ACA

Telemedicine Benchmark Study Provides Great Insight

Posted by Rene Quashie on May 09, 2017
ACA, Healthcare, Hospital, Telemedicine / No Comments

A recent telemedicine industry benchmark survey published by REACH Health provides great insight into where the industry has been and where it is headed. The survey was conducted among U.S. healthcare executives, physicians, nurses and other professionals. Organizations represented in the survey were diverse and included representatives from organizations with a $1 billion or more in revenue (about a third of respondents), and almost half with revenues under $50 million.

 

In reviewing the survey report, there were some significant takeaways:

  • Telemedicine is evolving from a specialty offering to a mainstream service.
  • More than half of respondents consider telemedicine to be a top or high priority.
  • Patient-oriented objectives—including improving patient outcomes, improving patient convenience, and increasing patient engagement and satisfaction—are the three top objectives for telemedicine programs.
  • There is an emphasis on better leveraging specialists with a large majority of respondents ranking this a top or high priority.
  • Nearly half of hospital and integrated delivery network respondents who began their telemedicine programs/initiatives with a departmental approach are transitioning to an enterprise approach.
  • The maturity of telemedicine programs varies widely among service lines and settings of care. Generally, settings requiring highly specialized treatment continue to be more mature than those requiring generalized treatment.
  • Telemedicine technology, reporting and analytics, as well as in-house physicians are viewed as highly important to the success of a program, whereas outsourced physician coverage services less so.

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Repeal Efforts Fail (for now): Can Obamacare Survive?

Posted by Chris Raphaely on March 28, 2017
ACA / No Comments

With the House GOP pulling the American Health Care Act (AHCA) due to lack of sufficient support even within its own party, Obamacare is not out of the woods.

The ACA’s two pillars, the individual marketplaces and Medicaid expansion, remain vulnerable and could be used as political bargaining chips in Washington as the battle over “health care reform” plays out in the coming months and years.

In response to the House’s failure to pass the AHCA, the President and House Speaker have expressly said that Obamacare will “implode” and the administration has many ways to see to it that it does sooner rather than later. On the other hand, the administration and Congress could also move on to on tax reform and other items while changes to the marketplaces are implemented by regulation.  The administration already has proposed regulations on the table that has been characterized as a “good faith” effort to implement minor changes to prop up the marketplaces. Reportedly, however, many insurers will want more in the form of funding for cost sharing reductions and reinsurance to keep sufficient numbers of insurers in the marketplaces long term.  Continue reading…

Chris Raphaely

Chris Raphaely

R. Christopher Raphaely joined Cozen O'Connor's Philadelphia office in 2014 as co-chair of the Health Care Practice Group. Chris joins the firm from Jefferson Health System, where he served as deputy general counsel and general counsel to the system’s accountable care organization and captive professional liability insurance companies.

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Trump Takes First Step Toward Dismantling ACA and Buys Time with an Executive Order: Is it Substantive or Merely Symbolic?

Posted by Chris Raphaely on January 23, 2017
ACA, HHS / No Comments

Hours after taking the oath of office President Donald Trump signed a broadly worded executive order (“Order”) intended to minimize if not eliminate the impact of the ACA’s least popular provisions. With the Order President Trump can claim immediate action towards fulfilling a major campaign pledge while giving his administration and the Republican led Congress time to come up with a replacement plan.

The Order directs the secretary of HHS and other agency heads to, among other directives:

[E]xercise all authority and discretion available to them to waive, defer, grant exemptions from, or delay the implementation of any provision or requirement of the [ACA] that would impose a fiscal burden on any State or a cost, fee, tax, penalty, or regulatory burden on individuals, families, healthcare providers, health insurers, patients, recipients of healthcare services, purchasers of health insurance, or makers of medical devices, products, or medications. [And] [t]o . . . exercise all authority and discretion available to them to provide greater flexibility to States and cooperate with them in implementing healthcare programs. [And] [t]o . . . encourage the development of a free and open market in interstate commerce for the offering of healthcare services and health insurance, with the goal of achieving and preserving maximum options for patients and consumers.

The Order makes it clear that any agency actions under the order must be within the confines of the law and its existing regulations, both of which remain in place at least for now. The agencies still have the option of amending or repealing ACA regulations but the Order gives them the authority to take some action before going through the regulatory approval process.

