On June 20, 2017, The Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule which would exempt a greater number of small practices from complying with the  Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”).

CMS’s Administrator, Seema Verma has been quoted as saying that CMS has “heard the concerns that too many quality programs, technology requirements and measures get between the doctor and the patient. . . That’s why we’re taking a hard look at reducing burdens. ”

In order to accomplish this goal, CMS proposes to now exempt physician practices with less than $90,000 in Medicare revenue or physicians with fewer than 200 unique Medicare patients.  The current rule only exempts physician practices that have less than $30,000 in Medicare revenue or fewer than 100 unique Medicare patients.  This proposed rule could mean another 834,000 clinicians could be exempt from the quality reporting under MACRA.

While this seems like a large increase in the number of physicians that are exempt, a recent Modern Healthcare article notes that “65% of Medicare payments would still be reported under methods that adhere to MACRA even if this draft rule were finalized.”

If you are interested in commenting on the proposed rule you may do so through August 30, 2017.  The proposed rule can be found at the following website: Proposed Rule.

If you would like more information about MACRA please see the Fox Rothschild Health Law Alert – Medicare Quality Payment Program from January 2017.

USA Today, New York Times, BNA, and several other news outlets have been reporting over the last few weeks about non-competition agreements and non-compete laws especially related to low-wage workers.  There have been interesting changes and proposed changes to state laws that may affect several industries including healthcare.

In a recent article on Law360, titled “Noncompete Agreements Under Siege At The State Level,” the authors highlighted some developments in non-compete law.  They posit that many areas of employment and labor law have seen changes, but the law of noncompetition agreements has been relatively static.  Until recently, most changes came from case law in this area of law; however, more recently we are seeing that many state legislatures are taking up the issue.

Some states like Massachusetts, Oregon and Missouri are offering laws which include broad prohibitions on the enforcement of noncompetition agreements.  However these proposals have not made much legislative progress according to the authors.

Other states have offered legislation that has health care industry-specific prohibitions.  For example, the authors note that last year Rhode Island enacted legislation that effectively renders physician noncompetition agreements void and unenforceable, while Connecticut imposed new limits as to when noncompetition agreements can be enforced.

According to the authors, in 2017 the trend is continuing.  West Virginia enacted a statute regarding physician noncompetition agreements, which limits the ability to enforce such provisions.  The authors state:

Measures have also been introduced recently in Pennsylvania, Minnesota, Oregon (home care workers), New Mexico (certified nurse practitioners and midwives), and Connecticut (homemakers, companions and home health aides) that target noncompete enforcement against physicians and others in the health and medical profession. (emphasis added)

Low-wage employee non-compete clauses have also come under scrutiny.  The authors note that this year several states have or are currently considering income-based restrictions, including Massachusetts, Maine, Maryland (did not pass), and Washington.

With the landscape of this very important issue changing, individual healthcare providers, their employers, and anyone else who uses, or is subject to, non-compete provisions will need to keep on top of developments to their state’s specific laws.  As the laws change, it will be more important than ever to have non-compete provisions and agreements reviewed or re-reviewed to ensure you understand the effect of such changes.

The Office of Inspector General (“OIG”) of the Department of Health and Human Services, generally, would have concerns about a potential or existing referral source receiving free goods or services, since these free goods and services could be used to provide unlawful payments for the referral of Federal health care program business.  However, under Advisory Opinion 16-09, the OIG decided not to pursue sanctions against a company that provides computerized point-of-care storage and dispensing systems for vaccines (the “Dispensing System”) to physicians free of charge due to the specific circumstances in this arrangement.

The Arrangement:  A manufacturer of a refrigerated vaccine storage and dispensing system (the “Dispensing System”) would retain title to their Dispensing System and the internal data, but would provide the system free of charge to certain physicians.  The manufacturer would enter into two types of agreements:

1)  Sole-Source Vaccine Agreement – The Dispensing System manufacturer would enter into an agreement with manufacturers who are the sole suppliers of a vaccine (“Sole-Source Vaccine”).  The Sole-Source Vaccine manufacturer would pay the Dispensing System manufacturer a fee for each unit of vaccine that a participating physician dispenses out of the Dispensing System (the “Dispense Fee”).

