340B Mega Guidance Withdrawn

On January 31, 2017, the Health Resources and Services Administration (“HRSA”) withdrew the 340B Program Omnibus Guidance (often referred to as the Mega Guidance).   The guidance addressed a number of significant issues under the 340B Program, including the definition of eligible patient and contract pharmacy arrangements.   The Mega Guidance was issued by HRSA in August 2015 after a HRSA “Mega Rule” was withdrawn in response to concerns that the issuance of the issuance of the “Mega Rule” exceeded HRSA’s regulatory authority.

Joy Hord

Joy Hord

Joy Hord focuses her practice on regulatory and compliance matters specifically related to the health care industry. Her clients include hospitals, physicians, pharmacies and other health care providers. Ms. Hord also has significant experience representing health care professionals and organizations with business law and transactional issues, such as mergers, acquisitions and joint ventures. Ms. Hord leads Parker Poe’s Health Care Practice, which includes attorneys from the firm’s North Carolina and South Carolina offices.

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Physician Practices Beware: Scam Email Disguised as Communication from Office of Civil Rights Regarding HIPAA Audit

Receiving an email that your practice has been identified for participating in the HIPAA Privacy, Security, and Breach Rules Audit Program is enough to raise anyone’s blood pressure. The likely response is to open the email immediately, determine the scope of the audit, and mobilize a team to prepare for the response.Read More

Joy Hord

Joy Hord

Joy Hord focuses her practice on regulatory and compliance matters specifically related to the health care industry. Her clients include hospitals, physicians, pharmacies and other health care providers. Ms. Hord also has significant experience representing health care professionals and organizations with business law and transactional issues, such as mergers, acquisitions and joint ventures. Ms. Hord leads Parker Poe’s Health Care Practice, which includes attorneys from the firm’s North Carolina and South Carolina offices.

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OIG Releases 2017 Work Plan

On November 10, 2016, the Office of Inspector General (“the OIG”) of the U.S. Department of Health and Human Services (“DHHS”) released its 2017 Work Plan.  Published annually and updated throughout the year, the Work Plan identifies the OIG’s key areas of focus as it carries out its mission of protecting the integrity of programs within DHHS.  The OIG is charged with ensuring the integrity of more than 100 programs administered by DHHS, including those within the Centers for Medicare and Medicaid Services, Center for Disease Control and Prevention, the Food and Drug Administration, and the National Institute of Health. The OIG Work Plan summarizes the OIG’s current activities – comprised of both new and revised activities — along with information regarding previously identified activities that have been completed, postponed, or cancelled.

The Work Plan highlights new and continuing priorities applicable to various provider types, including hospitals, nursing homes, hospices, home health, clinical laboratories, physicians and other health professionals, medical equipment suppliers and manufacturers, pharmaceutical manufacturers and other providers and suppliers.

The 2017 Work Plan is available here.

The following is a sampling of some of the new and ongoing efforts highlighted in the Work Plan:

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Amanda Hayes

Amanda Hayes

Amanda Hayes counsels clients in connection with mergers and acquisitions, divestitures and other business matters, with a particular focus on the health care industry. She regularly serves as lead counsel on acquisitions and divestitures, guiding the client through deal structuring, due diligence, drafting, negotiation and closing. In addition to health care, Ms. Hayes’ mergers and acquisition experience includes a variety of industries, such as manufacturing, retail, automotive, contract research, environmental remediation, engineering and construction supply.

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OCR Issues Guidance on Ransomware Attacks and Determining Whether a Reportable HIPAA Breach Exists

The Office of Civil Rights (“OCR”) has issued new guidance in connection with an increase of malicious cyberattacks, namely ransomware attacks on healthcare organization’s computer systems. Ransomware is a defined by HHS as a type of malicious software whose defining characteristic is that it attempts to deny access to a user’s data, usually by encrypting the data with a key known only to the hacker until the requested ransom is paid.Read More

Chara O'Neale

Chara O'Neale

Chara O’Neale focuses her practice primarily on the representation of hospitals, physician groups and other health care providers in the resolution of legal, regulatory and business issues for entities involved in the health care industry.