Apparently, the agencies will decide which stakeholders’ costs and “burdens” under the ACA will be reduced. This presents them with an interesting challenge given the opposing interests inherent in the broad group of stakeholders expressly targeted for relief under the Order. For example, if the scope of the individual mandate (likely the prime target of the Order) were reduced relieving some individuals of the cost of buying health insurance, it would likely skew the risk pool of the exchange plans to less healthy participants increasing the cost and burden on the exchange’s insurers and those individuals who want to purchase insurance through the exchanges. That action could also end up reducing overall insurance coverage increasing the uncompensated care hospitals and other providers would be required to deliver.

Perhaps the most interesting aspect to watch, however, will be whether the Order ultimately has any significant substantive effect or simply ends up being a symbolic gesture. Some observers have contended that significant delays to, or gutting of, a portion of the ACA’s tightly woven and inter-related pieces mid-year 2017 would create chaos in the affected programs, like the health insurance exchanges, which are already underway this year. Therefore, there has been speculation that actions under the Order are not likely to be effective until 2018. The question is whether any actions under the Order, which are expressly limited to those that are permissible under the ACA, will mean anything in 2018 when it is almost certain that the ACA will have already been repealed.

Whether substantive or symbolic, clearly the first step in the ACA’s dismantling has been taken and we will be watching very closely as the administration and Congress take many more.

 

 

Chris Raphaely

Chris Raphaely

R. Christopher Raphaely joined Cozen O'Connor's Philadelphia office in 2014 as co-chair of the Health Care Practice Group. Chris joins the firm from Jefferson Health System, where he served as deputy general counsel and general counsel to the system’s accountable care organization and captive professional liability insurance companies.

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Finally! CMS Publishes the 60-Day Rule for Reporting and Repaying Medicare Overpayments

Posted by Ryan Blaney on February 12, 2016
ACA, Affordable Care Act, False Claims Act, Final Rule, Fraud and Abuse / No Comments

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.

Ryan Blaney

Ryan Blaney

Ryan Blaney joined Cozen O'Connor as a member of the firm's Health Law group. Ryan practices in the firm's Washington, D.C., office. He focuses his practice on representing clients in the health care and life sciences industries in a wide range of matters, including health care fraud and abuse, civil and criminal government investigations, qui tam and whistle-blower disputes under the False Claims Act and other federal and state laws and regulations, HIPAA privacy and data security, compliance and transactional services, and antitrust matters.

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Ignorance Is Not Bliss: The Clock under the ACA’s “60 Day Rule” Can Start Ticking Well Before the Exact Amount of Overpayment is Identified

Posted by Chris Raphaely on August 05, 2015
ACA, Affordable Care Act, False Claims Act, Medicaid, Medicare / No Comments

shutterstock_186812807

On August 3, 2015, a federal judge in the Southern District of New York ruled that the United States’ and state of New York’s complaints in intervention can move forward against a group of hospitals, under the federal False Claims Act (“FCA”) and New York’s FCA corollary. The hospitals allegedly failed to report and return Medicaid overpayments that were brought to their general attention over two years before all of the relevant repayments were made.

The judge’s opinion denying the defendants’ motions to dismiss in Kane v. Health First, et al. and U.S. v. Continuum Health Partners Inc. et. al., should be of particular note to providers because it contains extensive discussion and guidance as to how at least one federal judge interprets the Affordable Care Act’s (“ACA”) “60 day rule.” Specifically, the ACA’s rule requires any provider who receives an overpayment from Medicare or Medicaid to repay such overpayment within 60 days of the “date on which the overpayment was identified.” Further, retention of such an overpayment beyond the sixty-day period can result in liability under the FCA.

Continue reading…

Chris Raphaely

Chris Raphaely

R. Christopher Raphaely joined Cozen O'Connor's Philadelphia office in 2014 as co-chair of the Health Care Practice Group. Chris joins the firm from Jefferson Health System, where he served as deputy general counsel and general counsel to the system’s accountable care organization and captive professional liability insurance companies.

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Supreme Court Upholds ACA Subsidies: What’s Next?

Posted by Chris Raphaely on June 26, 2015
ACA, Affordable Care Act / No Comments

On Thursday, June 25, the Supreme Court of the United States issued its much anticipated ruling in King v. Burwell, the second major Court challenge to a core element of the Affordable Care Act (“ACA”).  The Court, by a 6-3 margin, issued a victory for the ACA.

