Health Care Watch: September 27, 2021
The following FHP Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from September 20 – September 26. 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 20, Speaker Nancy Pelosi (D-CA) released a Dear Colleague urging the House to proceed with the reconciliation package and reassured that the House and Senate are already in agreement on most of the policy. On September 25, the Budget Committee voted to advance the $3.5 trillion reconciliation bill to the floor. Speaker Pelosi has committed floor time to consider this bill and the Senate-passed $1.2 trillion infrastructure bill the week of September 27.
On September 20, Energy & Commerce Committee Chairman Frank Pallone (D-NJ) and Ranking Member Cathy McMorris Rodgers (R-WA) voiced their support for the provisions in the CY 2022 Medicare Hospital Outpatient Prospective Payment System (OPPS) Proposed Rule to increase penalties for hospitals not in compliance with the Hospital Price Transparency Final Rule. Chairman Pallone and Ranking Member McMorris Rodgers urged the U.S. Department of Health & Human Services (HHS) to increase price transparency measures and increase information available to consumers and employers about health care prices.
On September 21, the House passed (220-211) a short-term funding bill to prevent a government shutdown until December 3. The package also raises the debt limit through December 2022. On September 23, Senate Majority Leader Chuck Schumer (D-NY) filed cloture to break a filibuster on the package. This bill is not expected to pass the Senate given Republican opposition. The borrowing limit is expected to be reached by the end of October.
On September 21, 37 Democrats sent a letter to President Biden urging him to increase the global COVID-19 vaccine supply and distribution efforts to combat COVID-19.
On September 22, the Select Subcommittee on the Coronavirus Crisis held a hearing entitled Recognizing and Building on the Success of Pandemic Relief Programs. Witnesses included: Diane Whitmore Schanzenbach, Professor of Human Development and Social Policy, Director, Institute for Policy Research, on behalf of Northwestern University; Reverend Starsky Wilson, MD, President, Children’s Defense Fund Luke Shaefer, Associate Dean for Research and Policy, University of Michigan Ford School of Public Policy; Indivar Dutta-Gupta, Co-Director, Georgetown Center on Poverty & Inequality; and Douglas Holtz-Eakin, President, American Action Forum.
On September 23, the Committee on Oversight and Reform released a report as part of its drug pricing investigation entitled Lost Savings: How Prohibiting Medicare Negotiation Has Cost Taxpayers. The report found that Medicare could have saved more than $25 billion between 2014 and 2018 if it secured the same discounts as other federal health care programs on seven drugs the Committee is investigating. For the three frequently-used insulin products investigated by the Committee (Humalog, NovoLog, and Lantus), Medicare could have saved more than $16.7 billion between 2011 and 2017. The Committee also argued that drug companies rely on Medicare to boost profits. A summary of the report is available here.
Senate
On September 20, Finance Committee Chairman Ron Wyden (D-OR) supported the CY 2020 OPPS Proposed Rule, specifically proposals amending existing hospital transparency regulations.
On September 22, the Finance Committee held a hearing on the Nominations of Christi A. Grimm to be HHS Inspector General; and Neil Harvey MacBride to be General Counsel for the Treasury Department.
On September 24, Sen. Chuck Grassley (R-IA) announced that he is running for re-election/
NON-CORONAVIRUS REGULATORY UPDATE
On September 20, the Centers for Medicare & Medicaid Services (CMS) awarded $15 million to 20 states to support expanding community-based mobile crisis intervention services for Medicaid beneficiaries by connecting people who are experiencing a mental health or substance use disorder crisis to a behavioral health specialist or critical treatment.
On September 20, the Department of Labor announced that it will provide health plans with guidance on how to comply with recent requirements that they publicly disclose prescription drug prices.
On September 20, HHS issued a final rule entitled Patient Protection and Affordable Care Act; Updating Payment Parameters, Section 1332 Waiver Implementing Regulations, and Improving Health Insurance Markets for 2022 and Beyond.
On September 20, the Department of Defense (DoD) Office of Inspector General (OIG) released a report entitled Evaluation of the Department of Defense’s Mitigation of Foreign Suppliers in the Pharmaceutical Supply Chain. The Defense Logistics Agency identified the DoD’s reliance on foreign suppliers in the pharmaceutical supply chain as a risk. The report concluded that pharmaceutical supply disruptions could compromise the standard of care to DoD beneficiaries and manufacturers could cause a drug shortage that would affect every level of the U.S. health care system. DoD OIG made a series of recommendations, including developing and issuing implementing guidance for DoD supply chain risk management for DoD material; pursuing Federal legislation requiring pharmaceutical manufacturers to include APIs and final drug product country of origin information of the pharmaceuticals’ lot on the pharmaceuticals’ packaging; assessing risks to the pharmaceutical supply chain, identifying the pharmaceuticals most critical to beneficiary care at DoD Military Treatment Facilities, and establishing policy for allocating scarce pharmaceutical resources in case of a supply disruption; and other improvements.
