SIGN UP! If you’d like to continue receiving Washington Examiner’s Daily on Healthcare newsletter, SUBSCRIBE HERE: http://newsletters.washingtonexaminer.com/newsletter/daily-on-healthcare/

FDA proposes massive crackdown on flavored e-cigarette and tobacco products. The Food and Drug Administration announced Thursday that it would pursue sweeping regulations to restrict e-cigarette and traditional tobacco products that the agency believes are contributing to a rise in use among minors. The agency said that it will move to ban menthol cigarettes and flavored cigars, and restrict access to flavored e-cigarettes. FDA Commissioner Scott Gottlieb said that rules are a response to expanding use of the products among minors. “I believe these menthol-flavored products represent one of the most common and pernicious routes by which kids initiate on combustible cigarettes,” Gottlieb said in a statement. “The menthol serves to mask some of the unattractive features of smoking that might otherwise discourage a child from smoking.” It will also move to have all flavored products besides mint and menthol flavors, to be only sold in age-restricted, in-person locations. It will still allow sales of such products, which include flavored e-cigarettes, online, but only with heightened age verification processes. Gottlieb only said that he is seeking updates to the agency’s compliance policy for tobacco products and didn’t say when such a ban would take effective or when any regulations would be issued.

Welcome to Philip Klein’s Daily on Healthcare, compiled by Washington Examiner Executive Editor Philip Klein (@philipaklein), Senior Healthcare Writer Kimberly Leonard (@LeonardKL) and Healthcare Reporter Robert King (@rking_19).  Email [email protected] for tips, suggestions, calendar items and anything else. If a friend sent this to you and you’d like to sign up, click here. If signing up doesn’t work, shoot us an email and we’ll add you to our list.

The FDA had been telegraphing a move on flavored products for months and new data played a role. The Trump administration also laid out new data from the 2018 National Youth Tobacco Survey that found rates of use of e-cigarettes is skyrocketing. The survey found that more than 3.6 million middle and high school students used an e-cigarette in the past 30 days of when they were surveyed in 2018. That is an increase of more than 1.5 million students in 2017. “These new data show that America faces an epidemic of youth e-cigarette use, which threatens to engulf a new generation in nicotine addiction,” said Health and Human Services Secretary Alex Azar, in a statement. “By one measure, the rate of youth e-cigarette use almost doubled in the last year, which confirms the need for FDA’s ongoing policy proposals and enforcement actions.” But the proposal for a sweeping ban is going to start a major fight with the burgeoning e-cigarette industry and the tobacco industry.

Alex Azar launches latest defense on controversial drug pricing proposal. Health and Human Services Secretary Alex Azar made his latest attempt to fight back at critics of a major proposal to tie prices for certain Medicare drugs to prices paid overseas. Azar said at the Commonwealth Fund’s International Symposium on Health Care Policy that the proposal isn’t an attempt to install foreign price controls. The proposal outlined last month would tie prices for physician-administered drugs reimbursed under Medicare to prices paid by wealthy countries such as Germany or Japan, which can lower prices through negotiation by government-run healthcare systems. But Azar said that the proposal is pretty market driven. “We’ve chosen the most market-driven index we could come up with: the prices at which drug companies voluntarily choose to sell their drugs to a basket of comparably placed peer countries to the United States,” Azar said. “Besides being a dynamic index, relying on other major payers to determine what price manufacturers can bear, the international price index also provides incentives for manufacturers to balance out the burden of innovation.”

Fewer people are signing up for Obamacare plans, so far. Around 1.17 million people got Obamacare plans through the federally run healthcare.gov over the first 10 days of open enrollment for 2019, the Trump administration reported Wednesday. That number represents about a 16 percent decrease from the same time period last year, although the administration cautioned that this year’s count covers one fewer day of signups — Nov. 1 through Nov. 10, rather than through Nov. 11. “As in past years, enrollment weeks are measured Sunday through Saturday,” the Centers for Medicare and Medicaid Services said in a release. “Consequently, the cumulative totals reported in this snapshot reflect one fewer day than last year.” However, the totals were down when looking at comparable time frames. For instance, from Nov. 5 to Nov. 11, 2017, healthcare.gov signed up 876,788 people. But from Nov. 4 to Nov. 10, 2018, the exact same time frame, healthcare.gov signed up 804,556 people. It remains early in the enrollment period that ends on Dec. 15, but totals will be heavily scrutinized by Congress.

