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Below is this week’s “Capitol Hill Healthcare Update,” posted on Mondays when Congress is in session.

Featured in this week’s Update, the Senate votes today on opioids legislation (the House is not in session this week); Congress reaches an agreement on fiscal 2019 healthcare funding; the pharma industry last week suffers both a setback and a victory on the Hill; House, Senate advance pharmacy “gag clause” bills; and more.



SENATE TO VOTE ON OPIOID LEGISLATION TODAY

The Senate is expected to vote today on <a href="http://email.prnewswire.com/wf/click?upn=cihcl7Nv-2FWrAJFaF1BA2WVhVdJbPkLoNVQ-2BrbMEyz62iS0heeazaMUl275of7UOptidGrmvQohXSGZ-2BDzl5FD-2BATct1XOHEDlSH2ytbFAZnbHlRA-2BuPUVOtFLhCUxc7GMSM2JWacZqJ-2BuhpqJs-2F67xuH-2F9CzYAJ-2BXr3GzASGpjJLMgaatVwK0F09NnsT5PQipzO1Ghq1Gr4-2F656Y-2FLeST7VaP1yUM1N4j-2BnT4icgLr0E1R-2BKVt1TT40vixvzVn-2Bgzy0RwH1IrnduK-2BzA-2BiMKBA-3D-3D_uCUFpGLUoBzd6VlLevGlNxFQuWB1GSUZnRxkkpbgPEv1DgMreMCfeF0Ag6gFQwez7y3vUZCWMQI84xOG8aLIU2hyHv8h3ECSOPN7tFjOb6APnkdmrk7vdodH5DLv0N3iUtd4jS40jjrm1eqTV872tdD8Scy2Qm6ned3kxo8Sodb35WM4tSCnfrCk8GyxZkWhyF5O5olCl24ZktV2mU5gXY59MKhs1ICvPMS3sXFrpqx2-2Bm1dVStdZKIrGu-2BhIp8Jjkc8W1CqS4NPrDL0QjNXZUMjy3r9hdVaFxfAJvRXBFoO5acNzHfneEeJG5txHnYUK-2BiuFYkkOjrMut5taHEz2w-3D-3D">legislation</a> to address the opioid epidemic, including expanding access to medication-assisted treatment, cracking down on illicit drug shipments in the mail and new funding to spur research on nonaddictive painkillers.

[caption id="attachment_5489" align="alignleft" width="150"]<img class="wp-image-5489 size-thumbnail" src="https://ohioclockblog.bakerhostetlerblogs.com/wp-content/uploads/sites/27/2018/09/alexander-lamar-rgb-2400-3600-150x150.jpg" alt="" width="150" height="150" /> Sen. Alexander Lamar, R-Tenn.[/caption]

<a href="https://www.help.senate.gov/chair/about">HELP Committee Chairman Lamar Alexander</a>, R-Tenn., has spent the last several weeks stitching together the final legislation, which is composed of more than 70 individual bills approved by five Senate committees, creating new federal treatment options and expanding current ones. The package is expected to win wide bipartisan support.

It would expand telehealth coverage for treatment options, give the <a href="https://www.portman.senate.gov/public/index.cfm/2018/6/senate-house-leaders-release-agreement-on-the-stop-act">U.S. Postal Service new tools</a> to block mail delivery of fentanyl and synthetic opioids, and allow the FDA to require opioids to be prescribed in blister packs of three or seven days’ worth of medication rather than 30-day supplies.

The bill also includes language by <a href="https://www.grassley.senate.gov/">Judiciary Committee Chairman Chuck Grassley</a>, R-Iowa, to expand Sunshine Act reporting to include payments by prescription drug and medical device manufacturers to nurse practitioners, physician assistants, clinical nurse specialists, certified registered nurse anesthetists and certified nurse midwives.

The <a href="https://www.nbcnews.com/politics/congress/house-passes-massive-package-address-opioids-crisis-n884761">House overwhelmingly approved a separate opioid measure</a> in June. Lawmakers are racing to try to pass an opioids bill before Congress adjourns ahead of the November midterm elections, and they hope to be able to approve a final bill before the end of the month. First they will have to resolve differences in each chamber’s bills, notably language in the House-passed bill that would permit Medicaid reimbursement for inpatient drug rehabilitation services, and allowing Medicare to cover non-opioids.

LAWMAKERS AGREE ON FUNDING FOR HHS, HEALTH PROGRAMS

House and Senate appropriations negotiators agreed last week to a <a href="https://www.appropriations.senate.gov/news/defense-labor-hhs-education-minibus-conference-report-filed">spending bill</a> for HHS, federal health programs and medical research that also would avoid a potential government shutdown Oct. 1.

