reduce paperwork and authorization delays for laboratories seeking Clinical Laboratory Improvement Amendments certification to test for COVID-19.
White House
No events of note.
Other
On September 22, America’s Health Insurance Plans released a report finding that more than 4% of companies offering workplace insurance could not pay their employee premiums in April and May due to COVID-19. The report also estimated that almost 7.5 million Americans enrolled in commercial health insurance lost their coverage during the same time period.
On September 23, Johnson & Johnson (J&J) launched a Phase III COVID-19 vaccine trial for the company’s vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. The trial will enroll 60,000 volunteers, with the goal of the vaccine being available early 2021 through EUA. J&J is manufacturing the vaccine and projects it will be able to provide one billion doses of a vaccine each year on a not-for-profit basis. The company also released the study protocol, as Moderna, Pfizer, and AstraZeneca have also done.
On September 23, the Russian Direct Investment Fund and ChemRar increased the availability of Avifavir, the Russian COVID-19 treatment, making the drug now available in 23 countries.
On September 24, Novavax launched a Phase III clinical trial for the company’s COVID-19 vaccine candidate, NVX-CoV2373. The trial will enroll 10,000 participants. Novavax projects manufacturing capacity will reach 2 billion annually by mid-2021.
On September 24, New York Gov. Cuomo announced the state will create a Clinical Advisory Task Force to review COVID-19 vaccines authorized by the FDA, due to concerns of political interference in the vaccine approval process.
As of September 25, the U.S. had 7,079,869 confirmed COVID-19 cases resulting in 204,499 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
Payment Policies for Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) (CMS-1738); Proposed Rule; Received 4/28/20
Modernizing and Clarifying the Physician Self-Referral Regulations (CMS-1720); Final Rule; Received 7/21/20
Revisions to Medicare Part A Enrollments (CMS-4194)l Proposed Rule; Received 9/9/20
Transparency in Coverage (CMS-9915); Final Rule; Received 9/11/20
HHS-FDA
Annual Summary Reporting Requirements Under the Right to Try Act; Proposed Rule; Received 3/31/20
Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment; Guidance for Industry; Notice; Received 5/28/2020
HHS-OCR
HIPAA Privacy: Changes To Support, and Remove Barriers to, Coordinated Care and Individual Engagement; Proposed Rule; 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
REPORTS
HHS Office of Inspector General (OIG)
On September 21, OIG released a report entitled Illinois Should Improve Its Oversight of Selected Nursing Homes' Compliance With Federal Requirements for Life Safety and Emergency Preparedness. The report found that Illinois did not ensure that nursing homes that participated in the Medicare or Medicaid programs complied with CMS requirements for life safety and emergency preparedness. OIG identified that deficiencies occurred because the existing life safety training program for nursing home management could not educate all Illinois nursing home management in a timely manner, and the state did not offer an emergency preparedness training program for nursing home management. OIG recommends that Illinois conduct more thorough emergency preparedness reviews for the safety and protection of nursing home residents and staff, correct identified deficiencies, and work with CMS to develop emergency preparedness training and expand life safety training sessions to accommodate all nursing home management. The state agency generally agreed with the findings and recommendations and described actions to address them. A summary of the report is available here.
On September 21, OIG released a report entitled Incorrect Acute Stroke Diagnosis Codes Submitted by Traditional Medicare Providers Resulted in Millions of Dollars in Increased Payments to MA Organizations. Almost all of the selected acute stroke diagnosis codes that physicians submitted to CMS under traditional Medicare and that CMS later used to make payments to MA organizations for 2015 or 2016 did not comply with Federal requirements. These errors resulted in over $14.4 million in inaccurate payments to MA organizations. OIG identified that CMS did not have policies and procedures to identify beneficiaries who transferred from traditional Medicare to MA and evaluate whether the acute stroke diagnosis codes submitted under traditional Medicare on their behalf complied with Federal requirements. OIG recommends that CMS educate physicians on how to correctly submit acute stroke diagnosis codes and implement policies to identify beneficiaries with acute stroke diagnoses transferring from traditional Medicare to MA. CMS agreed with the findings and recommendations and described actions to address them. A summary of the report is available here.
On September 22, OIG released a report entitled North Carolina Should Improve Its Oversight of Selected Nursing Homes' Compliance With Federal Requirements for Life Safety and Emergency Preparedness. The report found that North Carolina did not ensure that all nursing homes that participated in the Medicare or Medicaid programs complied with CMS and State requirements for life safety and emergency preparedness. OIG found that these instances of noncompliance occurred because nursing homes had inadequate management oversight and high staff turnover and North Carolina did not have a standard life safety training program for all nursing home staff. OIG recommends that North Carolina correct identified deficiencies, work with CMS on developing life safety training for nursing home staff and conduct more frequent surveys at nursing homes with a history of multiple high-risk deficiencies. North Carolina agreed with some of the recommendations and findings. A summary of the report is available here.
On September 22, OIG released a report entitled Vermont Did Not Always Invoice Rebates to Manufacturers for Physician-Administered Drugs. The report found that Vermont did not always comply with Federal Medicaid requirements for invoicing manufacturers for rebates for physician-administered drugs, resulting in $483,458 in uncollected rebates. OIG recommends Vermont refund claims and consider invoicing drug manufacturers for rebates for missed claims. Vermont agreed with the recommendations. A summary of the report is available here.
On September 23, OIG released a report entitled CMS Should Pursue Strategies To Increase the Number of At Risk Beneficiaries Acquiring Naloxone Through Medicaid. The report found that access to naloxone for Medicaid beneficiaries has expanded significantly, but Medicaid paid for only 5% of all naloxone distributed in the United States in 2018. The program has been able to recoup a large percentage of its spending on naloxone through statutory rebates paid by manufacturers to Medicaid. OIG recommended that CMS pursue strategies to increase the number of at-risk beneficiaries acquiring community-use versions of naloxone through Medicaid. A summary of the report is available here.
On September 23, OIG released a report entitled Oregon's Oversight Did Not Ensure That Four Coordinated-Care Organizations Complied With Selected Medicaid Requirements Related to Access to Care and Quality of Care. The report found that coordinated care organizations (CCOs) did not comply with federal and state requirements related to provider credentialing and beneficiary grievances and appeals, due to insufficient oversight of, and guidance to the CCOs and their subcontractors. OIG recommended that Oregon provide additional guidance to CCOs on provider credentialing and for beneficiary grievances and appeals and monitoring subcontractors. A summary of the report is available here.
On September 23, OIG released a report entitled Arkansas Medicaid Fraud Control Unit: 2019 Onsite Inspection. The report found that the Arkansas Unit generally complied with applicable legal requirements, but the Unit did not always comply with Federal regulations regarding its fiscal controls. OIG recommended that the Arkansas Unit strengthen fiscal controls, improve its communication and seek more opportunities to investigate joint cases with OIG, and take steps to ensure that its staff reports all convictions and adverse actions to Federal partners within the appropriate timeframes. The unit agreed with the recommendations. A summary of the report is available here.
On September 24, OIG released a report entitled CMS's Monitoring Activities for Ensuring That Medicare ACOs Report Complete and Accurate Data on Quality Measures Were Generally Effective, but There Were Weaknesses That Could Be Improved. The report found that CMS's monitoring activities were generally effective for ensuring that ACOs report complete and accurate data on quality measures through claims and administrative data and the CMS web portal but there were some weaknesses. OIG found that CMS did not always ensure that contractors verified survey vendors' correction of identified issues, provided feedback reports in time, and reviewed survey instruments. OIG recommends that CMS improve its monitoring activities by updating the Statement of Work to require its contractor to verify that survey vendors have corrected identified issues, confirm that all implemented changes to address the identified issues are included in qualified allocation plans before they are approved, and review translated documents to ensure they are consistent with the English versions. A summary of the report is available here.
On September 24, OIG released a report entitled Connecticut Did Not Meet Federal and State Requirements for Claiming Medicaid School-Based Child Health Services for Hartford Public Schools. The report found that State Department of Social Services (DSS) did not claim Federal Medicaid reimbursement for school-based health services submitted by Hartford Public Schools (HPS)in accordance with Federal and State requirements, resulting in estimated that DSS improperly claimed at least $1,522,359 for Medicaid payments made to HPS. OIG recommended refunding the $761,179 for the Federal share of improper Medicaid payments, working with CMS to review other payments, and strengthening oversight of the program. DSS agreed with the recommendations and findings. A summary of the report is available here.
