The DOJ says a prompt resolution of the Texas-led challenge 'will help reduce uncertainty in the healthcare sector and other areas affected by the ACA.'
The Trump administration has asked a federal appeals court to expedite oral arguments in a lawsuit that could determine the future of the Affordable Care Act.
In a filing Monday with the Fifth Circuit Court of Appeals, the Department of Justice requested that the case be scheduled for oral argument the week of July 8.
"Prompt resolution of this case will help reduce uncertainty in the healthcare sector, and other areas affected by the Affordable Care Act," the DOJ said.
U.S. District Judge Reed O'Connor last December declared the entire ACA invalid, as a Texas-led coalition of plaintiff states had requested. The ruling was appealed to the Fifth Circuit by a California-led coalition of states intervening in defense of the ACA.
The DOJ's filing said the other parties and intervenors involved in the case don't oppose the motion to expedite.
O'Connor's ruling invalidating the ACA went much further than what DOJ had urged. Last month, however, DOJ reversed course and notified the appeals court that it agrees with the plaintiffs' argument and O'Connor's ruling, and would entirely abandon its partial defense of the ACA.
New partnership plans to increase availability of patient-centered primary care with easy access to multiple medical and wellness services.
Blue Cross and Blue Shield of Texas and Sanitas USA will partner to open 10 advanced primary care clinics in Dallas and Houston, the two companies announced Monday.
The clinics, scheduled to open on January 1, 2020, will provide primary care, urgent care, lab and diagnostic imaging services, care coordination, and wellness and disease management programs--all under one roof, the companies said.
"Our partnership with Sanitas is another example of collaborating with healthcare providers to deliver the best possible care and support to our members," said Dan McCoy, MD, president of BCBSTX.
"We believe that this partnership will advance primary care services and is an effective approach to providing quality healthcare outcomes, improving member engagement and experience, and lowering costs for our members, including populations that may have difficulty accessing care," McCoy said.
Some clinics will be open 365 days a year, and every location will have extended weekday and weekend hours. The clinics will service Blue Cross and Blue Shield card holders and accept self-pay patients and seniors with traditional Medicare coverage, the companies said.
"Our approach to care is centered on our patients and their families, giving them more time with the doctor and the convenience of a one-stop medical center for their everyday healthcare needs," said Joseba Grajales, president of Keralty Group, the parent company of Sanitas USA.
"Our expansion to Texas will continue to build on our success in Florida, New Jersey and Connecticut, serving more than 200,000 patients in diverse communities," he said.
The 10 medical centers will be located throughout Harris and Dallas counties: Bellaire, Katy, Northwest Houston, Southeast Houston, Spring and West Houston in Harris County; and Irving, Las Colinas, Mesquite and Richardson in Dallas County. Construction begins this spring.
Sanitas operates 29 clinics in Florida, Connecticut and New Jersey, often in collaboration with health insurance companies.
The pharmacy benefits managers-backed study says it would be 'premature' for policymakers to adopt the rule without better understanding its impact.
The federal government's proposed rule on prescription drug rebates is getting panned by the pharmacy benefits management lobby.
"The Administration has expressed a strong concern about the cost of prescription drugs in the U.S. healthcare system. Oddly, the proposed rule will increase revenues and reduce costs for drugmakers," said Alex Brill, CEO at Matrix Global Advisors, the author of a studycommissioned by the Pharmaceutical Care Management Association.
According to Brill, the proposed rule, released in February by the HHS Office of Inspector General, would "raise net drug prices in Medicare Part D under the guise of reducing list prices, shift drug costs from the commercial market to the Medicare Part D market, and raise costs on all Medicare beneficiaries through higher premiums in order to lower out-of-pocket costs for those with expensive prescription drugs."
"More concerning is the uncertainty regarding the effects of the proposed rule in numerous critical regards," Brill wrote. "It would be premature for policymakers to proceed without better understanding the proposed rule's impact on federal healthcare programs and beneficiaries, its far-reaching effects in the drug supply chain, and its indirect effects on the commercial market."
