AHA, AAMC sue Trump administration over site-neutral payment rule

https://www.fiercehealthcare.com/hospitals-health-systems/aha-aamc-file-suit?mkt_tok=eyJpIjoiTjJNNFpUVTJPR0UwT1dRMyIsInQiOiJ5ZEdxMWV6aFZESWlcL2lJdUw1WG4yMkNTS3B5VFY5cmRxNVFYS3lGVmh0VkZmSDdVUlhFTGZVRllpVm1sdkFBZWU2QmhXbndMZFdOK0cxQjkzRUVHTk5pYkEwNVdncWVYUlh2cFYwMEp3S3d2dEJyOGg4NnFcL1NjeVpRSmY5YWxnIn0%3D&mrkid=959610

Wooden gavel and gold legal scale that appear to have sunlight falling on them

Two of the nation’s largest healthcare groups are suing the Trump administration over a final rule to institute site-neutral payments for clinic visits, saying the policy would hurt patients.

Last month, the Centers for Medicare & Medicaid Services (CMS) finalized the 2019 Outpatient Prospective Payment System (OPPS) rule (PDF), which will gradually institute site-neutral payments in the Medicare program over the next two years. Agency officials said site-neutral payments for clinic visits will lower out-of-pocket costs for beneficiaries and save the program as much as $380 million in 2019.

In a complaint filed in the U.S. District Court for the District of Columbia, the American Hospital Association (AHA) and the Association of American Medical Colleges (AAMC) said the rule would lead to access problems as hospitals cut services, hurting vulnerable patients. The associations claimed the administration is overstepping its legal bounds  and were joined in the legal action by Olympic Medical Center in Port Angeles, Washington; Mercy Health in Muskegon, Michigan; and York Hospital in York, Maine.

“These cuts directly undercut the clear intent of Congress to protect hospital outpatient departments because of the real and crucial differences between them and other sites of care,” said Rick Pollack, president and CEO of the AHA, in a statement.

AHA said it was planning legal action shortly after the rule was finalized.

Physician groups, including the American Association of Family Physicians (AAFP) and the American College of Physicians (ACP) as well as groups like the Cancer Oncology Alliance, have supported site-neutral payments for some time. AAFP has said site-neutral payments can also help community clinics stay open at a time many have had to close due to vertical integration, consequently advancing patient choice and reducing costs.

But hospital groups oppose the rule, which also expands a CMS policy limiting how much drug companies can charge hospitals for their products in the 340B program.

“Patients who receive care in a hospital outpatient department are more likely to be poorer and have more severe chronic conditions than patients treated in an independent physician office,” Pollack said. “In addition, only hospitals provide 24/7 access to care for patients, regardless of their ability to pay, hospitals are held to far higher regulatory requirements, and hospital outpatient departments in inner cities and rural areas are often the only sites of care that provide the services they do.”

Most recently, AHA had sued CMS over the 340B program changes before HHS bumped up the implementation date last month for changes that would set price ceilings and add civil monetary penalties for manufacturers—two changes the AHA supported.

 

On Health Care, Dems Go From Running to Baby Steps

https://www.rollcall.com/news/policy/health-care-democrats-congress-baby-steps?utm_source=rollcallheadlines&utm_medium=email&utm_campaign=newsletters&utm_content=102918&bt_ee=laxMKcbLquOQ38r3vgGpAMJX0zq6rDqxygOXbPDfSwKSHMjaEgq8JGZkmOJJy/1x&bt_ts=1542196035790&utm_source=rollcallheadlines&utm_medium=email&utm_campaign=newsletters&utm_content=102918&bt_ee=tH6eZI6YXwNy2ZGbobMIrH2ZCUu8d3EvTOK0U9Cxlbepc1ICeXiBfznzGL6Gj8mS&bt_ts=1542196035723

Image result for health policy

Incremental measures will dominate action on the health law in a largely gridlocked Congress.

The midterm elections all but ended the Republican push to repeal the 2010 law known as Obamacare, but as a defining issue for Democrats in their takeover of the House, health care will likely remain near the top of lawmakers’ policy and political agenda.

