The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from August 3 – August 9. 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
On August 5, Majority Leader Mitch McConnell (R-KY) announced the Senate will be in session the week of August 10 to work on a coronavirus relief package. However, many lawmakers will return to their home states as votes will not occur unless a deal is reached.
On August 5, the Veterans Affairs Committee held a markup to consider pending legislation. The Committee reported the following bills:
S. 2558 the Nursing Home Care for Native American Veterans Act, would support the construction of veteran nursing homes on tribal lands by authorizing the Department of Veterans Affairs (VA) Secretary to make certain grants available for nursing home construction on tribal lands, and
S. 3643 VA Mission Telehealth Clarification Act, would authorize certain postgraduate health care employees and health professions trainees of the VA to provide treatment via telemedicine.
On August 6, Appropriations Chairman Richard Shelby (R-AL) suggested a Continuing Resolution (CR) will likely be needed to fund the government past September 30, as Democrats want to use annual spending bills to advance their priorities, such as pandemic aid and police reform, while Republicans favor a clean bill. Chairman Shelby predicted any potential CR would not be marked-up in Committee. He previously suggested that Congress could combine a relief package with a CR.
On August 6, Sens. Mark Warner (D-VA) and Cory Booker (D-NJ) proposed the Fair Drug Prices for Kids Act. This bill gives states the option to extend the Medicaid drug rebate program to the Children’s Health Insurance Program (CHIP).
House
The House will not officially begin its August recess until a pandemic relief package is passed. Members have been instructed to be prepared to return to Washington on 24-hours notice.
On August 6, Ways & Means Rural and Urban Underserved Taskforce co-chairs Reps. Terri Sewell (D-AL), Brad Wenstrup (R-OH), Jodey Arrington (R-TX), and Worker & Family Support Subcommittee Chairman Danny Davis (D-IL) held a roundtable discussion entitled Examining the Role of Telehealth during COVID-19 and Beyond. Rep. Sewell highlighted the four policy areas the task force will be focusing on, including addressing direct social determinants of health, enacting payment system reforms, strengthening technology and infrastructure, and reinforcing the workforce. Witnesses included: Tearsanee Carlisle Davis, Director, Clinical & Advanced Practice Operations, University of Mississippi Medical Center, Center for Telehealth, Assistant Professor, School of Nursing, UMMC; Ateev Mehrotra, MD, Associate Professor, Health Care Policy, Department of Health Care Policy, Harvard Medical School, Associate Professor, Medicine & Hospitalist, Beth Israel Deaconess Medical Center; Keris Myrick, Chief of Peer & Allied Health Professions, Los Angeles County Department of Mental Health; and Jason Tibbels, MD, Chief Quality Officer, Teladoc Health, President, The Institute of Patient Safety and Quality of Virtual Care.
NON-CORONAVIRUS REGULATORY UPDATE
On August 3, Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2021 Physician Fee Schedule (PFS) Proposed Rule. The rule updates payment policies, payment rates, and other provisions for services furnished under the Medicare PFS on or after January 1, 2021. CMS proposes a conversion factor of $32.26, a $3.83 decrease from CY2020. Notably, under the rule, certain specialties could see payment rate increases of 17%, while others could see reductions of 11% due to budget neutrality requirements linked to the CY2020 rule’s increase in pay for evaluation and management (E/M) visits starting in 2021.
Additionally, in line with President Trump’s Improving Rural and Telehealth Access EO, CMS proposes to add certain telehealth services that were initially added only for the duration of the COVID-19 Public Health Emergency (PHE) to the permanent list of Medicare-covered telehealth services that are considered “Category 1.” CMS also proposes to create a temporary category (“Category 3”) of telehealth codes that include telehealth services added to the Medicare telehealth list during the PHE that will remain on the list through the calendar year in which the PHE ends. A fact sheet on the telehealth provisions is available here. The proposed rule also includes changes to the Medicare Diabetes Prevention Program, the Medicare Shared Savings Program, and coverage of Opioid Use Disorder services provided by Opioid Treatment Programs. Comments on the proposed rule are due by October 5. A fact sheet is available here.
On August 3, the Food and Drug Administration (FDA) released an update of the Purple Book: Database of Licensed Biological Products. The Purple Book now includes information from the Center for Biologics Evaluation & Research on all FDA-licensed allergenic, cellular and gene therapy, hematologic, and vaccine products.