2) Physician Agreement – Dispensing System manufacturer would enter into agreements with only those Physicians who had not previously stocked adult vaccines previously, or only stocked vaccines sporadically or in low volumes.  The Dispensing System would be free of charge to physicians, provided the physician agrees to stock at least one Sole-Source Vaccine that has an Agreement with the Sole-Source Vaccine manufacturer.  The physician would be responsible for the internet connectivity and utilities for the system.  The physician could use the Dispensing System to store other vaccines.  However, the physician may only store Sole-Source Vaccines if the vaccine manufacturer has an agreement with the Dispensing System manufacturer.

OIG’s Analysis: Due to the following “unique factors” the OIG concluded that the following arrangement would be permissible.

  • No Dispense Fee is shared with the physicians.
  • The Dispense Fee is paid directly to the Dispensing System manufacturer, who does not generate Federal healthcare program business.
  • The risk of unfair competition is reduced because (1) only Sole-Source Vaccine manufacturers can enter into an agreement with the Dispensing System manufacturer; (2) More than one Sole-Source Vaccine manufacturer can have their vaccines in any machine and each would be paying the Dispense Fee; and (4) Since a physician needs the Sole-Source Vaccine for patient, the physician has inherently chosen the manufacturer, since they cannot get the vaccine from anywhere else.
  • Physicians may store any non-sole-source vaccines in the Dispensing System that they wish.
  • The manufacturer will not advertise, market or promote any specific vaccine.
  • Adult vaccines are administered in limited manner and serve to prevent diseases, which if not prevented could lead to costlier services to federal payors.
  • The Arrangement helps achieve the CDC’s goal to improve adult vaccination rates which is a benefit from a public policy perspective.
  • The Dispensing System helps mitigate one of the key challenges – proper vaccine storage and management

While it appears the opinion is likely limited to the discrete issue of vaccine storage, it does demonstate that the OIG may be willing to entertain proposals that align with public health concerns or other government agency goals, even in situations where there could be a risk of fraud or abuse to federal payor programs.

If your practice is interested in guidance regarding free vaccine dispensing systems or similar arrangements, be sure to consult experienced counsel.

As a follow up to our most recent post on What You Need to Know About PA’s Child Protective Services Law, you should know that the Pennsylvania Superior Court (PA’s primary appellate court) recently held that a physician may be sued for malpractice for failing to report suspected child abuse, even though there is not an express right to sue a physician for failing to report such abuse under the PA Child Protective Services Law (the “Child Abuse Law”).

You likely know that the Child Abuse Law requires any licensed or certified health care practitioner to immediately report suspected child abuse to the Department of Human Services electronically or by phone when the individual has reasonable cause to suspect that a child is a victim of abuse.  23 Pa. C.S. § 6311(a).  A health care practitioner may have reasonable cause to suspect child abuse from contact with the child in the practitioner’s practice or from a specific disclosure to the health care practitioner by the child or an individual unrelated to the child.  23 Pa. C.S. § 6311(b).  If the health care practitioner willfully fails to report suspected child abuse, the practitioner commits a misdemeanor of the second degree.  If the abuse suffered by the child constitutes a first degree felony or more severe crime, the health care practitioner commits a third degree felony.  23 Pa. C.S. § 6319(a).

In K.H. v. Kumar, the PA Superior Court was presented with the sad case of an infant’s severe brain injury from child abuse that went repeatedly unreported by the infant’s physicians.  The trial court held that the physicians could not be sued for malpractice because the Child Abuse Law, which expressly creates a duty for physicians to report suspected child abuse and establishes criminal penalties for a failure to do so, does not expressly permit non-reporting physicians to be sued in civil court for malpractice.

However, upon review, a unanimous three-judge panel from the PA Superior Court overturned the lower court’s ruling and held that the Child Abuse Law does not prevent physicians from being sued for malpractice for their failure to report suspected child abuse.  The Court noted that the Child Abuse Law does not expressly prohibit suits for malpractice against non-reporting physicians, and emphasized that physicians have a duty of reasonable care to their patients as a result of the physician-patient relationship.  Whether a particular physician fails to meet that duty of care is a question for the jury, not the judge to decide.