Newly emboldened Democrats are expected to not only push legislation through the House, but use their majority control of key committees to press Trump administration officials on the implementation of the health law, Medicaid work requirements, and insurance that does not have to comply with Obamacare rules.

Both parties are looking to address issues that voters prioritized, such as lowering prescription drug prices, though different approaches by Republicans and Democrats could mean incremental changes stand a better chance of enactment than any major bill.

Early on, lawmakers may find themselves dealing with the fallout of a court ruling that could overturn the law’s mandate that health insurance cover pre-existing conditions, putting Congress on the spot in the face of widespread voter support for those protections.

All of these issues, which dominated this year’s elections, will play out against the backdrop of the next congressional and presidential contests.

“In a lot of ways, the purpose of legislation in this Congress for the Democrats is going to be to set the agenda for the 2020 election,” said Dan Mendelson, the founder of the consulting firm Avalere.

Drug prices

Lowering drug prices is a top priority for House Democrats and President Donald Trump. Leaders of both parties identified this issue last week as a possible area for bipartisanship.

But Democrats’ more ambitious plans, like allowing Medicare to negotiate drug prices, aren’t expected to advance in the Republican Senate. Instead, issues like increasing transparency or speeding up approvals for new treatments could be ones where both parties can find agreement.

Texas Democratic Rep. Lloyd Doggett, a contender to lead the Ways and Means Health Subcommittee, is pushing a measure that would require HHS to negotiate prices for drugs covered by the Medicare Part D program. While most Democrats say they back price negotiations, there will likely be debate within the party about the details, particularly if they seem to be close to the government setting prices.

“When you start getting into anything that looks like price controls, you might get some bipartisan support for, but you also might get bipartisan support against,” said Ben Isgur, the leader of PwC’s Health Research Institute.

Democrats’ other focal points center on price-gouging for pharmaceuticals, which gained significant attention in recent years. The House Democrats’ “Better Deal” legislative agenda envisions a “price-gouging” enforcer, which would be a Senate-confirmed position to lead a new agency focused on stopping significant price increases for prescription drugs. Democrats also hope to require drug manufacturers to provide data to justify significant price increases.

Their plan would require drugmakers to justify price increases of certain amounts at least 30 days before they take effect.

Leaders in both parties have said since the election that drug pricing will be on the agenda, but have appeared skeptical of whether their efforts would yield a successful outcome.

“The jury’s out in my mind,” Democratic Rep. Pramila Jayapal said in a call with reporters last week. “If he is serious about taking on those pharmaceutical drug companies and ensuring that we can really get prescriptions filled for our seniors and negotiate prices for our pharmaceutical drugs the way we do for our VA, then we might have something we can work on.”

Mendelson predicted that even if a major bipartisan agreement to lower prices doesn’t advance in the next Congress, the Trump administration will keep taking steps that could eventually lower prices. Food and Drug Commissioner Scott Gottlieb has earned bipartisan praise for speeding new drug approvals, for instance.

The Trump administration could try to stay in command of drug pricing politics ahead of the 2020 election, he added, although Democrats will also seek to control the issue.

“There could well be significant progress over the next year or two because the administration has a lot of authority and they will use it to neutralize the issue before the 2020 election,” said Mendelson, a former Clinton administration official.

Health care law

The electrifying election-year issue of pre-existing condition protections is likely to win a House vote as Democrats seek to prove their commitment to that popular part of the law.

Both parties are bracing for a ruling from U.S. District Court Judge Reed O’Connor of Texas in a lawsuit filed by 20 state officials seeking to overturn the 2010 law. O’Connor heard oral arguments in September, although the Trump administration asked to delay a ruling until after the open enrollment period ends on Dec. 15.

If O’Connor strikes down all or part of the health care law, Democrats expect a group of state attorneys general defending the law to seek an immediate injunction and appeal the decision. Legal scholars on both sides of the aisle question the arguments of those attempting to kill the law, but the case could reach the Supreme Court.

