THE PROGNOSIS

Patient advocates and health insurers are pitted against each other in the Trump administration’s latest move to lower drug costs. The two groups disagree sharply over a proposal to allow Medicare insurers to stop covering certain drugs.

Any presidential administration that tries to slash prescription drug spending risks angering parts of the massive health-care industry, whether it’s insurers, drug makers, pharmacies or even patients. This particular dispute — which underscores how much antagonism the administration faces in its effort to make a dent in drug prices — relates to drugs in six “protected” classes that insurers currently must cover as a condition for participating in Medicare’s Part D prescription drug program.

Those categories of must-cover drugs include medicines especially crucial for patients mental and physical health, including antidepressants, HIV drugs, cancer medicines and immunosuppressant therapies for those who have received organ transplants. Seema Verma, administrator of the Centers for Medicare and Medicaid Services, isn’t trying to eliminate entire classes of drugs now covered by insurance — but she is seeking to lighten insurers' load in a few key ways.

Here’s the problem CMS is trying to solve: How do you ensure patients can access the medicines they need while still putting pressure on drugmakers to cut prices for those medications?

Under the proposal Verma announced Monday, insurers could refuse to cover a drug in a "protected" category if certain conditions are met, such as the drug's price increasing significantly. Insurers would still be required to cover at least two drugs in each of the protected categories no matter what, but patient advocates are up in arms over the proposed rule, saying it could force seniors to switch to less-effective drugs.

“Access to affordable medication is important,” said Catherine Finley, a senior adviser to the Partnership for Part D Access. “But access to an affordable drug that doesn’t work isn’t helpful.”

The partnership is composed of a number of patient advocacy groups, including the National Council for Behavioral Health, the National Alliance on Mental Illness, the National Kidney Foundation and the AIDS Institute, among others.

Today, the group is releasing a study conducted by Avalere Health arguing that Part D plans already have plenty of tools to encourage use of lower-cost drugs in the protected classes. For example, plans require seniors to pay coinsurance for 80 percent of branded drugs but just over one-third of generic drugs in protected classes, according to the study.

Insurers agree on this point — that there’s a good reason protected classes were added to Part D when the program was created back in 2003. Policymakers had deep concerns that seniors — especially those with lower incomes — could suffer if insurers participating in the program denied them coverage of drugs in these crucial categories.

But prescription drug spending has skyrocketed since then, and insurers contend that it’s a lot harder for them to broker a good deal on costs with pharmaceutical companies -- even on drugs in these categories. Insurers must cover these medicines no matter what, so they lack any negotiating power to bring down prices on them. Kristine Grow, a spokeswoman for America’s Health Insurance Plans, said drugmakers paid rebates on just 13 percent of protected drugs versus 36 percent of drugs overall.

“When a drug becomes a protected class, that immediately limits our ability to negotiate lower prices for it, including any kind of rebates,” Grow said.

Verma made a similar case this week, telling reporters the current rules around protected classes were never intended to be permanent and are in need of an update.

“Because under the protected class policy nearly every individual drug has to be covered, competition is thwarted,” Verma said.

The proposal is nuanced, requiring certain conditions to be met before an insurer could deny coverage for medicines in protected classes. But it does open the door to insurers requiring more authorization from doctors or denying coverage altogether if a drug is a new formulation of an existing drug or if its price increases beyond a certain threshold.

But to patient advocates, the changes go much too far. They feel insurers shouldn’t be let off the hook at all from comprehensively covering important medicines — even if lightening the requirements could save some money in the long run.

“We’re really hopeful we’ll be able to meet with [the Department of Health and Human Services] and really help them understand the unintended consequences here,” said Tonya Saffer, vice president of health policy at the National Kidney Foundation. “By punishing the manufacturers, they’re really punishing patients.”

AHH, OOF and OUCH

AHH: CVS Health and Aetna completed their nearly $70 billion merger, creating a new health-care giant nearly a year after the deal was initially announced.

“The merger combines CVS's pharmacies with Aetna's insurance business, blurring traditionally distinct lines in hopes of lowering costs,” CNBC’s  Angelica LaVito reports. “CVS also has one of largest pharmacy benefits managers through CVS Caremark and a major Medicare Part D plan sponsor through its SilverScript unit.”

CVS chief executive Larry Merlo said in an interview with CNBC that consumers won’t see immediate changes in local CVS retailers. But in 2019, they may start to see stores with additional health services. “These new locations will likely focus on managing common chronic conditions, adding more primary health services at CVS's MinuteClinics, guiding discharged hospital patients through their at-home plans and managing complex conditions,” LaVito reports.