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New Part B Drug Payment Model Proposed

On March 11, 2016, CMS proposed implementation of a new two-phase model for drugs reimbursed under Part B of the Medicare Program (“the Proposed Model”).  Drugs reimbursed under Part B include drugs administered in hospital outpatient departments or in physician offices.  The purpose of the Proposed Model is to test alternative drug payment designs with the goal of (i) reducing overall costs to the Medicare program, and (ii) enhancing quality of care.Read More

Joy Hord

Joy Hord

Joy Hord focuses her practice on regulatory and compliance matters specifically related to the health care industry. Her clients include hospitals, physicians, pharmacies and other health care providers. Ms. Hord also has significant experience representing health care professionals and organizations with business law and transactional issues, such as mergers, acquisitions and joint ventures. Ms. Hord leads Parker Poe’s Health Care Practice, which includes attorneys from the firm’s North Carolina and South Carolina offices.

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Catastrophe Averted…What’s Next for ICD-10?

From time to time the Parker Poe Health Care Blog asks experts in the health care field to serve as guest bloggers. Our guest blogger today is Amy Poplin Dunatov, MPH, FACMPE, ICDCM-CT.

If the October 1, 2015 ICD-10 transition buildup felt to you like Y2K all over again, then you are not alone. Although some hospitals have reported delays in payments, physician practices have not experienced delays in processing of their professional claims. In fact, the majority of physician practices are reporting no problems related to the transition, and CMS reports denial rates are at the same level as prior to the ICD-10 transition.
Now that the catastrophe seems to be averted, what do we do next? The subsequent challenge is how to use the more specific data available with ICD-10. The value of ICD-10 data lies in the diagnosis specificity of each patient encounter. If the practice is coding “unspecified” for each patient encounter, then the value of that data is diminished. The initial focus for physician practices should be to code to the highest level of specificity for every patient encounter. The practice should continue to educate providers and coders to maximize the data’s value.

The next challenge lies in how to transition the thousands of ICD-10 codes from each patient encounter into usable data for reinforcing the quality of patient care and, thereby, negotiating higher reimbursement with the payers as we become partners in caring for the population. To facilitate this data compilation, the practice should invest in a robust electronic medical record (EMR) and/or practice management system (PMS) that can offer assistance in mining data. The practice must have the ability to gather and compare their information with the information payers so expertly mine, and they should use the data to support improvements in overall health and utilization. For example, a practice may have a clinical pathway that tracks diabetic patients with a hemoglobin A1C outside of the normal range. The patient is brought back to the office for counseling and support. This intervention helps the patient get their lab results back into the normal range while avoiding a costly hospital visit. A win-win-win for the patient, the practice, and the payer.

Practices that continue to make progress down the road to higher specificity of ICD-10 codes will be more prepared for the major changes on the healthcare horizon, such as value-based care. The ability to thrive in the new payment environment depends on the ability to accurately document and code the patient encounter. So, my advice for you is to keep exploring the nuances of ICD-10 coding. Clinical and financial performance depends on it.

Amy Poplin Dunatov is an independent practice management consultant with extensive experience in medical practice management, including both private practice and hospital-owned multispecialty group settings.  She has comprehensive knowledge of billing and E&M coding, physician compensation plan design, financial and operational benchmarking especially as it relates to physician compensation and productivity. Amy is an ICD-10 certified trainer and has worked with both large and small practices over the last two years to assist with ICD-10 education. She can reached at: amy.Dunatov@outlook.com  and www.linkedin.com/in/amypoplindunatov

 

Amanda Hayes

Amanda Hayes

Amanda Hayes counsels clients in connection with mergers and acquisitions, divestitures and other business matters, with a particular focus on the health care industry. She regularly serves as lead counsel on acquisitions and divestitures, guiding the client through deal structuring, due diligence, drafting, negotiation and closing. In addition to health care, Ms. Hayes’ mergers and acquisition experience includes a variety of industries, such as manufacturing, retail, automotive, contract research, environmental remediation, engineering and construction supply.

