HEALTH CARE BRIEFING: Democrat Seeks United Party on Home Health

A top senator is trying to unify fellow Democrats in supporting a massive investment in home- and community-based health-care services, but faces slim margins in both chambers of Congress.

Sen. Bob Casey (D-Pa.) yesterday unveiled his plan to make what he calls a “historic investment” in Medicaid home- and community-based services. His goal is to cut down the waitlists for such services for the elderly and disabled, as well as to improve pay for home-care workers.

“We can’t just say we’re going to expand Medicaid to get rid of the waiting list—but we’re still going to have the same $12-an-hour-workforce,” Casey said in an interview. “We want that balance.”

Casey said he’s found no support from Republicans for his plan, and hopes to pass the bill as part of a wider jobs and infrastructure package with only Democratic votes in the Senate. That means Casey will need to unify Democrats behind his plan in an even, 50-50 split chamber. Already 40 Senate Democrats have signed onto the legislation.

Casey told reporters yesterday the main obstacles are likely the price tag and finding ways to pay for it. The plan would authorize $100 billion for state grants, but the final cost may wind up much higher, depending on how many states elect to participate.

Helping Casey’s effort: unions and domestic workers groups that often align with Democrats are backing the proposal, saying it’s an essential start to better pay and benefits for home-care workers. “So many years we’ve been pushing on this, with no traction,” Ai-jen Poo, executive director of the National Domestic Workers Alliance, said. Read more from Alex Ruoff.

Happening on the Hill

Nominations: Two high-level nominees for the Department of Health and Human Services were confirmed yesterday by voice vote in the Senate. Dawn O’Connell will serve as assistant secretary for preparedness and response, and Miriam Delphin-Rittmon as assistant secretary for mental health and substance use. Read more from Brent Bierman.

Senate Floor: The Senate yesterday by voice vote passed S. 1662, to increase funding for the Reagan-Udall Foundation for the Food and Drug Administration and for the Foundation for the National Institutes of Health.

House Sets Appropriations Markups: The House Appropriations Committee announced the schedule for markups of the fiscal 2022 spending bills. The Agriculture-FDA subcommittee will consider its bill today. The subcommittee yesterday unveiled the bill, which would give the FDA almost $3.5 billion in discretionary funds, an increase of $257 million from fiscal 2021 levels, Megan U. Boyanton reports.

• Follow the appropriations process with Bloomberg Government’s Appropriations Table here.

House Panel Hearing Eyes Health Data Infrastructure: Many of the bills considered in yesterday’s House Energy and Commerce hearing focused on strengthening data infrastructure and standardizing health data collection. “Data doesn’t happen in a vacuum, they need systems,” Karen DeSalvo, Chief Health Officer at Google Health and a witness at yesterday’s hearing, said. States need to refresh their IT and security systems often, meaning better data infrastructure requires long-term commitment.

Lawmakers pushed for collecting better data on new coronavirus variants and societal issues that affect health like transportation accessibility. Other bills with Democratic support pushed for money to establish programs to address systemic racism or maternal mortality. While Republicans generally agreed for stronger data collection infrastructure, Reps. Brett Guthrie (R-Ky.) and Neal Dunn (R-Fla.) were wary of spending more money without first analyzing how past funds were used.

Meanwhile, Rep. Larry Bucshon (R-Ind.) said he wants to make sure that any new data collection wouldn’t put additional administrative burden on health-care providers. Such providers suffer from burnout already, in part due to enormous amounts of paperwork, Buschon said, Jacquie Lee reports.

• ‘Next Pandemic’ Early-Warning System Said to Need Real-Time Data: Public health analysts are recommending real-time data on emerging diseases and robust systems for sharing that information to allow the U.S. to respond more quickly in the event of another disease outbreak. The U.S. health system was ill-prepared when Covid-19 landed. Federal responsibility was spread out across agencies such that accountability for responding to catastrophic events was unclear, industry participants said. Read more from Lesley Torres.

Diagnostics Authority to Fall to FDA in Bill: The FDA would reclaim some of its ability to oversee diagnostic tests developed in a single laboratory under a bipartisan measure unveiled yesterday. The measure, titled the “VALID Act,” aims to resolve an ongoing debate about the agency’s authority over lab-developed diagnostics, an uncertainty the Trump administration contributed to last year when it allowed more tests to hit the market without FDA review. Read more from Jeannie Baumann.

Warren, Cassidy Urge Hearing on Biogen Drug: The Senate Finance Committee should convene a hearing to examine the cost of Biogen’s Aduhelm drug, Sens. Elizabeth Warren (D-Mass.) and Bill Cassidy (R-La.) said in a letter to committee leadership. “Approval of the new product has dramatic implications for our health care system that stretch well beyond the scope of FDA’s jurisdiction,” the senators wrote. Read more from Brody Ford.

