Recently in Health Law News Category

May 20, 2016

Phase 2 HIPAA audit notices are being issued

The HHS Office for Civil Rights ("OCR") has begun issuing notices for Phase 2 HIPAA Audits applicable to covered entities and their business associates. In Phase 2, OCR will review the policies and procedures adopted and employed by covered entities and their business associates to satisfy standards and implementation specifications of the Privacy, Security, and Breach Notification Rules. Phase 2 audits will primarily be desk audits, however, some on site audits will occur.

Please be sure to check your spam filters and junk email folders because notices for Phase 2 HIPAA Audits are sent via email. The initial email notice for a Phase 2 HIPAA Audit seeks to confirm an entity's address and contact information. Following confirmation of this contact information OCR will send a pre-audit questionnaire.

We have a number of clients who are undergoing Phase 2 HIPAA Audits and our experience in responding to these audits will minimize any potential disruption to your healthcare operations. Contact Clinton Mikel, Esq., at cmikel@thehlp.com, or at 248-996-8510, for guidance and counsel on how best to respond to any Phase 2 HIPAA Audit notice that you have received.

Additional information about OCR's Phase 2 HIPAA Audits can be found on our blog at: http://www.healthlawattorneyblog.com/2016/03/ocr-launches-phase-2-of-hipaa.html

May 10, 2016

Join Clinton Mikel of The Health Law Partners for Politico's "Outside, In: Unhealthy Hacking: Medical Privacy in the Age of Cyber Attacks"

On Tuesday, May 10, 2016, Clinton Mikel, a Partner at The Health Law Partners and Chairman of the eHealth, Privacy and Security Interest Group of the American Bar Association Health Law Section, will be a guest speaker at Politico's "Outside, In: Unhealthy Hacking: Medical Privacy in the Age of Cyber Attacks," a live event featuring leading voices in health care, technology, and policy discussing privacy and cybersecurity in the healthcare sector.

In addition to Clinton Mikel, panelists include Texas Representative Will Hurd, Leslie Krigstein, VP of CHIME (College of Healthcare Information Management Executives), and Deven McGraw, Deputy Director for Health Information Privacy, HHS Office for Civil Rights, among others.

Among the issues the panelists will address are the following: Can health care providers afford security? Is the cyber-kidnapping of hospitals the new normal? Is greater health information exchange going to lead expanded, dangers/hacks? Is the need to secure records another driver toward consolidation in health care, because of the costs? Do we need more congressional or regulatory action to assure our records are safe and secure?

Politico will live stream the May 10 event at http://www.POLITICO.com/live beginning at 5:30 p.m. EST.

Continue reading "Join Clinton Mikel of The Health Law Partners for Politico's "Outside, In: Unhealthy Hacking: Medical Privacy in the Age of Cyber Attacks"" »

April 7, 2016

American Bar Association's Physicians Legal Issues Conference on June 9-10, 2016, in Chicago, IL.

Adrienne Dresevic, Esq., of The Health Law Partners, PC, and Kathleen DeBruhl of DeBruhl Haynes, The Health Law Group, are pleased to announce the American Bar Association Health Law Section's Physicians Legal Issues Conference on June 9-10, 2016, in Chicago, Illinois. This annual conference is attended by both attorneys and physicians and is held in conjunction with the Chicago Medical Society and the American Association for Physician Leadership.

This year's theme is "Thriving in a Time of Change: Attorneys and Physicians Working Together". Physicians continue to face challenging odds in a rapidly evolving healthcare market--whether remaining independent, adapting to "employment" by an integrated system, or addressing consolidated payer markets with little or no negotiating power. This unique conference offers physicians, attorneys and their administrative partners an opportunity to hear how these issues are being addressed by physicians and how physicians can succeed at maintaining viable medical practices that offer quality services at their core.

Physicians and their legal counsel will have access to national speakers and will be educated on key issues affecting employer and hospital relationships, business and industry responses to payer consolidation and market control, and every day "survival" techniques in hospital and private practice settings. Whether you are a physician or entering the field of healthcare law, this conference will provide valuable insight and strategies that can improve your practice.

Continue reading "American Bar Association's Physicians Legal Issues Conference on June 9-10, 2016, in Chicago, IL." »

April 6, 2016

Adrienne Dresevic and Clinton Mikel Earn the "Pulitzer Prize" of Legal Writing

Please join The Health Law Partners, P.C., in congratulating Adrienne Dresevic (a Founding Shareholder), and Clinton Mikel (a Partner), for earning what has been described as the "Pulitzer Prize of Legal Writing".

The Burton Award for Distinguished Legal Writing, which is run in association with the Library of Congress and co-sponsored by the American Bar Association, is earned each year by 35 exceptional authors nationwide.

