Tag Archives: HHS

Appeals court overturns ruling requiring HHS to clear Medicare appeals backlog by 2021

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http://www.beckershospitalreview.com/finance/appeals-court-overturns-ruling-requiring-hhs-to-clear-medicare-appeals-backlog-by-2021.html

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The U.S. Appeals Court for the District of Columbia on Friday overturned an order requiring HHS to clear its backlog of Medicare reimbursement appeals by the end of 2020.

On Dec. 5, 2016, U.S. District Judge James Boasberg granted a motion for summary judgment filed by the American Hospital Association in AHA v. Burwell — a lawsuit that centers on the Recovery Audit Contractor Program.

He ordered HHS to incrementally reduce the backlog of 657,955 appeals pending before the agency’s Office of Medicare Hearings and Appeals over the next four years, reducing the backlog by 30 percent by the end of 2017; 60 percent by the end of 2018; 90 percent by the end of 2019; and to completely eliminate the backlog by Dec. 31, 2020.

HHS filed a motion Dec. 15, 2016, asking the judge to reconsider his decision. HHS argued it would be impossible to reduce the appeals backlog on the schedule provided by the court without improperly paying claims, regardless of merit. In January, Judge Boasberg denied HHS’ motion for reconsideration.

In late January, HHS filed an appeal in the case, seeking to avoid the district court’s order enforcing the plan to clear the appeals backlog by the end of 2020.

On Friday, the appellate court sided with HHS.

Since HHS said it was impossible to lawfully comply with the district court’s order, the appellate court ruled it was “an error of law” and “an abuse of discretion” for the district court judge to order HHS to abide by the schedule to clear the Medicare appeals backlog.

“In sum, it was an abuse of discretion to tailor the mandamus relief without tackling the Secretary’s claims that lawful compliance would be impossible,” states the appellate court’s opinion.

The appellate court held that on remand the lower court should determine if compliance with the timetable to reduce the Medicare appeals backlog is impossible.

Trump administration, HHS stepping away from Affordable Care Act promotion, bundled payments

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http://www.healthcarefinancenews.com/news/trump-administration-hhs-stepping-away-affordable-care-act-promotion-bundled-payments?mkt_tok=eyJpIjoiWlRsaE56QTFZMk00WVdVdyIsInQiOiJPV2NZVXpmSXoxY2s2blNFdG9DYmt0UHh1bnkzc0NcL0R3YnpCcEhqdm5lWVwvNlJrN2xDVlwvUFZ5ZFBzOElGY253OGFMZWVKVnh5a3dTSDM1RFwvdFN3cklQTGd0NmN0YzFrQjIrK21WUW5UTWhaUXVUdUhZZU41dGNwcUtvYmZUaEMifQ%3D%3D

New bundled payment models for cardiac care may be on chopping block, along with changes to joint replacement.

Lacking a repeal and replacement bill for the Affordable Care Act, President Trump appears to be following through on his Twitter promise to “let Obamacare implode.”

The Trump administration and the Department of Health and Human Services is distancing itself from several groups which in the past have helped market open enrollment, according to talkingpointsmemo.

HHS has not reached out to the Latino Affordable Care Act Coalition, the United Methodist Church, the American Congress of Obstetricians and Gynecologists, the American Medical Student Association, the National Urban League, the National Latina Institute for Reproductive Health, the National Hispanic Medical Association, and the National Partnership for Women and Families, according to the report.

Open enrollment in the ACA marketplace starts November 1.

The new bundled payment model for cardiac care coordination and cardiac rehabilitation may also be on the chopping block, along with unspecified changes to the joint replacement model, according to a proposed rule published August 10 in the Office of Management and Budget.

The models were introducted by the Centers for Medicare and Medicaid Services’ Innovatoin Center, or CMMI, run by Patrick Conway, MD, who last week announced he was leaving CMS to head Blue Cross Blue Shield North Carolina.

