Monthly Archives: February 2016

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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Medical Home Plans Saved Minnesota $1 Billion from 2010-2014

Posted by Marc Goldsand on February 11, 2016
HCH / No Comments

shutterstock_320140895A five-year study released by the Minnesota Department of Health this week, which recorded reams of data in comparing traditional primary care practice patient and cost results with those of health care home practices (“HCH”), gives a fascinating, data-driven glimpse of patient center medical home plans established within the existing Medicare/Medicaid/third party payor system over a five-year period. The findings are especially notable in that these HCHs remained within the traditional reimbursement system as opposed to a direct primary care medical home practice model, which generally requires the practice to forego traditional insurance and seek payment only from the patient.

Some notable results:

  • HCHs had significant and substantial savings on their Medicare, Medicaid, and Medicare/Medicaid dual-eligible patients compared to non-HCHs between 2010 and 2014.
  • HCHs had lower costs.
  • In the subject population, there was a major decrease in the use of hospital services, which was the primary driver of cost savings.
  • In the subject population, there was a modest decrease in prescription drug use.
  • HCHs generated over $1 billion in savings.

The full study is available here.

For more information about this blog, please contact Marc I. Goldsand, Esq., or another member of Cozen O’Connor’s Health Care team.

Marc Goldsand

Marc Goldsand joined Cozen O’Connor’s Miami office as an associate in the Health Care Practice Group in 2015. Marc focuses his practice on the corporate representation of physicians and healthcare businesses, bringing value and experience in an array of corporate and regulatory areas, including but not limited to, capital raising, enterprise sales, and mergers and acquisitions, while counseling clients regarding federal and state rules and regulations, including Anti-Kickback, Stark, Affordable Care Act, and HIPAA compliance and data privacy.

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Will Congress Come Together for Telemedicine?

Posted by Marc Goldsand on February 05, 2016
Healthcare, Medicare, Telehealth, Telemedicine / No Comments

Consistent with what we have been seeing in our own practice, and consumers’ growing demand for better access to telemedicine services, a bi-partisan movement is growing in both houses of Congress to expand telehealth services, improve health outcomes, and reduce healthcare costs. On Wednesday February 5, 2016, U.S. Senators Brian Schatz (D-Hawaii), Roger Wicker (R-Miss.), Thad Cochran (R-Miss.), Ben Cardin (D-Md.), John Thune (R-S.D.), and Mark Warner (D-Va.) introduced the Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act (s. 2484), which seeks to overhaul Medicare’s treatment of the practice of telemedicine and its related technologies. Companion legislation was introduced in the House of Representatives by U.S. Reps. Diane Black (R-TN), Peter Welch (D-VT), and Gregg Harper (R-MS). According to the Senate bill’s sponsors, the CONNECT for Health Act would:

  1. Create a bridge program to help providers transition to the goals of the Medicare Access and CHIP Reauthorization Act (MACRA) and the Merit-based Incentive Payment System (MIPS) through using telehealth and RPM without most of the 1834(m) restrictions contained in the aforementioned Senate bill;
  2. Allow telehealth and Remote Patient Monitoring to be used by qualifying participants in alternative payment models, without most of the aforementioned 1834(m) restrictions;
  3. Permit the use of remote patient monitoring for certain patients with chronic conditions;
  4. Allow, as originating sites, telestroke evaluation and management sites; Native American health service facilities; and dialysis facilities for home dialysis patients in certain cases;
  5. Permit further telehealth and RPM in community health centers and rural health clinics;
  6. Allow telehealth and RPM to be basic benefits in Medicare Advantage, without most of the aforementioned 1834(m) restrictions; and
  7. Clarify that the provision of telehealth or RPM technologies made under Medicare by a health care provider for the purpose of furnishing these services shall not be considered “remuneration.”