Submissions for the Distinguished Legal Writing Award are extremely competitive. The award is generally selected by professors from Harvard Law School, Yale Law School, Stanford Law School, and Columbia Law School, among others.

This year, Adrienne Dresevic and Clinton Mikel join this distinguished group of authors for their journal article titled "Final CY 2016 Stark Law Changes--Welcomed Revisions to Stark". Their article was published in the December issue of the American Bar Association's peer-reviewed Health Lawyer publication (the flagship publication of the ABA's Health Law Section) - it meticulously dissects major revisions to the Physician Self-Referral Law (Stark Law).

The Burton Awards will be held in Washington D.C. on May 23, 2016. U.S. Supreme Court Justice Stephen Breyer will be the featured guest speaker and U.S. Supreme Court Justice Ruth Bader Ginsburg will memorialize Justice Scalia during the program.

March 22, 2016

OCR Launches Phase 2 of HIPAA Audit Program

The HHS Office for Civil Rights ("OCR") has announced that it will begin the 2016 Phase 2 HIPAA Audit Program, the next phase of audits of covered entities and their business associates. In Phase 2, OCR will review the policies and procedures adopted and employed by covered entities and their business associates to satisfy standards and implementation specifications of the Privacy, Security, and Breach Notification Rules. Phase 2 audits will primarily be desk audits, however, some on site audits will occur. OCR will evaluate the results and procedures used in the Phase 2 audits to develop a permanent audit program.
The Phase 2 audit process begins with OCR sending an email to covered entities and business associates requesting verification of an entity's address and contact information. OCR will then send pre-audit questionnaires to obtain information about the size, type, and operations of covered entities and business associates. This information will be used in conjunction with other information to create potential audit subject pools.
If a covered entity or business associate does not respond to OCR's email request to verify contact information or the pre-audit questionnaire, OCR will use publically available information to verify contact information or respond to the questionnaire. Thus, covered entities and business associates should be aware that ignoring OCR's emails will not keep them from being part of potential audit subject pools.
OCR will post updated audit protocols on its website closer to when it will begin to conduct the 2016 audits. The audit protocol will be updated to reflect HIPAA Omnibus Rulemaking.

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March 14, 2016

6th Circuit Court Ruling May Significantly Reduce Recoverable FCA Damages by Feds

In U.S. ex rel. Wall v. Circle C. Construction, Case #14-6150, 2016 WL 423750 (6th Cir. Feb. 4, 2016), the 6th Circuit Court held that damages in false certification cases should be based on the difference between the value of the items or services the government should have received and the value of the items or services the government actually received. The holding, which arose in the non-healthcare context of a construction contract, arguably applies in healthcare matters where medically necessary items or services were furnished pursuant to referrals that violated AKS or Stark laws and thus the government did not sustain any actual damages. A court could then find that the treble damage provision under the False Claims Act is not applicable and the government's damage recovery is limited to the $5,500-11,000 per claim penalty.

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February 9, 2016

Medicare Appeals Delay Case Moves Forward

As many hospitals, as well as other health care providers and suppliers with pending requests for ALJ hearing are acutely aware, lengthy adjudication delays exist within the Medicare appeals process. These delays are most significant at the third level of appeal, i.e., the Administrative Law Judge (ALJ) stage of appeal.

On May 22, 2014, the American Hospital Association (AHA), together with three hospitals, filed suit in the United States District Court for the District of Columbia, requesting mandamus relief, compelling the Secretary of the Department of Health and Human Services (HHS) to act within the statutorily required timeframes. Disappointing appellants nationwide, the District Court entered a decision mandamus relief was not warranted.

However, following an appeal of the lower court's decision, on February 9, 2016, the United States Court of Appeals for the District of Columbia reversed the decision and remanded the case back to the District Court for further consideration. A copy of the February 9, 2016 order is accessible here: http://www.aha.org/advocacy-issues/legal/litigation.shtml.

For an in-depth look at the ALJ appeals adjudication backlog, please see the following articles: http://www.thehealthlawpartners.com/docs/6.6.14.pdf and http://www.thehealthlawpartners.com/docs/5.21.14.pdf.

For more information regarding Recovery Audits, please contact Jessica L. Gustafson, Esq. or Abby Pendleton, Esq. at (248) 996-8510.

December 15, 2015

Broad Cross-Section of Medical Professionals Prescribing Prescription Opioids

Researchers have examined Medicare claims from 2013 to see which doctors prescribed opioids (including OxyContin, morphine and codeine) and how many prescriptions they filled. Research found that these drugs are being prescribed by a broad cross-section of medical professionals, rather than concentrated among a small group of practitioners. While it is not surprising that pain management specialists and anesthesiologists wrote the most prescriptions for opioids when compared to other specialties, primary care physicians such as family practitioners had the highest volume of opioid prescriptions since there are more primary care physicians than specialists. As such, primary care physicians should recognize that future efforts to curb opioid prescribing (including but not limited to state licensing and DEA registration actions) are likely to focus on them. Moreover, the Centers for Disease Control and Prevention has issued new guidelines urging physicians to take a more conservative approach to prescriptions and to closely monitor their patients' use of opioids.