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Managed Care Narrow Networks

Narrow networks (managed care provider networks that include a limited choice of participating healthcare providers and suppliers) have been widely criticized by consumers and consumer-rights groups, particularly in light of the number of narrow network products that are included in the ACA exchange marketplace.  Use of narrow networks by self-insured businesses is also growing more prevalent.  For consumers who have multiple options for insurance coverage, the question is often one of choice – am I willing to pay more in premiums in order to continue to see my existing doctor, go to the hospital of my choice, or have a wider range of options if I need to see a specialist?

From the doctor’s perspective, however, narrow networks are very confusing.  In many cases, it is unclear why a particular doctor is, or is not, allowed to participate in the network.  In some cases, only certain physicians are invited to participate in the network, leaving other physicians without knowledge that the plan even exists until a patient calls to find out why the physician does not participate.

While willingness by the physician or physician group to accept the reimbursement rates offered by the payor is one criterion for participation in the narrow network plans, other criteria come into place as well.  An invitation to participate in a narrow network may be based upon the payor’s rating of the ability of the physician to offer quality of care and to provide care efficiency (a cost-based rating system).  The tier and rating systems, however, are not consistent among payors and often criticized for producing inaccurate, irrelevant and unreliable results.  Physicians also worry that there may be a loss of professional autonomy if physicians are pressured, in the course of providing care, to meet the tier and rating criteria developed by the payors in order to participate in the narrow networks rather than to exercise independent medical judgement.

A number of measures have been recently introduced to address consumer-driven concerns with narrow networks.   The Patient Protection and Affordable Care Act – HHS Notice of Benefit and Payment Parameters for 2017 (available here: https://www.federalregister.gov/articles/2015/12/02/2015-29884/patient-protection-and-affordable-care-act-hhs-notice-of-benefit-and-payment-parameters-for-2017) proposes that states should be required to develop rules to test the adequacy of provider participants in payor networks.  In addition, the National Association of Insurance Commissioners has been working to update model legislation regarding plan network access and adequacy.  Finally, legislation regarding network adequacy has been adopted or proposed in a number of states.  Typically, state laws incorporate rules regarding maximum travel distances for a patient to see a participating provider, maximum wait-times and/or acceptable provider-to-beneficiary ratios.

If you have questions regarding your relationship with third-party payors, such as managed care contracting, billing audits, or inclusion in narrow networks, Parker Poe has a number of experienced attorneys able to assist.

Joy Hord

Joy Hord

Joy Hord focuses her practice on regulatory and compliance matters specifically related to the health care industry. Her clients include hospitals, physicians, pharmacies and other health care providers. Ms. Hord also has significant experience representing health care professionals and organizations with business law and transactional issues, such as mergers, acquisitions and joint ventures. Ms. Hord leads Parker Poe’s Health Care Practice, which includes attorneys from the firm’s North Carolina and South Carolina offices.

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Two New Exceptions to Stark to Become Effective in the New Year

Starting January 1, 2016, physicians and certain health care organizations will be able to take advantage of two new exceptions to the physician self-referral law (commonly referred to as the “Stark Law”).  Stark contains two broad restrictions.  First, it prohibits physicians from making referrals of certain designated health services (“DHS”) payable by Medicare to an entity with which he or she (or an immediate family member) has a financial relationship, unless an exception applies.  Second, Stark prohibits those entities from billing for the referred services.

