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Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. Highlights this week: The Senate will give the final OK to opioids legislation, HHS gets full-year funding for the first time in forever, new bipartisan legislation would allow FDA to update labels on older generic drugs, and more.



SENATE THIS WEEK EXPECTED TO PASS OPIOIDS BILL

After months of hearings, anguished testimony and negotiations over policy and funding, the Senate this week is expected to give final congressional approval to <a href="https://www.congress.gov/bill/115th-congress/house-bill/6?q=%7B%22search%22%3A%5B%22hr6%22%5D%7D&amp;r=1">sweeping bipartisan legislation</a> that aims to respond to the national opioid crisis.

The revised legislation would authorize $8 billion in grant programs for states, crack down on illicit drug shipments in the mail, and expand Medicare coverage of telehealth services to treat opioid and substance abuse. It also would expand access to and Medicaid reimbursement of addiction treatment services, including coverage of certain inpatient substance abuse facilities.

A section-by-section analysis of the legislation can be found <a href="https://urldefense.proofpoint.com/v2/url?u=https-3A__energycommerce.house.gov_wp-2Dcontent_uploads_2018_09_HR6-5F09.26.18-2DFinal-2DOpioid-2DSec-2Dby-2DSec-5FBIPART-2DBICAM.pdf&amp;d=DwMFAg&amp;c=tlFs99Fl3Rlo51LXUBQcug&amp;r=IBlATBCE-HcC5TsewbmtEO1rqHIG4NnQw39wBu6HhuU&amp;m=Bjc9o2umjpQPlZ-FzXhLrTP1RsaLPflfb0mjAuCLNeg&amp;s=z5aJSnf1LC7U1gzOyDXa0S69PgvBhJSmHJhcJBbi21o&amp;e=">here</a>.

The House on Friday <a href="http://clerk.house.gov/evs/2018/roll415.xml">approved</a> the bill 393-8.

FULL-YEAR HHS, HEALTH PROGRAM FUNDING SIGNED INTO LAW

President Donald Trump last week <a href="https://www.appropriations.senate.gov/news/president-signs-defense-package-into-law-enacts-most-on-time-spending-bills-in-two-decades">signed into law</a> the fiscal 2019 <a href="https://www.appropriations.senate.gov/news/president-signs-defense-package-into-law-enacts-most-on-time-spending-bills-in-two-decades">appropriations bill for HHS</a>, marking the first time in more than two decades that Congress has approved yearlong funding for federal health programs and medical research.

Since 1996, Congress has passed HHS funding only in temporary, stopgap bills because lawmakers were bogged down by partisan disputes over funding and controversial policy riders.

The 2019 federal fiscal year begins today.

Under the new law, HHS receives $90.5 billion, a $2.3 billion increase. NIH sees a $2 billion increase to $39 billion for basic research in oncology, and for Alzheimer’s and other diseases, according to a <a href="https://appropriations.house.gov/news/documentsingle.aspx?DocumentID=395415">summary released by the House Appropriations Committee</a>.

The CDC receives $7.9 billion for programs to protect against health threats such as pandemics and biological threats, and $2 billion for biomedical research, acquisition of medical supplies and vaccines, and hospital preparedness grants. Federal programs that help fight, treat and stop substance abuse and those that support access to mental health services receive $6.7 billion.

The law also includes stopgap funding through Dec. 7 covering the seven other appropriations bills Congress didn’t approve before today. 

BIPARTISAN SENATE BILL SEEKS TO UPDATE LABELS FOR GENERIC DRUGS

New <a href="https://www.congress.gov/bill/115th-congress/senate-bill/3519?q=%7B%22search%22%3A%5B%22s3519%22%5D%7D&amp;r=1">bipartisan legislation</a> introduced in the Senate last week would give FDA authority to update labels for generic drugs that don’t have branded competitors.

Introduced by <a href="https://www.hatch.senate.gov/public/index.cfm/home">Senate Finance Committee Chairman Orrin Hatch</a>, R-Utah, and <a href="https://www.bennet.senate.gov/public/">Sen. Michael Bennet</a>, D-Colo., the legislation would authorize FDA to modify outdated labels to reflect new evidence relevant to a drug and its use – including off-label use.

