On The Hill

Congress Fails to Advance ‘Skinny’ Relief Bill

On Thursday (Sep. 10), the Senate voted 52-47 on the Republican COVID-19 relief “skinny package.” The bill did not receive the 60 votes necessary to pass out of the chamber. Senator Rand Paul (R-KY) was the sole Republican to vote against the bill. The legislation included funding for the Paycheck Protection Program, expanded unemployment benefits, schools, the U.S. Postal Service, and liability protections for businesses, schools, and health care providers.

 

WH Requests Inclusion of Health Extenders in Budget CR

While the House has passed ten of its twelve FY 2021 appropriation packages, the Senate has not. Leadership has indicated a Continuing Resolution (CR) will be necessary to avert a government shutdown after the September 30 funding expiration date. The Office of Management and Budget (OMB) has requested a number of extenders, including many health extenders, to be included in the impending CR.

A number of health programs, including the Special Diabetes Programs, teaching health center graduate medical education program, community mental health services demonstration, Money Follows the Person demonstration, State Health Insurance Programs, Area Agencies on Aging, and Aging Disability and Resource Centers, were extended through November 30 in the CARES Act. However, OMB is requesting these programs be included in the CR.^[1] 

Additionally, OMB would like to see the following programs extended: a floor on the work geographic adjustments under the Medicare Physician Fee Schedule, funding for CMS’ quality measure work, spousal impoverishment protection for beneficiaries of home- and community-based services, a further extension of the DSH cut delay and an extension of the Medicare Rural Community Hospital Demonstration.

To view the complete OMB request, click here.

A list of health extenders can be found on page 3. Inclusion in this request does not guarantee inclusion in the CR.

 

HHS Submits Canadian Drug Importation Final Rule for Review

On Thursday (Sep. 10), HHS submitted a final rule on the importation of prescription drugs from Canada to the White House for review.

Under the new rule, states and other non-federal entities would be permitted to propose importation plans to the FDA. Importation plans could be co-sponsored by pharmacies, wholesalers, states, or non-federal entities. FDA would approve the plans based on the level of consumer savings.^[2] 

Controlled substances, biological products, and intravenous drugs – including insulin – are excluded from importation under the proposed rule.

U.S. drug manufacturers and pharmacists oppose the plan. U.S. manufacturers have cited safety issues that may arise due to a lack of supply chain and labeling oversight, and pharmacists doubt the proposal would lower costs significantly as high cost drugs, like insulin, are excluded under the rule. Additionally, pharmacists claim the costs of relabeling and retesting drugs that are included would outweigh savings.

Canadian pharmacists also oppose the proposal due to concerns that populous states, should they opt to participate, could enhance Canada’s drug shortages by importing already limited drug stores.

Six states – Colorado, Vermont, Florida, Maine, New York, and New Mexico – have already begun work on their Canadian drug importation plans.

 

HHS Releases COVID-19 Vaccine Pharmacist Guidance

Last Thursday (Sep. 3), HHS released guidance for state-licensed pharmacists on COVID-19 vaccine administration. The guidance denotes these practitioners as an Authority Having Jurisdiction under the Public Readiness and Emergency Preparedness Act (PREP Act) to order and administer COVIS-19 vaccinations to individuals aged three and up. Additionally, registered pharmacy interns under the supervision of a state-licensed pharmacist are authorized to administer a vaccine. State-licensed pharmacists and pharmacy interns licensed or registered by their State board of pharmacy must satisfy a number of requirements.

To view the HHS guidance and list of requirements, click here.

 

Hahn, Shah Publish CNBC Op-Ed on Medical Supply Chain

On Thursday (Sep. 10), Food and Drug Administration (FDA) Commissioner Stephen M. Hahn and Deputy Commissioner for Medical and Scientific Affairs Anand Shah wrote an op-ed in CNBC about onshoring America’s critical medical supply chain and modernizing infrastructure for life sciences. Hahn and Shah argued the U.S. supply chain was under pressure prior to the COVID-19 pandemic. They noted the rapid depletion of the Strategic National Stockpile (SNS) and shortages of drugs and medical supplies, including gowns and masks, as a result of the U.S.’ dependency on other countries.

The article highlights two main problems: companies are incentivized to outsource medical manufacturing to countries such as China and India due to low labor and manufacturing costs; and the adoption of new manufacturing technologies has been slow, leaving companies to rely on old processes for producing drugs and devices. As a solution, they called for improved data to “untangle the knots in our supply chains,” efforts to incentivize manufacturers to return to the U.S., and investments in medical manufacturing focused on new technologies.

Hahn and Shah claim COVID-19 serves as an “overdue reminder” for medical manufacturing to return to the U.S., and the U.S. needs commitments from industry to give the health system the choice to “Buy American” when it comes to medical products.

To view the full op-ed in CNBC, click here.

 

Biden Adds Detail to “Buy America” Plan

On Wednesday (Sep. 9), Democratic presidential nominee Joe Biden outlined his plans to boost manufacturing and toughen “Buy American” provisions for federal contracts. Additionally, Biden proposed tax penalties on companies that manufacture U.S.-bound products outside the country, incentives to keep jobs in the U.S., and close what he called “Trump loopholes” that allow companies engaged in offshoring to avoid paying U.S. taxes.

To view the Biden/Harris Buy America fact sheet, click here.

 

Senate HELP Receives COVID-19 Vaccine Update from Dir. Collins, SG Adams

On Wednesday (Sep. 9), the Senate Committee on Health, Education, Labor and Pensions heard testimony from NIH Director Francis Collins and U.S. Surgeon General Jerome Adams on vaccine safety, efficacy, and distribution planning.

To view an executive summary of the hearing, click here.

 

House E&C Holds Markup of 26 Health Bills

On Wednesday (Sep. 9), the House Committee on Energy and Commerce held a 38 bill markup. All 26 health bills – which centered on public health program reauthorization, mental health, and substance use – were reported favorably to the House.

To view an executive summary of select health bills, click here.

For a complete list of bills and amendments, click here.

 

References

^[1] Stein, Michelle, “White House Wants Extenders In Fiscal 2021 Continuing Resolution,” Inside Health Policy, 9 Sep. 2020 https://link.edgepilot.com/s/37cd666a/FoMcdIBh406PB-kvPAqZQA?u=https://insidehealthpolicy.com/daily-news/white-house-wants-extenders-fiscal-2021-continuing-resolution

^[2] Cohen, Ariel “Canadian Drug Imports Final Rule Under Review At OMB,” Inside Health Policy, 11 Sep. 2020. https://link.edgepilot.com/s/572ebe48/IL7_RHRrgE_X4DVopSXcfA?u=https://insidehealthpolicy.com/inside-drug-pricing-daily-news/canadian-drug-imports-final-rule-under-review-omb%23:%7E:text=HHS%2520submitted%2520for%2520White%2520House%2Cimport%2520prescription%2520drugs%2520from%2520Canada.%26text=The%2520proposal%2520would%2520allow%2520states%2Cimportation%2520programs%2520for%2520FDA%2520review