PCMA issued a media release calling the HHS proposal "poorly conceived." J.C. Scott, president and CEO of PCMA, said the analysis his association paid for "confirms that the proposed policy changes risk significantly raising costs for Medicare beneficiaries and taxpayers, disrupting Part D."
"PBMs share the Administration's goals. To better achieve them, we believe that if the proposed rule moves forward, it should be modified so that PBMs continue to be able to negotiate for lower drug prices for consumers and be empowered to help administer any new system."
HHS unveiled the proposed rule in February, and said that eliminating rebates would incentivize drugmakers to lower list prices, and incentivize PBMs to negotiate greater discounts from drugmakers. Ultimately, HHS said, "the goal of this policy is to lower out-of-pocket costs for consumers and reduce government spending in Federal health care programs."
Brill said his report jibes with the Centers for Medicare & Medicaid Services Office of the Actuary concerns that restricting rebates will lead to lower price concessions by drug manufacturers, which will increase spending on prescription drugs and create a windfall for drugmakers.
Addressing the skyrocketing costs of prescription drug prices has been a top item on the agenda of Congressional Democrats and Republicans, and the Trump Administration. The Senate Finance Committee on Tuesday hosts executives from five leading PBMs as part of its ongoing efforts to address the issue.
The companies alleged used the foundations as a conduit for copays that induced patients to use their drugs, with the higher prices eventually billed to government-sponsored health plans.
Three pharmaceutical companies will pay a combined $122.6 million to resolve separate allegations that they used third-party foundations as conduits for copays for their own products, the Department of Justice said.
The companies—Jazz Pharmaceuticals plc, Lundbeck LLC, and Alexion Pharmaceuticals Inc.—will pay $57 million, $52.6 million, and $13 million, respectively, to resolve alleged violations of the federal False Claims Act in the kickback schemes that resulted in higher costs for Medicare and the Civilian Health and Medical Program, DOJ said.
The alleged schemes occurred between 2010 and 2016, DOJ said.
The Anti-Kickback Statute bans drug makers from paying any remuneration, including copays, to induce government-sponsored health plan enrollees to purchase the companies' drugs.
"Pharmaceutical companies undercut a key safeguard against rising drug costs when they create assistance funds to serve as conduits for the companies to subsidize the copays of their own drugs," Assistant Attorney General Jody Hunt of DOJ's Civil Division, said in a media release.
"These enforcement actions make clear that the government will hold accountable drug companies that directly or indirectly pay illegal kickbacks," Hunt said.
Jazz and Lundbeck each entered five-year corporate integrity agreements with the Department of Health and Human Services' Office of the Inspector General.
Alexion was exempted from a CIA "because it made sweeping and fundamental organizational changes following the bad conduct," DOJ said.
The changes included firing the C-suite, and ousting half of the members of its board of directors. In addition, 40% of Alexion's employees are new and the company relocated its corporate headquarters to Boston, DOJ said.
Jazz
The allegations against Jazz center on the sale of its narcolepsy drug Xyrem. Jazz allegedly used the Caring Voice Coalition to established a "Narcolepsy Fund" for which Jazz was the sole donor.
"Although Xyrem accounted for a small share of the overall narcolepsy market, the fund almost exclusively used Jazz's donations to pay copays for Xyrem and required non-Xyrem patients on competing products to obtain a denial letter from another assistance plan before helping them," DOJ said.
Prosecutors also allege that Jazz made Medicare patients ineligible for the drug maker's free drug program and instead referred Xyrem Medicare patients to the foundation, enabling Jazz to generate revenue from Medicare and induce purchases of the drug, rather than continuing to provide these patients with free drugs.
Meanwhile, Jazz raised the price of Xyrem by over 150% over the course of the scheme.
Jazz also sold Prialt, an injectable severe chronic pain medication. The government alleged that Jazz asked the same foundation to create a fund ostensibly to assist patients with the co-pays of any severe chronic pain drugs, but which, in practice, almost exclusively paid Prialt Medicare copays.
