This week in Washington: Mnuchin and Pelosi continue discussions for COVID-19 stimulus package.
Congress
House
- Democrats Ask GAO to Investigate Legality of President Trump’s Medicare Drug Gift Cards
- Pelosi Rejects Trump Administration’s $1.8 Trillion COVID-19 Relief Package, Mnuchin Willing to Negotiate Further
Senate
- Sen. Alexander and Rep. Walden Ask for Input on Modernizing 340B Drug Pricing Program
Administration
- CMS Administrator Verma Says Innovation Center Needs Course Correction
- CMS Changes Medicare Payment for Faster COVID-19 Diagnostic Testing
- CMS Approves Medicaid Work Requirements, Partial Expansion for Georgia
- CMS Expands Medicare Telehealth List
- CDC Adds COVID-19 Vaccine Information to Website
- FDA Advises Health Care Professionals and Patients on Insulin Pen Packaging and Dispensing
- Tribal Nations Can Choose Whether to Get Vaccine from IHS or States
- Trump Administration Concerned with Challenges Facing Drug Import Rule
Proposed Regulations/Guidance
- HHS: Stakeholder Group to Address Health Coverage for Released Inmates
- HHS Proposes Rule to Implement President Trump’s Insulin Executive Order
Final Regulations/Guidance
- FDA: Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests during the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
Courts
- Public Citizen Sues HHS to Release Coronavirus Vaccine Contracts
House
Democrats Ask GAO to Investigate Legality of President Trump’s Medicare Drug Gift Cards
On Oct. 13, House Energy & Commerce Chair Frank Pallone (D-NJ), House Ways & Means Chair Richard Neal (D-MA) and Senate Finance ranking member Ron Wyden (D-OR) sent a letter to the Government Accountability Office (GAO) to review the legality of President Trump’s $200 Medicare drug discount cards. President Trump promised to hand out $200 gift cards to help Medicare Part D beneficiaries cover their copays. Only seniors would receive the cards before the election. However, the Democratic members say in the letter that the cards are almost like buying votes, and question whether the cards are legal before an upcoming presidential election.
Pelosi Rejects Trump Administration’s $1.8 Trillion COVID-19 Relief Package, Mnuchin Willing to Negotiate Further
On Oct. 12, House Speaker Nancy Pelosi (D-CA) rejected the Trump administration’s $1.8 billion COVID-19 stimulus offer. She argued that the proposal ignored key economic issues during the pandemic and is $400 billion less than the Democrats’ proposal. The topline spending amounts and some of the major provisions have been confirmed, but no one has publicly seen the text. Democrats oppose an insufficient strategy for COVID-19 testing and tracing, and liability protection, which would shield corporations from coronavirus-related lawsuits. Treasury Secretary Steven Mnuchin responded that the Trump administration is willing to compromise with House Democrats over a provision on testing in a relief proposal.
Senate
Sen. Alexander and Rep. Walden Ask for Input on Modernizing 340B Drug Pricing Program
On Oct. 9, Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Lamar Alexander (R-TN) and House Energy and Commerce Committee ranking member Greg Walden (R-OR) released a statement calling for input on how to improve the 340B Drug Pricing Program. Suggestions from stakeholders must be submitted by Oct. 30, 2020, to the following email addresses: 340B@help.senate.gov and 340B@mail.house.gov.
Find the full statement here.
Administration
CMS Administrator Verma Says Innovation Center Needs Course Correction
On Oct. 15, the Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma said the Innovation Center (CMMI) demonstrations are losing money and CMS needs a course correction, including less-generous model benchmarks. CMS has developed 54 payment models, but evaluation data on the early models shows only five models indicated statistically significant savings and only three have been expanded nationally. Only a handful have seen significant quality improvements. Another concern by Verma is that the voluntary demos are designed with an abundance of financial carrots to attract providers, but that is not enough to avoid significant losses. She pointed to evaluations that reveal net losses after participants see their enhanced payments.
CMS Changes Medicare Payment for Faster COVID-19 Diagnostic Testing
On Oct. 15, the Centers for Medicare and Medicaid Services (CMS) announced actions to pay for expedited COVID-19 test results. As of Jan. 1, 2021, Medicare will pay $100 only to laboratories that complete high throughput COVID-19 diagnostic tests within two calendar days of the specimen’s being collected. In addition, for laboratories that take longer than two days to complete these tests, Medicare will pay a rate of $75. Medicare will make an additional $25 add-on payment to laboratories for a COVID-19 diagnostic test run on high throughput technology if the laboratory: a) completes the test in two calendar days or less, and b) completes the majority of their COVID-19 diagnostic tests that use high throughput technology in two calendar days or less for all of their patients the previous month.
Find more information here.
CMS Approves Medicaid Work Requirements, Partial Expansion for Georgia
On Oct. 15, the Centers for Medicare and Medicaid Services (CMS) approved an 1115 waiver to allow Georgia to partially expand Medicaid and impose work requirements. However, as Georgia did not fully expand Medicaid, CMS declined to give the state an enhanced federal match for its expanded population, keeping with a policy it publicly established last year. Georgia’s waiver, which was submitted in December, establishes a partially expanded Medicaid program for adults with incomes up to 95 percent of the federal poverty level who were not previously eligible for Medicaid. This new category of Medicaid beneficiaries will be required to complete a minimum of 80 hours of work requirements a month. Those in the program will be required to report their work requirements activities monthly.