The two new Stark exceptions, when satisfied, will permit (1) remuneration from a hospital, federally-qualified health center (“FQHC”) or rural health clinic (“RHC”) to a physician to assist the physician to compensate certain non-physician practitioners (“NPPs”) who will provide primary care or mental health services in the geographic area served by the hospital, FQHC or RHC (the “NPP Recruitment Exception”) and (2) arrangements in which physicians (or physician organizations) and hospitals may use one another’s space, equipment, personnel, items, supplies or services to provide services on a time-sharing basis (the “Timeshare Arrangements Exception”).

In announcing the new exceptions, CMS recognized several important policy considerations, many of which relate to increasing access to care.  CMS noted NPPs’ increased role in health care delivery in light of health coverage expansion under the Affordable Care Act and the looming shortage of primary care physicians.  Also, in a victory for mental health providers, CMS was persuaded to include clinical psychologists and clinical social workers within the definition of NPP and to add mental health care services to the scope of permissible services that may be provided by NPPs engaged under the NPP Recruitment Exception.  (The exception, as initially proposed by CMS, included only physician assistants, nurse practitioners, clinical nurse specialists and certified nurse midwives and restricted their services to primary care.)  The Timeshare Arrangements Exception reflects a similar acknowledgment that time-sharing may increase access to specialists in rural areas that cannot support a specialist on a full-time basis.

Both the NPP Recruitment Exception and the Timeshare Arrangements Exception include several elements that must be strictly satisfied in order for the arrangement to qualify for protection.  Health care organizations and physicians interested in learning more about the new exceptions, or whether arrangements they are considering might qualify, should feel free to contact Parker Poe.

Amanda Hayes

Amanda Hayes

Amanda Hayes counsels clients in connection with mergers and acquisitions, divestitures and other business matters, with a particular focus on the health care industry. She regularly serves as lead counsel on acquisitions and divestitures, guiding the client through deal structuring, due diligence, drafting, negotiation and closing. In addition to health care, Ms. Hayes’ mergers and acquisition experience includes a variety of industries, such as manufacturing, retail, automotive, contract research, environmental remediation, engineering and construction supply.

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How Medicaid Providers Can Challenge Rate Cuts in the Wake of Armstrong v. Exceptional Children’s Center

The Federal Lawyer, a national magazine by the Federal Bar Association, just published an article by one of Parker Poe’s health care attorneys.   The article looks at the implications of a recent Supreme Court decision and explores how Medicaid providers can still challenge rate cuts.

The article is available here.

Matt Wolfe

Matt Wolfe

Matt Wolfe concentrates his practice in the areas of administrative litigation, government relations, and other regulatory matters. Matt formulates comprehensive political and public relations strategies on a broad range of federal and state policies. He drafts and monitors legislation, intervenes directly with legislative, executive, and local officials, and appears before state and federal executive agencies. Within his administrative litigation practice, Matt advises and counsels health care providers subject to federal and state regulatory actions.

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First, Do No Harm: Analyzing the Certificate of Need Debate in North Carolina

From time to time the Parker Poe Health Care Blog will be asking experts in the health care field to serve as guest bloggers. Our first guest blogger is Daniel Carter from Ascendient. Ascendient is a Health Care Consulting firm located in Chapel Hill, North Carolina, that provides strategic health care planning and Certificate of Need advice and analysis. Ascendient has recently completed an in-depth analysis of the Certificate of Need (“CON”) law in North Carolina to determine how a potential repeal of the law would affect health care providers and consumers in the state. After reading it, we decided we should share this analysis with you. Here is a summary with a link to the full report.

Much of the debate over whether North Carolina’s Certificate of Need (“CON”) law should be repealed has focused on market theories without a great deal of focus on measurable realities. Ascendient decided to expand the perspective beyond the ideological arguments and review the data to see if it could draw some conclusions about how a potential repeal of the CON law in North Carolina would affect health care providers and consumers.

Based on an analysis of facts and objective data, we conclude that any move now to deregulate North Carolina’s healthcare system by reducing or eliminating the CON program would be premature and put already vulnerable hospitals at much greater risk as new entrants pick off their best patients without taking up the burden of indigent care.

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