Shortly after creating the fund, the foundation allegedly told Jazz that when severe chronic pain patients seeking assistance with other drugs contacted the foundation, it would refer them elsewhere. Prosecutors said Jazz knew that the fund did not appear on the foundation's website, which minimized the number of non-Prialt patients seeking assistance.
Jazz issued a statement noting that the settlement "is not an admission by Jazz of liability or the facts alleged by the DOJ but a settlement of the government’s claims" against the company. The company said it has rigorous compliance guidelines in place for its relationships with independent foundations that provide patient support.
Lundbeck
Lundbeck sells Xenazine, the only drug that was approved to treat chorea associated with Huntington's disease until a generic version became available until 2015.
Prosecutors said Lundbeck was the sole donor to a fund at a foundation that ostensibly provided financial support only for patients with Huntington's Disease. However, Lundbeck allegedly referred Xenazine patients with many other conditions to this foundation, which then paid the Xenazine copays for these unapproved uses.
After the foundation determined in 2014 that its Huntington's Disease fund would no longer pay the copays of patients taking Xenazine for non-Huntington's diseases, Lundbeck repurposed prior donations to the Huntington’s Disease fund to a "general fund" at the foundation to pay patients’ Xenazine copays, DOJ said.
Lundbeck also allegedly made subsequent "unrestricted" payments to the foundation with the understanding that the foundation would use these payments to pay Xenazine copays for these same patients.
When Lundbeck asked the foundation if there was a risk of getting caught, the foundation alleged replied that government regulators "don't know what we use the general fund for," DOJ said.
Lundbeck wouldn’t let Medicare or ChampVA patients participate in its free drug program for Xenazine, which was open to other financially needy patients, even if those Medicare or ChampVA patients could not afford their copays for Xenazine.
Instead, in order to generate revenue from Medicare and ChampVA and to induce purchases of Xenazine, Lundbeck allegedly referred financially needy non-Huntington’s Disease Xenazine patients to the foundation, which resulted in claims to Medicare and ChampVA to cover the cost of the drug, DOJ said.
Lundbeck issued a statement saying that the settlement "allows us to put this matter behind us and continue our focus on providing innovative medications for people living with brain disorders. The agreement does not include any admission that we violated any law."
Alexion
The allegations against Alexion involve the sale of Soliris, a $500,000-a-year drug that is used to treat patients with paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
Prosecutors allege that Alexion made donations to a "Complement-Mediated Disease" fund at a foundation to pay the Medicare copay obligations of patients taking Soliris and to induce those patients' purchases of Soliris.
Alexion allegedly knew that sky-high price would make the drug unaffordable for many patients, so the company asked a foundation in 2010 to create a financial assistance fund for Soliris patients. The fund paid Medicare copays and other medical expenses.
Alexion—the sole donor to the fund—knew the foundation's financial help for patients was contingent on the patients taking Soliris.
Alexion wouldn’t let Medicare patients to participate in its free drug program, which was open to other financially needy patients, even if those Medicare patients could not afford their copays for Soliris.
Instead, in order to generate revenue from Medicare and induce purchases of Soliris, Alexion allegedly referred Medicare patients prescribed Soliris to the foundation, through the foundation's "referral portal" software.
Allegedly, the "referral portal" reported information back to Alexion confirming those Soliris patients who were approved for copay from the foundation, and detailed the foundation’s payments to them, which resulted in claims to Medicare to cover the cost of Soliris.
Alexion said in a media release that it was "pleased to have reached a constructive resolution with the government that recognizes the significant positive changes achieved over the last two years under the company’s new leadership."
UPMC applauds the ruling, but the Pennsylvania Attorney General's Office says it will file an appeal with the state supreme court.
A state court has rejected the Pennsylvania Attorney General's attempt to modify and extend a five-year consent decree governing University of Pittsburgh Medical Center's dealings with rival Highmark.