On September 21, the Food & Drug Administration (FDA) released a report entitled the Biosimilar Biological Product Reauthorization Performance Goals and Procedures fiscal years (FY) 2021 through 2027. The FDA committed to ensuring the effectiveness of the biosimilar review program, enhancing biosimilar and interchangeable development and regulatory science, continued enhancement of user fee resource management, and improving FDA hiring and retention of review staff.
On September 21, the White House Office of Management & Budget (OMB) received a notice from CMS entitled Request for Information: Transplant System Modernization (CMS-3409).
On September 22, the HHS Office of the National Coordinator for Health Information Technology (ONC) awarded $73 million as part of its Public Health Informatics & Technology Workforce Development Program to strengthen public health information technology (IT) efforts, improve COVID-19 data collection, and increase representation of underrepresented communities within the public health IT workforce.
On September 22, the National Institutes of Health (NIH) National Institute on Drug Abuse (NIDA) published a study in JAMA Psychiatry that found that methamphetamine overdose deaths tripled from 2015 to 2019 among U.S. adults under 65. The study also found that populations with methamphetamine use disorder have become more diverse, though there has not been a steep increase in methamphetamine use.
On September 22, the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) held a meeting examining relevant health outcomes in studies for cerebrovascular disease treatment, with a particular focus on new technologies of interest to CMS.
On September 22, the Health Resources and Services Administration (HRSA) officially referred Lilly, Sanofi, AstraZeneca, Novo Nordisk, Novartis, and United Therapeutics to the HHS OIG regarding the drug makers not awarding 340B drug discounts to contract pharmacies.
On September 23, OMB received an interim final rule from HHS entitled Prescription Drug and Health Care Spending (CMS-9905).
CMS will hold a New Technology Town Hall Meeting on the FY 2023 New Technology Add-on Payment (NTAP) Applications on December 14-15.
NON-CORONAVIRUS WHITE HOUSE UPDATE
None of note.
CORONAVIRUS UPDATE
House
On September 20, Rep. Tim Ryan (D-OH) announced that he has tested positive for COVID-19.
On September 26, Rep. Brian Baban (R-TX) announced that he has tested positive for COVID-19.
Senate
None of note.
Regulatory
On September 19, NIH National Institute of Allergy and Infectious Diseases Director Anthony Fauci predicted that Moderna and Johnson & Johnson (J&J) will submit COVID-19 vaccine booster data within a few weeks. NIH Director Francis Collins predicted that booster shot eligibility will be expanded in the coming weeks.
On September 20, HHS Secretary Xavier Becerra announced Leslie Dach as a temporary adviser to assist with HHS messaging on the pandemic response.
On September 21, CMS announced a new Medicare.gov tool to compare COVID-19 vaccination rates for nursing home staff and residents. CMS and the Centers for Disease Control and Prevention (CDC) is also using this data to monitor vaccine uptake among residents and staff and to identify facilities in need of additional resources or assistance to respond to COVID-19.
On September 22, the FDA amended the emergency use authorization (EUA) for Pfizer’s COVID-19 vaccine to support booster doses for those 65 and older, those at high risk of severe COVID-19, and those in high-risk occupations.
On September 22-23, the CDC Advisory Committee on Immunization Practices (ACIP) held a meeting to discuss COVID-19 vaccine boosters. The Committee voted 9-6 in support of the use of Pfizer's COVID-19 vaccine boosters for those 65 and older and those at high risk of severe COVID-19. Notably, the Committee did not recommend boosters for those in high-risk occupations. On September 24, CDC Director Rochelle Walensky overrode the ACIP recommendation and announced that workers in high-risk occupations, including health care workers, teachers and grocery store clerks, are eligible to receive the booster shot.
On September 24, CMS announced that it will continue to provide coverage for COVID-19 booster shots without cost sharing.
White House
On September 20, White House COVID-19 Response Coordinator Jeff Zients announced a reversal of some international travel restrictions, allowing fully-vaccinated foreigners that also show proof of a negative COVID-19 test to enter the U.S. beginning in November. New guidance also requires unvaccinated Americans to be tested within a day before returning to the U.S. and after they arrive back to the U.S.