Key Obamacare replacement architect loses re-election bid. Rep. Tom MacArthur, R-N.J., has lost his re-election bid, a contest in which his role crafting a House Republican Obamacare replacement bill, became a political liability. MacArthur was defeated by Democratic challenger Andy Kim, the Associated Press reported. Kim is a national security expert and former diplomat who repeatedly criticized the incumbent over his role in the Obamacare repeal fight. MacArthur, who has served in the House since 2015, authored a controversial Obamacare replacement compromise that proved to be a double-edged sword for House Republicans. On the one hand, the compromise enabled conservatives in the Freedom Caucus to get on board with Obamacare repeal. The Freedom Caucus rejected an earlier version of the Obamacare repeal bill, called the American Health Care Act, because it did not touch pre-existing condition protections and other insurer regulations, which the group believes are among the biggest drivers of high premiums. So MacArthur, a former leader of the centrist “Tuesday Group,” authored an amendment to the American Health Care Act that would have allowed states to ignore protections for pre-existing conditions. The compromise worked, and the Freedom Caucus backed the bill, which narrowly passed the House in 2017. But the amendment opened up Republicans to scorching attacks from Democrats that they voted to strip protections for people with pre-existing conditions.

House GOP picks Kevin McCarthy as leader. House Republicans, soon to be relegated to the minority, picked Rep. Kevin McCarthy to stay on as their party leader in the 116th Congress by a vote of 159-43 in a closed-door GOP vote. McCarthy, R-Calif., will replace retiring Speaker Paul Ryan as the top House Republican, but he won’t inherit the gavel. As minority leader, he’ll oversee a much smaller GOP conference which will have very little power beginning in January. McCarthy handily defeated top House conservative Jim Jordan, R-Ohio, who is the founder of the House Freedom Caucus. Jordan had argued Republicans need a change in the top leadership and a leader who will prioritize fiscal restraint, border security, and other conservative priorities. But Jordan lacked the popularity, fundraising strength, and personal relationships forged over the years by McCarthy, who has been a member of the GOP leadership team for nearly a decade.

Pro-Obamacare group slams McCarthy vote. The pro-Obamacare group Protect Our Care called McCarthy a “anti-healthcare, out-of-touch politician,” saying that the votes of other California lawmakers had caused as many as six of them to lose seats to Democrats. “We look forward to working with a new House, including health care champions Josh Harder, Katie Hill, Harley Rouda, and Mike Levin, to lower premiums and expand coverage for all Americans in the 116th Congress,” Brad Woodhouse, the group’s executive director, said in a statement.

But was praised by SBA List. The anti-abortion group Susan B. Anthony’s List praised McCarthy’s work on abortion restrictions, including his leadership passing a 20-week abortion ban. “Congressman Kevin McCarthy is a great friend to the pro-life movement and we congratulate him on his election to serve as House Minority Leader,” Marjorie Dannenfelser, SBA List president, said in a statement. “Having a strong pro-life ally like McCarthy in this key position will be important to safeguarding pro-life policies that will come under attack by pro-abortion House Democrats who seek abortion on demand, funded by the taxpayers.”

Republicans add woman to Senate leadership team, re-elect McConnell. Senate Republicans on Wednesday added a woman to their leadership team for the first time in several years, by electing Sen. Joni Ernst, R-Iowa, to serve as GOP conference vice chair. But the GOP left most of its team intact for the next Congress that starts in 2019. Senate Majority Leader Mitch McConnell, R-Ky., will be the chamber’s top lawmaker for a third term. Sen. John Thune, R-S.D., was approved as the GOP’s new majority whip after having served as Republican Conference chairman since 2011. Sen. John Barrasso, R-Wyo., ran unopposed to move up one place in the leadership ladder to become Conference chair. Sen. Roy Blunt, R-Mo., the policy committee vice chair, ran unopposed to take over as policy committee chair. The position of Republican conference vice chair was the only contested race. Senate Republicans next year will begin their third consecutive Congress in the majority in January.