On August 3, Office of Management and Budget (OMB) received a CMS final rule entitled Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System.
On August 4, the U.S. District Court for the Southern District of New York filed a lawsuit against Cigna, accusing the insurer of overbilling Medicare $1.4 billion between 2012-2017 by intentionally using improper diagnostic codes to “upcode” patients and collect higher capitated payments from Medicare.
On August 4, CMS released the CY2021 Hospital Outpatient Prospective Payment System (OPPS)/Ambulatory Surgical Center (ASC) Proposed Rule. CMS proposes to: increase payment under the OPPS and ASC payment platforms by 2.6%; reduce payment for separately payable drugs and biologicals acquired through the 340B program to average sales price (ASP) minus 28.7% (or alternatively, ASP minus 22.5%); eliminate the “inpatient only” list over three years; reform the Hospital Star Rating program; and reform the process by which services are added to the ASC Covered Procedures List (CPL). Comments are due by October 5. A fact sheet is available here.
On August 4, it was reported that CMS Administrator Seema Verma’s Chief of Staff Brady Brookes will leave the Agency at the end of August, where she has worked since 2017. Calder Lynch will serve as the Acting Chief of Staff and Anne Marie Costello will replace Lynch as the Acting Medicaid Director.
On August 4, CMS released the Fiscal Year (FY) 2021 Inpatient Rehabilitation Facility (IRF) final rule. This rule updates coverage requirements, the post-admission physician evaluation, and payment requirements. Aggregate Medicare program payments to IRFs will increase by about $260 million, a 2.8% increase over FY2020. Notably, this rule eliminates the requirement for physicians to conduct a post admission visit since much of the information is included in the pre-admission screening documentation, a flexibility initially only offered during the COVID-19 PHE. A fact sheet is available here.
On August 5, CMS updated the Skilled Nursing Facility Provider Preview Reports to include assessment-based measures data from January 1, 19 through December 31, 2019 and claims-based measures data from October 1, 2017 through September 30, 2019. CMS will release additional data on outcomes and other measures in October 2020.
On August 5, the FDA released the annual report on Performance of Drugs and Biologics Firms in Conducting Postmarketing for FY2019.
On August 6, the U.S. Court of Appeals for the Fourth Circuit ruled 2-1 to reverse a lower-court decision to block the Administration’s “public charge” rule from going into effect. This rule seeks to expand the types of public benefits considered for a “public charge” classification to potentially deny green card eligibility, to include non-cash supplementary assistance such as Medicaid. However, the rule will not go into effect due to an injunction issued in late July by U.S. District Judge George Daniels of New York that delays implementation until after the PHE.
On August 6, HHS awarded 116 organizations in 42 states and D.C. over $101 million in grants to combat substance use disorders (SUD) and opioid use disorders (OUD) through enhancing and expanding service delivery. Many organizations that received funding target high-risk rural communities.
Medicare Administrative Contractors (MACs) will resume fee-for-service medical review activities on August 17, 2020. Reviews were put on hold due to the COVID-19 PHE. MACs will resume post-payment reviews of items/services provided before March 1, 2020.
NON-CORONAVIRUS WHITE HOUSE UPDATE
On August 3, President Trump signed an EO entitled Improving Rural Health and Telehealth Access. The EO directs Health and Human Services (HHS) to create a new Medicare payment model within 30 days to promote telehealth among rural health care providers and to issue rules within 60 days to make permanent certain telehealth measures created during the PHE, including covering more types of telehealth services and increasing staffing and supervision flexibilities.
On August 6, President Trump signed an EO entitled Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States. The EO requires federal agencies to buy essential drugs and medical supplies domestically to reduce the nation’s reliance on importing these products. The EO also calls for HHS to identify supply chain vulnerabilities and for the Environmental Protection Agency (EPA) to streamline regulatory requirements of facilities making these products.
On August 7, President Trump announced that he will pursue an EO requiring insurance companies to cover pre-existing conditions. Notably, however, the Affordable Care Act (ACA) already requires insurers to cover pre-existing conditions. Additionally, the Trump administration argued in a Supreme Court briefing in late June that the entire ACA should be invalidated, including its pre-existing condition protections.
