Health Care Watch: August 23, 2021
The following FHP Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from August 16 – August 22. 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
The House will return from recess on August 23 to consider the Senate-passed budget resolution and other legislation. The House Rules Committee will meet on August 23 to formulate a rule on the fiscal 2022 budget resolution, the Senate’s bipartisan infrastructure package, and voting rights legislation.
On August 16, Transportation Committee Chair Peter DeFazio (D-OR) called for House Democrats to pass a budget resolution next week. On August 17, Speaker Nancy Pelosi (D-CA) called for the House to pass the budget resolution when the House returns from recess in a Dear Colleague. On August 21, Speaker Pelosi stated that her goal is to pass the Senate-passed bipartisan infrastructure bill and a $3.5 trillion partisan infrastructure bill by October 1.
On August 19, Energy & Commerce Committee Chairman Frank Pallone (D-NJ) and Oversight & Investigations Subcommittee Chair Diana DeGette (D-CO) sent letters to Lilly, Novo Nordisk, and Sanofi requesting additional information on their respective insulin products, including any specific steps the companies have taken to lower the cost of insulin and increase patient access, the gross revenue and net profit from the insulin products, and whether COVID-19 has affected the companies’ insulin products. These letters were following up on January 2019 letters asking similar questions.
Senate
Nothing of note.
NON-CORONAVIRUS REGULATORY UPDATE
In a letter issued on August 13, the Centers for Medicare & Medicaid Services (CMS) extended eligibility reviews of Medicaid enrollees to one year, from six months, following the ending of the COVID-19 public health emergency.
On August 18, the Health Resources & Services Administration (HRSA) announced over $19 million in funding for 36 award recipients to strengthen telehealth services in rural and underserved communities and expand telehealth innovation and quality nationwide. The funding includes:
$6.5 million to assess telehealth strategies and services to improve health care in rural medically underserved areas that have high chronic disease prevalence and high poverty rate;
$4.55 million for regional and national Telehealth Resource Centers;
$4.28 million to build sustainable tele-mentoring programs and networks in rural and medically underserved communities; and
$3.85 million to help health networks increase access to telehealth services and to assess the effectiveness of telehealth care for patients, providers, and payers.
On August 18, the Centers for Disease Control and Prevention (CDC) announced the creation of the Center for Forecasting and Outbreak Analytics to advance the use of forecasting and outbreak analytics in public health decision making through the efforts of academics and business leaders. The Center will accelerate access to and use of data for public health decision makers across sectors and will be operational in 2022.
The White House Office of Management & Budget (OMB) received the following regulatory actions this week:
A Proposed Rule entitled Medical Devices; Ear, Nose and Throat Devices; Establishing Over-the-Counter Hearing Aids and Aligning Other Regulations;
A Notice entitled Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; and
A Final Rule entitled Patient Protection and Affordable Care Act, Updating Payment Parameters and Improving Health Insurance Markets for 2022 and Beyond (CMS-9906)
CMS will hold a virtual meeting on August 23 of the Advisory Panel on Hospital Outpatient Payment to advise CMS on the clinical integrity of the Ambulatory Payment Classification (APC) groups and their associated weights and supervision of hospital outpatient therapeutic services.
The Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) will hold a public meeting on September 22 to examine relevant health outcomes in studies for cerebrovascular disease treatment, with a particular focus on new technologies of interest to CMS.
The CDC Advisory Committee on Immunization Practices (ACIP) postponed their August 24 meeting to the week of August 30. The Committee will also hold a meeting on September 29 and 30 to review and revise the list of vaccines for administration to vaccine-eligible children through the Vaccines for Children program.
NON-CORONAVIRUS WHITE HOUSE UPDATE
None of note.
CORONAVIRUS UPDATE
House
On August 17, 108 Democratic Representatives requested a briefing from the Food & Drug Administration (FDA) on the status and timeline of Emergency Use Authorizations for COVID-19 vaccines for children ages 2-11.
On August 18, Rep. Mark Pocan (D-WI) introduced the COVID Defense Act, which would transfer $9.6 billion in military funding $9.6 billion to global vaccination efforts.
Senate
On August 19, Sens. Roger Wicker (R-MS), Angus King (I-ME), and John Hickenlooper (D-CO) announced that they tested positive for COVID-19, despite being vaccinated.
Regulatory
On August 16, the National Institutes of Health (NIH) announced it has developed a faster COVID-19 diagnostic test that does not require RNA extraction kits.