CMS Expands Medicare Telehealth List
On Oct. 14, the Centers for Medicare and Medicaid Services (CMS) expanded the list of telehealth services that Medicare Fee-for-Service will pay for during the coronavirus pandemic. CMS is also providing additional support to state Medicaid and Children’s Health Insurance Program (CHIP) agencies in their efforts to expand access to telehealth. For the first time using a new expedited process, CMS has added 11 new services to the Medicare telehealth services list since the publication of the May 1, 2020, COVID-19 Interim Final Rule. CMS will begin paying eligible practitioners who furnish these newly added telehealth services effective immediately, and for the duration of the pandemic. These new telehealth services include certain neurostimulator analysis and programming services, and cardiac and pulmonary rehabilitation services.
Find more information here.
CDC Adds COVID-19 Vaccine Information to Website
On Oct. 14, the Centers for Disease Control and Prevention (CDC) added vaccine information to its COVID-19 webpage. The new content includes what health care providers should know about U.S. vaccination plans, how the CDC makes vaccination recommendations and answers to frequently asked questions.
Find the update here.
FDA Advises Health Care Professionals and Patients on Insulin Pen Packaging and Dispensing
On Oct. 13, the Food and Drug Administration (FDA) clarified the intent of the November 2019 revisions to labeling for insulin pens, which state that health care professionals should dispense the pens to a single patient in the original sealed carton. There is an increased risk of dispensing errors and patients’ using the wrong product if individual insulin pens are stored or dispensed outside of their carton. Insulin pens dispensed individually outside of their cartons may have contributed to medication errors including wrong-drug and wrong-dose errors resulting in hyper- or hypoglycemia, missed doses, complaints of possible tampering and dispensing without the instructions for use.
Find more information here.
Tribal Nations Can Choose Whether to Get Vaccine from IHS or States
On Oct. 9, the Centers for Disease Control and Prevention (CDC) announced that tribes would be able to choose whether they receive future COVID-19 vaccines through their states or through the Indian Health Service (IHS). As part of its distribution and allocation planning, the federal government is aiming to enter an agreement with tribes that will establish how tribal nations decide access to a COVID-19 vaccine for their own members. The federal government also will provide ongoing technical assistance to tribes and IHS, just as it does with other jurisdictions at the state, territorial or city levels.
Trump Administration Concerned with Challenges Facing Drug Import Rule
On Oct. 15, a Trump campaign policy advisor said legal and regulatory obstacles might challenge the implementation of the administration’s drug importation rule. The $200 Medicare Part D gift cards for seniors promised by President Trump are dependent on the drug importation rule’s going into effect. Four states have taken steps to import drugs from Canada: Vermont, Colorado, Florida and Maine. New Mexico and New York also plan to import drugs from Canada and are working on their respective plans.
Proposed Regulations/Guidance
HHS: Stakeholder Group to Address Health Coverage for Released Inmates
On Oct. 1, the Department of Health and Human Services (HHS) solicited nominations for a group that will examine policies and strategies to help individuals who were eligible for Medicaid while incarcerated transition back into health coverage when they reenter communities.
The group will consist of 24 stakeholders, including two federal members, and will meet once to develop best practices for states to ease the health care-related transition for an individual who is incarcerated back to the community. The group will also discuss practices that ensure continuity of health insurance coverage under commercial coverage or Medicaid; and ensure that transition is done no later than 30 days after the individual is released.
The group is required to submit a report to HHS and Congress. HHS is seeking 22 non-federal members who are representatives of managed care organizations, Medicaid beneficiaries, health care providers, the National Association of Medicaid Directors, state Medicaid agencies and representatives from local and state prison systems. HHS will appoint one member to lead the group.
Find the solicitation here. Nominations are due by Oct. 23, 2020.
HHS Proposes Rule to Implement President Trump’s Insulin Executive Order
On Sept. 28, the Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), released a notice of proposed rulemaking to ensure community health centers receive grants for the purchase of insulin and injectable epinephrine through the 340B Drug Pricing Program. These discounted drugs will be available to community health center patients with low incomes who also have health insurance with a high cost-sharing requirement for either insulin or injectable epinephrine, health insurance with a high unmet deductible or no health insurance.
Find the proposed rule here. Public comments are due by Oct. 28, 2020.
Final Regulations/Guidance
FDA: Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests during the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
On Oct. 12, the Food and Drug Administration (FDA) released a final guidance to provide a policy to help expand access to certain FDA-cleared molecular assays intended for detection and identification of influenza (flu) viruses, including those molecular influenza assays that also detect and identify respiratory syncytial viruses (RSV), during the influenza season and for the duration of the COVID-19 public health emergency. This policy is intended to remain in effect only for the duration of the COVID-19 pandemic.
Find the final guidance here.
Courts
Find a comprehensive look at “Courts and Healthcare Policy in 2020” here.
Public Citizen Sues HHS to Release Coronavirus Vaccine Contracts
On Oct. 15, Public Citizen filed a lawsuit against the Department of Health and Human Services (HHS) to compel disclosure of coronavirus vaccine development and manufacturing contracts with major pharmaceutical corporations that are worth billions of dollars. The suit, filed in the U.S. District Court for the District of Columbia, challenges HHS’s withholding of records requested by Public Citizen under the Freedom of Information Act (FOIA) related to Operation Warp Speed, the Trump administration’s initiative to accelerate the development of COVID-19 treatments and vaccines.
Find more information here.