On September 21, the White House announced that it is purchasing 60 million over-the-counter COVID-19 diagnostic tests for $647 million from OraSure Technologies, Quidel, Abbott, and Intrivo Holdings.
On September 22, Vice President Harris announced that the U.S. would commit $250 million to establish a Global Health Security Financial Intermediary Fund to finance global health security initiatives and prevent future pandemics.
On September 22, the U.S. hosted the Global COVID-19 Summit. President Biden urgedworld leaders to pledge to expand the COVID-19 vaccine supply and essential medical supplies; solve logistical challenges; support administration arms; reduce vaccine hesitancy; and provide sustainable financing, capacity, and global leadership to improve prevention, detection, and response of COVID-19 and for future biological threats. President Biden also announced a partnership between the U.S. and European Union to further the global COVID-19 vaccination effort. President Biden then announced that the U.S. is purchasing an additional 500 million of Pfizer’s COVID-19 vaccine doses to donate to low and lower-middle income countries, with shipments starting in January 2022. This brings the total number of vaccines donated by the U.S. to over 1.1 billion doses. The U.S. Agency for International Development (USAID) and CDC will provide an additional $370 million for global vaccine readiness, and distribution and administration efforts. Notably, in President Biden’s remarks, he voiced support for a COVID-19 TRIPS Waiver to waive intellectual property protections for COVID-19 vaccines during the pandemic.
Other
On September 20, Pfizer announced results from a Phase II/III trial that its COVID-19 vaccine, in a smaller dose, is safe and generates strong antibody responses for children five to 11. Pfizer aims to submit this data to the FDA “as soon as possible.”
On September 21, J&J released data from real-world-evidence and Phase III data supporting that its COVID-19 vaccine is 79% effective against COVID-19 infections and 81% effective against COVID-19-related hospitalization, and that there was no evidence of reduced effectiveness over time. J&J also found that a booster dose provided two months after the first shot provided 94% protection against symptomatic COVID-19 and a booster dose six months after the first dose provided a 12-fold increase in antibodies.
On September 21, a cost estimate from Fair Health found that the average COVID-19 hospitalization bill is $208,136, with a hospitalization with complexities reaching $317,810.
On September 22, the Kaiser Family Foundation released a report tracking COVID-19 vaccine donations that found that the U.S. has donated approximately 140 million doses to at least 93 countries and more than half of the doses went to lower-middle-income countries. The Moderna vaccine accounts for the largest share of U.S. donated doses and the majority of donated doses were distributed through COVAX.
On September 22, Gilead announced positive Phase III results for the use of its COVID-19 treatment, remdesivir. Remdesivir reduced hospitalizations by 87% in high-risk patients diagnosed early.
As of September 25, more than 213 million people in the U.S. have received the first dose of COVID-19 vaccines (more than 183 million have received both doses) and more than 471 million doses have been distributed, according to the CDC COVID Data Tracker.
As of September 25, the U.S. had nearly 43 million confirmed COVID-19 cases resulting in 687,789 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center.
RULES AT THE WHITE HOUSE OMB
HHS-CMS
Request for Information: Transplant System Modernization (CMS-3409); Notice; 9/21/21
Prescription Drug and Health Care Spending (CMS-9905); Interim Final Rule; 9/24/21
HHS-FDA
Medical Device De Novo Classification Process; Final Rule; 6/28/21
Medical Devices; Ear, Nose and Throat Devices; Establishing Over-the-Counter Hearing Aids and Aligning Other Regulations; Proposed Rule; 8/18/21
Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Notice; 8/18/21
Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Revised Draft Guidance for Industry; Availability; Notice; 8/31/21
Rescission of the Final Rule entitled "Implementation of Executive Order on Access to Affordable Life-Saving Medications"; Final Rule; 9/9/21
HHS-Office of the Secretary
Securing Updated and Necessary Statutory Evaluations Timely; Proposed Rule; 8/31/21
Streamlining HHS Guidance Practices; Proposed Rule; 6/28/21
Department of Labor-Employee Benefits Security Administration
Requirements Related to Surprise Billing, Part 2; Interim Final Rule; 8/2/21
REPORTS
HHS Office of Inspector General (OIG)
On September 21, OIG released a report entitled New Mexico Medicaid Fraud Control Unit (MFCU): 2020 Review. The report identified several factors that contributed to the MFCU's low case outcomes during FYs 2017-2019, including significant turnover of MFCU's management and staff, insufficient steps were taken to ensure that MFCU received quality referrals from the State Medicaid agency and other sources, significant investigative delays, a lack of regular communication and joint cases with Federal partners, and inconsistent periodic supervisory reviews and documentation. OIG also identified areas for improvement in its compliance with Federal regulations. OIG recommended that MFCU develop and implement action plans to address these issues. The Unit agreed with all the recommendations. A summary of the report is available here.