Pennsylvania Commonwealth Judge Robert Simpson ruled Wednesday that the AG's office did not have the authority to modify the consent decree—which expires June 30—without the consent of both Highmark, which agreed with the modifications, and UPMC, which did not.
"Because the OAG does not plead fraud, accident or mistake, this court lacks the power or authority to modify the termination date of the consent decree without the consent of the parties, even if it were in the public interest to do so," Simpson wrote in a 45-page ruling.
UPMC Chief Communications Office Paul Wood said in prepared remarks that the health system "agrees with the Commonwealth Court ruling that the Consent Decrees end on June 30, 2019, which is exactly what the Pennsylvania Supreme Court unanimously decided last year."
Simpson declined to rule on UPMC's counterclaims that Pennsylvania Attorney General Josh Shapiro did not have the authority to regulate nonprofit organizations, nor did the judge rule on Shapiro's claim that UPMC was not meeting its charitable obligations.
Shapiro's office filed suit against UPMC in February, asking the court to allow for the modification and extension of the consent decree indefinitely, arguing that UPMC was violating its obligations as a nonprofit organization.
UPMC countersued two weeks later, claiming the AG's office lacks the legal authority to meddle in UPMC's negotiations with Highmark and other health plans.
Shapiro's spokesman Joe Grace said the AG will appeal the ruling with the Pennsylvania Supreme Court.
"Judge Simpson ruled that Commonwealth Court itself could not extend the date of the consent decrees—not that such a modification was barred," Grace said. "This enables our office to quickly appeal to the Supreme Court, which we will do in short order given the impending scheduled expiration date."
"As this complex legal process plays out, Attorney General Shapiro will continue fighting for the best interest of patients, payers and the public in Western Pennsylvania and uphold their access to the healthcare facilities they have contributed to building," Grace said.
The UPMC-Highmark feud has been long-running, as the payer-provider organizations have jockeyed for market dominance in western Pennsylvania.
State officials required the two to work together, imposing a consent decree in 2014 that required each health plan to cover services provided by the other organization. That decree is set to expire June 30.
A federal report found no generally accepted estimate of downstream healthcare costs associated with untreated behavioral health conditions.
Nearly 57 million adult Americans have a substance abuse or mental health condition, and nearly 40 million of them go untreated, according to data cited by the Government Accountability Office.
"Not treating behavioral health conditions can lead to other health care costs, such as the costs of emergency care for an overdose," GAO said in a recent report. "However, GAO found that research on such costs is limited and there is no generally accepted estimate of all the healthcare costs associated with untreated behavioral health conditions."
Citing 2017 survey data from the Substance Abuse and Mental Health Services Administration, more than 80% or respondents who reported a mental health or substance abuse problem said they did not perceive need treatment.
A further breakdown of SAMHSA survey results showed that:
Of the 18.7 million people with substance abuse disorders, 17.2 million are untreated.
Of the 11.2 million people with serious mental illness, 3.7 million are untreated.
Of the 35.4 million people with other mental illness, 22.9 million are untreated.
The SAMHSA survey found that people who perceived a need for behavioral health treatment but did not receive it blamed cost, stigma, and access challenges, such as not knowing where to go for treatment.
GAO said a review of existing literature on untreated substance abuse and behavioral health could not provide any downstream cost estimates.
"According to experts GAO met with, available research in this area is limited by methodological challenges, including determining which healthcare costs can be attributed to an untreated behavioral condition, and by limited data on the full prevalence of certain behavioral health conditions," the report said.
The 29 studies GAO reviewed for the report compared the healthcare costs associated with treating and not treating certain behavioral health conditions in adults focused more on specific behavioral health conditions and specific geographic areas.
By combining traditional medical data with self-reported SDOH data, the codes trigger referrals to social and government services to address people's unique needs.
UnitedHealthcare, and the American Medical Association have launched a collaboration to create nearly two dozen ICD-10 codes to better incorporate social determinants of health into healthcare delivery.
The collaborative wants to standardize how SDOH such as food, housing, transportation, employment, and financial means are collected, processed and used in patients' care plans, noting that there exists no consistent, organized method to capture that data.
