The Environmental Protection Agency had the authority and information to issue an emergency order protecting residents of Flint, Mich., from lead-tainted water a full seven months before it did so, an EPA internal investigation has concluded.

“It is clear that EPA intervention was delayed,” the report from the EPA’s inspector general states. “These situations should generate a greater sense of urgency.”

By June 2015, the EPA regional office “had information that the city of Flint exceeded the lead level at which corrosion control is required, and that Flint was not using a corrosion inhibitor.” It also knew that testing showed high levels of lead in at least four homes. Finally, the regional office “knew that the state and local authorities were not acting quickly to protect human health.”

That is enough to issue an emergency order, the report says. Such action “could have required the city and state to provide alternative water supplies to affected residents, study the extent and severity of lead contamination within the water system, or immediately begin corrective actions to reduce and eliminate lead contamination in the drinking water system.”

And yet, the EPA did not issue an order until January 2016. According to the report, local authorities “believed that the state of Michigan’s actions to address the Flint situation barred formal federal action.” But that was incorrect – the Safe Drinking Water Act states that the EPA can take action if “state actions are deemed insufficient.”

The watchdog’s report concludes that the agency “needs to clarify for its employees how its emergency authority can and should be used to intervene in a public health threat.”

The EPA is among the people and groups under fire for the slow response to Flint’s lead-laced water. An independent task force concluded earlier this year that a state environmental agency called the Michigan Department of Environmental Quality bears primary responsibility, though others are also to blame.

The problem began when Flint switched to a new water source in 2014 for cost reasons. But water from that new source, the Flint River, was not adequately treated with corrosion controls and caused lead from the city’s pipes to leach into the drinking water supply. And as we’ve reported, the city switched back to its original water supply late last year, but it was too late to reverse the damage to the pipes.

The city is in the process of treating its water system and recent test results show that lead levels have improved.

High levels of lead are especially dangerous for children and can cause “learning disabilities, behavioral problems and mental retardation,” the World Health Organization said.

Catching up on the lead crisis in Flint? Our timeline takes you through how the public health disaster unfolded, step by step.

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Rate hikes are likely on the way for insurance plans issued under the Affordable Care Act, health policy analysts say. Consumers’ out-of-pocket costs are expected to climb in 2017 and some major insurers have signaled they are pulling out of the health insurance exchanges in a number of states.

In a meeting Wednesday with reporters and representatives of groups working to increase enrollment in the health plans, Department of Health and Human Services Secretary Sylvia Burwell acknowledged that the Affordable Care Act’s fourth enrollment season — scheduled to begin Nov. 1 and run until Jan. 31 — is a pivotal time for the federal health law.

“Building a new market is never easy,” she told the group at HHS headquarters. “We expect this to be a transition period for the marketplace. Issuers are adjusting their prices, bringing them in line with actual data on costs.”

Burwell’s comments foreshadow the higher premiums expected when federal officials release details on the health plans to be offered on HealthCare.gov for 2017. Those details are likely to come just days before a presidential election that could determine whether the ACA is repealed or revamped.

While the health law hasn’t been a central issue in the current election season, it has been at the center of a bitter battle between political parties since it was passed in 2010. The House of Representatives has voted more than 60 times to repeal all or part of the measure. The law has survived some court challenges and faces others.

Burwell noted those fights Wednesday when talking about issues that arose in the law’s implementation. “It also hasn’t helped,” she said, “that at nearly every turn, we’ve had to overcome partisan attempts to repeal and undermine the law through legislation and litigation.”

Enrollment in the state and federal marketplaces is expected to grow by about a million people next year — from about 12.7 million to 13.8 million, according to federal estimates released Wednesday. The number of consumers who actually pay premiums and stay in the market is expected to average about 10.5 million per month in 2016 and about 11.4 million per month in 2017.

Consumers flow in and out of ACA plans because they change jobs, get coverage from other sources and face other factors that affect where and how they enroll in health insurance, including affordability. About 9.2 million of the 13.8 million people who now have ACA coverage are expected to reenroll, according to HHS.

This year, Burwell said, health officials working to increase insurance coverage among the uninsured are intent on making the enrollment process faster and simpler, and will particularly focus on signing up healthier consumers – including people between the ages of 18 and 34, who tend to have fewer ailments. They will also remind consumers of the penalty for not having coverage, which for adults in 2016 is $695 or 2.5 percent of income, whichever is higher. The flat penalty will be adjusted for inflation in 2017.

Federal officials are also focusing enrollment efforts on the 5.1 million Americans who are eligible to purchase health care coverage on the exchanges but buy it elsewhere, according to HHS figures. Of that group, 2.5 million people could be eligible for the law’s financial assistance if they sign up for coverage during open enrollment, which ends Jan. 31.

The outcome of the November elections may well determine the future of the ACA. Republican presidential nominee Donald Trump has promised to repeal and replace the law, while Democratic nominee Hillary Clinton has said she wants to fix the law, making it more affordable for consumers who don’t qualify for subsidies, yet struggle to afford coverage.

Burwell called on Congress to work with her and the Obama administration to make needed changes to the law. “To make more substantial changes — like a public option to encourage competition — we’ll need cooperation from Congress,” she said. “And we are hopeful that soon, we’ll see more bipartisan efforts to make improvement.”

Bipartisan cooperation isn’t likely to happen until the next Congress meets, if then. Much will depend on the outcome of the presidential and congressional elections – on who is in power and whether GOP leaders think the ACA is still a potent political issue, as well as on how willing Democrats are to make changes that appeal to Republicans.