Notably, the Court also held that the hospital that employed the physicians could be found negligent for failing to have appropriate policies and procedures in place for the retention and availability of patients’ prior radiological studies.  This is an important warning to medical practices and health care institutions, which should ensure that they have policies and procedures in place to give their physicians ready access to all patient records that could indicate prior physical abuse to a minor patient.

In the conclusion of its opinion, the Court quoted the Hippocratic Oath and its sentiments recognizing that treatment of a patient involves consideration of the patient’s family situation.  The Court emphasized that these sentiments are central to the intent of the sections of the Child Abuse Law requiring health care practitioners to report suspected child abuse.

The full-text of the eloquently written case is accessible at this link:  http://www.pacourts.us/assets/opinions/Superior/out/j-a08018-15o%20-%201023340425279130.pdf#search=%22k.h. kumar%22.

The Takeaway:  Any health care practitioner who has a reasonable suspicion that his or her minor patient has suffered child abuse should not hesitate to report the abuse immediately.  Willfully failing to report the abuse is a crime and can result in civil liability.  Health care institutions should also ensure that policies and procedures are in place to give physicians ready access to patient records that could indicate patterns of child abuse.

To report suspected child abuse in PA, go to www.compass.state.pa.us/cwis or call (800) 932-0313.

These are uncertain times for physicians.  The future of healthcare is uncertain for everyone involved, from payors to providers to consumers.  In fact, there may be only one universal certainty about the future of healthcare: things are changing and are going to continue to change.

The federal Affordable Care Act (ACA) has sent shivers of panic through all levels of the industry.  Payors are scrambling to find ways to control burgeoning premium and provider costs.  Their stated goal is to transition reimbursement from fee-for-service to models based on quality and performance metrics (though no one has really figured out how to accomplish that goal).

Hospitals and other providers are racing to form Accountable Care Organizations (ACOs) and other networks to try to take advantage of these promised “new reimbursement models”.  Unfortunately, developing a network that can effectively control costs and performance across a continuum of care is virtually impossible without knowing what criteria payors will pay for, how those criteria will be measured and how they will be incentivized/rewarded.  As a result, most of the provider networks  I have encountered in the last couple of years are suffering “all hat, no cattle syndrome” — which is to say that they have big plans for managing care but don’t yet have any payor contracts that will pay them for doing so.

For many physicians, particularly those in private practice, the lack of certainty and the resulting panic in the marketplace can be maddening.   Looking for any kind of certainty, many physicians have sold or are considering selling out to a hospital.  Unfortunately, as noted above, hospitals generally have no better idea of what the future of healthcare will look like than anyone else.  Not surprisingly then, most hospital-physician employment agreements have a term of no more than three years, and more and more often, hospitals are building mechanisms into their employment agreements to permit them to reevaluate compensation even before the end of the agreement term.

What will make the most sense for a particular physician or practice will depend on a variety of factors, many of which will be subjective.  While there can likely never be any guaranty that a particular decision in this regard will result in success, the chances of making the right decision will be greatly improved with some careful self-evaluation and planning.

The next several posts on this blog will explore some of the big practice planning decisions physicians are being faced with and the various practical and legal considerations  that physicians should evaluate in making those decisions.  Topics to be covered will include whether to sell, merge or stay the same, identifying the right “partners”, optimizing practice performance to adapt to change and contracting for successful relationships.

According to various news outlets, physicians at the University of California student health centers (as many as 150 physicians in all) went on strike this week in protest of what they believe are unfair labor practices by the University.  These physicians are members of the Union of American Physicians and Dentists.  The protest stems from contract negotiations between the Union and the University which have been ongoing for many months.  While this is only the first time in more than 25 years that physicians in the United States have gone on strike, with more and more physicians becoming employees of large health systems and insurance companies, this strike could be a sign of things to come in the not too distant future.

Last week, the Centers for Medicare and Medicaid Services (CMS) issued the final Physician Fee Schedule for Fiscal Year 2015.   The annual Physician Fee Schedule includes various policy and payment changes to be implemented in the coming year.  This year’s Fee Schedule includes details regarding Medicare’s payment for services outside of a face-to-face visit for managing the care for Medicare patients with two or more chronic conditions beginning in 2015. as well as a new, more transparent process for setting physician payment rates which is designed to allow for public input into the process.  Other changes announced include changes to the quality reporting initiatives: Physician Quality Reporting System (PQRS), Medicare Shared Savings Program, and Medicare Electronic Health Record (EHR) Incentive Program, and further implementation of the physician value-based payment modifier.  A summary of the FY2015 policy and payment changes can be viewed on CMS’ website Here.

Physicians in Pennsylvania who have been dispensing and billing for prescription drugs under the Pennsylvania Workers’ Compensation program will be disappointed to learn that House Bill 1846 (which already passed the House) was approved by the Pennsylvania Senate yesterday, essentially clearing the way for the bill to be signed into law.  HB 1846, among other things, limits the amount a physician may charge for drugs under the Workers’ Compensation program to 110% of the Average Wholesale Price of the drugs.  The Bill also limits the amount of drugs a physician can dispense to a Workers’ Compensation patient to a 7-day supply for Schedule II and III drugs and to an initial 30-day supply for any other drug.  The final bill can be viewed here:  Pennsylvania House Bill 1846

According to a final rule published by the Centers for Medicare and Medicaid Services on August 4, 2014, providers will be required to use  the International Classification of Diseases, 10th Revision for diagnosis coding starting on October 1, 2015.  Until then providers are to continue using the 9th Revision (ICD-9).

Given the winding path that ICD-10 has taken thus far, whether this new compliance date will stick remains to be seen.   The Department of Health and Human Services (HHS) announced in 2009 that ICD-10 would be the standard code set (required by HIPAA) to replace ICD-9.  The original implementation date was to be October 1, 2013.  However, citing a lack of resources and readiness to implement ICD-10, in 2012, HHS extended the complianc deadline to October 1, 2014.  But, the Protecting Access to Medicare Act of 2014 (PAMA), which was adopted on April 1, 2014, prohibited HHS from implementing ICD-10 before October 1, 2015 — hence the new “official” compliance date.

Physician ancillary service joint ventures continue to proliferate and not surprisingly, federal and state regulators are on the lookout for arrangements which may violate fraud and abuse laws .  In its recent “Special Fraud Alert: Laboratory Payments to Referring Physicians”, the Office of Inspector General (OIG) has (once again) expressed concern over financial arrangement between physicians and clinical laboratories to which they may refer.  In the alert, the OIG focus on two types of financial arrangements which they believe raise substantial risk under the anti-kickback statute:

1.            Payments by clinical laboratories to physicians to collect, process, and package patients’ specimens; and

2.            Payments by clinical laboratories to physicians to report patient data to “registries” established by the clinical laboratories.

With regard to specimen collection arrangements, the OIG cites the following characteristics as potentially problematic:

  • Payments that exceed fair market value for services actually rendered by the physician;
  • Payment for services for which payment is also made by a third party, such as Medicare;
  • Payments made directly to the ordering physician rather than to the ordering physician’s group practice, which may bear the cost of collecting and processing the specimen;
  • Payments made on a per-specimen basis for more than one specimen collected during a single patient encounter or on a per-test, per-patient, or other basis that takes into account the volume or value of referrals;
  • Payments offered on the condition that the physician order either a specified volume or type of tests or test panel, especially if the panel includes duplicative tests;
  • Payments made to the physician or the physician’s group practice, despite the fact that the specimen processing is actually being performed by a phlebotomist placed in the physician’s office by the laboratory or a third party.

With regard to registry arrangements, the OIG cites, among other things, the following characteristics of concern:

  • The laboratory requires, encourages, or recommends that physicians who enter into Registry Arrangements perform the tests with a stated frequency (e.g., four times per year) to be eligible to receive, or to not receive a reduction in, compensation;
  • The laboratory collects comparative data for the Registry from, and bills for, multiple tests that may be duplicative or that otherwise are not reasonable and necessary;
  • Compensation paid to physicians on a per-patient or other basis that takes into account the value or volume of referrals;
  • Compensation paid to physicians which is not fair market value for the physicians’ efforts in collecting and reporting patient data; and
  • Compensation paid to physicians that is not supported by timely documentation memorializing the physicians’ efforts.

Physicians considering entering in to financial arrangements with clinical labs should review their arrangements carefully for compliance with not only the federal anti-kickback statute but other federal and state fraud and abuse laws.