On September 21, OIG released a report entitled Indian Health Service (IHS) Use of Critical Care Response Teams Has Helped To Meet Facility Needs During the COVID-19 Pandemic. The report found that the IHS Critical Care Response Teams (CCRTs) provided hands-on training to strengthen staff skills and capacity to handle surges of COVID-19 patients which facility administrators found valuable. IHS officials and staff credited the CCRT training with saving lives and stated that the teams' presence boosted staff's confidence and skills. CCRTs also provided direct patient care, particularly during patient surges. OIG also found that facilities provided close oversight and communicated frequently with IHS headquarters and Area Offices about CCRT activities. OIG recommended that IHS solicit feedback from CCRTs regarding their observations of potential need for broader IHS-wide improvements beyond COVID-19-related care; share the CCRTs' recommendations across all IHS and Tribal facilities; and assess whether IHS could use the CCRT model to provide support and training for non-COVID-19-related care. IHS agreed with the recommendations. A summary of the report is available here.
On September 21, OIG released a report entitled States Reported Multiple Challenges With Using Telehealth To Provide Behavioral Health Services to Medicaid Enrollees. The report found that most States reported multiple challenges with using telehealth, including a lack of training for providers and enrollees, limited internet connectivity for providers and enrollees, difficulties with providers' protecting the privacy and security of enrollees' personal information, the cost of telehealth infrastructure and interoperability issues for providers, lack of licensing reciprocity, and difficulties with providers obtaining informed consent from enrollees. OIG identified that these challenges limit States' ability to use telehealth to meet Medicaid enrollees’ behavioral health needs. OIG recommended that CMS share information to help States address the challenges they face with using telehealth, including examples from States that describe how they have responded to these challenges; issue best practices from States and information about working with other State and Federal partners; and collect information from States detailing their experiences and lessons learned in response to the COVID-19 pandemic that address these challenges. CMS agreed with one of the recommendations. A summary of the report is available here.
On September 21, OIG released a report entitled Opportunities Exist To Strengthen Evaluation and Oversight of Telehealth for Behavioral Health in Medicaid. The report found that most States can identify which services are provided via telehealth, but a few are unable to, which limits their ability to evaluate and oversee telehealth. The few States that have evaluated the effects of telehealth in their State found increased access and reduced costs. OIG found that other States believe that telehealth increases access, has uncertain impacts on costs, and raises concerns about quality. Though States have expressed concerns about fraud, waste, and abuse, many do not conduct monitoring and oversight specific to telehealth. OIG recommended that CMS ensure that States that are unable to distinguish telehealth from in-person services implement indicators to identify which services are provided via telehealth; conduct evaluations, and support State efforts to evaluate the effects of telehealth on access, cost, and quality of behavioral health services; and conduct monitoring for fraud, waste, and abuse, and support State efforts to oversee telehealth for behavioral health services. CMS agreed with the first recommendation but did not indicate whether it agreed with the other recommendations. A summary of the report is available here.
On September 22, OIG released a report entitled Some Medicare Advantage (MA) Companies Leveraged Chart Reviews and Health Risk Assessments (HRAs) to Disproportionately Drive Payments. The report found that some MA companies' use of chart reviews and HRAs increased their risk adjusted payments disproportionately, relative to their size and their peers. Twenty MA companies drove a disproportionate share of the $9.2 billion in payments from diagnoses that were reported only on chart reviews and HRAs, and on no other service records. OIG noted that these companies' higher share of payments could not be explained by the size of their beneficiary enrollment. OIG recommended that CMS provide oversight of the 20 MA companies that had a disproportionate share of the risk-adjusted payments from chart reviews and HRAs; determine the appropriateness of payments and care for the one MA company that substantially drove risk adjusted payments; and perform periodic monitoring to identify MA companies that had a disproportionate share of risk adjusted payments from chart reviews and HRAs. OIG did not publish the names of the companies audited in this report but will provide specific information to CMS on the companies included in this report. CMS stated that it will take OIG’s recommendations under consideration, as part of its ongoing process to determine policy options for future years. A summary of the report is available here.