President Trump has alluded to unveiling his Administration’s health care plan, though details remain vague. Sen. Lindsey Graham (R-SC) signaled the plan may be published as an EO.
CORONAVIRUS UPDATE
Legislative
On August 3, White House Chief of Staff Mark Meadows said he was “not optimistic” about quickly reaching an agreement on a relief package. President Trump added that if Congress fails to pass a new package, he would consider taking executive action to extend the eviction moratorium and the enhanced federal unemployment benefits (using unspent funds previously appropriated by Congress for the PHE), as well as delay collection of the federal payroll tax and student loans. However, it is unclear if the President has the authority to implement all of these actions. On August 4, White House and Congressional leaders said they are aiming to finalize a package to extend unemployment benefits and eviction restrictions by the end of the week. On August 5, Meadows said that if a deal is not reached by August 7, then “there’s no sense to continue” negotiating. On August 7, Congressional leaders and the White House were unable to reach an agreement over a COVID-19 relief package. Treasury Secretary Steven Mnuchin and Meadows indicated that President Trump will pursue EOs to extend some of the relief measures.
On August 4, Sens. Chris Murphy (D-CT) and Roy Blunt (R-MO) introduced the Temporary Reciprocity to Ensure Access to Treatment Act. The bill would allow any health practitioner to provide services, including telehealth, in any state during a national emergency. It would also allow health practitioners to practice across state lines.
On August 4, Ways & Means Chairman Richard Neal (D-MA) called for CMS to improve COVID-19 nursing home data collection and reliability, specifically data on staffing and resident COVID-19 cases and PPE.
On August 5, Energy & Commerce Chairman Frank Pallone (D-NJ) and Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO) asked the White House Coronavirus Task Force and HHS for information on the administration’s vaccine planning efforts. This letter follows a previous letter to the White House Coronavirus Task Force requesting the same information.
On August 5, Reps. Joe Kennedy (D-MA), Yvette Clarke (D-NY), and Robin Kelly (D-IL) asked President Trump about his Administration’s vaccine distribution plan and other potential supply chain issues associated with distributing a vaccine.
On August 5, 41 Senate Democrats called on Majority Leader McConnell to include additional health provisions in the next relief package, as well as to drop the liability protections currently included in the Senate GOP’s Health, Economic Assistance, Liability Protection, and Schools (HEALS) Act. Specifically, the lawmakers requested additional funding for: Medicaid by raising the enhanced Federal Medical Assistance Percentage and maintaining access to essential Medicaid benefits; nursing homes and other congregate care settings to support frontline workers and to purchase personal protective equipment and testing supplies; and home and community-based services to decrease waitlists and keep Americans out of nursing homes.
On August 6, Sen. Elizabeth Warren (D-MA) and Reps. Carolyn Maloney (D-NY) and Katie Porter (D-CA) asked 10 large mental health and addiction treatment centers about their COVID-19 plans and to what extent the virus has spread in their facilities.
On August 6, Sens. Maggie Hassan (D-NH) and Bill Cassidy (R-LA) introduced the Patient Matching Improvement Act of 2020. This bill would support contact tracing efforts by improving electronic health record sharing for hospitals, health departments, and other health vendors through a U.S. Postal Service-like format.
On August 6, Chairman Frank Pallone announced an investigation of health and dental insurance companies’ business practices due to multiple companies recently reporting increases in second-quarter profits during the COVID-19 PHE. Chairman Pallone is calling for insurers to reduce premiums and to cover COVID-19 testing in light of reports that some companies are not complying with current law that requires testing be free to consumers.
On August 6, Armed Services Committee Ranking Member Jack Reed (D-RI) and Health, Education, Labor & Pensions Committee Ranking Member Patty Murray (D-WA) urged HHS and the Department of Defense (DoD) to allow the Centers for Disease Control & Prevention (CDC) to lead the COVID-19 vaccine distribution and administration process. The letter responds to the decision to allow DoD to lead the vaccine distribution process.
On August 6, the Committee for a Responsible Federal Budget released a report detailing states’ spending rates of Coronavirus Aid, Relief, and Economic Security (CARES) Act funding. Spending varied by state, with California spending $11.4 billion out of $15.3 billion and South Carolina spending $763,028 out of $2 billion. This unspent funding would be drawn on in the Health, Economic Assistance, Liability Protection & Schools (HEALS) Act for testing and contact tracing or for potential EOs, in lieu of a relief package.