HHS Secretary Tom Price, an orthopedic surgeon appointed by the president, has consistently voiced his opposition to mandatory bundled payment programs.

HHS general counsel candidate vows to uphold ACA

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http://www.healthcaredive.com/news/hhs-general-counsel-candidate-vows-to-uphold-aca/448682/

Dive Brief:

  • During his nomination hearing in front of the Senate Finance Committee, Robert Charrow, who is a candidate for general counsel to the HHS, told senators he will resist changes to the Affordable Care Act (ACA) as long as it is law.
  • Charrow, who is an attorney with the international law firm of Greenberg Traurig, said he is a “firm believer in applying the law as written and passed by Congress. And if an action is inconsistent with the law, I will not approve it.”
  • The hearing, which also included the nominee for HHS assistant secretary for legislative affairs, Matthew Bassett, comes as the Government Accountability Office is looking into the use of official HHS communication channels to promote ACA repeal legislation.

Dive Insight:

While all of the Republican attempts to repeal the ACA have thus far failed, its supporters are still worried about threats, including from President Donald Trump, to sabotage the exchange markets. Trump said he wanted the ACA to “implode” and force senators to the negotiating table.

Charrow’s expressed willingness to defend the ACA could certainly come into play if he is approved. His boss would be HHS Secretary Tom Price, who is a vocal opponent of the ACA. If confirmed, Charrow may need to stand up to both his boss and the president.

The most immediate concern for the ACA is cost-sharing reduction (CSR) payments to payers, which Trump called a “bailout” for insurance companies. Payers say that without those subsidies they will need to raise rates or leave the ACA market. Because of the uncertainty, some payers have increased rates by more than 20% for 2018, dropped out of the market or cut down on their footprint.

The issue appears to be in limbo for now, with Congress out for its annual summer break and Trump beginning a 17-day vacation.

The Senate Finance Committee didn’t vote on the Charrow’s nomination, but we’ll soon know whether his statements were enough to quell Democratic fears.

Price: Trump was joking about firing me

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http://thehill.com/homenews/sunday-talk-shows/344512-price-trump-made-a-humorous-statement-about-firing-me

Price: Trump was joking about firing me

Health and Human Services Secretary Tom Price on Sunday brushed off President Trump’s remark last week that he might be fired if he is unable to get an ObamaCare repeal-and-replace measure through Congress.

“Oh, I think that statement was a humorous comment that the president made, but I think what it highlighted is the seriousness with which he takes this issue,” Price told host Martha Raddatz on ABC’s “This Week with George Stephanopoulos.”

The secretary then pivoted to listing the flaws with the current healthcare law of the land.

“He understands the American people are hurting because of ObamaCare,” Price said. 

On Monday, Trump had said that he would use his now infamous line “you’re fired” on Price, a phrase that he popularized as host of the competitive reality TV show “The Apprentice.”

“Hopefully he’s going to get the votes tomorrow to start our path toward killing this horrible thing known as ObamaCare that’s really hurting us. He better. Oh, he better. Otherwise, I’ll say, ‘Tom you’re fired,’” Trump said during a speech at the National Boy Scout Jamboree. 

The Senate’s effort to pass an ObamaCare “skinny” repeal deal collapsed overnight on Friday.

Medicaid And The Latest Version Of The BCRA: Massive Federal Funding Losses Remain

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http://healthaffairs.org/blog/2017/07/14/medicaid-and-the-latest-version-of-the-bcra-massive-federal-funding-losses-remain/

Washington, DC at the Capitol Building

Where Medicaid is concerned, the most notable thing about the latest version of the Better Care Reconciliation Act (BCRA) is that despite the drama of the past two weeks—the flood of news coverage regarding the potential impact of the losses; mounting concerns raised by Senators from expansion and non-expansion states alike; and the massive outcry from hospitals, physicians, insurers, and health care organizations—the new iteration leaves untouched the fundamental Medicaid contours of the earlier version.