A final hurdle in the merger between the two companies was getting state insurance regulators who may have been opposed to sign off on the deal. “To win approval from California, CVS agreed to a number of conditions, including not raising premiums as a result of acquisition costs and keeping premium increases to a minimum. This came after Aetna said it would sell its Medicare Part D drug plan business to WellCare Health Plans for an undisclosed amount in order to ease concerns about the overlap between the CVS and Aetna Medicare Part D plans.”

OOF: Four weeks into the Affordable Care Act enrollment period for 2019, sign-ups are down compared with enrollment last year.

Overall sign-ups are down by more than 356,000 compared with the fourth week of signs-up last year, a decline of nearly 13 percent. The total number of sign ups after 24 days this year are at 2,424,913, according to CMS data, compared with 2,781,260 after 25 days of enrollment last year. This year's fourth week of enrollment also included the Thanksgiving holiday. Enrollment runs through Dec. 15.

The Health 202 wrote earlier this week about a lag in enrollment figures in the first three weeks, despite the fact that more Americans have the ability to get Obamacare plans for free in 2019.

Democrats are starting to criticize the administration for declining sign-ups.

“While there are still two weeks remaining in Open Enrollment, these lagging numbers show that Republicans’ sabotage of our nation’s health care system is working,” Reps. Frank Pallone (N.J.), Richard Neal (Mass.) and Bobby Scott (Va.), the ranking Democrats on the House Energy and Commerce, Ways and Means, and Education and Workforce committees, said in a statement.

“The Trump Administration has starved the program intended to help families get covered by refusing to make congressionally-required investments in outreach and enrollment. And the administration’s promotion of inadequate coverage options, like short-term health plans, has led to cost increases for Americans, particularly those with preexisting conditions.”

OUCH: Life expectancy in the United States dropped again in 2017, according to a series of new reports from the federal government that reveal the impact of the drug and suicide crisis across the country, our Post colleague Lenny Bernstein reports.

Americans could expect to live 78.6 years at birth in 2017, which is down a tenth of a year from the previous year’s estimate. For men specifically, anticipated life span dropped a tenth of a year to 76.1 years in that time while life expectancy for women remained unchanged at 81.1 years.

The declines are reported in the Center for Disease Control and Prevention’s National Center for Health Statistics.

The data continues the longest sustained decline in life expectancy at birth in a century, “an appalling performance not seen in the United States since 1915 through 1918,” Bernstein writes. “That four-year period included World War I and a flu pandemic that killed 675,000 people in the United States and perhaps 50 million worldwide.”

“Drug overdoses set another annual record in 2017, cresting at 70,237 — up from 63,632 the year before, the government said in a companion report,” Bernstein reports. “The opioid epidemic continued to take a relentless toll, with 47,600 deaths in 2017 from drugs sold on the street such as fentanyl and heroin, as well as prescription narcotics. That was also a record number, driven largely by an increase in fentanyl deaths.” He adds other factors in the decline include more deaths from flu, increased numbers of deaths from chronic lower respiratory diseases, Alzheimer’s disease, strokes and suicide.

 “Life expectancy is improving in many places in the world. It shouldn’t be declining in the United States,” Joshua M. Sharfstein, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health told The Post, calling the report findings a “very dismal picture of health” for the nation.

OPIOID OPTICS

— First lady Melania Trump spoke Wednesday about raising awareness and reducing stigma around the opioid crisis.

Speaking at a town hall event at Liberty University, she told the audience that even if they are not individually suffering from addiction, “the chances of you knowing someone who struggles with it are very high.”

"And if you, or someone you know, needs help, you need to be brave enough to ask and strong enough to stand with them as they fight through the disease," she said, CNN’s Kate Bennett reports. The first lady also said one of things that has struck her as she has spoken about the opioid crisis and visited hospitals and treatment facilities is “how this epidemic has touched so many people — whether it is because of personal use, or that of family members, friends, coworkers or neighbors — opioid addiction is an illness that has truly taken hold of our country.”

REPRODUCTIVE WARS

— While the responsibility for preventing pregnancy has largely rested on the shoulders of women, another option may be inching closer to reality. The National Institutes of Health is set to test an experimental birth-control gel for men.

The experimental gel will be applied to the back and shoulders, Bloomberg News’s Michelle Cortez reports, and “combines two types of hormones to halt the production of sperm while maintaining the energy and libido benefits of testosterone.” The NIH study will include 420 couples, and researchers will determine how successful the gel is at preventing pregnancies.

“There are some men who may like to control their own fertility, who may or may not be in a monogamous relationship,” Diana Blithe, chief of the contraceptive development program at the National Institute of Child Health and Human Development and an investigator in the trial, told Cortez. “This would be an option for them.”

