Monday, October 12, 2015

Primary Care Providers: Are You Feeling the Pinch?

It was nice while it lasted. Due to a provision of the Patient Protection and Affordable Care Act, services furnished by certain primary care providers were subject to an enhanced payment rate for calendar years 2013 and 2014. These PCPs had to have been (a) Board-certified in the specialty designation of family medicine, general internal medicine or pediatric medicine or have a subspecialty designation recognized by specific boards or associations, or (b) furnished more than 60% of claims in specific evaluation and management or vaccine administration services under certain codes to have been eligible for these enhanced payments [1].  The payments were raised to the level of the Medicare Part B fee schedule rate (unless the actual billed charge for the service was lower), and providers had until April 1, 2013 to self-attest to being eligible [2].  The increase applied to both fee-for-service and managed care Medicaid plans.

Sunday, September 20, 2015

FCC Guidance on Cellphones Puts the
Squeeze on Medical Debt Collectors

In July, the FCC released an order it touted as strengthening “consumer protections against unwanted calls and texts.” It was a series of rulings based on the Telephone Consumer Protection Act meant to clarify the use of autodialers, procedures for wrong numbers and consent to call, mainly concerning cellphones.  Under these new regulations, healthcare providers must get express written consent to be able to contact patients on their mobile phones about medical debt and billing.

The problem for medical debt collectors is that they are required to confirm that they have received express consent before using an autodialer to contact a cellphone. If they call a cellphone number that has been reassigned, they have a one-call safe harbor to receive constructive notice that the number has been reassigned or is the wrong number.

Tuesday, August 11, 2015

Changes and Challenges for Mental and Behavioral Health Providers

As Kentucky’s Senate Bill 192 highlights, coverage and treatment of substance abuse problems is dramatically changing, as the current penal model is slowly being replaced with a treatment model. Even terminology for what has been called "drug addiction" is now referred to as a "substance disorder" problem. Behavioral health has become the new catchall name for both mental health and substance disorders.

As substance disorders become medical problems rather than drug abuse problems, the Federal Mental Health Parity Act and the Affordable Care Act now mandate that substance disorders and mental health problems, which often go hand in hand, must be covered by health insurance just as medical problems are covered. As of January 1, 2015, these illnesses must also covered by Medicare and Medicaid. Paving the road for coverage, however, has not been easy, as a wealth of new federal and state government regulations are creating a complicated framework with a host of changes for behavioral health providers. While Kentucky struggles to provide and pay for services for the 150,000+ new Medicaid beneficiaries, these new laws and regulations significantly affect not just behavioral health providers, but also employers as the struggle to treat individuals who suffer from these maladies is addressed.

Friday, July 31, 2015

CMS Proposes Sweeping Changes for Nursing Home Oversight

On July 16, 2015, the Center for Medicare and Medicaid Services published a Proposed Rule with new standards that will have a sweeping effect on the long-term care industry. This new Rule is the first comprehensive review and update to Medicare and Medicaid nursing home standards since 1991. Since the last update, the number of Medicare beneficiaries, excluding Medicare Advantage beneficiaries, residing in nursing homes has tripled to 1.8 million residents and the Medicaid Program has become the primary payer of long term care (64% of residents are on Medicaid)[1].

The 403 page Proposed Rule sets high standards for quality of care and patient safety in nursing homes and long term care facilities that participate in Medicare and Medicaid [2].  The U.S. Department of Health and Human Services summarizes the proposed changes as follows:

Friday, July 17, 2015

Think Twice About DEA Voluntary Surrender

It can be an intimidating experience, to be sure.

A DEA agent or Diversion Investigator, on an unscheduled visit to your office, confronts you with a KASPER, a KBML complaint or some other state regulatory action and alleges violations of the Controlled Substances Act. The DEA Agent then asks you to sign DEA Form 104.

This form, which is titled “Voluntary Surrender of Controlled Substances Privileges,” is placed in front of you while the agent explains why you should sign it immediately, rather than face potential action to revoke your DEA and other adverse consequences. The DEA Agent tells you that you are already in deep, deep trouble (of a vague and unspecified nature), and that the simple act of signing this form can make your troubles go away and prevent federal action. Also, he tells you that all you have to do to get the number back is to reapply!

Hold on. This is not the full story!