On August 17, the CDC awarded $47 million in COVID-19 funding to the Task Force for Global Health to expand the influenza and COVID-19 vaccine coverage in low- and middle-income countries and help prepare for vaccine deployment in future pandemics. The CDC will award the Task Force for Global Health $100 million in total funding over five years.
On August 17, the Transportation Security Administration announced it will extend the mask mandate for airline flights and public transportation to January 18, 2022, due to the spread of the delta variant.
On August 18, CMS and CDC announced that they intend to develop an emergency regulation requiring nursing homes to vaccinate their staff, or they will be at risk of losing their Medicaid and Medicare funding.
On August 18, the CDC released three studies finding that currently authorized COVID-19 vaccines decrease in effectiveness against the delta variant over time. The first study with adult New York residents found that COVID-19 vaccines declined in effectiveness from 91.7% to 79.8% from May 3–July 25. The second study found that COVID-19 mRNA vaccines did not decline in effectiveness against COVID-19 hospitalization over 24 weeks, remaining stable at around 85% effective. The third study found that among nursing home residents, mRNA vaccines declined in effectiveness from 74.7% to 53.1% against COVID-19 infection.
On August 18, the U.S. Department of Health & Human Services (HHS) announced that it plans to offer COVID-19 booster shots to those who received a Pfizer or Moderna COVID-19 vaccine eight months ago, beginning the week of September 20. This plan is subject to FDA conducting an independent evaluation and determination of the safety and effectiveness of a third dose of the Pfizer and Moderna vaccines and CDC’s ACIP issuing booster dose recommendations based on a review of the evidence.
On August 18, the NIH published a study in the New England Journal of Medicine that found that early use of convalescent plasma did not prevent COVID-19 progression in high-risk adults.
White House
None of note.
Other
On August 16, Pfizer announced it submitted Phase I safety and efficacy data to the FDA to support a COVID-19 booster dose.
On August 16, CureVac and GSK released preclinical data supporting its second-generation mRNA COVID-19 vaccine showing strongly improved immune responses, compared to CureVac’s first-generation COVID-19 vaccine. The second-generation COVID-19 vaccine was effective against Beta, Delta, and Lambda variants.
On August 16, New York City Mayor Bill de Blasio announced that people will be required to provide proof of vaccination before being admitted to indoor venues beginning September 13.
On August 17, Texas Governor Greg Abbott (R) announced that he tested positive for COVID-19 despite being vaccinated.
On August 18, the Robert Wood Foundation published a report finding that more than 1-in-10 adults delayed or are going without health care in the past 30 days due to fear of COVID-19 exposure. The report also found that nearly 1-in-10 parents delayed or did not get care for their children for fear of COVID-19 exposure.
On August 18, Johnson & Johnson (J&J) announced that it plans to share new data regarding J&J COVID-19 vaccine boosters with the FDA and CDC soon.
On August 19, a U.K. study that is not yet peer-reviewed found that the Pfizer COVID-19 vaccine decreased from 85% effective against the delta variant two weeks after the second shot to 75% effective after 90 days. The study also found that the AstraZeneca COVID-19 vaccine decreased from 68% to 61% over the same period. Researchers predicted that after around four to five months, the two vaccines would be similar in the level of protection they provide.
On August 19, the American Medical Association announced that it created new billing codes for third doses of Pfizer’s and Moderna’s COVID-19 vaccines.
On August 19, the Kaiser Family Foundation (KFF) released a report finding that 72% of large health plans no longer provide cost-sharing waivers for COVID-19 treatments.
On August 20, AstraZeneca released positive Phase III results of its COVID-19 antibody treatment, which reduced the risk of developing symptomatic COVID-19 by 77%, and announced that it will seek regulatory approval for the treatment.
As of August 22, more than 201 million people in the U.S. have received the first dose of COVID-19 vaccines (nearly 171 million have received both doses) and more than 428 million doses have been distributed, according to the CDC COVID Data Tracker.
As of August 22, the U.S. had more than 37.7 million confirmed COVID-19 cases resulting in 628,492 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center.