King v. Burwell was not a challenge to the ACA per se.  Rather, the plaintiffs challenged an Internal Revenue Service (“IRS”) rule which permits the provision of subsidies for the purchase of health insurance to lower-income residents of states that use Healthcare.gov, the exchange operated by the federal government.  Essentially, the plaintiffs, and three Justices in a vigorous dissent penned by Justice Scalia, argued that the plain language of the statute limited the subsidies to residents of states that operate their own exchanges.  This would have eliminated subsidies in at least 36 states, and would have had innumerable indirect effects on other provisions of ACA (including eliminating the penalties for violations of the employer mandate in those states).

Although the decision will be of great interest politically and to administrative and constitutional law scholars, it does nothing to change the implementation of the ACA.  The exchange system that is currently in place will move forward unless it is changed legislatively or by executive action. This was welcomed by businesses in the two sectors most directly affected by the ruling, insurance and health care providers, and was reflected  in  sharp one day gains of stock prices for the large insurance companies and for-profit hospital chains.

Another aspect of the ACA that will now definitely move forward as a result of the decision is the scheduled implementation of the employer mandate on January 1, 2016.  Accordingly, affected entities (employers of 50 or more full time equivalents) should continue, and in some cases quickly step up, their compliance efforts by reviewing their employment and benefits policies to make certain that they do not run afoul of the employer mandate once it becomes fully effective.

Chris Raphaely

Chris Raphaely

R. Christopher Raphaely joined Cozen O'Connor's Philadelphia office in 2014 as co-chair of the Health Care Practice Group. Chris joins the firm from Jefferson Health System, where he served as deputy general counsel and general counsel to the system’s accountable care organization and captive professional liability insurance companies.

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ProMedica and the AHA Seek Guidance from SCOTUS on Hospital Consolidations and Mergers

Posted by Ryan Blaney on February 05, 2015
ACA, Federal Trade Commission, FTC, Supreme Court / No Comments

FTCStatueThe New Year started out with a bang in the healthcare antitrust circles with ProMedica Health Systems Inc.’s (“ProMedica”) well-publicized petition to the US Supreme Court and the American Hospital Association’s (AHA) amicus brief in support of ProMedica.  ProMedica hopes that the Supreme Court will hear the case and overturn a Sixth Circuit ruling requiring ProMedica to divest St. Luke’s Hospital, a non-profit hospital in Toledo, Ohio.  As evidence of the complexity and the lengthy litigation challenges between ProMedica and the Federal Trade Commission (“FTC”) this merger occurred almost five years ago in 2010.  The FTC and the Ohio Attorney General had sued to dissolve the deal because they considered it anti-competitive; arguing that ProMedica would control 60% of the hospitals in the greater Toledo area. The FTC ordered ProMedica to divest St. Luke’s (21 HLR 467, 3/29/12).  The Sixth Circuit agreed with the FTC on the grounds that the merger would likely result in higher prices for payors and consumers and lead to unintended precedent for future hospital mergers.

ProMedica’s petition argues that this case is “a rare and uniquely apt vehicle for consideration of the [merger law] issues based on a fully-developed record.”  Hospital merger cases rarely are litigated through appeal and this case is an opportunity for the Supreme Court to clarify fundamental aspects of merger law nearly 40 years after the United States v. General Dynamics Corp., 415 U.S. 486 (1974) decision.  ProMedica argues that over the last 40 years confusion has developed over the FTC’s unilateral-effects theory and consolidation pressures have increased with the passage of the Affordable Care Act and other federal regulations.

ProMedica’s petition focuses on three merger law questions that the lower courts are divided on as the primary reasons why the Supreme Court should hear the case:

  1. How the FTC defines relevant market product for a merger analysis and whether the FTC can base it on supply-side considerations. ProMedica argued that the FTC should have either analyzed hospital services market by market because one kind of surgery is not a substitute for another or the FTC should have considered all four levels of hospital services as a package-deal market.
  2. Where the FTC relies exclusively on a unilateral-effects theory in challenging a merger may a court adopt a strong presumption of anti-competitive harm based solely on market-share statistics?
  3. Can the FTC rely on market-share statistics to preclude consideration of the merger target’s financial weakness to rebut a presumption of harm based on market-share statistics in unilateral-effects cases?

