Posted by Chris Raphaely
on June 26, 2015
ACA,
Affordable Care Act /
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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.
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Tags: ACA
Posted by Health Law Informer Author
on February 05, 2015
ACA,
Federal Trade Commission,
FTC,
Supreme Court /
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The 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:
- 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.
- 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?
- 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 rblaney@cozen.com.
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Tags: ACA, Affordable Care Act, Antitrust, Consolidation, contracting, hospitals, Merger
Posted by Health Law Informer Author
on December 12, 2014
ACA,
HHS,
HIPAA,
Medicaid,
Medicare,
OIG /
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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.
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Tags: Compliance, fiscal year 2015, HIPAA, hospitals, improper claims, Inpatient, labs, managed care, MCO, medicaid, medicare, outpatient, payment, work plan
Posted by Health Law Informer Author
on September 26, 2014
ACA,
CMS,
HHS,
HIPAA,
HITECH,
Privacy /
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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…
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Tags: audit, breach, Business Associate, HHS, HIPAA, HITECH, NIST, OCR, Privacy Rule, Security Rule
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.
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Tags: ACO, contracting, Health reform, HIPAA, indemnification, reimbursement
Posted by Health Law Informer Author
on June 05, 2014
ACA,
Affordable Care Act,
HHS,
OIG /
1 Comment
In May, the Office of Inspector General of the Department of Health and Human Services (OIG) proposed a new rule (Rule) that would implement changes included in the ACA. The Rule would expand OIG’s authority to exclude individuals and entities from participation in federal health care programs, among other changes.
The Rule would build on OIG’s existing authority, but enable the agency to impose penalties for a broader array of conduct. OIG currently has the authority to exclude individuals and entities from participation in federal health care programs who are deemed “untrustworthy.” Certain bases for exclusion require OIG to impose a mandatory exclusion period of at least five years. Other bases allow OIG broad discretion to determine whether to impose an exclusion and for how long.
The Rule change includes three proposed bases for permissive exclusion: (1) conviction related to the obstruction of an audit; (2) failure to supply payment information for items or services; and (3) to make, or cause to be made, false statements, omissions, or misrepresentations of material facts in an application to participate in a federal health care program.
In addition, the Rule would give OIG the power to issue testimonial subpoenas during exclusion investigations, and remove any statute of limitations on exclusion actions stemming from false claims proceedings. The proposed removal of the statute of limitations would give the authority to impose exclusions at any time, even when the exclusion is due to violations of another statute that might have a specified time limit. OIG considered but did not finalize a similar provision in 2002. The Rule also includes a proposition to modify exclusion reinstatement rules such that individuals excluded as a result of losing their licenses could rejoin the federal health care programs earlier if they meet certain criteria.
Comments to the Rule are due on July 8, 2014.
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Tags: audit, exclusion authority, federal health care program, Fraud and Abuse, investigation, mandatory exclusion, permissive exclusion, statute of limitations