RULES AT THE WHITE HOUSE OMB
HHS-CMS
Modification of Limitations on Redesignation by the Medicare Geographic Classification Review Board (CMS-1762); Interim Final Rule; Received 2/26/21
Basic Health Program; Federal Funding Methodology for Program Year 2022 (CMS-2438); Final Rule; Received 5/12/21
Reporting Requirements Related to Air Ambulance and Agent and Broker Services and HHS Enforcement Provisions; Proposed Rule; 7/7/21
HHS-FDA
Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification; Guidance for Industry; Availability; Notice; 5/11/21
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability; Notice; Received 5/11/21
Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers; Guidance for Industry; Availability; Notice; 5/11/21
Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability; Notice; 5/11/21
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
Patient Protection and Affordable Care Act; Updating Payment Parameters and Improving Health Insurance Markets for 2022 and Beyond (CMS-9906); Final Rule; 8/19/21
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 August 16, OIG released a report entitled Medicare Paid New Hospitals Three Times More for Their Capital Costs Than They Would Have Been Paid Under the Inpatient Prospective Payment System (IPPS). OIG identified significant potential cost savings to Medicare if the IPPS exemption were removed and capital payments to new hospitals were made through the IPPS. The report found that IPPS exemption resulted in new hospitals being paid three times more under the reasonable cost methodology than if they had been paid for their capital costs under the IPPS, costing taxpayers an extra $1.3 million per hospital each year. OIG recommended that, if CMS determines that a separate payment methodology for capital costs at new hospitals is no longer warranted, it should change its regulations to require new hospitals to have their Medicare capital costs paid through the IPPS with an option for payment adjustments or supplemental payments if necessary. CMS agreed with the recommendation. A summary of the report is available here.
On August 16, OIG released a report entitled Missouri Claimed Federal Reimbursement for $3.4 Million in Payments to Health Home Providers That Did Not Meet Medicaid Requirements. The report found that Missouri claimed Federal Medicaid reimbursement for some payments made to health home providers that did not comply with Federal and State requirements because Missouri did not adequately monitor providers for compliance with Federal and State requirements regarding the maintenance of medical records that documented the health home services that the providers furnished to beneficiaries. This resulted in at least $3.4 million improperly claimed payments. OIG recommended that Missouri refund the overpayments and improve its monitoring of the health home program to ensure that health home providers comply with Federal and State requirements for maintaining documentation to support the services for which the providers billed and received payments. Missouri did not agree with the first recommendation and disagreed with the findings but agreed that the health home programs should be monitored. A summary of the report is available here.
On August 17, OIG released a report entitled Mississippi Medicaid Fraud Control Unit: 2020 Inspection. The report found that Mississippi reporting requirements imposed a significant workload on the Mississippi Medicaid Fraud Control Unit (MFCU) that led to many convictions of patient abuse or neglect but also presented challenges to MFCU operations. Mississippi’s MFCU fraud caseload and numbers of fraud convictions were low, compared to those of similarly sized MFCUs. Its efforts to maintain fraud referrals from the Medicaid agency were inconsistent and the MFCU received few fraud referrals. OIG also found operational issues. OIG recommended that the Mississippi MFCU examine its intake process for complaints of patient abuse or neglect and identify improvements, take steps to avoid investigation delays and ensure that delays are documented in the case files, develop and implement a plan to increase fraud referrals from the Medicaid agency and other sources, and improve communication and coordination with OIG investigators and other Federal partners. The Mississippi MFCU agreed with 11 of the recommendations and did not concur with 1 recommendation. A summary of the report is available here.
On August 17, OIG released a report entitled Comparison of Average Sales Prices (ASP) and Average Manufacturer Prices: Results for the First Quarter of 2021. OIG found that six drug codes met CMS' price substitution criteria by exceeding the 5% threshold for two consecutive quarters or three of the previous four quarters, in the first quarter of 2021. OIG provided the six drug codes to CMS for its review. OIG recommended that CMS review this information to determine whether to pursue price substitutions that would limit excessive payments for Part B drugs. A summary of the report is available here.
On August 19, OIG released an advisory opinion regarding an arrangement to incentivize the Medigap policyholders to seek inpatient care from a hospital within the preferred hospital organization network.
On August 19, OIG released a report entitled CGS Administrators, LLC, Claimed Some Unallowable Medicare Supplemental Executive Retirement Plan III Costs Through Its Incurred Cost Proposals.The report found that CGS claimed $6,705 in unallowable Medicare Supplemental Executive Retirement Plan III costs on its Incurred Cost Proposals (ICPs) for CYs 2015 and 2016. OIG recommended that CGS work with CMS to ensure that its final settlement of contract costs reflects a decrease in Medicare SERP III costs. CGS said that it would work with CMS to ensure that its final settlement of contract costs is appropriate. A summary of the report is available here.
On August 19, OIG released a report entitled CGS Administrators, LLC, Claimed Some Unallowable Medicare Pension Costs Through Its Incurred Cost Proposals. The report found that CGS claimed $293,893 in unallowable Medicare pension costs on its ICPs for CYs 2012 through 2016 because it used incorrect indirect cost rates when claiming pension costs for Medicare reimbursement. OIG recommended that CGS work with CMS to ensure that its final settlement of contract costs reflects a decrease in Medicare pension costs. CGS said that it would work with CMS to ensure that its final settlement of contract costs is appropriate. A summary of the report is available here.
