Lauren Clason

New state laws highlight an escalating battle in the war over drug pricing
The laws restrict insurance from excluding manufacturer coupons or financial assistance from cost-sharing responsibilities

Recent laws in several states that protect drugmakers’ contributions toward patients’ prescription copays are highlighting an escalating battle in the larger war on drug pricing.

In the past month, Arizona, Virginia and West Virginia became the first states to enact laws restricting insurance companies from excluding most drug manufacturer coupons or other financial assistance from a patient’s cost-sharing responsibilities. Similar bills are pending in a host of other states, including Connecticut, Illinois, Indiana, Kentucky and North Carolina.

Single-payer health care systems are no easier in the states
Politics, costs and federal restrictions have already undercut efforts in Vermont and California

The hurdles for a government-run, single-payer health care system are amplified at the state level, where universal coverage ambitions are hampered by politics, costs and federal restrictions.

These realities ultimately undercut efforts in two of the nation’s most liberal states — Vermont, which ended its attempts to institute a single-payer system in 2014, and California, which is expected to fall short again this year.

Will FDA keep cracking down on teen vaping, other initiatives, after Gottlieb leaves?
Scott Gottlieb, fought teen vaping and approved record numbers of generic drugs will resign next month

Food and Drug Administration Commissioner Scott Gottlieb, who launched a campaign against teen vaping and approved a record number of generic drugs, is resigning next month.

The departure raises questions about whether the agency would continue to vigorously seek to curb the exploding use of e-cigarettes among young people, among other Gottlieb initiatives. But the commissioner, in a resignation letter listing accomplishments on this and other issues, said he was “confident that the FDA will continue to advance all these efforts.”

Azar touts rebate proposal as solution to 'broken' system
The proposal would create safe harbors under the anti-kickback statute for upfront discounts to patients and flat service fees to PBMs

Health and Human Services Secretary Alex Azar on Friday pitched a proposal he released the day before as a major step in reforming the complex system of the prescription drug supply chain and lowering prices.

The proposed rule released by HHS and the Office of the Inspector General Thursday would eliminate federal protections for manufacturer rebates paid to health plans and pharmacy benefit managers under federal health programs, although Azar expects the rule would also trigger changes in the commercial market. The proposal would instead create safe harbors under the anti-kickback statute for upfront discounts to patients and flat service fees to PBMs.

House, Senate panels begin hearings seeking drug cost solutions
Future hearings will likely focus more on legislative proposals, and at some point members hope that drug companies will share their ideas

Lawmakers emphasized the steep cost of the diabetes treatment insulin and ways to use Medicare and Medicaid to discourage companies from setting high prices as Congress kicked off a series of drug price hearings Tuesday.

Hearings before the Senate Finance and the House Oversight and Reform committees featured academics and patient advocates as lawmakers in both chambers investigate why drug prices are high and what Congress can do about it.

Health Industry Reports Lobbying Costs the Size of a Grapefruit — Drugmakers Lead
Expenses on track to surpass 2017 numbers

Prescription drugmakers are on track to exceed their lobbying spending from last year, according to third quarter disclosure forms that were due Monday.

In 2017, the industry spent $171.6 million. During the first half of 2018, drugmakers spent almost $95.4 million, putting them on pace to top last year’s total.

Republicans Won’t Probe Influence of Trump Friends at Veterans Department
Dems have questions about trio named in lawsuit

Updated 3:31 p.m. | Top Republican lawmakers have no plans to examine the alleged influence that a trio of President Donald Trump’s friends have at the Department of Veterans Affairs, even as Democrats call for an investigation.

The controversy peaked in recent weeks after reports that Marvel Entertainment Chairman Ike Perlmutter, Palm Beach doctor Bruce Moskowitz and D.C. lawyer Marc Sherman hold undue sway with VA leadership, including senior adviser Peter O’Rourke, who formerly served as acting secretary. Liberal veterans group VoteVets filed a lawsuit against the administration last week, claiming the VA is violating federal protocol related to private influence in matters of federal policy.

Veterans Affairs Watchdog Finds Significant Problems in VA Caregiver Program
Report comes as caregiver program is set to expand

Family caregivers seeking help from the Department of Veterans Affairs encountered extended wait times and spotty aid from the agency, according to a new report from the VA’s Office of Inspector General.

The OIG investigation found that 65 percent of the more than 1,800 applicants between January and September 2017 were forced to wait longer than the required 45-day timeframe to be approved for the program. Fifty-five percent of the applicants waited between three and six months for approval, while 14 percent waited even longer, according to thereport released Thursday.

House Committee Pledges to Roll Back More Medicare Regulations
Regulatory burdens now come at expense of patient care, Roskam says

The House Ways and Means Committee said it would continue exploring ways to reduce regulations in Medicare, after issuing a report last week on its conversations with health care providers.

While light on specifics, the committee said it is engaging in “ongoing dialogue” with the Trump administration over where legislative solutions are needed to reduce what it deems unnecessary regulations.

Number of Pregnant Women Abusing Opioids Skyrockets
Vermont and West Virginia most affected

The number of women giving birth with opioid use disorder quadrupled between 1999 and 2014, a new report from the Centers for Disease Control and Prevention shows.

The increase underscores the severity of the country’s opioid epidemic as a legislative package aimed at helping states curb addiction rates idles in the Senate. Newborns exposed to drugs while in the womb can suffer severe complications, including withdrawal, preterm birth and death.

