On June 1, 2018, New Jersey Governor Phil Murphy signed into law the Out-of-Network Consumer Protection, Transparency, Cost Containment and Accountability Act (the “Act”), available at: http://www.njleg.state.nj.us/bills/BillView.asp?BillNumber=A2039, which becomes effective on the 90^th day after enactment.

The Act enhances consumer protections related to surprise out-of-network healthcare charges, and affects health care facilities, health care professionals, and health insurance carriers. Requirements under the Act specific to facilities, professionals, and carriers are summarized below.

Health care facilities or carriers that violate any provision of the Act will be liable for not more than $1,000 for each violation, where each day on which a violation occurs is considered a separate violation, up to $25,000 per occurrence. Health care professionals who violate the Act will be liable for up to $100 per violation, where each day on which a violation occurs is considered a separate violation, up to $2,500 per occurrence. Other penalties may be initiated by the Commissioner of Banking and Insurance, the Commissioner of Health, or the relevant professional or licensing board, as appropriate, pursuant to rules that may be adopted under the Act.

The Act also creates an arbitration process to resolve out-of-network billing disputes, so healthcare providers should be prepared for the new, multi-step arbitration process that will be utilized in New Jersey. Continue reading…

The sweeping Republican tax reform bill, H.R. 1 (115), was passed by Congress on Wednesday afternoon, and signed by President Trump today. Although the President said on Wednesday that, “ObamaCare has been repealed in this bill,” due to the bill’s elimination of the Individual Mandate, it remains to be seen whether this will truly strike the final blow to ObamaCare (the Affordable Care Act, or “ACA”) as envisioned by the President.

If the ACA manages to survive, it will not be for lack of trying on the Trump administration’s part. On top of the elimination of the Individual Mandate, the Trump administration has removed some subsidies, halved the insurance enrollment period, destroyed the Obamacare marketing campaign, and has permitted skimpy new health plans that will inflict even more damage on the ACA. All together, these add up to an incremental corrosion of the law.

However, although the ACA is weakened, it has so far survived the assault, even if in a diminished form. In fact, numerous polls have found that the ACA is increasingly popular with the American public. And several factors indicate that the ACA may be able to weather the storm. Continue reading…

The U.S. District of Minnesota has ruled in Peterson v. Unitedhealth Grp. Inc., No. 14-CV-2101 (PJS/BRT), 2017 WL 991043 (D. Minn. Mar. 14, 2017) that ERISA does not permit United Healthcare (“United”) to claw back alleged overpayments related to patients from one plan by reducing or eliminating payments related to patients from different self-insured plans, dealing a potential blow to the use of an effective tool that health insurers have used to recoup alleged overpayments from providers.

In Peterson, the Plaintiffs were healthcare providers who brought suit against United as assignees of patients who were enrolled in United-administered plans. United had allegedly overpaid Plaintiffs for services provided to certain patients, and offset these alleged overpayments by reducing or eliminating payments for services that Plaintiffs provided to other patients, who were members of different United-administered self-insured ERISA plans. This practice is known as cross-plan offsetting. Continue reading…

Word spread quickly Monday (December 20, 2016) about CMS’ issuance of final regulations (to be published in the Federal Register on January 3, 2017) rolling out new mandatory bundled payments models for Acute Miocardial Infarction (AMI), Coronary Artery Bypass Graft (CABG), Surgical Hip and Fracture Treatment (SHFFT), a Cardiac Rehabilitation (CR) incentive model and Track 1+ Accountable Care Organizations. Speculation that President-elect Donald Trump’s nominee for HHS secretary, Rep. Tom Price, would move to roll the regulations back spread just as quickly.

The new regulations mandate bundled payment models (covering the period from admission to ninety days post-discharge) for AMI and CABG in 98 geographies covering 1,120 hospitals; for SHFFT in the 67 geographies where the Comprehensive Joint Replacement (CJR) has already been mandated covering 850 hospitals and for CR in 90 geographies covering 1,320 hospitals. CMS’ chart of geographies covered by each program is set forth here. The AMI, CABG and SHFFT programs give participant clinicians the opportunity to be excluded from Medicare and CHIP Reauthorization Act of 2015’s (MACRA) Medicare Incentive Payment System (MIPS) and to qualify under MACRA’s Advanced Alternative Payment Model (AAPM). Continue reading…

In a final rule published today in the federal register (“Final Rule”), CMS announced numerous changes to the consolidated Medicare and Medicaid requirements for participation for long term care (LTC) facilities (42 CFR part 483, subpart B), which take effect on November 28, 2016 (see the March 7, 2016 blog for information about the July 16, 2015 proposed rule (“Proposed Rule”)). Much to the satisfaction of elder care advocates, the Final Rule provides that nursing homes may no longer require prospective nursing home residents to agree to binding arbitration. This strikes a blow at LTC facilities, which generally used arbitration as a tool to avoid incurring the onerous costs associated with litigation.