The <a href="https://www.appropriations.senate.gov/download/conf-report_-hr-6157">sweeping spending package</a> covering labor, health and education programs would be paired with Pentagon funding – covering almost 70 percent of government discretionary spending for fiscal 2019.

The package includes stopgap funding through Dec. 7 covering any separate appropriations bill not approved by the Oct. 1 start of the fiscal year. If signed into law by President Donald Trump, the legislation would delay any partisan fights over unresolved spending issues – such as funding for the U.S.-Mexican border wall – until after the midterm elections in November.

Under the agreement, HHS’ budget would rise to $90.5 billion, $2.3 billion more than the current fiscal year, according to a <a href="https://appropriations.house.gov/news/documentsingle.aspx?DocumentID=395415">summary released by the House Appropriations Committee</a>. NIH would receive a $2 billion increase to $39 billion. The additional funding would target oncology and Alzheimer’s research.

CDC would receive $7.9 billion for programs to protect against health threats such as pandemics and bio-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 support access to mental health services would receive $6.7 billion.

The Senate is expected to vote on the legislation this week, and the House would take it up next week.

PHARMA INDUSTRY SUFFERS SETBACK ON PART D BUT WINS ON ADS

Despite months of aggressive lobbying, Congress last week didn’t adopt language sought by pharmaceutical manufacturers to lower the industry’s contributions to eliminate the coverage gap in the Medicare Part D prescription drug program.

Industry is fighting to roll back a change Congress passed in February that requires manufacturers to increase from 50 percent to 70 percent the discount provided for brand-name drugs in the coverage gap, or the so-called donut hole. That change actually reduced costs for Part D insurers and pharmacy benefit managers. Congress’ budget scorekeepers acknowledged after the change was enacted that they had miscalculated the impact of increasing the manufacturer’s contribution.

Congressional leaders had a tenuous bipartisan agreement to pair lowering the industry’s donut hole contribution to 63 percent with separate legislation to prevent manufacturers from delaying generic companies’ access to <a href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609365.htm">drugs protected by FDA’s REMS safety program</a>. But negotiations on the donut hole were complicated because House and Senate leaders were backing different REMS language that also would have had different budget scoring impacts.

Industry officials and their allies on Capitol Hill were trying to include the coverage gap change – along with blocking a planned 2020 increase in seniors’ Part D out-of-pocket costs – in the fiscal 2019 appropriations bill for HHS and federal health programs. But it was dropped amid the final horse trading on scores of separate policy riders in the underlying bill.

The pharma industry will try again to attach its fix to year-end budget legislation Congress is expected to consider in December.

<a href="https://twitter.com/ChuckGrassley/status/1040261329557381120"><img class="alignright wp-image-5508 size-medium" src="https://ohioclockblog.bakerhostetlerblogs.com/wp-content/uploads/sites/27/2018/09/GrassleyTweet091718-300x232.png" alt="" width="300" height="232" /></a>The industry was successful in rebuffing Senate-approved language backed by the Trump administration that would have required drugmakers to include prices in their television and other consumer advertising. The provision was pushed by <a href="https://www.grassley.senate.gov/">Senate Judiciary Committee Chairman Chuck Grassley</a>, R-Iowa, and <a href="https://www.durbin.senate.gov/">Democratic Whip Dick Durbin</a>, D-Ill. Grassley <a href="https://twitter.com/ChuckGrassley/status/1040261329557381120">tweeted</a> that dropping his provision from the final bill was a “bow to big pharma at expense of consumers.”

In negotiations with the Senate, House Republicans advocated removing the provision, saying it could lead to confusion among consumers and was misleading because consumers’ out-of-pocket expenses depend on the discounts and rebates their insurers negotiate. Still, HHS is developing a plan to implement the pricing requirement through <a href="https://www.reginfo.gov/public/do/eoDetails?rrid=128403">proposed rulemaking</a>.

TRANSPARENCY, INNOVATION SUBJECT OF SENATE PANEL HEARINGS

The Senate HELP Committee on Tuesday will hold a <a href="https://www.help.senate.gov/hearings/reducing-health-care-costs-examining-how-transparency-can-lower-spending-and-empower-patients">hearing</a> on how transparency can lower healthcare costs for patients and payers.

The committee scheduled <a href="https://www.help.senate.gov/hearings/reducing-health-care-costs-improving-affordability-through-innovation">another hearing</a> for Sept. 27 that will focus on how innovation is reducing healthcare spending.

Scheduled witnesses Tuesday include Leah Binder, president and CEO of The Leapfrog Group in Washington; Bill Kampine, senior vice president for client analytics for Healthcare Bluebook in Nashville; Nancy Giunto, executive director of the Washington Health Alliance in Seattle; and Ty Tippets, administrator of the St. George Surgical Center in St. George, Utah.