House Democrats plan to consider a bill by Rep. Jacky Rosen of Nevada who won a Senate bid last week, that would allow the House to intervene in the case and defend the health law, aides say.

Across the Capitol, 10 Senate Republicans introduced a bill this summer to guarantee coverage of pre-existing conditions, which GOP aides say could be part of a response to the lawsuit.

Democrats have criticized the Senate GOP bill because it doesn’t require insurers to cover certain services for patients with pre-existing conditions. Republicans like North Carolina Sen. Thom Tillis, who sponsored the measure, defend it.

“If they do strike down large parts of the legislation, Sen. Tillis’ bill could be one important part of a larger health care legislative effort,” said Adam Webb, a spokesman for Tillis.

Senate Majority Leader Mitch McConnell of Kentucky declined to reveal after the election how the chamber would respond to a ruling striking down parts of the law, but called for bipartisan fixes to the health law.

A draft bipartisan stabilization bill, which has been at an impasse for nearly a year, could re-emerge in the next Congress, but it’s not clear if lawmakers can resolve a fight over abortion restrictions that blocked an agreement or how that measure could change a year later.

“The first thing we need to do is stop Republican attacks on coverage of pre-existing conditions, stop any movement toward extending these short-term plans,” Iowa Rep.-elect Cindy Axne, who defeated Rep. David Young, said in a call with reporters last week.

Top Democrats — Frank Pallone Jr.Richard E. Neal of Massachusetts, and Robert C. Scott of Virginia, who are expected to chair the Energy and Commerce, Ways and Means, and Education and Workforce committees, respectively — introduced legislation this year to shore up the health law. It would increase the size of the tax credits that help people pay their premiums and expand eligibility. It would also block Trump administration rules to expand health plans that don’t meet the 2010 law’s requirements.

Aides caution the bill could see minor changes next year based on developments since it was introduced in March and say it could be tied into a stabilization debate.

Since falling short in their efforts to overhaul the law last year, Senate Republicans pivoted to rising health care costs, a focus that will likely extend into next year. Several senators showed interest in legislation to prevent surprise medical bills, but it’s not clear what other topics could lead to bipartisan agreement, which will still be needed in the Senate even with a larger Republican majority.

Oversight

Oversight of the health care law will dominate House action on the health law in a largely gridlocked Congress. House Democrats plan to bring administration officials to Capitol Hill to explain what critics call “sabotage” of the law’s insurance exchanges.

“We’ll be looking at what they’re doing administratively to undermine the operations of the Affordable Care Act and what consequences they may have caused to literally millions of people,” Minority Whip Steny H. Hoyer told reporters in September.

Oversight could touch on issues such as Trump’s funding cuts to outreach and advertising for the exchanges, reductions in enrollment help and the effects of repealing the law’s mandate to get coverage.

Maryland Rep. Elijah E. Cummings, who is expected to lead the House Oversight Committee, will likely rev up an investigation into drug companies high prices that he has been conducting as ranking member and could bring executives in to testify before the panel.

In a post-election press conference, the presumed incoming House speaker, Nancy Pelosi of California, highlighted the Energy and Commerce Committee as another “big oversight committee” that will be active.

“We do not intend to abandon or relinquish our responsibility … for accountability, for oversight and the rest,” said Pelosi. “This doesn’t mean we go looking for a fight, but it means that if we see a need to go forward, we will.”

 

Two Lawsuits with Implications for the Coverage of Millions of Americans

http://www.commonwealthfund.org/publications/blog/2018/jun/lawsuits-implications-for-coverage?omnicid=EALERT1421015&mid=henrykotula@yahoo.com

Image result for us district court of district of columbia

Significant legal challenges have marked the history of the Affordable Care Act (ACA) since its passage in 2010, and have largely determined the outlines of the law’s current structure. Similarly, as Sara Rosenbaum argues in a brief published this week, the courts have substantially shaped the Medicaid program over its 53-year history. Two recent legal challenges have potentially far-reaching implications for both the Affordable Care Act and the Medicaid program, and the millions of Americans who depend on them for their health insurance. While the plaintiffs take different positions regarding the ACA and Medicaid, the cases and the Trump Administration’s responses to them reveal an executive branch that is consistent in its efforts to reduce the federal government’s role in guaranteeing health insurance coverage for Americans.