Friday, July 10, 2015

The Compounding Regulations
Surrounding Drug Compounding

Drug compounding as a practice has, until recently, been met with far looser regulation than the manufacture of drugs. This practice serves to meet the needs of individuals who require certain formulations not available in manufactured form, such as discontinued medications or forms of manufactured drugs that do not contain ingredients to which a patient might be sensitive.  Compounding may also change the form of the drug for patients who cannot take manufactured drugs in the manner in which they exist commercially.  As industrial-level compounding grows to provide larger amounts of compounded drugs, regulators are scrambling to ensure the quality and safety of these drugs.

The biggest difference between a manufacturer of drugs and a drug compounding facility is that drug manufacturers must receive FDA approval before selling drugs to the public. Drugs from compounding facilities are not tested in the same manner for safety, efficacy or quality.  After an outbreak of Aspergillus Meningitis between 2012 and 2013 due to tainted steroid injections from a compounding facility, Congress passed the Drug Quality and Security Act of 2013 in 2013, and a particular title called The Compounding Quality Act to regulate the compounding industry. The DQSA/CQA set up a new regulatory regime that applies to all compounding pharmacies, and those pharmacies, large or small, should take notice as the FDA will soon release final rules implementing the provisions of the acts.

Thursday, May 21, 2015

What Physicians Should Know About New
Kentucky Law Regarding Physician Assistants

During the 2015 legislative session of the Kentucky General Assembly, HB 258 was approved by lawmakers and signed by Governor Beshear. This legislation amends KRS 311.854 to allow a physician to supervise up to four physician assistants at the same time. This amended regulation goes into effect on June 24, 2015.

PAs perform a wide range of duties, including providing routine care, treating acute and chronic illnesses, managing hospital inpatients, performing minor surgeries, and assisting during major surgeries. To a large degree, supervising physicians are granted the flexibility to delegate tasks to PAs and determine appropriate supervision methods, but state scope-of-practice laws sometimes limit physicians’ authority.

Tuesday, May 19, 2015

FDA Issues Guidance for Mobile Medical Apps

Just so you know, that iPhone or iPad you have with you may be an FDA-regulated medical device. More precisely, the apps on the device may meet the definition of a medical device under the Federal Food, Drug, and Cosmetic Act [1].  In February of this year, the FDA released a revised set of guidance concerning how it will apply regulatory oversight to mobile apps, addressing the growing number and potential uses of these apps as they proliferate alongside rapidly changing mobile technology.

In this new guidance, FDA set forth three classifications of mobile apps: those that do not meet the definition of a medical device under the FD&C Act, those that may meet the definition but pose a low risk to the public, and those that do meet the definition of a medical device, the functionality of which could risk patient safety in a malfunction. The determining factor in whether an app meets the definition of a medical device for purposes of the FD&C Act is the intended use of the app, which FDA will determine through labeling, advertising, and statements by the manufacturer. If a mobile app is intended to perform a medical device function, such as diagnosing or curing disease, it is considered a medical device.

Friday, May 15, 2015

Exclusive Laboratory Arrangements Under Fire

The Office of Inspector General of the Department of Health and Human Services recently released Advisory Opinion 15-04 [1], in which the OIG concluded that certain exclusive arrangements between a laboratory and various physician practices could potentially violate the Anti-Kickback Statute and result in exclusion from federal healthcare programs for excessive charges.

According to the laboratory that requested the opinion, physicians had expressed a desire to work with a single laboratory in an exclusive arrangement because of the convenience of receiving all test results with consistent reference ranges and because of the efficiency gained from maintaining a single interface with one laboratory. However, as the exclusive laboratory provider under the arrangements in question, the Requestor would be out-of-network for, and ineligible to receive payment from, payers covering approximately 10 to 40 percent of the practices' patients. Accordingly, for these patients, the Requestor proposed to waive the laboratory fees and not bill the patient, the physician practices or the payers. The Requestor would continue to bill all other patients, regardless of whether privately insured or covered under a federal healthcare program.

Thursday, May 7, 2015

New OIG Guidance: Great Expectations for Health Care Boards

For the first time in almost ten years, the Office of Inspector General at the U.S. Department of Health and Human Services issued new compliance guidance for healthcare-governing boards. This guidance, “Practical Guidance for Health Care Governing Boards on Compliance Oversight,” provides timely advice for Boards on how to exercise appropriate oversight of compliance programs at a time when healthcare companies and individuals are facing increasing fraud enforcement.