The new draft retains the federal funding bar for Planned Parenthood (§ 123) as well as the earlier version’s limit on states’ ability to fund their programs through lawful, broad-based provider taxes (§ 131). The new bill does virtually nothing to lessen the financial losses to states that will flow from the prior iteration. According to the Congressional Budget Office (CBO), these losses would surpass $770 billion over 10 years as a result of provisions that eliminate the enhanced funding for the adult expansion population and superimpose flat annual growth restrictions on Medicaid’s historic federal funding formula (§124 and §132).

By 2036, CBO reports, federal Medicaid funding would be about 35 percent below current law, a catastrophe of epic proportions. According to one study that sought to translate BCRA’s Medicaid provisions into state-by-state loss estimates, California alone would lose between $37 and $52 billionbetween 2020 and 2027, depending on how the cap’s arbitrary growth limits play out over time. Indeed, depending on how the cap, which is tied to a general economic inflation rate that cannot be known with certainty, plays out against actual state spending needs—triggered by everything from new vaccines to long-term services and supports to address the opioid crisis or the consequences of Zika—the federal funding losses could grow from catastrophic to unimaginable.

Small Crumbs Of Money

Perhaps Congressional leaders have sought to convince their colleagues to disregard the CBO estimates and these studies, arguing that Congress, in fact, will never allow the bottom to fall out on states and will come through with additional funding. But the newest version of the bill underscores the fundamentally meaningless nature of such assurances.

Small crumbs of Medicaid give-backs can be found at various places in the new version. One that might be thought of as the Louisiana Purchase is designed to help one state cope with massive loss; over the long term, however, the adjustment washes out in the far larger picture of declining federal funding for an exceptionally poor state.

For purposes of setting the arbitrary growth limits over time, the original bill relied on per capita spending data from the 2014-2015 time period. The new draft would allow a late-expanding state (i.e., Louisiana) to use 2016 as its base period (§ 132). But regardless of whether it is tied to 2014-2015 or 2016, nothing can mask the fact that the base period is part of a growth formula unrelated to the real world of Medicaid spending. All state programs will be tied to the distant past where federal Medicaid funding is concerned.

Furthermore, the new version does not exempt the state from the bill’s exceptionally clumsy rate-setting procedures, which lack adjustments for volume and intensity or new technology and that allow the Health and Human Services (HHS) Secretary’s power to unilaterally alter what he considers to be unreliable state data. The measure continues to permit the Secretary to claw back what he determines to be “excessive” funding by reducing later payments without a prior hearing; in the event of state evidence of underpayment, the Secretary can withhold federal funds owed until a lengthy appeals system is exhausted.

As was the case with the prior version, the new draft tips its hat toward non-expansion states, further sweetening the pot by tweaking the disproportionate share hospital payment formula in ways that favor payments to states with the highest uninsured populations (§ 126, Restoring Fairness in DSH Allotments). Like its predecessor, the new version thus rewards states that have refused to insure their poorest residents and harshly penalizes struggling hospitals serving the remaining uninsured in those that have.

As an additional lure, the new version expands the block grant option in the earlier measure to enable states to use block grants for the ACA expansion population as well as for traditional low-income adults (§ 133). Like the earlier version, state block grant funding would remain virtually frozen, leaving states increasingly on the hook for care for millions of grievously under-funded adults.

The Illusion Of A Public Health Emergency Exemption To The Per Capita Cap

One of Medicaid’s most important dimensions is its irreplaceable role in addressing the immediate and long-term effects of public health crises. Medicaid is by far the nation’s biggest single source of health care financing for dealing with critical public health threats. These threats may begin with an initial, recognized period of a formally declared emergency. They then can morph into events with very long-term effects felt for years or decades after. This was the case with the World Trade Center attacks, which led to an immediate surge in health care spending, followed by years of elevated spending to address the long-term health fallout triggered by the emergency itself. One need think only about Zika or the opioid crisis now gripping the nation to understand the near-term/long-term nature of public health threats.