Stewart v. Azar

Oral arguments in U.S. District Court for the District of Columbia begin today in a class action lawsuit brought by 15 Kentucky Medicaid enrollees. The case challenges the legality of several aspects of Kentucky’s 1115 Medicaid demonstration waiver, which allows the U.S. Department of Health and Human Services (HHS) and states to test time-limited innovations in Medicaid and other public welfare programs without congressional action. Set to go into effect on July 1, the Kentucky waiver’s most controversial provision is the requirement that Medicaid beneficiaries work or perform community service for at least 80 hours per month to retain coverage. The suit also challenges the authority of HHS, now led by Secretary Alex Azar, to both encourage and approve Medicaid work demonstrations generally and the approval of Kentucky’s demonstration in particular.   The suit also challenges the legality of other aspects of the waiver, including the imposition of premiums, the use of six-month lock-out periods for beneficiaries who don’t comply with work requirements or pay their premiums on time, and the elimination of Medicaid’s requirement that new beneficiaries receive three months of retroactive coverage. Three other states have received approval for similar waiversseven states have applications under review at the Centers for Medicare and Medicaid Services, and several others are developing them. Because the case challenges both the Kentucky waiver and HHS policy, it has implications for these states, as well as the future of the Medicaid program.

A critical issue highlighted by the case goes to the heart of the entitlement nature of the Medicaid program. Under the Medicaid Act and subsequent amendments, Congress has determined certain groups of people to be eligible for Medicaid coverage by virtue of their age, income, or health needs. These mandatory coverage groups include children, pregnant women, and the elderly, blind and disabled. Because working-age adults with low incomes were the least likely to work in a job that comes with health benefits, the ACA created a new mandatory eligibility category for adults with income less than 138 percent of the federal poverty level. The Supreme Court decision in 2012 effectively made this optional for states. But once a state elects to cover people who fall into this group, individuals at this income level become a mandatory coverage group. Kentucky expanded eligibility for this group in 2014, and most, but not all, of its waiver provisions apply only to this group. The lawsuit argues that suspending a beneficiary’s coverage for failure to comply with the new waiver requirements would be in violation of their entitlement to coverage under the Medicaid Act. In public speeches, Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma, also named as a defendant in the suit, has maintained that Congress’s decision to expand eligibility for Medicaid to “able-bodied” adults was a departure from the historical mission of the program and that states should have the opportunity to alter that through work and other requirements. While the vast majority of adults who have coverage through the ACA’s Medicaid expansion have jobs, work requirements will likely impose significant administrative barriers that could trigger eligibility losses even among those working full time. Estimates of coverage losses range from 95,000 to nearly 300,000 people in Kentucky. Because low-income workers remain the least likely group in the U.S. workforce to have coverage through their jobs, many will likely become uninsured.

Texas v. Azar

Secretary Azar is also the defendant in this case, brought by Texas and 19 other Republican-led states. So-called amici, or friend of the court briefs, are due today and several groups have filed briefs. The suit claims that Congress’s repeal of the individual mandate penalty renders the individual mandate — still part of the ACA — unconstitutional. Because the mandate is essential to the operation of the law, the case argues that the entire law is invalid. In an extraordinary departure from executive branch precedent — and as noted by Tim Jost — Attorney General Jeff Sessions notified Congress last Thursday that the administration agreed with the plaintiffs that the individual mandate was unconstitutional. Because of this, the administration argues that insurers selling policies in the individual market can no longer be banned from denying people coverage or charging higher premiums because of their health, gender, or age. However, the administration maintains that other parts of the law, including the Medicaid expansion, are not affected.