"Broader Strategies Necessary to Counter Painkiller Over Prescribing, Researchers Say" [link]

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December 9, 2015

AFIRM Act Seeks to Improve the Medicare Audit and Appeals Process

On December 9, 2015, Senate Finance Committee Chairman Orrin Hatch (R-Utah) and Ranking Member Ron Wyden (D-Ore.) introduced Senate Bill 2368, the Audit & Appeal Fairness, Integrity, and Reforms in Medicare (AFIRM) Act of 2015. The purpose and goal of AFIRM is to improve the Medicare audit and appeals process by reducing the burden on providers and implement reforms to the Medicare audit and appeals process.
In fiscal year 2014, the Centers for Medicare & Medicaid Services (CMS), conducted audits of more than one billion claims in an effort to curb approximately $60 billion in improper Medicare payments. This many audits has resulted in a corresponding number of appeals leading to a backlog of nearly one million claims causing a near two year backlog.
Among the many ways that AFIRM seeks to resolve this backlog are the following:
 Increase the amount in controversy limits for review by an administrative law judge (ALJ) to $1,500 or more. For cases not meeting this threshold, a Medicare Magistrate program allows senior attorneys with expertise in Medicare law and related policies to adjudicate cases in the same way as ALJs. This is intended to allow ALJs to maintain their focus on complex cases (AFIRM § 1-3).
 Establish a process whereby an ALJ can certify an appeal for expedited access to judicial review (AFIRM § 5).
 Establish a voluntary alternate dispute resolution process allowing multiple claims with similar issues of law or fact to be settled together where they are submitted by the same individual or entity (AFIRM § 6).
 Permit an adjudicator, with the consent of the appellant, to use statistical sampling and extrapolation in reaching a decision (AFIRM § 6).
 Establish a process whereby the Office of Medicare Hearings and Appeals and the Departmental Appeals Board of the Department of Health and Human Services (HHS) can refer cases to law enforcement where there is a credible suspicion of fraudulent activity (AFIRM § 7).
 Publish on the internet appeal information that includes at least the following (AFIRM § 9):
o the percentage of appeals that received fully favorable, partially favorable, and unfavorable decisions;
o the percentage of appeals that received fully favorable, partially favorable, and unfavorable decisions for each ALJ;
o for each type of service, the percentage of appeals that received fully favorable, partially favorable, and unfavorable decisions; and
o the average length of time that has passed between the initial request for review and a final decision.
 Establish alternative resolution dispute processes permitting an individual or entity entitled to a redetermination by a Medicare administrative contractor, or a reconsideration by a qualified independent contractor, to enter into an alternative dispute resolution with CMS (AFIRM § 9).
 Authorize the Secretary to designate a point of contact to oversee and undertake at least the following (AFIRM § 10):
o Develop a strategy for claim review determinations that identifies and reduces claim errors that have the largest impact on improper payment rates and are likely to negatively affect quality of care, in addition to reducing unnecessary burdens on providers of services and suppliers;
o Develop methods to ensure review contractors do not unnecessarily conduct duplicate reviews of individual claims;
o Work with review contractors to develop a uniform, consistent, and transparent review process to reduce the burden on providers of services and suppliers;
o Develop qualification standards for review contractors requiring prepayment and post-payment reviews of claims to be conducted or approved by medical doctors with knowledge of relevant Medicare laws, regulations, and program instruction;
o Verify that decisions by review contractors are consistent with Medicare laws, regulations, and program instruction; and
o Determine whether additional punitive actions against ineffective review contractors could be taken and what, if any, financial incentives or disincentives could be used to promote accuracy of a review contractor's reviews.
 Appoint a Medicare Reviews and Appeals Ombudsman who will (AFIRM § 11):
o identify, investigate and assist in the resolution of complaints and inquiries related to the Medicare audits and appeals process;
o identify trends in complaints and inquiries to provide recommendations for improvements to the claims review and appeals system;
o design a system to measure and evaluate reviewer responsiveness to addressing inquiries from providers of services and suppliers; and
o publish appeal data.
 Establish a compliance incentive program to increase the accuracy of providers of services and suppliers in addition to encouraging consistency with review guidelines, regulations and program instructions for review contractors (AFIRM § 13).
Jessica Gustafson and Abby Pendleton, founding partners of The Health Law Partners, P.C., practice in all areas of healthcare law devoting a substantial portion of their practice on Recovery Audit Contracts and Medicare audit appeals. For more information, please contact Abby Pendleton, Esq. or Jessica Gustafson, Esq., or visit The HLP website.