The unilateral effects analysis is the degree to which the merging hospitals are substitutes for each other.  The higher the substitutability between two merging hospitals, the greater the competition among them and the greater the power.  Here, ProMedica argues that Mercy Hospital, not St. Luke’s, is the closest substitute in the Toledo area.

ProMedica received support from the American Hospital Association (“AHA”) on the third issue, the “weakened competitor” doctrine.  On January 21, 2015, AHA filed an amicus brief asking the US Supreme Court to review the Sixth Circuit decision and the lower court’s characterization that the “weakened competitor” argument is a “Hail Mary” that deserves credence only in rare situations.  AHA argues that the Sixth Circuit’s erosion of the “weakened competitor” doctrine leaves the “viability of many small and stand-alone hospitals in jeopardy.”  AHA also argues that there are conflicting interpretations by the lower courts on how to read the General Dynamics decision.  Clarity is needed from the Supreme Court especially in the context of health care mergers.  Hospitals should not have to wait until they are on the edge of bankruptcy to merge.  AHA believes that the Sixth Circuit errored when it did not apply the General Dynamics weakened competitor analysis to the ProMedica acquisition.

The case is ProMedica Health System Inc. v. Federal Trade Commission, case number 14-762, in the Supreme Court of the United States.  The FTC has until March 2, 2015 to file a response.  It is unknown when the Supreme Court will decide about hearing the case.

For further information contact Ryan P. Blaney, Washington, DC, at [email protected]

Ryan Blaney

Ryan Blaney

Ryan Blaney joined Cozen O'Connor as a member of the firm's Health Law group. Ryan practices in the firm's Washington, D.C., office. He focuses his practice on representing clients in the health care and life sciences industries in a wide range of matters, including health care fraud and abuse, civil and criminal government investigations, qui tam and whistle-blower disputes under the False Claims Act and other federal and state laws and regulations, HIPAA privacy and data security, compliance and transactional services, and antitrust matters.

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With a New Year Rolls in a New OIG Work Plan

Posted by Robert A. Chu on December 12, 2014
ACA, HHS, HIPAA, Medicaid, Medicare, OIG / No Comments

Recently, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) released its Work Plan for Fiscal Year 2015 (“Work Plan”).  The OIG protects the integrity of HHS programs by identifying fraud and abuse and by suggesting improvements to HHS programs.  The Work Plan informs the public of new and ongoing reviews that OIG plans to pursue during the current fiscal year.

For Fiscal Year 2015 and beyond, OIG intends to focus on emerging payment, eligibility, management, and IT systems security vulnerabilities in the ACA programs, such as the health insurance marketplace.  OIG stated that it would also focus on the efficiency and effectiveness of payment policies in inpatient and outpatient settings, for prescription drugs, and in managed care.

Some specific new items of note include: (1) identifying clinical laboratories that routinely submit improper Medicare claims, (2) reviewing the rate of and reasons for transfers from group homes or nursing facilities to emergency departments as a potential indicator of poor quality, (3) identifying Medicaid MCO payments made on behalf of deceased or ineligible beneficiaries, and (4) assessing the extent to which hospitals comply with the contingency planning requirements of HIPAA.

The Work Plan is a valuable resource annually published by the OIG for providers to identify potential compliance risk areas.

Cozen O’Connor recently published another blog of the Work Plan with the Work Plan’s specific focus on HIPAA and/or information technology that the OIG will examine and address during Fiscal Year 2015.

Robert A. Chu

Robert A. Chu

Rob Chu is an associate in the firm’s Health Law Group, focusing on the litigation of health law matters. Upon graduation from Villanova School of Law, Rob was awarded the ABA-BNA Award for excellence in the study of health law. Rob earned an MBA from Villanova University and Master of Public Health from Yale University.