Uninsured rate keeps falling despite claims Trump is sabotaging Obamacare. The number of people without health insurance fell during the first six months of 2018, federal data show, despite warnings from Democrats and outside groups that the Trump administration sought to “sabotage” the healthcare system. The data, released Thursday by the Centers for Disease Control and Prevention, show that roughly 28.5 million people, or 8.8 percent of the population, were uninsured during the first half of the year. CDC scientists said the number was “not significantly different from 2017,” when the uninsured rate was 9.1 percent, or 29.3 million people. The decrease occurred despite actions the Trump administration took, including ending payments to insurers in Obamacare, and despite actions from Republicans in Congress seeking to overhaul the healthcare law. The information, conducted through surveys each year, helps to reveal how U.S. residents get their health insurance. Among adults between the ages of 18 and 64, 20 percent are covered by the government, meaning through Medicaid or Medicare, and 69.2 had private health insurance, whether purchased directly from an insurer, through the Obamacare marketplaces, or provided by an employer.

Next year the results may be different. Democrats and analysts from the Congressional Budget Office have warned that the number of uninsured will rise in the coming years because Republicans zeroed out the fine for going uninsured beginning in 2019. They also say the Trump administration has given people options to less expensive health insurance plans with fewer benefits that do not meet Obamacare’s rules, which don’t count as plans that help lower the uninsured rate.

CBO to update its estimates on the uninsured. The Congressional Budget Office, in a letter sent Wednesday to Sen. Mike Enzi, R-Wyo., detailed its plans to release a new estimate of the uninsured. These estimates in recent years have provided fodder for Democrats as they attacked Republicans over healthcare and tax bills, pointing to the figures that projected millions more people would be uninsured should the legislation pass. The estimates received criticism from Republicans, leading to CBO officials reconsidering how its evaluations are done, using input from various groups such as Senate aides, hospitals, insurers, and doctors. CBO also will publish details about how it makes its projections. “We are currently enhancing it through a process that is thorough and transparent and that includes extensive peer review and broad external validation,” CBO said in its letter.

AHIP asks for Obamacare fixes. America’s Health Insurance Plans issued a list of recommendations Wednesday to help stabilize the individual market that included lowering costs for people who don’t currently receive subsidies under Obamacare. The list included more oversight over whether people on Medicare are being improperly steered toward the individual market, setting up a permanent reinsurance program, and increasing the advertising budget for healthcare.gov.

Senators introduce bill to expand chiropractic care in TRICARE. Sens. Tammy Baldwin, D-Wis., and Jerry Moran, R-Kansas, on Wednesday introduced legislation to expand chiropractic health services for military retirees and members of the National Guard and Reserve. The Chiropractic Health Parity for Military Beneficiaries Act –  being billed as an alternative to turning to opioids for pain – would require TRICARE to cover chiropractic services for all military service members, both active and retired, and non-activated reservists.

CMS approves waiver from Michigan to change how Medicaid pays for drugs. The Centers for Medicare & Medicaid Services approved a waiver request from Michigan to change how it pays for drugs under the state’s Medicaid program. Currently Michigan and all states pay a flat rate for drugs covered under Medicaid, which is a federal and state partnership program. But under the waiver, Michigan can now enter into value-based payment arrangements with drugmakers. This would ensure that Michigan would only pay for a drug if it is proven to demonstrate a clinical value or outcome. “Michigan’s waiver will empower it to demand results from drug manufacturers in exchange for paying for medicines,” said CMS Administrator Seema Verma in a speech in Washington Wednesday. The agency approved a similar waiver for Oklahoma earlier this summer. CMS is trying to shift its payments under Medicare and Medicaid away from a fee-for-service approach that pays a flat rate for each medical procedure or drug, and instead towards a value-based approach that takes into account the outcomes of the patient when providing a reimbursement.

RUNDOWN

Axios The long road back to Obamacare competition

The Hill Maine governor says he would run again if incoming Democratic governor doesn’t expand Medicaid sustainably

NPR How doctors and nurses cope with the human toll of gun violence

Reuters U.S. state spending exceeds $2 trillion for the first time, with Medicaid costs a major factor

CNN Blue Wave shrinks states’ anti-Obamacare coalition

Chicago Tribune Illinois backs off limits on which Medicaid patients can get costly but lifesaving hepatitis C drugs