By combining traditional medical data with self-reported SDOH data, the codes trigger referrals to social and government services to address people's unique needs, connecting them directly to local and national resources in their communities, the collaborative said in a media release.
Through this collaboration, UnitedHealthcare and the AMA's Integrated Health Model Initiative are supporting the creation of nearly two dozen new ICD-10 codes related to SDOH.
"The collaboration reinforces the importance of social and environmental factors in patient care, and will shape IHMI's efforts to support clinical decisions with useful and valid data to achieve broad improvements in health and greater health equity," said Tom Giannulli, MD, CMIO at IHMI.
Using its data model, UnitedHealthcare said it has made more than 700,000 social-service referrals for enrollees in its Medicare Advantage plans since 2017.
Increasingly, payers, providers, and state and federal governments are acknowledging the critical role that SDOH plays in proactive care delivery.
In 2016, CMS amended the Medicaid managed care rule to prompt Medicaid MCOs to help patients with nonmedical expenses that were considered crucial to achieving health outcomes and cutting costs.
Under the CMS Accountable Health Communities Initiative, many Medicaid MCOs assess patients' unmet social needs, including housing instability, food insecurity, utility needs, interpersonal violence, and transportation requirements.
An increasing number of states are requiring Medicaid MCOs to address social determinants of health as part of contractual agreements. In New York, The Empire State's Value Based Payment Roadmap requires MCOs to offer startup funds for partners in Value Based Payment agreements who are conducting social determinant of health interventions.
National and state hospitals groups warn that invalidating the Affordable Care Act would have 'disastrous' consequences for tens of millions of Americans and the nation's healthcare infrastructure.
The nation's largest hospital associations and 24 state hospital associations on Monday filed amicus briefs urging a federal appeals court to reject a Texas court's "judicial repeal" of the Affordable Care Act.
"If upheld, it will unwind eight years of progress under the ACA's broad set of reforms," read the joint amicus brief submitted by the American Hospital Association, Federation of American Hospitals, the Catholic Health Association of the United States, America's Essential Hospitals, and the Association of American Medical Colleges.
"And if upheld, it will cause tens of millions of patients to lose their health insurance, returning them to the ranks of the long-term uninsured and putting their health at risk," the associations said.
U.S. District Judge Reed O'Connor last December declared the entire ACA invalid, as the Texas-led coalition of plaintiff states had requested. The ruling was appealed to the 5th U.S. Circuit Court of Appeals by a California-led coalition of states intervening in defense of the ACA.
O'Connor's ruling invalidating the ACA went much further than what DOJ had urged. Last week, however, DOJ reversed course and notified the appeals court that it agrees with the plaintiffs' argument and O'Connor's ruling, and would entirely abandon its partial defense of the ACA.
The AHA-led amicus brief said that repealing the ACA only benefits the "plaintiffs' idiosyncratic health-policy preferences."
"But for the rest of the country, which has benefitted from expanded health-insurance coverage, the birth of a stable individual-insurance market, an expanded Medicaid safety net, and many other protections, it would be disastrous," the brief read.
"It would result in more Americans going without basic medical care and more Americans waiting to seek care until they are seriously ill, placing their health at greater risk and making it harder to treat their conditions successfully," the brief said.
In a separate amicus brief, also filed Monday, 24 state hospital associations also urged the appellate court to reverse O'Connor's ruling.
"This court should reverse the district court’s order striking down the ACA," the brief read. "If the court holds the minimum coverage provision unconstitutional, it should sever that one provision and leave the rest of the law intact."
"Any other ruling would disrupt nine years of innovations that have become enmeshed in the health care landscape, wreak havoc in healthcare delivery in this country, and subvert the will of Congress," the 24 hospital associations wrote.
Prosecutors allege that CareWell executives developed schemes to create mandatory but unnecessary examinations that were billed to state and federal healthcare programs.