Medicaid enrollees are disproportionately likely to live in poor communities, and poor communities are disproportionately likely to face public health threats ranging from environmental hazards to infectious disease. These communities also are inherently less likely to have fewer resources to cope with the effects of an emergency. Thus, a program such as Medicaid is crucial in its ability to deploy health care financing resources to the hardest-hit populations. Indeed, two thirds of all Louisiana Medicaid beneficiaries lived in the parishes affected by Hurricane Katrina.

Section 319 of the Public Health Service Act authorizes the HHS Secretary to declare the existence of a public health emergency arising from events such as a “disease or disorder,” “significant outbreaks of infectious diseases or bioterrorist attacks,” or other events identified as public health emergencies by the HHS Secretary. Whether to declare an emergency is entrusted to the Secretary’s judgment, and during the immediate emergency period, the Secretary enjoys expanded powers to deploy resources to designated populations or geographic areas. These special powers end when the declared emergency period ends. In the aftermath, states and local communities effectively are on their own, relying on the resources they have.

In and of itself, a loss of federal health funding as large as that imposed by BCRA elevates the threat risk. This risk grows exponentially when a true crisis hits, if Medicaid is crippled in its ability to provide a large-scale surge in public health care spending both during the emergency and thereafter. To understand how little the revised bill does to mitigate the crippling impact of the initial draft one need only look carefully at what the revisions would do when a true emergency strikes.

The press release accompanying the new draft states that “if a public health emergency is declared, state medical assistance expenditures in a particular part of the state will not be counted toward the per capita caps or block grant allocations for the declared period of the emergency.” But a close read of the actual bill text reveals its fundamental inadequacy.

First, the period of exemption lasts only five years, from January 1, 2020 through December 31, 2024. Emergencies happening after this date won’t qualify for the spending adjustment. Second, the bill provides no additional federal spending during the period of a declared emergency. The draft simply allows states to eventually qualify for additional federal funding in the years following the emergency if they can prove to the Secretary that their spending on the affected population went up compared to prior years and then only for immediate emergency costs. What state will have the money in advance? And what state will be able to take a chance on spending more given the purely speculative nature of whether an emergency will be declared and emergency expenditures recognized?

Third, states would receive no additional funding ever unless the HHS Secretary actually declares an emergency in the affected portion of the state or for the state’s affected populations. Many public health threats may not rise to a level that triggers a formal Secretarial determination, and the Secretary may be inclined not to make such a determination because of other, spillover effects that come with such a determination, such as the elevated demand for other types of resources.

Fourth, the additional amount of federal funding made available would be limited to the difference between what the state spent on the population in connection with the emergency and the state’s previous expenditures for the same population. Expenditures to cope with the emergency aftermath would not count, and of course these expenditures likely would not occur simultaneously with the emergency expenditures. For example, Zika has triggered emergency expenditures aimed at preventing the spread of the virus, but the true costs of Zika will roll out slowly in the form of babies left permanently and severely disabled by the virus.

And here is where the public health implications of BCRA become clear: other than exempting state expenditures on children classified as disabled from the caps, the revised bill, like its predecessor, makes no adjustment for long-term consequences. To be sure, as just mentioned, BCRA does exempt state expenditures on severely disabled children from the federal cap. But because the vast majority of children qualify for Medicaid based on poverty, this type of cramped classification system for measuring exemptions is sure to exclude spending for millions of children in severely compromised health from the exemption process.

Fifth, the bill allows only $5 billion in the aggregate for all additional federal funding over the five-year time period covered by the emergency exemption. In other words, the bill essentially creates a five-year, $5 billion mini-block grant to help all states address Medicaid spending for all emergencies occurring during this time period. The incredibly small size of the block grant alone would be likely to incentivize the HHS Secretary to avoid declaring emergencies out of concern that the money won’t be there to cover them.