December 9, 2015

Physician Groups Settle with Anthem Blue Cross and Blue Shield Over "Out-of Network Shenanigans"

Seven physicians groups, including the Connecticut State Medical Society, the American Medical Association, the California Medical Association, the Medical Association of Georgia and others, have reached a settlement with insurance company Anthem Blue Cross and Blue Shield ("Anthem") over allegations of 'out-of network shenanigans'. The suit, which was filed in 2007, accused Anthem of unfair practices when determining reimbursement rates for out-of-network care. Patients were unsure as to which providers were in or out of network and patients were responsible for higher than expected charges due to being misled about how much of the bill for out-of-network care the insurance company would accommodate.

The settlement amount has not been revealed but, according to general counsel for the Connecticut State Medical Society, Anthem will be upgrading their provider finder tool and will also provide a very small monetary reward to the medical societies involved.

"DOCTOR GROUPS SETTLE WITH ANTHEM OVER 'SHENANIGANS'" [LINK]

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November 23, 2015

Providers Likely To Face Higher Penalties For Fraud and Regulatory Violations

On November 2, 2015 the President signed The Bipartisan Budget Act of 2015, requiring that civil monetary penalties must be raised to account for inflation, followed by an annual review for further increases. Providers accused of False Claims Act (FCA) violations are likely to see an increase as high as 40% over the current penalty ranging from $5,500 to $11,000. Higher penalties may add up quickly in FCA cases, which generally involve hundreds of alleged tainted claims.

This could potentially have a negative impact on providers that have earmarked monies for quality of care improvement efforts who must now spend the money on paying higher penalties. The threat of higher penalties might also influence a provider's decision to settle FCA cases due to the risk of astronomical penalties that may be imposed.

Budget Deal Raises Stakes for False Claims, Civil Monetary Penalties [link]

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November 20, 2015

Per Alabama Court The Government Must Show More Than Difference of Opinion to Prove Falsity in False Claims Act (FCA) Action

After a ten week trial, a federal court in Alabama has granted a hospice care provider, Aseracare Inc.'s motion for a new trial in a False Claims Act (FCA) case. The Government alleged that this hospice care provider knowingly submitted false claims to Medicare for patients who were not terminally ill and thus did not qualify for hospice benefits. However, the Alabama federal court determined that there was reversible error in the jury instructions that left out that the FCA requires proof of an objective falsehood and that a minor difference in opinion is not enough to show falsity. At this time, the court is considering summary judgment given that the government maintains its only evidence for proving falsity is expert testimony and medical records of the patients at issue.

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November 12, 2015

NPDB Revamps its FAQs

Recently, the National Practitioner Data Bank (NPDB) website revised both the content and appearance of its Frequently Asked Questions (FAQs) pages in order to provide more insight and better guidance to its users based upon its call center statistics and other customer feedback. The revised questions and answers are now organized into new categories by audience: Health Care Professionals, Organizations, and Other Topics. There is also a FAQ search bar that allows the user to type in a keyword to search for a topic. See: http://www.npdb.hrsa.gov/faqs/faqs.jsp

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November 9, 2015

Investigations Mounting Against Widespread Pharmacy Fraud Claims to Military Health Program

The Wall Street Journal has reported that Federal prosecutors are investigating widespread fraud, in at least four states, by compounding pharmacies in claims submitted to TRICARE--the health-insurance program that insures over 9 million U.S. military members (active, guard/reserve and retired) and their families. Some of the allegations include: false billings, physicians writing prescriptions despite not meeting the beneficiaries in person, and improper kickbacks being received in exchange for referring business to a government agency.

"U.S. Targets Pharmacies Over Soaring Claims to Military Health Program" [link]

The major increase in spending on compounded drugs is believed to be the primary reason behind a $1.3 billion deficiency in the military's health-care budget earlier this year. As a result, funds had to be redirected from other programs to compensate for the shortage and Prosecutors are considering and pursuing civil and criminal charges against the pharmacies, physicians and drug marketers.

This action by Federal prosecutors is yet another example of the increased enforcement by federal authorities against the pharmaceutical industry seen in the last six months.

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November 4, 2015

Congress Considering Additional Legislation to Help Curb Medicare Prescription Drug Abuse

It was just released that Congress is contemplating whether Medicare will be able to restrict at-risk drug abuse beneficiaries to a limited number of pharmacies and providers when they seek narcotics. Currently, Medicaid and the Veterans Affairs (VA) are able to impose these restrictions, but Medicare is not.

If successful, this action will help prevent opioid abuse by averting doctor shopping and encouraging physicians and insurers to aid patients battling drug abuse.

"Congress Looks to Curb Medicare Prescription Drug Abuse"

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