Mary Agnes Carey reports for Kaiser Health News, an editorially independent news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

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The Affordable Care Act prohibits insurers from discriminating against people with serious illnesses, but some marketplace plans sidestep that taboo by making the drugs that people with HIV need unavailable or unaffordable, complaints filed recently with the Department of Health and Human Services’ Office for Civil Rights allege.

The effect may be to discourage people with HIV from buying a particular health plan or getting the treatment they need, according to the complaints.

The complaints – brought by Harvard Law School’s Center for Health Law and Policy Innovation – charge that plans offered by seven insurers in eight states are discriminatory because they don’t cover drugs that are essential to the treatment of HIV or require high out-of-pocket spending by patients for covered drugs.

The center filed complaints against Humana plans in six states: Alabama, Georgia, Illinois, Louisiana, Tennessee and Texas. Cigna plans were targeted in three states: Georgia, Tennessee and Texas. The group filed complaints against five other insurers: three in Pennsylvania, including Highmark, Independence Blue Cross and UPMC Health Plan; a complaint against Community Health Choice in Texas and a complaint against Anthem Blue Cross Blue Shield in Wisconsin.

“What’s most important to us is that there’s a robust enforcement mechanism around the promises … in the [Affordable Care Act] and its regulations, especially the anti-discrimination provisions,” said Kevin Costello, director of litigation at the health law center.

Although the center’s focus is on HIV drugs, the complaints may help people with other chronic illnesses who may face similar hurdles on access to drugs, Costello said.

The HHS Office for Civil Rights investigates and enforces violations of civil rights and health information privacy. The Harvard center complaints were filed in September.

Federal rules prohibit marketplace plans from adopting benefit designs — such as coverage rules or reimbursement rates — that discriminate based on age, illness, race, gender or sexual orientation, among other things. But federal regulators have declined to define discriminatory plan design, noting that they will examine the facts on a case-by-case basis.

They’ve hinted, however, at some specifics in the regulations. They say, for example, that refusing to cover a single-tablet drug regimen, which is often associated with better compliance because a number of different drugs are combined in one pill, or placing most or all of the drugs that treat a specific condition in the highest cost tiers are examples of “potentially discriminatory practices.”

Working with local AIDS groups in several states, the Harvard center examined hundreds of silver-level plans sold on the marketplaces to gauge whether their formularies would allow access to six treatment regimens that are the current standard of care for treating people who are newly diagnosed with HIV. In addition, they looked at the plans’ cost-sharing requirements, Costello said.

They found, for example, that this year Anthem silver plans in Wisconsin cover only four of the 16 drugs or combination products that are recommended to meet the current standard of care, and they fail to cover any single-tablet regimens. In Illinois, the center charged that Humana’s silver plans place 16 of the 24 most commonly prescribed HIV drugs in the highest cost-sharing tier, which requires patients to pay 50 percent of the cost. With estimated monthly costs ranging from $377 to $684 for different drug regimens, enrollees in the Illinois Humana plans would have to pony up between 8 and 14 percent of their average monthly income, according to the complaint.

“All Humana health insurance plans offered through the Health Insurance Marketplace fully comply with state and federal laws and regulations,” said Alex Kepnes, Humana’s director of corporate communications. He added, “Humana shares the concerns of HIV/AIDS organizations regarding the high cost of HIV/AIDS drugs and we are committed to working with them to lower prescription drug costs.”

Similarly, Anthem spokesman Scott Larrivee said, “Anthem Blue Cross and Blue Shield is committed to providing all of our members with access to the care and services they need, including appropriate coverage of medications for the treatment of HIV/AIDS. Anthem Blue Cross and Blue Shield in Wisconsin covers more than a dozen medications for the treatment of HIV/AIDS and all required therapeutic drug categories are included on our formulary/drug list which is compliant with (marketplace) requirements.”

Cigna spokesman Mark Slitt said his company doesn’t comment on pending legal matters.

The center’s work builds on an earlier discrimination complaint filed in 2014 with the Office for Civil Rights by two advocacy groups, the AIDS Institute and the National Health Law Program, against four Florida insurers that were selling marketplace plans. That complaint, against some of the same insurers highlighted by the Harvard center, charged that the insurers placed all the HIV drugs in the highest cost-sharing tier. The Florida insurance commissioner reached agreements with the four plans to move the HIV drugs to generic tiers and reduce cost sharing, and the same arrangement will continue in 2017, said Carl Schmid, deputy executive director of the AIDS Institute.

“We’ve been talking about these issues for years now,” Schmid said. “These things need to be addressed, and it could be through enforcement” by the Office for Civil Rights.

Marketplace coverage of drugs to treat HIV and other serious conditions have improved somewhat in recent years, according to research by Avalere Health, a consulting company. An analysis found that in the case of five classes of drugs that treat cancer, HIV and multiple sclerosis, fewer silver plans in 2016 placed all the drugs in the class in the top tier with the highest cost sharing or charged patients more than 40 percent of the cost for each drug in the class.

Speaking about HIV drugs, Caroline Pearson, a senior vice president at Avalere, said that while access and costs in marketplace plans are improving, they vary widely from plan to plan. Employer plans tend to offer better coverage, she said.

The new complaints may put more pressure on the Office for Civil Rights to address this issue, said Katie Keith, a steering committee member for Out2Enroll, a health insurance advocacy group for the lesbian, gay, bisexual and transgender community.

“It’s smart to do this in multiple states,” she said. “People are really pushing for more concrete guidance.”

Kaiser Health News is an editorially independent news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. Michelle Andrews is on Twitter:@mandrews110.

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