Looking forward

Taken together, these cases underscore the Trump Administration’s ongoing interest in reducing the number of people covered under the Affordable Care Act by withdrawing federal support for the law. Today’s oral arguments in the Stewart case will provide early indications as to how the courts will view the administration’s actions. The insurance coverage of millions of Americans and the future of the Medicaid program are at stake.

 

 

Justice Dept. argues key parts of ObamaCare are unconstitutional

http://thehill.com/homenews/administration/391292-justice-dept-argues-key-parts-of-obamacare-are-unconstitutional?userid=12325

Image result for aca challenge

The Department of Justice (DOJ) argued in court Thursday that key parts of ObamaCare are now unconstitutional, siding in large part with a conservative challenge to the law.

The move is a break from the norm of the DOJ to defend federal laws when they are challenged in court. Under President Trump, the department has opted not to defend a law that it strongly opposes.

Attorney General Jeff Sessions acknowledged in a letter to Speaker Paul Ryan (R-Wis.) that the DOJ has a “longstanding tradition” of defending federal laws, but argued that this is “a rare case where the proper course is to forgo defense” of the law.

The lawsuit in question was filed in February by Texas and 19 other GOP-led states, arguing that ObamaCare is unconstitutional and should be overturned.

Legal experts are deeply skeptical the challenge can succeed, and 17 Democratic-led states have already intervened to defend the law in the absence of DOJ action.

The DOJ argues that ObamaCare’s protections against people with pre-existing conditions being denied coverage or charged more should be invalidated, maintaining that the individual mandate that people have insurance or face a tax penalty is now unconstitutional.

The conservative states and DOJ point to the Supreme Court’s 2012 ruling that upheld ObamaCare’s individual mandate under Congress’s taxing power. Now that Congress has repealed the mandate penalty as part of last year’s tax bill – while technically keeping the mandate itself in place – they argue the mandate is no longer a tax and is now invalid.

They also argue that the key pre-existing condition protections cannot be separated from the mandate and should be invalidated. The DOJ argues the remainder of the law can stay.

The chances for that argument succeeding are viewed with deep skepticism by legal experts, in part because Congress itself indicated that the rest of ObamaCare could still stand without the mandate when it moved to repeal the tax penalty last year.

The case is currently before a federal district court judge in Texas, Reed O’Connor, who was appointed by former President George W. Bush.

Some supporters of ObamaCare view the DOJ’s move more as a damaging break from precedent rather than an actual serious legal threat to ObamaCare, since the lawsuit is unlikely to succeed.

 

 

20 states sue over Obamacare mandate — again

https://www.politico.com/story/2018/02/26/20-state-sue-over-obamacare-again-425825

A man is pictured entering health insurance exchange center. | Getty

Twenty states are suing the Trump administration over Obamacare’s individual mandate — again.

Wisconsin, Texas and several other red states said in a lawsuit filed today that since Congress repealed the individual mandate’s tax penalty for not having coverage, that means the mandate itself — and the whole health care law — is invalid.

The GOP tax law “eliminated the tax penalty of the ACA, without eliminating the mandate itself,” the states argue in a complaint filed today in U.S. District Court in the Northern District of Texas. “What remains, then, is the individual mandate, without any accompanying exercise of Congress’s taxing power, which the Supreme Court already held that Congress has no authority to enact.”

The Supreme Court in 2012 upheld Obamacare’s individual mandate in one of the highest-profile court cases in years. The justices did not agree then with the Obama administration’s main argument that the mandate penalty was valid under the Commerce Clause. But the justices did say that the mandate was a constitutional tax. The ruling riled conservatives who felt that Chief Justice John Roberts bent legal reasoning to preserve Obamacare.

Now, the states want to use that same Supreme Court ruling to take down the Affordable Care Act — which has withstood numerous legal challenges but which over the past year has been undermined by executive and regulatory actions the Trump administration has taken.

The states also argue that since the mandate is unconstitutional, the whole law should go. They note that Obamacare did not have a “severability clause” — a provision that says if one part of the law is struck by the courts, the rest would stand — so that once part of it is struck down, the rest in invalid.