CareWell Urgent Care Centers will pay $2 million to settle whistleblower allegations that the company submitted inflated and upcoded claims to Medicare and to Medicaid programs in Massachusetts and Rhode Island, the Department of Justice said.
According to state and federal prosecutors, between 2013 and 2018, Quincy, Massachusetts-based CareWell filed false claims with Medicaid, MassHealth, GIC, and Rhode Island Medicaid after inflating evaluation and management services and failing to identify the clinicians providing the care.
CareWell allegedly used several schemes, including ordering clinicians to unnecessarily examine and document at least 13 body systems during medical history inquiries, and at least nine body systems during physical examinations.
This unnecessary documentation was compiled even if patients' medical complaints or symptoms did not warrant it, prosecutors said.
CareWell ordered clinicians to use patient encounter templates within the clinics' electronic medical records that used "yes or no" questions about specific body systems, even when such inquiries were not medically necessary, prosecutors said.
"Even if medical personnel failed to ask a patient every question in an encounter plan template, the template contained a default 'no' response to each inquiry," prosecutors alleged. "CareWell used the default 'no' responses to assert that the associated body systems had been examined and billed accordingly, even when no such examination had occurred."
CareWell managers also allegedly lied to clinicians and told them that examinations unrelated to a patient's specific medical complaints or symptoms were required by a malpractice insurance carrier.
Prosecutors also allege that CareWell failed to reduce the amounts of its claims for services performed by unsupervised nurse practitioners.
"The CareWell urgent care centers engaged in a calculated scheme to reap unjustified economic benefit for their own gain from precious government healthcare resources," said Andrew E. Lelling, U.S. Attorney for the District of Massachusetts.
The settlement resolves whistleblower allegations brought by former CareWell employee Aileen Cartier, who will collect about $340,000.
CareWell Responds
CareWell said in a media release that it reached the settlement "after fully cooperating with the inquiry."
"We believe it is crucial to be thorough with each patient's examination in order to provide the best possible care," the company said.
CareWell operates 16 urgent care centers in Massachusetts, and one in Rhode Island.
The pilot program will provide temporary housing, tenant support and other services to people who are homeless or at risk of homelessness because of their disability.
The Centers for Medicare & Medicaid Services has approved a Florida section 1115 pilot program that provides behavioral health services and housing to adult Medicaid beneficiaries with serious mental illness, substance abuse disorders, or both.
"We are committed to supporting states that seek to test policies that are likely to improvebeneficiary health because we believe that promoting independence and improving health outcomes is in the best interests of the beneficiary and advances the fundamental objectives of the Medicaid program," Chris Traylor, CMS's deputy administrator and director, said in a letter this week to Beth Kidder, Florida's deputy director of Medicaid.
"In its consideration of Florida's MMA (Managed Medical Assistance amendment), CMS examined whether the demonstration was likely to assist in improving health outcomes, whether it would address health determinants that influence health outcomes, and whether it would incentivize beneficiaries to engage in their own healthcare and achieve better health outcomes," Traylor said.
"CMS has determined the Florida MMA Demonstration is likely to promote Medicaid objectives, and the waiver and expenditure authorities sought are necessary and appropriate to carry out the demonstration," he said.
The Behavioral Health and Supportive Housing Assistance Pilot will provide transitional housing, tenancy support services, mobile crisis management and self- and peer-support, along with home and community-based services to people who are homeless or at risk of homelessness because of their disability.
The waiver request was sent to CMS after Florida lawmakers in 2016 directed the state's Agency for Healthcare Administration to seek federal approval to pay for "flexible services" such as temporary housing for people with severe mental illness or substance abuse disorders.
In exchange for the waiver approval, Florida must follow home and community-based services requirements for person-centered planning, conflict of interest, and home and community-based setting requirements.
The state must also develop performance measures within 90 days following the approval of the waiver to address the requirements of the pre-tenancy services, tenancy sustaining services, mobile crisis management and self-help/peer support, CMS said.
"By paying these costs, the Medicaid program helps vulnerable populations afford the medical care and services they need to attain and maintain health and well-being," Traylor said.
