By press release on September 19, 2017, Massachusetts Attorney General Maura Healey announced the expansion of a pending review of an opioid related scheme to include additional manufacturers and distributors of opioids. The investigation has been undertaken by a 39-member bipartisan group of state attorneys general, which was first announced earlier this past summer. Our business and health care law firm follows developments in the pharmaceutical industry and our Country’s opioid addiction and overdose crisis that has led to many thousands of deaths and, in particular, related issues in Georgia and South Carolina.
The FDA has announced that it will begin requiring opioid manufacturers to provide more training for healthcare providers. At present, manufacturers must provide training about long-acting, extended release opioids to prescribers. In the future, the manufacturers of short-term and immediate release opioids will also be required to provide the same type of training. The training will be available to physicians, nurses, and pharmacists.
This change was brought about by the continuing high rate of drug overdose incidents by prescription drug abusers, particularly those abusing opioid painkillers. The training was previously only required by makers of long-acting opioids. However, the FDA stated statistics show that today the vast majority, 90% to be exact, of opioid pain medication prescriptions are for the short-acting variety. It has been found that abusers of opioids are misusing the short-acting, immediate release versions as well as the long-acting types. After becoming addicted to the commonly prescribed short-acting versions of the medication, most abusers graduate to higher doses of the prescription drugs or move to illegal drugs, which present a lower cost alternative.
In late 2016, the 21st Century Cures Act was passed to assist the FDA in keeping pace with the rapid changes in health care technology. Our business and healthcare law firm, follows developments in the healthcare industry.
Among other things, this Act amended the definition of a “device” in the Food, Drug, and Cosmetic Act to remove some medical software functions. The immediate result is that the FDA must draft new guidance for its oversight of software for medical devices.
Healthcare Technology Lawyers
Included in the concept of “Digital Health” are health information technology, wearable devices, personalized medicine, mobile health and telemedicine. The FDA has recognized that these technologies are used to reduce cost and inefficiencies, improve care and access, and better tailor medicine to the individual patient. Furthermore, patients can use the technology on their own to track and manage their own health activities. The FDA acknowledged that new technology allows unprecedented opportunities for people to obtain and potentially share information that can result in significant improvements in health care.
Georgia physicians seeking licensure in other states hope to benefit soon from a more streamlined process. In fact, a bill was recently introduced in the Georgia House of Representatives to allow Georgia to join the growing number of states participating in the Interstate Medical Licensure Compact. (House Bill 637). Such a bill, if passed by both houses of the legislature and signed into law by the Governor, would greatly simplify the process for Georgia physicians to obtain licenses in other member states, allowing a wider population of patients access to their services and expertise. This type of bill would not change the existing methods of obtaining a license in Georgia but would provide an additional route. Although the bill was not voted on, the effort indicates this type of change may be on the horizon.
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.
Georgia Health Care Law Firm
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.
Georgia Stark Law and Physician Self-Referral Attorneys
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.
Atlanta/Augusta, Georgia Physician Practice Lawyers
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.