On August 19, OIG released a report entitled Medicare Hospital Provider Compliance Audit: Jewish Hospital. The report found that the hospital did not fully comply with Medicare billing requirements for all audited claims, resulting in at least $13.5 million in overpayments. OIG recommended that the hospital refund the overpayments; exercise reasonable diligence to identify, report, and return any additional similar overpayments; and strengthen controls to ensure full compliance with Medicare requirements. The hospital disagreed with almost all the findings and recommendations. A summary of the report is available here.
On August 19, OIG released a report entitled Louisiana Medicaid Fraud Control Unit: 2020 Inspection. The report found that the Louisiana MFCU generally complied with applicable legal requirements, except one case that was ineligible for Federal matching funds during the review period. OIG observed that several positive practices may have contributed to the MFCU’s success, including strong collaboration with Federal law enforcement. OIG recommended that the Louisiana MFCU repay the Federal matching funds spent on the case that was ineligible for Federal funding. The MFCU agreed with the recommendation. A summary of the report is available here.
On August 20, OIG released a report entitled Medicare Home Health Agency Provider Compliance Audit: Catholic Home Care. The report found that Catholic Home Care did not comply with Medicare billing requirements for some audited home health claims, receiving at least $4.2 million in overpayments. OIG recommended that Catholic Home Care refund the overpayments for claims incorrectly billed; exercise reasonable diligence to identify, report, and return overpayments; and strengthen its procedures for billing home health services. report, Catholic Home Care disagreed with the findings. A summary of the report is available here.
Congressional Research Service
On August 18, the Congressional Research Service released a report entitled Status of FY2022 Labor, HHS, and Education Appropriations: In Brief. This report provides an update on the fiscal 2022 Appropriations for Labor, HHS, and Education.
UPCOMING CONGRESSIONAL HEARINGS
House
None of note.
Senate
None of note.
OTHER HEALTH POLICY NEWS
On August 16, eHealth released a report that found that average Affordable Care Act individual premiums decreased 1% year over year, from $456 to $450 per month, though average family premiums remained essentially unchanged, at $1,157 per month. Average premiums increased 40% while family premiums increased 39%, since 2016.
On August 16, Merck announced that it will stop giving contract pharmacies 340B drug discounts beginning September 1. This follows multiple other drug manufacturers also declining to give contract pharmacies 340B drug discounts, including AstraZeneca, Lilly, Novo Nordisk, Sanofi, BI, and United Therapeutics.
On August 16, the Texas Health and Human Services Commission sent a letter to Center for Medicaid & CHIP Services Deputy Administrator and Director Dan Tsai requesting more information regarding why CMS intends to withdraw the state’s Medicaid waiver, specifically which issues apply to which programs. On August 20, U.S. District Judge J. Campbell Parker granted a preliminary injunction to temporarily reinstate the state’s Medicaid waiver program.
On August 17, a study published in JAMA found differences in health care spending by race and ethnicity across different types of care from 2002 through 2016. Per-person spending on ambulatory care was significantly greater for Whites, compared to other races while per-person spending was significantly greater for Blacks for emergency department and inpatient care. Per-person spending was significantly greater for American Indian and Alaska Natives for emergency department care. Hispanic and Asian, Native Hawaiian, and Pacific Islanders had significantly less per-person spending than other populations for most types of care.
On August 17, a study published in JAMA found that between 1999 and 2018, some racial and ethnic differences in self-reported health status and health care access improved, but many differences persisted. Black individuals had a significantly higher prevalence of poor or fair health status than White individuals in 1999, regardless of income.
On August 17, KFF released a report that found that hospital admissions remain below expected levels through early April 2021 and health spending overall for hospitals and ambulatory care remains below expected levels through at least June 2021. The study did not find an increase in hospital admissions due to delayed or forgone care due to COVID-19.
On August 17, KFF released a report that found that Medicare spending for Medicare Advantage (MA) enrollees was $321 higher per person in 2019 than if enrollees had been covered by traditional Medicare. The higher Medicare spending per MA enrollee contributed an estimated $7 billion in additional spending in 2019. The report noted that growth in MA enrollment explains half of the projected increase in total MA spending between 2021 and 2029, while half is attributable to growth in Medicare payments per MA enrollee, after accounting for inflation.