CMS’ position in the final rule isn’t shocking as it had expressed concern about the use of arbitration agreements in nursing homes in its Proposed Rule. Although no longer permissible for LTC facilities to use as a condition of admission, according to Andy Slavitt, CMS’ Acting Administrator, and Kate Goodrich, Director of the Center for Clinical Standards & Quality, “facilities and residents will still be able to use arbitration on a voluntary basis at the time a dispute arises.” However, such agreements will still need to be “clearly explained” to residents.

Nursing homes that have traditionally asked residents to sign binding arbitration agreements should revisit their admissions processes and implement revised policies and procedures to ensure compliance with the Final Rule, so that, beginning November 28, 2016, residents at such LTC facilities are no longer required to agree to binding arbitration. LTC facilities may also consider revising their policies and procedures to incorporate recommending the use of arbitration to residents following disputes that may arise, and to ensure that any such recommendations are clearly explained to their residents.

For more information regarding the voluntary use of arbitration agreements in the nursing home context, contact J. Nicole Martin, Dana Petrillo or any member of Cozen O’Connor’s health care law team.

On April 17, 2016, Governor Wolf signed Act 16 of 2016, making Pennsylvania the 24^th state (plus the District of Columbia) to legalize marijuana for medical use. The full text of the act is available here.

Physicians, not surprisingly, will play a vital role in making medical marijuana available to Pennsylvanians, while ensuring patient safety in the process.  This is what they should know about Act 16: Continue reading…

MedStar, a Washington, D.C.-area hospital chain, became the latest healthcare industry victim of a cyber-attack when hackers breached its systems with a crippling virus. MedStar operates 10 hospitals in the D.C./Baltimore region, employs 30,000 staff, has 6,000 affiliated physicians, and serviced more than 4.5 million patient visits in 2015.

After being paralyzed by the virus, MedStar’s entire IT system for its 10 hospitals was forced to shut down and revert to paper records. The chain’s approximately 35,000 employees do not have access to emails and cannot look up digital patient records in the attack’s wake. The FBI is assisting the chain by investigating the incident. It’s unclear at the moment whether or not the hackers are demanding ransom from MedStar in exchange for removing the virus.

Monday’s cyber-attack at MedStar comes weeks after Hollywood Presbyterian Medical Center in Los Angeles paid hackers 40 bitcoins, or about $17,000, to regain control of its computer system, which hackers had seized with ransomware using an infected email attachment.

Hackers increasingly target healthcare entities as security protections in healthcare often lag behind those in banking and financial sectors. Healthcare information contains a treasure trove of patients’ personal information, and a complete healthcare record is worth at least ten times more on the black market than credit card information. Also, hospitals are considered critical infrastructure that cannot reasonably be closed or incapacitated for any great length of time, and so may be more inclined to bowing to hackers’ demands for ransom.

This latest attack just goes to show the importance of cybersecurity at hospitals and other healthcare entities. In addition to the recent Hollywood Presbyterian Medical Center attack, data breaches and cyber-attacks have also recently occurred at Excellus Blue Cross Blue Shield, UCLA Health System, Premera Blue Cross, and Anthem Inc.

For more information, please contact Dana Petrillo, or another member of Cozen O’Connor’s Health Law team.

After four years and 200 comments, CMS finalized the much‑awaited “60‑Day Rule” for reporting and repaying Medicare Part A and B overpayments (CMS issued a Final Rule related to Medicare part C and D overpayments in the May 23, 2014 Federal Register, 79 FR 29844, and will address Medicaid overpayments in future rulemaking). The 60-Day Rule is part of CMS’s efforts to reduce fraud, waste, and abuse in the Medicare program.