On August 8, due to a lack of progress on a Congressional relief package, President Trump announced actions to reduce payroll taxes for workers through the end of the year, extend higher unemployment benefits but at a reduced rate, renew a moratorium on housing evictions during the pandemic, and defer student loan payments and interest indefinitely.
White House
On August 3, President Trump reauthorized the Federal Emergency Management Agency (FEMA) funding for the National Guard to assist states with their COVID-19 response, after the National Governors Association called for the extension. FEMA will fund 100% of National Guard activities until August 21st. After this deadline, FEMA will fund 75% of National Guard activities until the end of 2020, leaving the states to fund the remaining 25%. Florida and Texas are exceptions, with FEMA continuing to provide 100% funding for National Guard activities through 2020. On August 5, 35 Democrats questioned DoD and the Department of Homeland Security about the decision to decrease federal funding for all states except Florida and Texas. On August 7, Arizona, California, and Connecticut received exemptions to funding cuts, with FEMA continuing to provide 100% funding for National Guard activities through 2020.
On August 5, the White House Coronavirus Task Force identified 10 cities that are seeing increases in positive COVID-19 cases and called for the areas to take additional actions to decrease their rates. The identified cities include: Baltimore, MD; Atlanta, GA; Kansas City, MO; Portland, OR; Omaha, NE; Central Valley, CA; Boston, MA; and Chicago, IL.
Regulatory
On August 4, CMS announced a temporary, voluntary policy to allow issuers to offer premium credits to support coverage continuity for individual and small group markets. This policy will be in effect until the end of 2020.
On August 4, the FDA granted Abiomed’s left-sided heart pump an Emergency Use Authorization (EUA) to help COVID-19-related heart and lung failures. This is the second EUA the FDA has granted for the company’s heart pumps during the PHE.
On August 5, Biomedical Advanced Research and Development Authority (BARDA) awarded Janssen, a subsidiary of Johnson & Johnson, $1 billion for manufacturing the company’s vaccine and securing 100 million doses, with the option to purchase 200 million more at a later date. The doses will be made available to Americans at no cost, if the shot proves effective.
On August 5, BARDA asked Moderna to publicly disclose the amount and percentage share of government funding of its vaccine.
On August 4, FDA Commissioner Stephen Hahn and Deputy Commissioner for Medical and Scientific Affairs Anand Shah released an article entitled Investing in Advanced Manufacturing to Support Public Health Preparedness, voicing support for advanced manufacturing and emerging technology to bolster supply, especially in the time of COVID-19. On August 5, Hahn penned an op-ed to reassure the public that a COVID-19 vaccine will be safe and effective. In addition, on August 7, Hahn, Shah, and Center for Biologics Evaluation and Research Director Peter Marks released an op-ed in JAMA Network reemphasizing the safety and effectiveness of a COVID-19 vaccine.
On August 6, the FDA granted NeuroRx Investigational New Drug permission to test the company’s COVID-19 therapeutic on patients with moderate and severe COVID-19 to prevent respiratory failure.
Other
On August 3, the National Bureau of Economic Research published a working paper entitled Nursing Home Staff Networks and COVID-19. The study found that employees who work in more than one nursing home facility may be significant spreaders of coronavirus infections. The study recommends limiting staff to one facility or securing additional PPE and testing and being aware of potential cross facility transmission.
On August 3, a study published in Health Affairs found a large gap in availability of intensive care unit (ICU) beds by income, concentrated in rural communities. Specifically, it concluded that more than half of all rural, low-income communities have no ICU beds. This study called for policies to facilitate hospital coordination to address shortages in low-income, rural communities.
On August 3, the COVID R&D Alliance, including AbbVie, Inc., Amgen Inc., and Takeda Pharmaceutical Co., announced a clinical trial to test combinations of their drugs to treat COVID-19 patients who require oxygen.
On August 3, Eli Lilly and National Institute of Allergy and Infectious Diseases (NIAID) announced a Phase III vaccine trial of 2,400 residents and staff at long-term care facilities. Furthermore, on August 4, the partnership also announced a Phase III trial for an antibody treatment in hospitalized COVID-19 patients with mild to moderate symptoms, as well as a Phase II trial of an antibody treatment for non-hospitalized patients with mild to moderate symptoms.