HOUSE COMMITTEE OKs BILL BLOCKING PHARMACY ‘GAG CLAUSE’

The House Energy and Commerce Committee last week <a href="https://energycommerce.house.gov/news/press-release/ec-advances-six-bipartisan-bills/">unanimously approved</a> bipartisan legislation that would allow pharmacists to tell patients that paying for certain prescription drugs with cash could be less expensive than their insurance copay.

[caption id="attachment_5509" align="alignleft" width="150"]<img class="size-thumbnail wp-image-5509" src="https://ohioclockblog.bakerhostetlerblogs.com/wp-content/uploads/sites/27/2018/09/Carter_Buddy-150x150.jpg" alt="" width="150" height="150" /> Rep. Buddy Carter, R-Ga.[/caption]

Currently, pharmacies can be contractually prohibited by insurers and pharmacy benefit managers from informing consumers that paying cash could be cheaper than using insurance. Sponsored by pharmacist and <a href="https://buddycarter.house.gov/">Rep. Buddy Carter</a>, R-Ga., the <a href="https://www.congress.gov/bill/115th-congress/house-bill/6733?q=%7B%22search%22%3A%5B%22hr6733%22%5D%7D&amp;r=1">legislation</a> would overturn those so-called pharmacist gag clauses in both employer-based insurance and Medicare.

The Senate earlier this month approved <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., banning gag clauses in Medicare plans. It plans to vote this week on <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 expand the ban to employer-provided plans as well as insurance exchange coverage.

Separately, the committee also approved legislation by Reps. <a href="https://joebarton.house.gov/biography/">Joe Barton</a>, R-Texas, and <a href="https://joebarton.house.gov/biography/">Betty Castor</a>, D-Fla., that aims to <a href="https://www.childrenshospitals.org/Issues-and-Advocacy/Children-With-Medical-Complexity">improve care under Medicaid for children with complex medical conditions</a&gt;; <a href="https://www.congress.gov/bill/115th-congress/house-bill/3891?q=%7B%22search%22%3A%5B%22hr+3891%22%5D%7D&amp;r=1">legislation</a> by Reps. <a href="https://walberg.house.gov/">Tim Walberg</a>, R-Mich., and <a href="https://welch.house.gov/">Peter Welch</a>, D-Vt., to enhance the authority of state Medicaid officials to investigate patient abuse and neglect; and <a href="https://www.congress.gov/bill/115th-congress/house-bill/5306?q=%7B%22search%22%3A%5B%22hr+5306%22%5D%7D&amp;r=1">legislation</a> by Reps. <a href="https://guthrie.house.gov/">Brett Guthrie</a>, R-Ky., and <a href="https://debbiedingell.house.gov/">Debbie Dingell</a>, D-Mich., to extend a federal pilot that provides resources to state Medicaid programs to transition individuals with chronic conditions and disabilities from institutions into local communities.

HOUSE APPROVES SERIES OF MEDICARE BILLS

The House last week <a href="https://waysandmeans.house.gov/brady-applauds-house-passage-of-4-bipartisan-health-bills/">approved four bipartisan healthcare bills</a>, including a Medicare smart card identification pilot program and codifying how Medicare contractors make local reimbursement decisions.

The <a href="https://www.congress.gov/bill/115th-congress/house-bill/6690?q=%7B%22search%22%3A%5B%22hr+6690%22%5D%7D&amp;r=1">smart card bill</a>, introduced by Reps. <a href="https://roskam.house.gov/">Peter Roskam</a>, R-Ill., and <a href="https://blumenauer.house.gov/">Earl Blumenauer</a>, D-Ore., would create a three-year pilot program to test the use of the technology.

Reps. <a href="https://lynnjenkins.house.gov/">Lynn Jenkins</a>, R-Kan., and <a href="https://kind.house.gov/">Ron Kind</a>, D-Wis., introduced the <a href="https://www.congress.gov/bill/115th-congress/house-bill/3635?q=%7B%22search%22%3A%5B%22hr+3635%22%5D%7D&amp;r=1">legislation</a> to codify requirements that Medicare administrative contractors must follow when making local coverage determinations, including open meetings for stakeholders, timely feedback to public comments and a reconsideration process. The medical device industry trade group AdvaMed <a href="https://www.advamed.org/newsroom/press-releases/advamed-urges-senate-action-following-house-passage-medicare-lcd-improvement">praised</a> House passage of the bill.

The House also approved <a href="https://www.congress.gov/bill/115th-congress/house-bill/6662?q=%7B%22search%22%3A%5B%22hr+6662%22%5D%7D&amp;r=1">legislation</a> by Reps. <a href="https://www.cms.gov/Medicare/Coverage/DeterminationProcess/index.html">Erik Paulsen</a>, R-Minn., and <a href="https://kind.house.gov/">Ron Kind</a>, D-Wis., codifying existing regulations that ensure certain Medicare beneficiaries have time to make decisions about their Medicare coverage.