The Guidance is the product of a collaboration among the OIG, American Health Lawyers Association, Association of Healthcare Internal Auditors, and Health Care Compliance Association. It echoes the three-part compliance series issued by the OIG and AHLA in the early 2000s,[1] while also reflecting new industry trends and health reform efforts. The Guidance makes clear that compliance programs are not "one size fits all" but should be adapted to an organization's size and complexity.

Monday, May 4, 2015

HIPAA Rules and Procedures in the
Event of a Data Breach, Part Two

My last post focused on the discovery and investigation of a data security breach to determine if breach notification is needed. Today’s post now turns to the requirements of breach notification triggered by a data security breach.

Notification to Individual Patients
When a breach is discovered and a covered entity (CE) determines that unsecured ePHI has been compromised, that entity must notify all individuals whose information was affected by the breach without unreasonable delay, defined as within 60 calendar days from discovery of the breach.[6]   Discovery is legally defined as having occurred on the first day the breach is known or should have known.[7] This definition means that the clock begins running from the moment the breach is or should have been discovered.  This requirement means that an investigation must be conducted quickly and efficiently after discovery of the incident, so that determination of the necessity of notification occurs quickly and breach notification, if necessary, is timely.

HIPAA Rules and Procedures in the
Event of a Data Breach, Part One

As discussed in my prior post, recent massive data breaches at major retailers and health insurance providers paint a bleak picture of modern data and emphasize the importance of strong security safeguards and plans for handling suspected security breaches for electronic protected health information (“ePHI”). In the healthcare context, a security breach of a covered entity or a Business Associate’s (BA) data security system triggers the Security Rule and can trigger certain breach notification requirements under Health Insurance Portability and Accountability Act (“HIPAA”) and Health Information Technology for Economic and Clinical Health Act (“HITECH”). This post will discuss the investigation needed to determine whether a breach has taken place, while the next post will discuss the necessary notifications in the event of a breach.

Friday, April 24, 2015

Pharmacists: Aren’t You Really Providers Already? Part Two

The first part of this article discussed pharmacist provider status and arguments both for and against it. Today’s post now turns to regulatory hurdles, developments towards provider status and the acknowledgment of changing roles in the pharmacist workforce.

Regulatory Hurdles
If and when they gain status as providers, pharmacists will become subject to more complex regulation. Laws such as the Anti-Kickback Statute and federal False Claims Act could create new liability for pharmacists as providers seeking fee-for-service reimbursement [1].  False Claims Act violations incur penalties of between $5,500 and $11,500 per violation, not including treble damages.
Pharmacies with large customer bases could expose themselves to unparalleled liability.  The Medicare Benefits Policy Manual also delineates specific classes of providers for purposes of reimbursement, each with its own set of conditions and requirements for billing. Provider status for pharmacists would likely receive a similar set of regulations and conditions of participation with new requirements for compliance and accreditation.

Thursday, April 23, 2015

Pharmacists: Aren’t You Really Providers Already?

While the passage of the Patient Protection and Affordable Care Act (“ACA”) ushered in a new era of access to health care, it only served to exacerbate a growing crisis in the provision of health care – lack of providers. As of April 2015, the Health Resources and Services Administration lists the population of the United States that lives within a health professional shortage area (“HPSA”) for primary care as 103,847,716, with 1,023,989 of those living in Kentucky [1].  This shortage calls for reimagining ways that non-physician providers can fill the care gap, and the debate surrounding the provider status of pharmacists with regard to federal health care programs is evidence of a changing mindset.

Tuesday, April 7, 2015

Important Recommendations from the
MedPAC March Report to Congress: Part Two

Important Recommendations from the MedPAC March Report to Congress: Part Two
Tuesday’s post discussed the recommendations of the Medicare Payment Advisory Commission (“MedPAC” or the “Commission”) with regard to fee-for-service (“FFS”) payment systems. Today’s post will discuss the Commission’s recommendations with regard to making FFS payments site-neutral, as well as its status reports on Medicare Advantage (“MA”) and the Medicare prescription drug program (“Part D”). 