In the end, the newest iteration of BCRA does nothing to alleviate the catastrophic effects of its predecessor: the difference in magnitude between what Medicaid can do today and what it will be capable of doing in the future is incalculable.

ACA Round-Up: Medicare Trustees Report Does Not Trigger IPAB, And More

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http://healthaffairs.org/blog/2017/07/14/aca-round-up-medicare-trustees-report-does-not-trigger-ipab-and-more/

Click to access TR2017.pdf

All eyes yesterday were focused on the Senate, which released significant new amendments to the Better Care Reconciliation Act. But the Senate was not the only game in town.

On July 13 the Medicare Trustees released their 2017 Medicare Trust Fund report. One of the most controversial creations of the ACA was the Independent Payment Advisory Board (IPAB). The ACA established specific target growth rates for Medicare and charged the IPAB with ensuring that Medicare expenditures stayed within these limits.

Each year the CMS Chief Actuary must make a determination as to whether the projected average Medicare growth rate for the 5-year period ending 2 years later will exceed the target growth rate. For each year since the provision went into effect in 2013, the CMS Chief Actuary has determined that the projected growth rates will not exceed these limits. It was thought that this year might be different, but for 2017 the Chief Actuary again concluded that the growth rate will not be exceeded, and said so in a letter to CMS.

The IPAB was supposed to be a 15-member board of experts that would, for years when Medicare growth rates were projected to exceed the threshold, make recommendations for cutting costs. These would be implemented unless Congress enacted an alternate approach that would achieve the same savings or waived the requirement to cut costs by a three-fifths majority. The IPAB has never been created, but under the ACA, in the absence of an IPAB its power to make program cuts devolves to the HHS Secretary.

The IPAB is deeply disliked in Congress and proposals to abolish it have wide support. But the IPAB statute seems to say that the IPAB can only be abolished by a joint resolution of Congress which must be introduced into Congress by February 1, 2017 and be enacted, following very specific procedures, by August 15, 2017.  In fact, one bill to abolish the IPAB was introduced into the Senate by February 1 with 36 Republican co-sponsors, and another with 12 Democratic co-sponsors, while a House bill was introduced on February 3 with 233 Democratic and Republican cosponsors. But August 15 is coming up quickly and Congress seems to have its hands full with other issues. Moreover, the CBO would likely view elimination of the IPAB as coming with a high price tag.

It may not matter much. The IPAB provision recognizes that Congress can always change its mind.  It could presumably change its rules to allow it to abolish the IPAB whenever it chose to do so. In fact, the rules that the House adopted for the 115th session provide that any IPAB submittals are not to be considered during the 2017-2018 session. But if Congress chose to proceed according to the ACA’s provisions, the IPAB would find few defenders.

Federal Exchange Eligibility Redeterminations And Re-Enrollment

CMS released on July 13 a guidance describing how it intends to handle eligibility redeterminations and re-enrollment for federal exchange enrollees for 2018. Basically, CMS intends to use the same procedures it used for redeterminations and reenrollment for 2017, which in turn were similar to those used for 2016.  The exchange will continue to auto-reenroll enrollees who fail to select a plan, and to terminate enrollees who have been auto-reenrolled more than once without contact with the exchange.

There is one change for 2018: CMS will discontinue advance premium tax credits (APTC) and cost-sharing reduction (CSR) payments not just for enrollees who received APTC or CSRs and did not file a tax return in a prior year in which they received ATPC or CSRs, as CMS did in 2016, but additionally for enrollees who failed to file form 8962 to reconcile the APTC they received and the premium tax credits to which they were entitled, and failed to contact the exchange and obtain an updated eligibility determination for 2018. Filing a tax return and reconciling APTC with premium tax credits is an eligibility requirement for receiving APTC and CSRs in subsequent years, but federal regulations prohibit termination of coverage for this reason unless direct notice is sent to the enrollee that coverage will be terminated for failure to file. Until now, CMS has not been able to provide the required notice for those who fail to reconcile.