On August 3, a study was published in JAMA Internal Medicine entitled Trends in Emergency Department (ED) Visits and Hospital Admissions in Health Care Systems in Five States in the First Months of the COVID-19 Pandemic in the US. This study finds that EDs across five states saw a decrease of 41.5 to 63.5% in visits and admission. The study suggests encouraging practitioners and public health officials to emphasize the importance of visiting the ED and not delaying care.
On August 4, Sen. Warren asked the SEC to investigate the $765 million Eastman Kodak loan to produce generic drug ingredients for COVID-19 for potential insider trading. Furthermore, on August 5, House Oversight & Reform Chair Maloney, Coronavirus Crisis Select Subcommittee Chair Jim Clyburn (D-SC), and Financial Services Chair Maxine Waters (D-CA) requested records on behalf of their respective committees from Kodak and the U.S. International Development Finance Corporation regarding this deal.
On August 4, 34 state Attorney Generals (AGs) requested that HHS, National Institutes of Health, and FDA take steps to ensure that Americans can afford and access a sufficient supply of Gilead’s remdesivir during the pandemic. The AGs argue Gilead has not been able to produce enough of the drug to match demand and has failed to market the drug at a reasonable price. Therefore, they request that the federal government's exercise its “march-in rights” and license the drug to a third party, or, at minimum, grant states the authority to do so. On August 5, Gilead defended that the company would be able to meet global demand of remdesivir in October. The company plans to produce more than two million drug courses by the end 2020 and predicts producing “several million more” in 2021. On August 7, Pfizer Inc. announced the company will manufacture and supply Gilead’s remdesivir as part of a multi-year agreement.
Onn August 4, Maryland, Michigan, Ohio, Louisiana, Massachusetts, North Carolina, and Virginia announced a partnership with the Rockefeller Foundation to purchase three million rapid point-of-care COVID-19 tests directly from diagnostics manufacturers Becton Dickinson and Quidel. The partnership allows for additional states to participate.
On August 4, Novavax released data from the company’s Phase I/II COVID-19 vaccine trial concluding the vaccine is “generally well-tolerated” and elicits a robust antibody response. Operation Warp Speed has already awarded the company $1.6 for late stage clinical development.
On August 4, BioNTech and Shanghai Fosun Pharmaceutical announced a Phase I trial of BNT162b1 – one of two vaccine candidates based on BioNTech’s proprietary mRNA technology – in China. The vaccine has already begun trials in Germany and the U.S. BNT162b2, the other vaccine candidate, is currently being evaluated in a global Phase 2b/3 trial conducted by BioNTech and Pfizer.
On August 5, NIAID and Moderna published results in Nature from the company’s mRNA vaccine, showing that the vaccine successfully triggers an antibody response in mice.
On August 5, approximately 400 public health advocates called for FDA Commissioner Hahn to require the FDA to evaluate and approve a COVID-19 vaccine before allowing its distribution in order to boost public confidence.
On August 6, the Center of American Progress released a report entitled A New Strategy To Contain the Coronavirus. The report compares policy differences between regions of the U.S. and between the U.S.’s and Japan’s response. The report recommends closing indoor dining and bars, monitoring potentially high-risk venues, enforcing state and local mask mandates, and adopting cluster-based contract tracing.
On August 6, a study published in JAMA Internal Medicine concluded that asymptomatic people with COVID-19 carry the same amount of the virus and remain infectious as long as those who display symptoms.
On August 6, U.S. District Court for D.C. dismissed House Minority Leader Kevin McCarthy’s (R-CA) lawsuit to deem the House’s proxy voting system unconstitutional. The system was created by House Speaker Nancy Pelosi (D-CA) in order to allow representatives to avoid traveling to DC during the PHE. Judge Rudolph Contreras ruled that the Court could not rule on the case due to limits on pursuing lawsuits over Congress' legislative efforts. Leader McCarthy intends to appeal the ruling, according to an aide.
On August 7, Maryland extended the Special Enrollment Period for the state’s health insurance exchange until December 15, 2020.