So far, the following organizations have publically endorsed the bill:

  • AARP
  • ACT | The App Association
  • Airstrip
  • Alliance for Aging Research
  • Alliance for Connected Care
  • Alliance of Community Health Plans (ACHP)
  • Alzheimer’s Foundation of America
  • America’s Essential Hospitals (AEH)
  • America’s Health Insurance Plans (AHIP)
  • American Academy of Neurology (AAN)
  • American Academy of Physician Assistants (AAPA)
  • American Association of Diabetes Educators (AADE)
  • American Heart Association/American Stroke Association (AHA)
  • American Medical Association (AMA)
  • American Medical Group Association (AMGA)
  • American Nurses Association (ANA)
  • American Occupational Therapy Association (AOTA)
  • American Osteopathic Association (AOA)
  • American Psychological Association (APA)
  • American Society of Nephrology (ASN)
  • American Telemedicine Association (ATA)
  • American Well
  • Anthem
  • Association for Ambulatory Behavioral Healthcare
  • Association for Behavioral Health and Wellness (ABHW)
  • CAPG
  • Cerner
  • DaVita
  • Federation of State Medical Boards (FSMB)
  • Hawaii Medical Service Association (HMSA)
  • Health Care Chaplaincy Network
  • Healthcare Leadership Council (HLC)
  • Healthcare Information and Management Systems Society (HIMSS)
  • Intel
  • Kaiser Permanente
  • LifeWIRE
  • NAADAC
  • National Association for Home Care & Hospice
  • National Association for the Support of Long Term Care (NASL)
  • National Association of ACOs (NAACOS)
  • National Association of Community Health Centers (NACHC)
  • National Council for Behavioral Health
  • National Council of State Boards of Nursing (NCSBN)
  • National Health IT Collaborative for the Underserved
  • Personal Connected Health Alliance (PCHA)
  • Population Health Alliance
  • Qualcomm Incorporated (and Qualcomm Life)
  • Telecommunications Industry Association (TIA)
  • The ERISA Industry Committee (ERIC)
  • The Evangelical Lutheran Good Samaritan Society
  • The Jewish Federations of North America
  • Third Way
  • University of Mississippi Medical Center (UMMC) Center for Telehealth
  • University of Pittsburgh Medical Center (UPMC)
  • University of Virginia (UVA) Center for Telehealth

The full text of the bill can be found here.

Marc Goldsand

Marc Goldsand joined Cozen O’Connor’s Miami office as an associate in the Health Care Practice Group in 2015. Marc focuses his practice on the corporate representation of physicians and healthcare businesses, bringing value and experience in an array of corporate and regulatory areas, including but not limited to, capital raising, enterprise sales, and mergers and acquisitions, while counseling clients regarding federal and state rules and regulations, including Anti-Kickback, Stark, Affordable Care Act, and HIPAA compliance and data privacy.

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Is This The Year Florida Recognizes Direct Primary Care?

Posted by Marc Goldsand on February 03, 2016
Affordable Care Act, DPC, Healthcare / No Comments

shutterstock_128160911Florida House Bill 37 and Florida Senate Bill 132, similar bills aiming to expressly authorize and regulate direct primary care medical home plans in the State of Florida (“DPCs”) and both stating that DPCs are not “insurance” under State law, have been smoothly sailing through committees in their respective chambers. The House Bill has already passed through the Select Committee on Affordable Healthcare Access, the Finance and Tax Committee, and the Health and Human Resources Committee. Its next step is a vote in front of the entire House. The Senate Bill cleared the Health and Policy Committee, but no word yet from the Banking and Insurance and Fiscal Policy Committees. At some point before the session ends on March 11, 2016, if they continue to move forward, the bills will be consolidated and approved by both chambers, after which the final bill will be subject to approval or veto of Governor Rick Scott. Passage is by no means certain, but there appears to be an appetite for this law with – so far – no real opposition this year.

 DPCs are private payment agreements between primary care physicians and their patients, whereby patients typically pay low dollar (perhaps $75 to $100) monthly payments directly to the provider for primary care services, in lieu of typical insurance covering primary care services.  In return for the monthly payments (which are easily collected by credit card or cash, without the need for insurance/managed care code-based reimbursement billing), primary care providers offer at little or no additional charge an array of primary care services to the member patients. When paired with a high-deductible “wrap-around” insurance policy, the DPCs comport with the requirements of the Affordable Care Act.     

 

Marc Goldsand

Marc Goldsand joined Cozen O’Connor’s Miami office as an associate in the Health Care Practice Group in 2015. Marc focuses his practice on the corporate representation of physicians and healthcare businesses, bringing value and experience in an array of corporate and regulatory areas, including but not limited to, capital raising, enterprise sales, and mergers and acquisitions, while counseling clients regarding federal and state rules and regulations, including Anti-Kickback, Stark, Affordable Care Act, and HIPAA compliance and data privacy.

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