GAO Finds Tax Credit Verification Procedures Wanting

Finally, on July 13, 2017, the Government Accountability Office released a report on Improvements Needed in CMS and IRS Controls over Health Insurance Premium Tax Credits. The report is long and detailed and reviews comprehensively the controls that CMS and the IRS have in place—or, more often, do not have in place—for ensuring that improper premium tax credits are not made.

The GAO scored both agencies for failing to provide accurate assessments of improper payments. It also criticized each agency for failing to have procedures in place for verifying most eligibility requirements for premium tax credits and for identifying and correcting errors in premium tax credit reporting and collecting overpayments. The agencies responded that they are working on improving verification and processing procedures, but that that they have limited resources and verification is not always possible.

In the end, a tax-based system for paying for health insurance that depends on accurate reporting and verification of citizenship or lawful alien status, incarceration status, income, residence, health insurance premiums, household composition, availability of alternative forms of coverage, and tax filing status of applicants and enrollees—and requires coordination of two independent federal agencies—is very difficult to administer. If the Senate’s BCRA is adopted, administration of the program will only become more complicated, as all of these factors remain relevant and to them will be added age and the possibility of new forms of coverage that do not qualify for premium tax credits, but can be paid for using tax-subsidized health savings accounts. The GAO has its future work cut out for it in any event.

HHS announces ‘largest fraud takedown in history’

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http://www.healthcarefinancenews.com/news/hhs-announces-largest-fraud-takedown-history-charging-400-defendants-schemes-involving-13?mkt_tok=eyJpIjoiTTJVNFlXUTBOR0pqTmpJMSIsInQiOiJ3S01TRnZaWE5GT2NZMG13bGNnMENVdEc0OTRaNHVac1RJemUzNlhBRjY1ckY3dDQ5TCtlM1RqcTN5NHN0NktPU3Vud3dvUTJMM2ZHdG12R0RGaXZ1SzRGVjdYbE9KVFwvcTVwVENVWVdMbFwvYzh4RGlkNlRcLzY0SFZhMmpDZlBwUiJ9

The Department of Health and Human Services Office of Inspector General, state and federal law enforcement executed a massive fraud takedown this month that charged more than 400 defendants in connection with healthcare fraud schemes that involved roughly $1.3 billion in fraudulent billings to government payers including Medicare and Medicaid, the OIG announced.

The takedown is being called the largest in history, both for the number of defendants charged and the amount of money lost, OIG said.

Additionally, OIG issued exclusion notices to 295 doctors, nurses, and other providers related to opioid diversion and abuse. The notices ban participation in or claim submissions to, all Federal healthcare programs.Those who got the notices include 57 doctors, 162 nurses, and 36 pharmacists.

“Takedowns protect Medicare and Medicaid and deter fraud — sending a strong signal that theft from these taxpayer-funded programs will not be tolerated. The money taxpayers spend fighting fraud is an excellent investment: For every $1.00 spent on health care-related fraud and abuse investigations in the last three years, more than $5.00 has been recovered,” OIG said in a statement.

The schemes spanned the entire nation, from Washington to Puerto Rico, and 115 of those charged are medical professionals, specifically doctors and nurses. Among the fraud schemes, a Texas provider was charged with overprescribing narcotics to patients who had no medical need for them, and some of whom died from drug overdoses. The doctor allegedly fraudulently billed Medicare, netting more than $1.2 million in reimbursement. Another scheme involved seven Michigan defendants, including five physicians, who allegedly perpetrated illegal kickbacks and billing for medically unnecessary joint injections, drug screenings, and home health services. One of the defendants owned multiple health-related businesses and allegedly billed Medicare $126 million as part of the fraud scheme.