As of August 7, the U.S. had 4,917,050 confirmed COVID-19 cases resulting in 160,072 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
Medicare Coverage of Innovative Technologies (CMS-3372-P); Received 7/30/2019
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 FY 2021 Rates (CMS-1735); Final Rule; Received 8/3/20
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 3, OIG released a report entitled Some Nursing Homes' Reported Staffing Levels in 2018 Raise Concerns; Consumer Transparency Could Be Increased. OIG found that CMS’s 2018 policy to downgrade Staffing Star Ratings for nursing homes without a registered nurse (RN) present resulted in a decrease of homes reporting days with no RN time. According to OIG, this suggests the policy led to an improvement in staffing levels but some homes still reported varied staffing levels. OIG recommends that CMS ensure that nursing homes meet daily staffing requirements and explore ways to provide consumers with additional information on nursing homes' daily staffing levels and variability. CMS has outlined a plan to follow these recommendations. A summary is available here.
On August 4, OIG released a report entitled Review of MAC Information Security Program Evaluations for Fiscal Year 2019. OIG reviewed Guidehouse’s evaluations of the MACs information security programs and found that there was an increase in gaps in MAC security programs from FY2018 to FY2019 from database and web server testing. Guidehouse recommends that CMS should continue oversight visits and ensure that the MACs remediate all gaps to improve the MACs’ IT security. A summary is available here.
On August 5, OIG released a report entitled Inadequate Edits and Oversight Caused Medicare to Overpay More Than $267 Million for Hospital Inpatient Claims With Post-Acute-Care Transfers to Home Health Services. OIG found that Medicare overpaid most inpatient claims subject to the transfer policy and that Medicare should have paid claims using a graduated per diem rate, rather than the full payment. OIG estimates that Medicare improperly paid $267 million during a two-year period. OIG recommends that CMS direct its Medicare contractors to reprocess and recover the claims overpayments and improve provider education related to the Medicare transfer policy. OIG also recommends that CMS consider reducing the need for clinical judgment when processing claims under the post-acute-care transfer policy. CMS agreed to all but the last recommendations. A summary is available here.
Government Accountability Office (GAO)
On August 4, GAO released a report entitled OUD: Treatment with Injectable and Implantable Buprenorphine. This report finds that buprenorphine is the only medication that is a controlled substance and available as an injection or implant to treat OUD. This report outlines the process providers and pharmacies must follow for treating OUD with injectable and implantable buprenorphine and concludes that the process is not difficult but requires proper coordination to ensure that the patient receives treatment.
On August 6, GAO released a report entitled SUD: Medicaid Coverage of Peer Support Services for Adults. This report found that 37 states covered peer support services for adults with SUDs in their Medicaid programs in 2018. GAO reviewed Medicaid programs in Colorado, Missouri, and Oregon and found that their Medicaid programs offered peer support services as a complement to clinical treatment for SUD.
UPCOMING HEARINGS
Senate
None of note.
House
None of note.
OTHER HEALTH POLICY NEWS
On August 3, the Pharmaceutical Care Management Association launched its second ad campaign in a month to combat the rebate rule included in President Trump’s recent drug pricing EO. The Campaign for Sustainable Rx Pricing also launched an ad campaign opposing the rebate rule.
On August 4, IQVIA released a report finding that total out-of-pocket (OOP) costs for prescriptions filled in retail pharmacies increased from $61 billion in 2015 to $67 billion in 2019. Patients using commercial insurance experienced a 5% drop in OOP expenses during this period, while costs increased by: 27% for Medicare Part D enrollees, 21% for Medicaid beneficiaries, and 21% for those paying cash. IQVIA also found that net drug price increases have plateaued at roughly 2% per year over the past five years. Lastly, IQVIA concluded that capping insulin OOP costs at $35 per month across all payer groups would have reduced patients’ OOP costs by $837 million in 2019 alone.
On August 4, Missouri voters elected to expand Medicaid, by a 53% to 46% vote. The ballot measure would add Medicaid expansion to the state’s constitution. By expanding eligibility to 138% of the federal poverty level, over 230,000 additional residents will qualify for coverage. The expansion will take effect July 1, 2021.
On August 4, Covered California, the state’s health plan exchange, announced premiums will rise an average of 0.6% next year across all 11 insurers, the lowest increase the exchange has seen since 2014.
On August 4, the National Association of Manufacturers launched an ad campaign to combat the Administration’s potential EO that would call on HHS to finalize the International Pricing Index model if Congress fails to pass drug pricing legislation by August 24.