Senators Back Agent Orange Benefits. The VA Is Not Convinced
‘Blue water’ bill would extend disability benefits to more Vietnam vets

The Senate Veterans’ Affairs Committee seems poised to advance a popular bipartisan bill extending disability benefits to Vietnam veterans who claim they were exposed to Agent Orange. But Department of Veterans Affairs officials said Wednesday the agency opposes the measure.

Lawmakers on both sides of the aisle expressed strong support for the legislation at a hearing Wednesday, questioning whether the VA adequately considers applications from vets who served in ocean vessels claiming exposure.

For New Veterans Affairs Chief, That Was the Easy Part
Robert Wilkie may have made it through the Senate, but the second-largest federal agency still has vacancies, other woes

His confirmation Monday drew scrutiny and nine dissenters. Now Veterans Affairs Secretary Robert Wilkie must face the real challenge: repairing the sprawling agency that serves the nation’s veterans, including 9 million who receive health care benefits through the department.

The second-largest federal agency is embarking on two major initiatives — a reorganization of its private medical care options and a $15.8 billion electronic health records project — at the same time that it seeks to fill key positions overseeing them.

Federal Watchdog Advises HHS to Recoup Price’s Travel Expenses
20 of 21 trips failed to comply with requirements, OIG finds

A federal watchdog is recommending the Department of Health and Human Services recoup $341,000 associated with former Secretary Tom Price’s travel expenses.

The HHS Office of the Inspector General released Thursday an audit that found 20 of 21 trips Price and other HHS officials took during his time in office did not comply with federal requirements. Price, a hardline fiscal conservative during his time in Congress, resigned last September after it was revealed that he regularly chartered private planes for routine business trips.

VA Weighs Lifting Exclusion on Gender Reassignment Surgery
Administration already fighting multiple lawsuits against its transgender policies

The Department of Veterans Affairs is considering removing an exclusion on medical coverage for transgender services as the Trump administration battles multiple lawsuits against its transgender policies.

The VA released a request for comment Friday in response to a 2016 petition it received under former President Barack Obama to allow coverage of sex reassignment surgery. The petitioners, Dee Fulcher, Giuliano Silva and Transgender Veterans of America, eventually sued the Trump administration in 2017 in the U.S. Court of Appeals for the Federal Circuit. The case is ongoing.

Trump Administration Finalizes Rule on Health Plans
“You’re going to save massive amounts of money and have much better health care,” president says

The Trump administration on Tuesday finalized a rule expanding the availability of alternative insurance plans that do not meet the 2010 health care law’s requirements despite objections from consumer advocates and the industry.

The rule will extend so-called association health plans, which allow insurance companies to skirt benefit requirements and other parts of the 2010 law. President Donald Trump heralded the new rule in a speech Tuesday to the National Federation of Independent Business trade group, or NFIB.

VA Faces Scrutiny as It Gears Up for Health Overhaul
Bipartisan bill expected to be signed by president this week

The Department of Veterans Affairs will face heavy scrutiny as it implements a major overhaul to its health care programs that President Donald Trump is expected to sign into law this week.

The bill, which moved through both chambers by wide bipartisan margins, would combine the VA’s seven programs for private medical care into one to streamline and simplify costs and access for veterans. The legislation would also extend the so-called Veterans Choice Program for one year, allowing veterans to seek care outside the VA under certain circumstances in the meantime.

Trump Targets Drug Pricing in Trade Agreements
‘It’s unfair, it’s ridiculous and it’s not going to happen any longer’

President Donald Trump has instructed trade ambassador Robert Lighthizer to grant the drug industry’s wish of making pharmaceutical prices a “top priority” in negotiations with other countries.

Trump revealed the instruction during a Friday announcement unveiling the administration’s overall strategy for lowering drug costs.

Drug Pricing Proposal Should Revamp Medicare, GOP Experts Say
Overhauling Part B drug benefit could have “massive impact overnight”

An upcoming Trump administration proposal on lowering drug costs should ask Congress to allow private insurance companies to negotiate prices for drugs administered in a doctor’s office or hospital, two Republican policy experts said.

The administration’s proposal is a request for comment on strategies to lower drug prices and out-of-pocket costs. It was originally expected to be released in tandem with a speech by President Donald Trump on Thursday, but the speech was delayed as Health and Human Services Secretary Alex Azar recovers from an infection.

Federal Officials Push for New Types of Flu Vaccines
The FDA has not approved a new class of antivirals in the last 20 years

The heads of multiple health agencies told a House subcommittee Thursday that both the government and industry need to invest more resources in researching new forms of flu vaccines in light of this year’s epidemic.

Vaccines are often developed using egg-based technology, but newer cell-based and recombinant DNA technologies offer more speed and flexibility for fighting viruses — like the flu — that mutate frequently. While the technology offers promise, it remains uncommon, with lingering gaps in technology.

Experts, Industry Push Back on Health Insurance Proposal
Trump administation wants to loosen ERISA regulations

Industry groups and policy experts are questioning a Trump administration proposal on health insurance even as it garners accolades from congressional Republicans. 

The proposed rule, announced on Thursday, would loosen regulations under the Employee Retirement Income Security Act, or ERISA, that govern association health plans. Such plans allow businesses to band together in purchasing health insurance. Supporters say the rule is intended to help consumers hit the hardest by rising premiums under the 2010 health care law.