“In an ideal world, a drug’s label would contain all available information healthcare professionals need to prescribe it effectively,” Hatch <a href="https://www.hatch.senate.gov/public/index.cfm/releases?ID=64AEC40C-2863-4216-933D-26EFDC0E652F">said</a>. “Due to a variety of reasons, that is not always the case, and physicians are sometimes left to consult outside sources for up-to-date prescribing information.”

Current law requires generic drugs to have the same labels as the brand drugs they reference. But when an older drug is withdrawn from the market, the generic manufacturer is unable to update its label.

FDA Commissioner Scott Gottlieb told a Senate appropriations subcommittee last spring that out-of-date labels can reduce the use of generic drugs and therefore increase costs for payers and patients.

“If the brand drug sponsor has voluntarily withdrawn their marketing application, there’s no sponsor who is responsible for making any necessary label updates that other generic applicants would follow,” <a href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm605539.htm">Gottlieb told the Senate panel</a>. “The result is that these drug labels get frozen in time.”

HOUSE GIVES FINAL OK TO PHARMACY ‘GAG CLAUSE’ BILLS

The House last week gave final congressional approval to two bills that would permit pharmacists to tell consumers that paying cash for certain prescription drugs could be cheaper than out-of-pocket costs using insurance.

The Senate last month approved <a href="https://www.congress.gov/bill/115th-congress/senate-bill/2554?q=%7B%22search%22%3A%5B%22S2554%22%5D%7D&amp;r=1">legislation</a> by <a href="https://www.collins.senate.gov/">Sen. Susan Collins</a>, R-Maine, to prohibit the so-called pharmacy gag clauses in employer-provided insurance plans. The Senate also backed <a href="https://www.congress.gov/bill/115th-congress/senate-bill/2553?q=%7B%22search%22%3A%5B%22S2553%22%5D%7D&amp;r=1">legislation</a> by <a href="https://www.stabenow.senate.gov/">Sen. Debbie Stabenow</a>, D-Mich., that would ban the gag clauses in Medicare and Medicare Advantage plans.

The House last week approved both bills on voice votes.

President Donald Trump is expected to sign the two bills into law. He <a href="https://twitter.com/realdonaldtrump/status/1041751173034848260?lang=en">tweeted</a> last week that “Americans deserve to know the lowest drug price at their pharmacy, but ‘gag clauses’ prevent your pharmacist from telling you!”

HOUSE OKs MEASURE FOR EMERGENCY HEALTH RESPONSE

The House last week <a href="https://energycommerce.house.gov/news/press-release/house-passes-bills-to-lower-prescription-drug-costs-improve-pandemic-preparedness/">approved</a> by voice vote <a href="https://www.congress.gov/bill/115th-congress/house-bill/6378?q=%7B%22search%22%3A%5B%22hr6378%22%5D%7D&amp;r=1">bipartisan legislation</a> reauthorizing federal health emergency programs, including research on vaccines and antibiotics for drug-resistant bacteria that could be needed during public health emergencies.

Introduced by Reps. <a href="https://susanwbrooks.house.gov/">Susan Brooks</a>, R-Ind., and <a href="https://eshoo.house.gov/">Anna Eshoo</a>, D-Calif., the legislation would support a federal framework for emergency preparedness in the case of a disease outbreak. It also would renew for five years key preparedness and response programs within the Pandemic and All-Hazards Preparedness Act.

It also would authorize $611 million annually through 2023 to develop medical countermeasures for pandemic influenza and emerging infectious diseases within the Biomedical Advanced Research and Development Authority. More than $7 billion could be used for the government to purchase and stockpile these treatments. However, the legislation does not include new market exclusivities to incentivize pharmaceutical manufacturers to invest in research for new antibiotics.

It’s not clear whether the Senate will take up the bill this month before adjourning for the November midterm elections. The Senate does have similar emergency health response <a href="https://www.congress.gov/bill/115th-congress/senate-bill/2852?q=%7B%22search%22%3A%5B%22s2852%22%5D%7D&amp;r=1">legislation</a> by <a href="https://www.burr.senate.gov/">Sen. Richard Burr</a>, R-N.C., that won approval this summer in the HELP Committee.

NOTE TO READERS: The House adjourned last week until after the November congressional elections. The Senate is likely to be session for nearly all of October but focusing mostly on approving judicial and other Executive Branch nominations. “Capitol Hill Healthcare Update” will resume publishing when Congress reconvenes after the elections. But check back here to the <a href="https://www.ohioclock.com/">Ohio Clock blog</a> for any healthcare policy developments or other news from Capitol Hill.