Section 6402(d) of the Affordable Care Act (ACA), created section 1128J(d) of the Social Security Act (codified at 42 U.S.C. 1320a-7k(d)), requiring a person or entity who has received an overpayment to report and return the overpayment to the appropriate entity by the later of: (1) 60 days after the date on which the overpayment was “identified”; or (2) the date any corresponding cost report is due (if applicable). Importantly, the ACA also made reporting and repaying overpayments within 60 days an “obligation” under the False Claims Act (FCA), and therefore subject to FCA liability. Proof of specific intent to defraud the government is not required for a person or entity to be liable under the 60-Day Rule.

The Final Rule slightly relaxes some of the onerous requirements in the 2012 Proposed Rule:

Six Year Lookback Period: CMS responded to numerous comments and concerns that the proposed 10-year look back period for identifying overpayments was too long. The 60-Day Rule changed the lookback period to 6 years, consistent with the statutory limitations for the FCA.

Definition of Identify: CMS acknowledged the numerous comments submitted on what it means to “identify” an overpayment and said, “We agree and have revised the language … to clarify that part of identification is quantifying the amount, which requires a reasonably diligent investigation.” According to CMS, “[t]he Final Rule clarifies that a person has identified an overpayment when the person has or should have, through the exercise of reasonable diligence, determined that the person has received an overpayment and quantified the amount of the overpayment.” CMS warned Medicare providers and suppliers not to use the “ostrich defense”; reasonable diligence includes both proactive compliance activities conducted in good faith by qualified individuals, and good faith investigation of credible information conducted in a timely manner by qualified individuals. Quantification of the amount of the overpayment may be determined using statistical sampling and extrapolation methodologies.

How to Report and Return Overpayments: The Final Rule states that providers and suppliers must use an applicable claims adjustment, credit balance, self-reported refund, or another appropriate process to satisfy the obligation to report and return overpayments.

The Final 60-Day Rule is available at: https://federalregister.gov/a/2016-02789. By way of comparison, the February 16, 2012 Proposed Rule is available at:  https://www.gpo.gov/fdsys/pkg/FR-2012-02-16/pdf/2012-3642.pdf

To learn more about reporting or making repayments under the Final Rule, please contact Ryan Blaney, Dana Petrillo or any member of Cozen O’Connor’s Health Law team.

On January 26, 2015, the Secretary of the United States Department of Health and Human Services (“HHS”), Sylvia Mathews Burwell, announced two important goals for the Department:

1. Increase the percentage of Medicare provider payments that are made through alternative payment models based on how well the providers care for patients, rather than the amount of care provided. The percentage goals for these alternative payment models are 30% by 2016 and 50% by 2018.
2. Tie virtually all Medicare fee-for-service payments (85% in 2016 and 90% in 2018) to quality and value.

This announcement puts hard numbers on the goal to move away from traditional fee-for-service Medicare payments that has been stated generally since at least 2010 when the Affordable Care Act was enacted. By clearly delineating specific figures for alternative payment models, such as accountable care organizations and bundled payment arrangements, from those figures for payment methods, HHS has made it clear that providers should be thinking not just about different forms of payment but different forms of organizations and relationships with other providers. Alternative payment models generally require coordination among different types of providers who may not otherwise be related to each other.

While the announced goals focus on the Medicare fee-for-service system, it is clear that HHS intends the impact of these goals to be far broader. Ms. Burwell also announced the creation of a Health Care Payment Learning and Action Network to facilitate a public-private sector partnership to “continue to build on our work with state Medicaid agencies, private payers, employers, consumers and other partners,” while welcoming the fact that “our partners in the private sector have the opportunity to be even more aggressive” in establishing alternative payment models and pay-for-value compensation systems. On the same day as Ms. Burwell’s announcement, the Centers for Medicare and Medicaid Services released a fact sheet stating that it is taking action with a goal to spend “our health dollars” more wisely, citing the importance of the goal for patients, families, providers, tax payers, employers, states and insurance companies, and making it clear that HHS and CMS fully intend to have their efforts to transform health care delivery and payment systems to reverberate well beyond the Medicare program.

December has been a busy month for CMS with respect to the Medicare Shared Savings Program (“MSSP”). Last week CMS announced that eighty-nine (89) more ACOs would begin participating in the MSSP starting in 2015, bringing the total number of ACOs in the program to four-hundred and five (405). Continue reading…