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“LoProCo”, 12,915 Complaints, and Other Lessons from OCR/NIST

Posted by Ryan Blaney on September 26, 2014
ACA, CMS, HHS, HIPAA, HITECH, Privacy / No Comments

 

12,915 complaints were reported in 2013 to the Department of Health and Human Services Office of Civil Rights (“OCR”) according to Illiana L. Peters, Senior Adviser for HIPAA Compliance and Enforcement.  Cozen O’Connor attended Ms. Peters’ presentation at the Safeguarding Health Information: Building Assurance through HIPAA Security conference on September 22-23, 2014.  The conference was hosted jointly by OCR and the National Institute of Standards and Technology (“NIST”).  Below are a few discussion points worth mentioning from the conference:

  • Between September 2009 and August 31, 2014, OCR investigated 1176 reports involving breach of Protected Health Information (“PHI”) where more than 500 individuals were affected and approximately 122,000 reports affecting less than 500 individuals.
  • According to Ms. Peters, 60% of the large breaches could have been prevented by encrypting the covered entities and business associates’ laptops and mobile devices.
  • Theft and loss continues to be the most common cause of breaches but OCR expects that IT hacking will continue to rise as a significant breach risk.
  • Since 2009, consumer complaints regarding HIPAA violations continue to rise.
  • Covered entities and business associates should already have in place business associate agreements that have been updated for the Omnibus Rule.
  • Business associates must comply with all of the HIPAA Security Rules applicable to covered entities, “PERIOD.”
  • Given the known risks of hacking, theft and loss and the direct guidance from OCR, covered entities and business associates must recognize that inadequate security, inadequate physical and technical safeguards is not acceptable.
  • OCR expects that covered entities and business associates will be familiar with recent corrective actions, resolution agreements such as Parkview, NYP/Columbia, Concentra, QCA, Skaget County, Adult & Pediatric Dermatology, P.C., and Affinity Health Plan, Inc.

Continue reading…

Ryan Blaney

Ryan Blaney

Ryan Blaney joined Cozen O'Connor as a member of the firm's Health Law group. Ryan practices in the firm's Washington, D.C., office. He focuses his practice on representing clients in the health care and life sciences industries in a wide range of matters, including health care fraud and abuse, civil and criminal government investigations, qui tam and whistle-blower disputes under the False Claims Act and other federal and state laws and regulations, HIPAA privacy and data security, compliance and transactional services, and antitrust matters.

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CMS and ACOs: A Busy Summer and a Busier Fall

Posted by Chris Raphaely on August 05, 2014
ACA, Accountable Care Organizations, Affordable Care Act, HIPAA, HITECH, Medicare, Privacy / No Comments

 

It has been a busy summer so far for the Centers for Medicare & Medicaid Services (CMS) with respect to Accountable Care Organizations (ACOs), as the agency has proposed altering the quality reporting measures under the Medicare Shared Savings Program (“MSSP”) for 2015 and beyond.  Expect an even busier fall as other, potentially broader, proposed rule changes for ACOs are analyzed by the Office of Management and Budget (OMB) and both sets of proposals wind their way through the public comment process.

The proposed changes concerning quality reporting would revise and update the measures used to evaluate MSSP ACOs’ performance. Overall, the CMS says it would like to focus more on outcome-based measures (as opposed to process-based measures), reduce duplicative measures, and reflect current clinical practices without increasing ACO’s reporting burden.

More specifically, the CMS proposes to add 12 new measures and remove eight, which would increase the total number of quality measures from 33 to 37. The new measures relate to “avoidable” admissions for patients with multiple chronic conditions, heart failure, and diabetes; depression readmission; readmissions to skilled nursing facilities; patient discussion of prescription costs; and updated composite measures for diabetes and coronary artery disease.

The CMS would like to modify the scoring system to award bonus points toward shared savings to ACOs that make year-over-year improvements on individual measures. Moreover, the agency would like to modify its benchmarking methodology to use flat percentages to establish the benchmark for a measure when the national FSS data results in the 90th percentile being greater than or equal to 95 percent. And, finally, the CMS proposes several ways to align MSSP reporting requirements with other reporting programs, including Medicare’s Electronic Health Records Incentive Program and the Physician Quality Reporting System.

Fewer details are available about the next set of proposed rules changes, which were submitted to OMB on June 26 and will be printed in the Federal Register after review. It is expected that these regulations will include changes to the MSSP’s payment provisions. The proposed changes would apply to existing ACOs and approved ACO applicants starting January 1, 2016. As soon as the text of the rule becomes publicly available, the Health Law Informer will provide more information.

Chris Raphaely

Chris Raphaely

R. Christopher Raphaely joined Cozen O'Connor's Philadelphia office in 2014 as co-chair of the Health Care Practice Group. Chris joins the firm from Jefferson Health System, where he served as deputy general counsel and general counsel to the system’s accountable care organization and captive professional liability insurance companies.

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