On September 23, OIG released a report entitled California Did Not Fully Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities. The report found that California did not fully comply with Federal Medicaid waiver and State requirements for reporting and monitoring critical incidents involving Medicaid beneficiaries with developmental disabilities who resided in Community Care Facilities (CCFs). California provided various reasons that providers and regional centers did not properly report some critical incidents, as well as reasons that reported critical incidents were not always reported in a timely manner and followed up on completely. OIG recommended that California provide additional guidance to providers, such as a standard reporting form that includes the types of incidents that are required to be reported, and provide additional training to providers on critical incident identification and reporting; provide additional guidance and training to regional centers; perform additional analytical procedures to identify potential critical incidents that have not been reported; improve oversight to ensure that timeliness and follow-up requirements related to reported critical incidents are met; and ensure that reported critical incidents involving the death of a beneficiary are reviewed by a mortality review committee as appropriate. California agreed with the first four recommendations, partially agreed with the fifth recommendation. A summary of the report is available here.
On September 23, OIG released a report entitled About Seventy-Nine Percent of Opioid Treatment Program Services Provided to Medicaid Beneficiaries in Colorado Did Not Meet Federal and State Requirements. The report found that Colorado's oversight did not ensure that Opioid treatment program (OTP) services provided to Medicaid beneficiaries met Federal and State requirements, resulting in over 1.1 million OTP services not meeting Federal and State requirements. OIG recommended that Colorado strengthen its biennial audits of OTPs to ensure that services provided are in accordance with Federal and State requirements, provide technical assistance to OTPs to ensure that the providers maintain adequate recordkeeping systems, and educate OTPs on the deficiencies we identified to increase their awareness of compliance issues regarding Federal and State requirements. A summary of the report is available here.
Government Accountability Office (GAO)
On September 23, GAO released a report entitled Health Care Capsule: Racial and Ethnic Health Disparities. This report draws from several GAO reports to describe examples of racial and ethnic health disparities, barriers that may contribute to disparities, and federal efforts to help address them. A summary of the report is available here.
On September 24, GAO released a report entitled Medicare Physician Services: Payment Rates, Utilization, and Expenditures of Selected Services in Alaska, Hawaii, and the U.S. Territories. The report found that Medicare Part B fee-for-service (FFS) populations in Alaska, Hawaii, and the U.S. territories varied considerably in size, demographic, and other key characteristics. GAO also found that Medicare payment rates for selected services were higher in Alaska, Hawaii, and the territories compared to national rates, 39% higher for certain ER visits. However, utilization of and expenditures for these services were generally lower, which may be attributable to differences in population demographics and access to services. A summary of the report is available here.
UPCOMING CONGRESSIONAL HEARINGS
House
Energy & Commerce Committee
TBD
Hearing on the Future of Biomedicine: Translating Biomedical Research into Personalized Health Care
Senate
None of note.
OTHER HEALTH POLICY NEWS
On September 20, a study published in JAMA Network Open found that rural hospital mergers were associated with better mortality outcomes for acute myocardial infarction and other conditions. Lower mortality rates continued for four years after the merger was executed.
On September 21, Kaiser Family Foundation released a report that found that 44% of Medicare beneficiaries reported difficulty hearing and 35% reported difficulty seeing in 2019. The report also found that on average, out-of-pocket spending reached $914 for hearing care, $874 for dental care, and $230 for vision care. MA beneficiaries spent less out of pocket for dental and vision care than beneficiaries in traditional Medicare in 2018, but there was no difference in spending on hearing care. In 2019, 16% of Medicare beneficiaries reported that they could not get dental, hearing, or vision care, with cost being a major barrier.
On September 21, data from a Gallup survey found that adults under age 65 are twice as likely as seniors to be unable to pay for prescription drugs, with 7% of U.S. adults reporting that they were unable to pay for at least one doctor-prescribed medication for their household during the prior three months. The survey also found that 10% of adults have skipped prescribed dosages to preserve drugs and save money.
On September 23-24, MACPAC held a meeting discussing the following topics
Plans for the 2021-2022 report cycle;
Beneficiary preferences for communications regarding eligibility, enrollment, and renewal;
Associations between state eligibility processes and rates of churn and continuous coverage;
Medicaid in the U.S. territories: considerations for long-term financing solutions;
Medicaid levers to address concerns about the primary and specialty care workforce;
Monitoring access to care for Medicaid beneficiaries;
Congressionally mandated study on Money Follows the Person demonstration program;
Panel discussion: Health IT adoption and use by behavioral health providers to support care integration; and
Vaccines for adults enrolled in Medicaid: access, coverage, and payment.