Senate Bill Requires Price Transparency in Drug Ads: Sens. Chuck Grassley (R-Iowa), Dick Durbin (D-Ill.) and Angus King (I-Maine) introduced a measure that would require cost disclosures on advertisements for prescription drugs “to empower patients and reduce spending on medications,” according to a statement. The trio cited a Government Accountability Office report that said direct-to-consumer drug ads “contribute to an enormous amount of Medicare costs.” Read the report here.

Klobuchar Bill Targets Toxic Metals in Baby Food: Sen. Amy Klobuchar (D-Minn.) and four others wrote to the Food and Drug Administration seeking “continued action to eliminate toxic heavy metals in baby food,” according to a statement. Their letter comes after the recent recall of Beech-Nut Nutrition’s infant rice cereal which tested above the guidance level for inorganic arsenic, a toxic heavy metal, the statement says. Read the letter here.

More Headlines:

• Senators Propose Help for Renters As CDC Extends Eviction Ban

The Coronavirus Pandemic

Biden Warns of Deadly Variant, Urges Shots: Biden warned of the risks posed by a highly transmissible and potentially deadlier coronavirus variant as he prodded Americans to get vaccinated amid a decline in the pace of inoculations.

“This new dangerous variant continues to emerge,” Biden said in Raleigh, North Carolina, as he warned of the delta variant, first observed in India. “It’s now the most common variant in America. Unvaccinated people are incredibly vulnerable.”

Biden spoke yesterday as part of his administration’s effort to re-ignite a U.S. vaccination campaign that is slowing to a crawl. The rolling average of new cases has halted its decline and the number of deaths has begun to tick up again. Read more from Josh Wingrove.

Covid-19 Disability Insurance Litigation Seen Coming: Litigation against insurance companies for failing to pay disability benefits to people who can no longer work after having Covid-19 is on the way, attorneys say, but the cases just need time to gain momentum. Deadline extensions from the Department of Labor, difficulty in getting medical records from doctors reeling from the health crisis, and work-from-home has drawn out an already lengthy appeals process beneficiaries must go through with an insurer before they can take their case to court.

While the delay has stalled litigation for now, disability insurance attorneys expect to see more cases filed in the future, as people return to their offices after periods of telework and learn how Covid-19 might affect their ability to work in the long term. “You’re getting these ‘long haul’ Covid type cases now and the symptoms are just really unknown,” Chris Roy, owner of Roy Law Group in Portland, Ore., who represents claimants. Read more from Lydia Wheeler and Jacklyn Wille.

More Headlines:

• Carve-Outs in OSHA Covid-19 Health-Care Rules Create ‘Gray Areas’
• Tamiflu-Esque Drugs Face Long Odds Against Virus ‘Runaway Train’
• Delta Variant Accounts for 25% of Covid-19 Cases in Regions of Italy
• Israel’s Return to Normal Hits Bump With Covid-19 Surge Tied to Delta
• Massachusetts Hospitals Move to Mandate Covid-19 Vaccinations

What Else to Know Today

FDA Says Terminal Patients Should Be Part of Research: Drug companies shouldn’t leave patients with incurable cancers out of clinical trials even if they haven’t received prior treatment, the FDA’s cancer chief said. The Food and Drug Administration released draft guidance yesterday to encourage the pharmaceutical sector to include patients who have cancers with no potential for a cure or prolonged survival. Read more from Jeannie Baumann.

Eli Lilly Alzheimer’s Drug Nabs FDA’s Breakthrough Label: Eli Lilly rose after its experimental drug for Alzheimer’s gained breakthrough status from U.S. regulators, a designation that will speed its consideration for approval. The Lilly drug now becomes the third to receive the designation based on its ability to attack amyloid, an abnormal protein believed to be linked in the damage Alzheimer’s causes in the brain. Read more from John Lauerman and Riley Griffin.

More Headlines:

• Pieris Gains After Cancer Medication Nabs FDA Orphan Designation
• Ultragenyx’s mRNA Encoding Enzyme Wins FDA Orphan Drug Label
• Primary Endpoint Not Achieved in Losmapimod Trials, Fulcrum Says
• Mirati’s Adagrasib Gets FDA’s Breakthrough Status for Cancer Drug

To contact the reporter on this story: Brandon Lee in Washington at blee@bgov.com

To contact the editors responsible for this story: Zachary Sherwood at zsherwood@bgov.com; Giuseppe Macri at gmacri@bgov.com; Michaela Ross at mross@bgov.com