Another notable fraud case recently announced by the Department of Justice involved a landmark settlement with historically unique requirements. Pharmaceutical manufacturer Mallinckrodt, one of the largest manufacturers of generic oxycodone, agreed to pay $35 million to settle allegations that it violated the Controlled Substances Act when it failed to report “suspicious orders” for controlled substances, as well as record-keeping infractions. The DOJ said that from 2008 until 2011, Mallinckrodt supplied distributors an “increasingly excessive quantity” of oxycodone pills but didn’t notify the DEA of these suspicious orders. The distributors then supplied various U.S. pharmacies and pain clinics.

The DOJ called the settlement groundbreaking for a couple reasons. First, it involves requiring a manufacturer to utilize chargeback and similar data to monitor and report suspicious sales of its oxycodone at the next level in the supply chain. This typically means sales from distributors to independent and small chain pharmacy and pain clinic customers. Also, it requires a parallel agreement with the DEA through which the company will analyze data it collects on orders from customers down the supply chain to identify suspicious sales.

It is clear government agencies and law enforcement are increasingly zeroing in on healthcare fraud, with other notable settlements in recent months with well-known providers related to False Claims Act violations. Those systems include Carolinas Healthcare, Freedom Health, Los Angeles hospital Pacific Alliance Medical Center, Genesis Healthcare, and even Walmart.

Senate GOP Considers Taxing Employer Plans in Bill

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https://morningconsult.com/briefs/health-brief-senate-gop-considers-taxing-employer-plans-bill/

Image result for Senate GOP Considers Taxing Employer Plans in Bill

Washington Brief

  • Senate Republicans are considering taxing employer health insurance plans, but haven’t decided whether to include such a provision in a draft health care bill to repeal and replace major parts of the Affordable Care Act being crafted this week. (The Wall Street Journal)
  • The California State Senate advanced a bill to adopt a single-payer health care system on Thursday, but the measure does not include a way to pay for the $400 billion tab. (The Los Angeles Times)
  • Freedom Partners and Americans for Prosperity, conservative groups affiliated with the Koch Brothers, is urging HHS Secretary Tom Price to take action on “Phase 2” work that would undo parts of the ACA through regulation ahead of Congress passing a bill.

Business Brief

  • Premiums for policies sold on the individual market in Pennsylvania next year are set to increase by 8.8 percent on average, but the state’s insurance commissioner warned that could jump to a 36.3 percent increase if the Trump administration does not enforce certain aspects of the Affordable Care Act. (Lancaster Online)
  • Hospital leaders are concerned that President Donald Trump’s decision to withdraw from the Paris climate agreement could hurt peoples’ health. (Axios)
  • Health insurers participating in models to improve care for beneficiaries enrolled in both Medicare and Medicaid originally struggled to find participants, but new data from the Centers for Medicare and Medicaid Services shows many have overcome that challenge. (Modern Healthcare)

HHS delays 340B drug program regulations: 4 things to know

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http://www.beckershospitalreview.com/finance/hhs-delays-340b-drug-program-regulations-4-things-to-know.html

Image result for 340b drug pricing program

HHS on Thursday delayed a regulation preventing drug companies from overcharging hospitals under the 340B drug discount program.

Here are four things to know.

1. The 340B drug pricing program, enacted in 1992, ensures hospitals treating a large proportion of low-income patients can buy drugs from manufacturers at a discount of 20 to 50 percent, according to the report. About one-third of U.S. hospitals — or 2,000 — participate in the program, purchasing about $12 billion in discounted drugs in 2015, reports The Washington Post.

2. In 2010, Congress instructed HHS to implement program regulations to set price ceilings fordrugs and establish civil monetary penalties on manufacturers that “knowingly and intentionally overcharge 340B covered entities,” according to a statement from HHS. The agency in January issued a final rule for the regulations to take effect March 6.