Important Recommendations from the
MedPAC March Report to Congress: Part One

Each March, the Medicare Payment Advisory Commission (“MedPAC” or the “Commission”) is tasked with reporting to Congress on the current state of the Medicare fee-for-service (“FFS”) payment systems, the Medicare Advantage (“MA”) program and the Medicare prescription drug program (“Part D”).  This report gives lawmakers recommendations on ways to improve and enhance the Medicare system, as well as shore up areas of concern. This year’s report again struck at the root of systemic problems, specifically noting that an increasing issue within Medicare is a fundamental problem with FFS payment systems – the system incentivizes the delivery of more services without taking into account the value of those additional services.  Several reforms in the report are the subject of current Congressional legislation as well. In the posts for both today and Thursday, we’ll parse the various statements and recommendations in MedPAC’s March report with an eye for their effect on the workings of the system.

Wednesday, March 11, 2015

Kentucky’s Evolving Behavioral Health Providers

One of the most important effects of the Patient Protection and Affordable Care Act (“ACA”) is the profound change in the coverage of behavioral health services.

Building on the Mental Health Parity and Addiction Equity Act of 2008, the ACA requires both Medicaid and Medicare to provide far more robust behavioral health benefits, especially in the area of substance abuse. This expansion of benefits is not without growing pains – health care providers are waking up to the new reality of a vastly expanded need for substance abuse and other mental health services as well as providers. As state Medicaid programs struggle to finance these new benefits, the need for behavioral health care providers and clinicians has become acute.  This is especially true in Kentucky, where access to substance abuse care is crucial due to the epidemic of prescription drug and heroin addictions.  Fortunately, however, the Cabinet for Health and Family Services has taken proactive steps to strengthen and expand behavioral health infrastructure to meet the ACA’s directives.

Hospital Mergers and Antitrust Laws

The rapidly-evolving field of health care has been moving lately towards a single-minded goal – coordination of patient care in the name of efficiency and efficacy. Hospital systems are more and more often merging with other medical practices to better achieve the standards and goals of the Patient Protection and Affordable Care Act (“ACA”). The Ninth Circuit Court of Appeals, however, recently provided a stark reminder that the ACA isn’t the only law hospitals need to consider compliance with in these mergers.

Saltzer Medical Group in Nampa, Idaho, had been seeking to make a change from fee-for-service to risk-based reimbursement and approached St. Luke’s Health System in Boise in 2012about a formal partnership. They entered into a five-year professional service agreement that contained language about wanting to move away from fee-for-service reimbursement but without any clear language on making that change. Saltzer received a $9 million payment on the deal. Other hospital systems in the area, the FTC, and the Idaho Attorney General all filed suit to enjoin the merger.

Friday, March 6, 2015

Are Medical Staff By-laws Contracts?
Minnesota Supreme Court Says, “Yes”

That sound you just heard was the simultaneous gasp of hospital boards of directors throughout the state of Minnesota.  In Medical Staff of Avera Marshall Regional Medical Center v. Avera Marshall, Minnesota’s highest court made two holdings that strengthened the autonomy of physicians and may shed light as to how courts may interpret medical staff by-laws in the future.

In the case at hand, the medical staff by-laws of Avera Marshall Regional Medical Center (“Avera Marshall”) included a provision that required a two-thirds vote of the eligible voting members (which included the medical staff) to revise or repeal the medical staff by-laws. Any changes to the by-laws approved by vote of the medical staff were still subject to the approval of the Board of Directors (“board”).  The by-laws were silent, however, on whether actions of the board concerning revision of the by-laws required approval by the other voting members.

Tuesday, February 10, 2015

Charitable Hospitals and Community Health Needs Assessments

In the last days of 2014, the IRS released regulations that finalized the compliance requirements for charitable hospitals. These new 2014 IRS regulations relate to the Community Health Needs Assessment (CHNA or needs assessment) requirements for nonprofit hospitals or nonprofit organizations operating a hospital contained in Section 501(r) of the tax code, which was created by the Patient Portability and Affordable Care Act (“ACA”).

Section 501(r) requires that thorough CHNAs be conducted every three years in order to maintain their 501(c)(3) nonprofit status. These needs assessments must define the community served by the hospital, the needs of the community, and a strategy addressing the identified community needs. Since each facility that fails to meet CHNA requirements loses its nonprofit status and has to pay a $50,000 excise tax, nonprofit hospitals and networks need to pay special attention to the changes and incorporate these new requirements into their needs assessments.