 

 

Hospital groups, health systems sue HHS to halt $1.6B in payment cuts

https://www.beckershospitalreview.com/finance/hospital-groups-health-systems-sue-hhs-to-halt-1-6b-in-payment-cuts.html

Image result for us district court of district of columbia

Three hospital groups and three provider organizations sued HHS Monday in an attempt to stop payment cuts for drugs purchased through the 340B Drug Pricing Program.

The lawsuit, which was filed in U.S. District Court for the District of Columbia, was filed by the following hospital groups: the American Hospital Association, America’s Essential Hospitals and the Association of American Medical Colleges. The groups were joined in the lawsuit by three health systems: Brewer, Maine-based Eastern Maine Healthcare Systems; Detroit-based Henry Ford Health System; and Hendersonville, N.C.-based Park Ridge Health.

Earlier this month, CMS released its 2018 Medicare Outpatient Prospective Payment System rule, which finalizes a proposal to pay hospitals 22.5 percent less than the average sales price for drugs purchased through the 340B program. That’s compared to the current payment rate of average sales price plus 6 percent. This change would reduce Medicare payments to hospitals by $1.6 billion.

The lawsuit argues the 340B provisions of the OPPS final rule violate the Social Security Act and should be set aside. The lawsuit further alleges the 340B provisions are outside of the HHS secretary’s statutory authority.

The hospital groups and health systems are seeking an injunction that would prohibit HHS from implementing the 340B provisions of the OPPS final rule pending resolution of the lawsuit.

“From its beginning, the 340B Drug Pricing Program has been critical in helping hospitals stretch scarce federal resources to enhance comprehensive patient services and access to care,” said Rick Pollack, president and CEO of the AHA. “CMS’s decision to cut Medicare payments for so many hospitals for drugs covered under the 340B program will dramatically threaten access to healthcare for many patients, including uninsured and other vulnerable populations. This lawsuit will prevent these significant cuts from moving forward.”

 

Another Health-Care Fraud Judgment Includes Personal Liability

https://www.bna.com/healthcare-fraud-judgment-b73014471303/?utm_campaign=LEGAL_NWSLTR_Health%20Care%20Update_102717&utm_medium=email&utm_source=Eloqua&elqTrackId=b4c0d096790e4f62a8a465ccca33d352&elq=3924f09b80454e158ead21b0e1788481&elqaid=9961&elqat=1&elqCampaignId=7532

Related image

The Department of Justice has put another notch on its Yates memo belt in securing a $2 million judgment against a home health provider and its owner personally.

A federal district judge issued the judgment Oct. 20 against Dynamic Visions Inc. and its owner Isaiah Bongam. The court previously granted the DOJ judgment on the issue of liability against Dynamic, and agreed that Bongam should be held personally responsible for Dynamic’s activities, which included forging physician signatures on patient care plans that were submitted to the District of Columbia’s Medicaid program.

The DOJ’s litigation strategy in the False Claims Act lawsuit aligned firmly with the 2015 Yates memo directive to hold individuals personally responsible for corporate fraud. While the court said there wasn’t sufficient evidence to tie Bongam to the forged signatures directly, it instead ruled that Bongam should be held personally liable for Dynamic’s actions because he was in sole control of the corporation.

Holding a person responsible for corporate liability, known as “piercing the corporate veil,” is available when the corporation is determined to be a mere shell or alter ego of a person, and therefore not deserving of the legal protection generally accorded the corporate form.

In this case, the court said not piercing the corporate veil to reach Bongam personally would be an “inequitable result,” citing Bongam’s disregard for corporate formalities and intermingling of personal funds with Dynamic’s accounts.

The judgment itself consisted of $1.5 million in damages and an additional $517,000 in fines for each alleged false claims submission. The DOJ asked for, and the court gave, the maximum $11,000 per claim damages for the 47 false claims that Dynamic submitted to Medicaid based on Dynamic’s egregious behavior.

Bongam is now on the hook for that judgment, unless it’s overturned on appeal. Bongam’s attorney told me that he intends to file an appeal, so stay tuned for an update.