3. After President Donald Trump initiated a hiring freeze on all federal agencies in early March, HHS pushed back the rule until May 22. The agency also requested comments over a proposal to further delay implementation of the regulations until October. After reviewing the comments, HHS decided to officially push back the regulations to take effect Oct. 1.

4. 340B Health, a lobby group representing hospitals and health systems in the 340B program, shared an emailed statement with Becker’s, saying it was “disappointed with HHS’ decision to further delay … a long-overdue regulation to police the pharmaceutical industry.”

CMS Checklist For State 1332 Waivers Focuses On High-Risk Pools, Reinsurance

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http://healthaffairs.org/blog/2017/05/12/cms-checklist-for-state-1332-waivers-focuses-on-high-risk-pools-reinsurance/

On May 11, 2017, the Centers for Medicare and Medicaid Services and the Department of the Treasury released a checklist for state 1332 innovation waiver applications. Following up on Health and Human Services Secretary Price’s letter to state governors of March 13, 2017, the checklist specifically focuses on state 1332 proposals to support high-risk pools or reinsurance programs.

Indeed, the checklist begins by stating:

The Department of Health and Human Services and the Department of Treasury (the Departments) are interested in working with states on Section 1332 waivers that would lower premiums for consumers, improve market stability, and increase consumer choice. In particular we welcome the opportunity to work with states to pursue Section 1332 waivers incorporating a high-risk pool/state-operated reinsurance program. State-operated reinsurance programs have a demonstrated ability to help lower premiums, and if the state shows a reduction in federal spending on premium tax credits a state could receive Federal pass-through funding to help fund the state’s reinsurance program.

The checklist restates the procedural requirements that states must meet under the current 1332 rules, such as posting a notice of the waiver proposal and accepting comments for at least 30 days, holding two public hearings, and consulting with Indian tribes where relevant.

Most elements in the checklist, however, describe specifically what information states must submit with applications for a 1332 waiver involving a reinsurance or high-risk pool program. While states must generally document state legislative authority to operate a 1332 waiver program, a state seeking a waiver to operate a high-risk pool or reinsurance program must establish that the legislation makes the program contingent on 1332 waiver approval or that the program will only become operational if the waiver is approved. Otherwise, the state would not be able to establish that federal 1332 waiver pass-through funding was necessary for the program.

A state must specify the provisions of the ACA it proposes to waive, which might, a footnote explains, include the ACA’s single-risk pool requirement for a reinsurance or high-risk pool proposal. State 1332 waiver proposals must include economic and actuarial data and analyses documenting the effect of the proposal on coverage and on comprehensiveness and affordability of coverage. A reinsurance/high-risk pool proposal would have to describe a baseline of premiums and coverage without the waiver and then compare this to projections of coverage and premiums under the waiver.

Proposals for 1332 waivers must explain how they would affect federal budget neutrality. A state seeking a reinsurance or high-risk pool waiver must establish a baseline of federal expenditures without the waiver and then show how federal expenditures or revenues for premium tax credits, shared responsibility payments, exchange user fees, and health insurance provider fees would change if the proposal is implemented.

States must further submit a timeline for implementation. They must describe whether they would use a condition-based list for a reinsurance program or an attachment-point-based model and the incentives they would offer providers, insurers, and enrollees to manage health care costs and utilization. They must describe how the program would affect other provisions of the Affordable Care Act and how it would provide out-of-state coverage for those who need it. States must report the actual second-lowest-cost silver benchmark plan premium annually, as well as an estimate of what it would have been without the program. The checklist further states, “For comprehensiveness, if there is no change to the provision of the ten Essential Health Benefits (EHB) identified in the benchmark plan, the state can indicate that it will report on any modifications from federal or state law on an annual basis.”

In sum, the checklist provides a roadmap for states that want to pursue high-risk pool or reinsurance 1332 waiver proposals, indicating again the priority that the Trump administration places on this approach for increasing the affordability of health insurance coverage.