On September 25, OIG released a report entitled States Continued To Fall Short in Meeting Required Timeframes for Investigating Nursing Home Complaints: 2016-2018
GAO
On September 21, the GAO released a report entitled COVID-19: Federal Efforts Could Be Strengthened by Timely and Concerted Actions. The report recommends that the federal government can prepare for the annual season public health issues, including flu season and hurricane season, while improving the federal response to COVID-19 by improving and stabilizing the medical supply chain and stockpiles, establishing a timeline and plan for the distribution and administration of COVID-19 vaccines, ensuring the collection of accurate and complete data, and other measures to promote public safety. A summary of the report is available here.
On September 23, the GAO announced appointments to the Patient-Centered Outcomes Research Institute Governing Board. Appointments include Kate Berry, Tanisha Carino, James Huffman, Connie Hwang, Eboni Price-Haywood, James Schuster, Danny van Leeuwen, and Barbara McNeil.
Congressional Budget Office (CBO)
On September 21, the CBO released a report entitled The 2020 Long-Term Budget Outlook. The report predicts that federal deficits will increase from 5% of gross domestic product (GDP) in 2030 to 13% by 2050, compared to the average deficit of 3% of GDP over the past 50 years. CBO also predicts that by the end of 2020, federal debt held by the public is projected to equal 98% of GDP and will continue to increase, to 104% of GDP in 2021, 107% of GDP in 2023, and to 195% of GDP by 2050. CBO projects the spending as a percentage of GDP rises in CBO’s projections, even after the pandemic. The report also projects that revenues measured as a percentage of GDP will rise. A summary of the report is available here.
On September 25, the CBO released a presentation entitled Estimating the Federal Budgetary Effects of Pandemic-Related Legislation. The presentation updates previous projections to include COVID-19 relief legislation, resulting in a projected deficit increase of $2.4 trillion over 2020-2030.
On September 25, the CBO released a response to Sen. Tammy Baldwin (D-WI) and Chris Murphy (D-CT) request regarding short-term insurance entitled CBO’s Estimates of Enrollment in Short-Term, Limited-Duration Insurance (STLDI). CBO determined that current evidence does not warrant changing expectation that there will be two categories of STLDI plans—those that provide what CBO considers insurance coverage and those that do not
UPCOMING HEARINGS
Senate
None of note.
House
Oversight and Reform Committee
September 30, 10:00 a.m., Cisco Webex
Unsustainable Drug Prices: Testimony from the CEOs (Part I)
Witnesses include: Mark Alles, Former CEO, Celgene Corporation; Giovanni Caforio, MD, CEO, Bristol Myers Squibb; and Kare Schultz, CEO, Teva Pharmaceuticals.
Energy & Commerce Committee
September 30, 11:00 a.m., Cisco Webex
Pathway to a Vaccine: Ensuring a Safe and Effective Vaccine People Will Trust
Witnesses include: Helene Gayle, MD, Co-Chair, Committee on Equitable Allocation of Vaccine for the Novel Coronavirus, National Academies of Sciences, Engineering, and Medicine; Ashish Jha, MD, Dean, School of Public Health, Brown University; Ali Khan, MD, Dean, College of Public Health, University of Nebraska Medical Center; Mark McClellan, MD, Founding Director, Duke-Margolis Center for Health Policy, Duke University; and Paul Offit, MD Director, Vaccine Education Center, Children’s Hospital of Philadelphia.
Oversight and Reform Committee
October 1, 10:00 a.m., Cisco Webex
Unsustainable Drug Prices: Testimony from the CEOs (Part 2)
Witnesses include: Robert Bradway, CEO, Amgen, Inc.; Mark Trudeau, CEO Mallinckrodt Pharmaceuticals; and Thomas Kendris, U.S. Country President, Novartis AG.
Select Subcommittee on the Coronavirus Crisis
October 2, 9:00 a.m., 2154 Rayburn House Office Building
Hybrid Hearing With Secretary Of Health And Human Services Alex M. Azar II
Witnesses include: Alex M. Azar II, Secretary, HHS.
OTHER HEALTH POLICY NEWS
On September 24, a study published in JAMA Network found that the implementation of the ACA was associated with 2 million fewer adults with catastrophic expenditures each year, concentrated in the poorest quartile of people. The report recognizes that 11 million US adults continue to experience catastrophic health expenditures annually, with numbers likely increasing due to loss of employment or unexpected medical care due to COVID-19.