"Millions of women around the world use birth control, which has been around for decades as a reliable, relatively convenient form of contraception," Cortez writes. "While many women would likely want to maintain control over the contraceptive method used in a sexual encounter, some either can’t take the pill or prefer not to."

MEDICAL MISSIVES

— The Kona Community Hospital in Hawaii is dealing with an outbreak of scabies, a highly contagious skin condition.

A “number of people” reported symptoms of the condition, though a spokeswoman for the hospital declined to say how many people had been infected, our Post colleague Lindsey Bever reports. It’s also not clear where the outbreak began.

“Scabies occurs when a microscopic mite, known as Sarcoptes scabiei var. hominis, digs into a person’s skin and lays eggs, causing an itchy rash, according to the Centers for Disease Control and Prevention,” Bever reports. “The condition is extremely contagious and spreads through prolonged skin-to-skin contact and through clothes, linens and furniture, the CDC said.”

The hospital informed the Hawaii State Department of Health to “ensure that all necessary steps to contain and mitigate the outbreak were being implemented," the hospital said in a statement

INDUSTRY RX

 — Leading genomic scientists called for a pause in the clinical use of gene editing, rebuking the Chinese researcher who they say violated international ethical standards in his experiment he claims produced the world’s first genetically edited babies.

“The statement came at the conclusion of the Second International Summit on Human Genome Editing, which became the focus of international attention this week following the stunning claim by Chinese scientist He Jiankui that he had created Lulu and Nana, twin girls whose genes had been edited to make them resistant to HIV,” our Post colleagues Carolyn Y. Johnson and Gerry Shih report.

“The committee, representing leading researchers from the United States, Britain and Hong Kong, did not call for an outright ban on gene editing,” our colleagues report. “Instead, it acknowledged that the field was moving toward a future where the procedures would be widely researched in clinical trials, and that researchers needed a rigorous framework to set ethical standards and guidelines. But in the meantime, the panel called for a halt.”

“Even if the modifications are verified, the procedure was irresponsible and failed to conform with international norms,” the organizers of the summit said about the scientist's experiment in a consensus statement. “The organizing committee concludes that the scientific understanding and technical requirements for clinical practice remain too uncertain and the risks too great to permit clinical trials of germ line editing at this time.”

— And here are a few more good reads from The Post and beyond: 

National
New data reveals an unsettling link between denying inmates treatment for mental health issues and an increase in violence and self-harm in federal prisons.
Christie Thompson and Taylor Elizabeth Eldridge | The Marshall Project
Social Issues
Several same-sex surviving spouses across the country have been denied social security benefits based on a nine-month marriage requirement.
Samantha Schmidt
Health
Hector Hernandez had a 77-pound cancerous tumor called a retroperitoneal liposarcoma growing in his abdomen.
Lindsey Bever
Morning Mix
The U.S. Postal Service touts itself as the most trusted government agency. But it is also trusted by drug traffickers transmitting illicit products.
Isaac Stanley-Becker
Morning Mix
Bea Sullivan-Knoff, a transgender woman in Chicago, alleges that the city's ban on topless women in establishments with liquor licenses both discriminates against women and is too vague as applied to transgender people.
Meagan Flynn
Amazon.com is selling medical products to patients based on one of the most private corners of the health system: electronic medical records.
Wall Street Journal
A California appeals court overturned a lower court order that had imperiled the state’s assisted suicide law, but a longer legal fight may loom because the ruling skirted the larger issue of whether the legislation was unconstitutional.
Associated Press
Lawyers representing hundreds of thousands of kids born with opioid withdrawal fear they could lose out in nationwide litigation over the drug epidemic.
Politico
Answer Sheet
The younger kids may just be more immature, the researchers found.
Valerie Strauss
AGENCY ALERT
The agency released a draft strategy outlining how vendors, providers and federal agencies can reduce the technology-related burden on clinicians, including by simplifying EHR reporting requirements.
Modern Healthcare
Celltrion Inc's Truxima on Wednesday became the first biosimilar to Roche H...
Reuters
HEALTH ON THE HILL
Business
A dispute over work requirements for food stamp recipients has divided the House and Senate.
Erica Werner and Jeff Stein
STATE SCAN
National
The lawsuit describes the harrowing moments after the now notorious all caps message went out to cellphones on the island on Jan. 13.
Eli Rosenberg
Virginia Politics
The County Board okays plans that will add 101 new beds to medical center.
Patricia Sullivan
DAYBOOK

Coming Up

  • The Senate Armed Services Committee holds a hearing on the nomination of Thomas McCaffery to be assistant secretary of defense for health affairs.
SUGAR RUSH

—A 6-foot-4-inch Australian steer named Knickers captivated the Internet:

Watch President Trump and first lady Melania Trump participate in the National Christmas Tree Lighting ceremony: