The United States only holds about 5% of the world’s population yet is consuming 99% of the word’s hydrocodone, 80% of the world’s oxycodone, and 65% of the world’s hydromorphone; all powerful narcotics. Those statistics show themselves in the most disheartening of ways with an opioid epidemic that has 1.3 million Americans needing hospital care for opioid related issues and over 30,000 dying from opioid overdoses in one year alone, with the number climbing every year. The nation’s opioid crisis also costs the U.S. over $70 billion a year when accounting for healthcare costs, productivity loss, addiction treatment and the costs of criminal justice actions and resources. The nation’s epidemic has garnered a federal response in the form of CDC guidelines that are discouraging primary care physicians from prescribing opioids as a first line of defense (or only line of defense) for patients with chronic pain and instead encouraging the use of non-opioid and even non-drug treatments for pain. A DEA response shortly thereafter indicated production quotas would be enforced for Schedule II pain medications, reducing the production of some medications by a quarter or even a third.
Prescribing opioids for pain can be a routine part of medical treatment, however, opioids are a national dilemma and though patients may need them for pain management, they are also highly addictive. Some patients being administered these prescriptions are recovering from opioid addictions and face a high-risk of relapse. And, because some more unscrupulous health care providers use “pill mills” to make money, there is a strong push in many states to protect patients. This push has brought about a new idea – patient directives that notify providers NOT to prescribe or administer opioids to them.
How could it not?
The healthcare industry is rapidly evolving. As recently reported in U.S. News and World Report, next on telemedicine’s horizon may be virtual care clinics. In fact, so-called virtual care will likely revolutionize the delivery of health care in the coming years. “Virtual,” in this context, alludes to the fact that care providers, doctors, nurses and therapists, may provide most care from many miles away.
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Various genres of “virtual care” delivery exists already. One notable pioneer is Mercy Virtual. Mercy, based in Chesterfield, Missouri, emphasizes that an objective of its mission is to ensure access to quality care, explaining: “Mercy Virtual’s mission is to connect patients with leading care providers whenever, wherever they need help.” In recent years, many other medical businesses are finding and developing their own niches in the evolving virtual healthcare world. Several of the numerous examples are: Teladoc, which provides online, 24/7 access to primary care physician services; American Well, which claims to offer “telehealth” to more than 100 million people in an online marketplace where customers select their healthcare provider from a list; Carena provides a range of healthcare services that include virtual visits for the employees of self-insured companies; Zipnosis is a platform that, through “phone and video care,” helps patients get answers to their healthcare questions and helps physicians treat primary care ailments; MeVisit enables “e-visits” that allow patients to use their mobile device to connect with a doctor.
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The Senate Report is, at a minimum, a strong indicator that calls for change in the law are heard and efforts are underway to evaluate improvements to the law.
A Brief History of Stark Law
Stark Law is Federal physician self-referral law premised upon the notion that physicians are prone to order (i.e., “refer”) more medical items and services if they stand to benefit financially from doing so. For example, where a physician has an ownership interest in a lab to which he refers patients, he will incentivized to send more patients to the lab for lab work.
Thus in 1989 Representative Fortney “Pete” Stark (D-CA), of whom the statute was named, proposed the law to address two perceived adverse consequences of financial incentives for physician self-referrals of medical items and services reimbursed by a Federal healthcare program: (1) overbilling of Federal healthcare programs; and (2) the provision of medical services that do not benefit a patient. Stark Law, Section 1877 of the Social Security Act, codified at 42 U.S.C. § 1395nn, as originally passed, was a fairly straightforward and narrow prohibition that precluded a physician from referring patients or specimens to clinical labs, including physician office labs, where labs paid for by fed programs (Medicare, Medicaid, or CHAMPUS) if the physician (or immediate family member) had a “financial relationship” with the lab. Indeed, Pete Stark declared in sponsoring the law that the intent was to create a “bright line” standard that would benefit physicians and protect Federal healthcare programs. But the law did not remain simple and expanded from the straightforward lab referral context to apply to a list of services and items known as “Designated Health Services,” identified by CMS billing codes.
CMS recently announced what it describes as the largest-ever multi-payer initiative to improve primary care in America,” known as Comprehensive Primary Care Plus (CPC+). Though much of the press release is couched in terms of improving patient care — and surely CPC+ is intended to do so — the real impetus appears to be the government’s critical need to control healthcare costs funded by federal programs.
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The idea is to support a new primary care delivery model that will incentivize and reward value and quality. The current Administration’s goal is to have 50% of all Medicare fee-for-service payments made via alternative payment models by 2018. The Center for Medicare and Medicaid Innovation, which exists pursuant to Section 1115A of the Social Security Act (added under the Affordable Care Act) for the purpose of testing new payment and service delivery models, developed CPC+ as part of its mission, to aid the federal government in its efforts to curb its healthcare costs and enhance the quality of healthcare delivery.
For several years, hospital administrators have been adjusting to changes in federal rules for calculating patients’ unpaid medical bills into hospital Medicare reimbursement.
The federal government provides funding to hospitals that treat indigent patients under so-called “Disproportionate Share Hospital (DSH) programs,” which provide partial compensation to facilities based on a formula. Many of the roughly 3,100 hospitals receiving DSH payments are teaching hospitals or those in large urban areas.
The Patient Protection and Affordable Care Act changed the formula for calculating DSH payments in fiscal year 2014, significantly reducing the share hospitals received, with goals of reducing funding for the Medicare DSH payments initially by 75 percent and subsequently increasing payments based on the percent of the population uninsured and the amount of uncompensated care provided; and to reduce the Medicaid DSH program by $18.1 billion by 2020.
In making a decision to pursue medicine and healthcare as a livelihood, it is likely that most physicians today did not contemplate the extent to which legally binding contracts would govern and impact their professional lives. Few other careers carry the same potential for commitment to so much paper and binding agreements that simultaneously foster professional opportunities and create hazardous legal and professional risks (for example, a non-compete agreement that bars future employment needed to avoid selling the house and moving; a contract with a hospital system that memorializes a compensation arrangement but, unbeknownst to the doctor when he signs, violates STARK law). In this day, all physicians should be mindful of the critical importance of good contracting principles and practices.
The healthcare industry, perhaps more dramatically than other industries, is prone to changes, trends, and developments. A sustained trend has been physician employment (versus private practice ownership). In the 1990s, with the evolution of HMOs, the industry trended toward high levels of physician employment, a trend that petered out some during the 2000s with decreasing physician employment as HMOs dissolved. In recent years, however, the healthcare industry returned to a strong trend toward physician employment driven by numerous factors derived from healthcare “reform.” Whether the current physician employment trend is more permanent than the last one is unknown, but some experts predict that the high level of physician employment is here to stay. As reported last year in the Dallas/Forth Worth Healthcare Daily, some experts believe that physicians’ need for stability with regard to future income will drive a lasting employment trend.
High on the list of trends in the healthcare industry in 2016 is the advancement of technology in the diagnosis and treatment of disease and medical conditions. According to a recent online article in Healthcare Finance, thirty-two percent of consumers in 2015 had at least one health, medical or fitness app on their mobile devices. Such apps can be useful for primary care and chronic disease management, among other areas. Telemedicine will continue to grow in 2016 as well, with physicians and other health providers consulting and treating patients remotely. Providers increasing their use of technology can expand the geographic reach of their practice to include a greater number of patient consumers. Indeed, the Affordable Care Act anticipates and encourages the use of telemedicine and other remote technologies as an efficient and cost-effective method for expanding the reach of healthcare services.
Of course, with the increasing use of technology in healthcare comes attendant legal and compliance concerns, ranging from issues of patient privacy and cybersecurity to state regulatory and medical ethics requirements governing patient care, billing and reimbursement.
Providers considering increasing their use of telemedicine and other technology in the provision of services should first evaluate the legal and regulatory issues carefully, understanding that federal and state entities have specific definitions, compliance and legal requirements governing these practices. Some concerns as to this mode of healthcare delivery are as follows:
The U.S. Centers for Medicare and Medicaid Services (CMS) issued a Final Rule earlier this week, which created prior authorization rules applicable to particular durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). The impetus for the rule is CMS’ determination that prior authorization will curb past issues with unnecessary utilization of DMEPOS, saving the government money and enhancing the care of Medicare beneficiaries.
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The Social Security Act (the Act) authorizes CMS to periodically revise its list of DMEPOS that is subjected to unnecessary utilization and to develop a prior authorization process for such items. See the Act, § 1834(a)(15). CMS broadly considers “unnecessary utilization” to include “the furnishing of items that do not comply with one or more of Medicare’s coverage, coding, and payment rules.” The Final Rule creates a Master List of specific DMEPOS potentially subject to prior authorization. The so-called “Master List,” together with pertinent other information regarding the list, can be accessed via this link. An items presence on the Master List does not automatically create a prior authorization requirement. CMS will implement a subset of items on the Master List, a “Required Prior Authorization List,” which will be published in the Federal Register with 60 days’ notice before implementation.
Open Enrollment Season for federal and state exchanges offering insurance coverage in the “Health Insurance Marketplace” for 2016 began this month, and will run through January 31, 2016. During this period, individuals may newly enroll with, renew or change their health insurance plans or providers. In fact, more than 543,000 people have already obtained coverage in the Marketplace during the first week of open enrollment for 2016. Thirty-four percent of those were new consumers, per a report by the federal Centers for Medicare and Medicaid Services.
According to an article published by “Shots,” the online channel for health stories from the National Public Radio Science Desk, the occasion of Open Enrollment Season has prompted many consumer questions about details of enrollment and available marketplace plans, including the impact of high deductible plans; options in obtaining in- and out-of-network health services; and confronting cost increases in marketplace health plans.
Some guidance provided in response to consumer questions are as follows: