July 22, 2016 – 7-Day Opioid Limitation Begins TODAY!!

Dr. Reid
PRESIDENT’S MESSAGE
Dr. Malcolm Reid
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July 22, 2016
Volume 16, Number 26

MLMIC

Dear Colleagues:

MSSNY will join several other patient advocacy groups next week in a meeting with Governor Cuomo’s top health policy staff to urge that he sign into law legislation (A.2834-D/S.3419-C) supported by MSSNY that would establish specific criteria for physicians to request an override of a health insurer “step therapy” medication protocol when it is in the best interest of their patients’ health.

To assist in these efforts, we ask you to do the following:

  1. Send a letter from MSSNY’s Grassroots Action Site asking Governor Cuomo to sign the bill into law; We know the insurers are strongly fighting this bill, so the Governor’s office needs to hear your support.
  2. Please share with us any recent examples you may have regarding unnecessary hassles health insurance companies have imposed when trying to request an override of such insurer’s step therapy protocol for your patient. Send your examples to mauster@mssny.org. . (Before sending, please remove any patient-identifying information such as patient names, ID numbers or claim numbers.)

Specifically, the bill would require a health insurer to grant a physician’s override request of an insurer step therapy protocol if one of the following factors are present:

  • the drug required by the insurer is contraindicated or could likely cause an adverse reaction;
  • the drug required by the insurer is likely to be ineffective based upon the patient’s clinical history;
  • the patient has already tried the required medication, and it was not effective or caused an adverse reaction;
  • the patient is stable on the medication requested by the physician;
  • the medication is not in the best interests of the patient’s health.

While the legislation would generally require the health insurer to make its decision within three days of the override request of the physician, the insurer would be required to grant the override request within 24 hours of the request if the patient has a medical condition that places the health of such patient in serious jeopardy if they do not receive the requested medication.

Perhaps most importantly, if the physician’s request for an override is denied, it would enable a physician to formally appeal the decision both within the plan’s existing appeal mechanism as well as taking an external appeal.

Malcolm Reid, MD, MPP
MSSNY President

Please send your comments to comments@mssny.org


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Please Take Our 10-Question Telemedicine Survey NOW!
MSSNY developed a brief 10-question survey to measure the membership’s interest in a member benefit related to telemedicine.

Seven Day Initial Opioid Prescribing Limitation Effective On Friday, July 22nd
TODAY, Friday, July 22, 2016 prescribing limitations will go into effect for prescribers under a new law signed as part of New York State’s efforts to curb opioid abuse.   The measure limits to seven days the prescription of Schedule II, III, or IV opioid upon initial consultation or treatment of acute pain.

  • Under the NYS Public Health law “acute pain” is defined to mean pain, whether resulting from disease, accidental or intentional trauma or other cause that the practitioner reasonably expects to last only a short period of time. Such term SHALL NOTinclude chronic pain, pain being treated as part of cancer care, hospice or other end-of-life- care or pain being treated as part of palliative care practices.
  • The new limitation applies to the initial prescription ONLY.  The measure gives flexibility to the prescriber to, upon any subsequent consultations for the same pain, issue  any appropriate renewal, refill or new prescription for the opioid or any other drug consistent with existing 30-day or 90-day statutory limits for Schedule II, III and IV medications.
  • The measure also limits application of co-pays for the limited initial prescription of an opioid to either (i) proportionate amount between the copayment for a thirty day supply and the amount of drugs the patient was prescribed or the equivalent to the copay for the full thirty-day supply provided that no additional copays may be charged for any additional prescriptions for the remainder of the thirty-day supply.
  • The New York State Department of Health has put into place temporary procedure for billing for the Medicaid Fee for Service Program.   The department’s letter can be found HERE.
  • The letter does stipulate that pharmacists are NOT required to verify with the prescriber whether an opioid prescription writer for greater than a seven-day period.
  • Additional information on opioids and this law may be obtained by contacting the NYS Department of Health’s Bureau of Narcotic Enforcement at 1-866-811-7957 or click HERE.
  • For billing questions please contact CSC at 1-800-343-9000.
  • Questions specific to Medicaid FFS policy can be directed to ppno@health.ny.gov or call 518-486-3209. 

Federal Government, New York AG Seeks to Block Health Insurance Mega-Mergers
Noting that the proposed mergers involving four of the five largest health insurance companies in the country “are unprecedented in their scale and in their scope”,  the US Department of Justice announced this week that it was initiating litigation to block the proposed mergers of Anthem (the parent of Empire) and Cigna, as well as Aetna and Humana.

MSSNY, along with hospital and consumer groups, have opposed the proposed merger between Anthem and Cigna as it would significantly increase health insurer market concentration in the metropolitan New York City area, and in particular on Long Island. MSSNY’s letter of opposition here.

Since Humana has very little market penetration in New York (aside from Medicare Advantage), MSSNY had concerns but did not issue a formal statement of opposition to its proposed merger with Aetna.  However, last week, while the New York DFS approved the merger between Aetna and Humana, it imposed several significant conditions including: approval by DOJ; requiring the combined entity to continue offering the same health insurance products; prohibiting acquisition costs from being passed on to consumers and providers; and assuring robust networks.

Several state Attorneys General, including New York AG Eric Schneiderman, joined in the litigation with the US DOJ to block the proposed merger of Anthem and Cigna.  To read AG Schneiderman’s statement, click here:.  Specifically, AG Schneiderman noted that “By reducing competition, this proposed merger has the potential to significantly increase the merged firm’s power in the marketplace, to the detriment of consumers. Employers will be left with fewer choices, and ultimately consumers could be saddled with higher premium costs, reduced access to providers, and lower quality care.  I stand with my federal and state partners in fighting to stop this merger before it harms New Yorkers.”

The AMA’s Advocacy Resource Center was extensively involved in both making arguments to DOJ in opposition to the mergers, as well as in assisting states with essential background information that better enabled state medical societies including MSSNY to make compelling arguments to state policymakers why these proposed mergers would have adverse impact on patients and care providers.

Bloomberg reports (7/20): “Aetna Inc. is ready to go to court if necessary to proceed with its $37 billion takeover of health insurance rival Humana Inc., the company said Wednesday. … The insurer is prepared to argue that there are several ways to ensure there’s enough competition in the market for health plans for the elderly, known as Medicare Advantage, according to a person familiar with the matter. In addition, it has already presented two separate divestiture proposals to U.S. officials, said the person, who spoke on condition of anonymity because the matter is private.” http://bloom.bg/29PB4of

JAMA: Medicare Beneficiaries Have Highest Rate of “Opioid Use Disorder”
research letter published Wednesday in JAMA Psychiatry found Medicare beneficiaries had the highest and most rapidly growing rate of ‘opioid use disorder.’” Data show six out of every 1,000 Medicare beneficiaries “struggle with the condition, compared with one out of every 1,000 patients covered through commercial insurance plans.” In addition, the letter suggested “Medicare beneficiaries may face a treatment gap,” because figures indicate that in 2013, physicians “prescribed a high number of opioid prescription painkillers for this population – which put patients at risk for addiction – but far fewer prescriptions for buprenorphine-naloxone, the only effective drug therapy for opioid use disorder covered by Medicare Part D.” 

Additional Information Regarding CMS Proposed 2017 Medicare Payment Rule
As reported last week, CMS has released its proposed revisions to the Medicare Part B payment system for 2017.  To read a summary prepared by the AMA of the highlights, click here.

Budget Neutrality Impact of “Add on” Codes

Of perhaps greatest significance, CMS is proposing an “add-on” code that could be billed with E/M codes for physicians treating people with mobility-related impairments.  While there is of course great merit in expanding access to patient care through increasing certain Medicare payments, this proposal is funded with an across-the-board cut in payment rates that would (due to “budget neutrality” requirements) completely nullify the 0.5% increase in Medicare payments that was required by MACRA.

2017 Potentially Misvalued Codes List

CMS has identified 83 services for reductions as “misvalued”.   This was required by the Protecting Access to Medicare (PAMA) and Achieving a Better Life Experience (ABLE) Acts of 2014 that set a 0.5% target for reductions for both 2017 and 2018.   To develop the list, CMS identified 0-day global codes that were billed with an E/M code 50 % of the time or more, on the same day of service, with the same physician and same beneficiary.  To prioritize its review, CMS identified codes that have not been reviewed in the last five years and have greater than 20,000 allowed services.

New York GPCI Adjustments

As is required every 3 years, CMS proposes changes to the Geographic Adjustment Factors (GAF) that   differentiates Medicare payments for over 100 different regions throughout the country, including within the 5 Medicare payment localities in New York State.  An initial review of the proposed revised GAFs shows that New York’s 5 payment localities would experience slight reductions in these regional adjustments, almost entirely due to a reduction in the malpractice cost component that helps to determine Medicare fees.  While there has been some leveling in recent years, New York’s malpractice premium costs still continue to far exceed almost all other states, calling into question CMS’ data.  Therefore, MSSNY has asked Senator Schumer’s office to question whether CMS’ data is accurate.

Other Highlights

  • Expand the duration and scope of the Diabetes Prevention Program (DPP), and changes the name to the Medicare Diabetes Prevention Program (MDPP).
  • Recognizing two new CPT codes for separate payment for non-face-to-face prolonged E/M services, which are currently considered to be bundled.
  • Require claims-based reporting regarding the number and level of pre- and post-operative services furnished for 10- and 90-day global services. Specifically, physicians would be required to report a set of time-based, G-codes that distinguish between the setting of care (hospital, office, email/telephone) and whether the services are furnished by a physician or by their clinical staff.
  • Expanding telehealth payment related to the use of a new place of service code specifically designed to report services furnished via telehealth, including for End-stage renal disease (ESRD) related services for dialysis, Advance care planning services; and Critical care consultations
  • changes to the quality measure set that ACOs are required to report to better align the MSSP quality measure set with the measures recommended by the Core Quality Measures Collaborative

To read the entire 856-page rule, click here:.  A chart detailing the specialty by specialty impact of the proposed changes to the Medicare fee schedule are on pp. 788-789.

MSSNY will be working with the AMA and the federation of medicine to review the rule and to make comments on key components. 

Congratulations to 61 NY Practices in the Million Hearts® Risk Reduction Model
The Centers for Medicare and Medicaid Services announced Thursday that 61 groups in New York State were selected for a new program that aims to reduce the risks for heart attacks and strokes among Medicare fee-for-service patients by applying select preventive measures.

The Million Hearts® Cardiovascular Disease (CVD) Risk Reduction Model is a randomized controlled trial that seeks to bridge a gap in cardiovascular care by providing targeted incentives for health care practitioners to engage in beneficiary CVD risk calculation and population-level risk management. Instead of focusing on the individual components of risk, participating organizations will engage in risk stratification across a beneficiary panel to identify those at highest risk for atherosclerotic cardiovascular disease (ASCVD).

There are a total of 516 participating organizations (List) involved in the Million Hearts® Cardiovascular Disease (CVD) Risk Reduction Model. 

Court Case Examines Telemedicine Safety Regulations
A case before a United States Court of Appeals could restrict a state medical board from protecting patient safety through the regulation of telemedicine in that state.

At stake in Teladoc, Inc. v. Texas Medical Board is whether the Texas Medical Board has demonstrated immunity from federal antitrust laws.

The Court of Appeals is being asked to determine whether the Board may be held liable under the antitrust laws for its rule requiring a “defined physician-patient relationship to exist before a physician may prescribe dangerous or addictive medications. The necessary relationship is defined as established through either an in-person examination or an examination by electronic means with a health care professional present with the patient.

Teladoc, which uses telecommunications to connect patients and physicians, provides services in a way that would allow physicians to prescribe medications without the establishment of the required patient-physician relationship. Teladoc alleges that if the Board’s rule is valid, Teladoc would be limited in the way it could carry on business in Texas. It contends that this rule is anticompetitive and seeks to hold the Board liable under federal antitrust laws.

Telemedicine is advancing rapidly as a tool to improve access to care and reduce the growth in health care spending. Last month the AMA House of Delegates adopted new ethical ground rules for telemedicine. But the telemedicine standards of care and practice guidelines are constantly evolving and vary based on specialty and the services provided. It is important that state medical boards remain free to regulate the practice of medicine to ensure patient safety and appropriate prescribing.

“Telemedicine offers significant potential benefits to patients, including expanded access to medical care,” the Litigation Center of the AMA and State Medical Societies said in an amicus brief (log in). “At the same time, telemedicine is inappropriate for certain medical conditions, and it carries risks. Because a physician treating a patient remotely may be called upon to act with limited information, the quality of care may suffer, and a potential exists for fraud and abuse.”

“Given the complex and evolving state of telemedicine,” the brief said, “Texas’ balance of reliance on the expert board to act in the first instance, with state supervision as needed, is entirely appropriate—and should not be subject to second-guessing under the federal antitrust laws.”

Why Telemedicine Regulation Matters

Patient safety is the guiding force behind the Texas Board’s rule. With telephonic consultations, there may be no observation or physical examination of the patient, and there may be no laboratory or other diagnostic work that the physician can use to determine a diagnosis and course of treatment.

One patient case detailed in the brief offers an example of how telephonic consultation, without an in-person examination to establish a patient-physician relationship, led to treatment errors.

“There can be real, material risk of harm from treatment without any physical examination,” the brief said. “That risk is amplified where, as in this complaint, treatment is provided to a patient who cannot even communicate his or her own condition but must rely solely on characterizations by a layperson.”


Telehealth Poised To Revolutionize Health Care
University of Rochester Medical Center, 07/20/2016
Telehealth is growing rapidly and has the potential to transform the delivery of health care for millions of persons. That is the conclusion of a review article appeared in the New England Journal of Medicine. The piece, co–authored by Ray Dorsey, MD, MBA, with the University of Rochester Medical Center and Eric Topol,MD, with the Scripps Research Institute, argues that the growth of telehealth over the next decade and beyond will have profound implications for health care delivery and medicine. This delivery of virtual care over a distance could help address long–standing concerns about the distribution and number of physicians and provide greater flexibility to both patients and clinicians. Telehealth holds the potential to disrupt established patterns of care, the authors argue, because it provides access in a manner that is convenient to the patient and at potentially lower cost.

Many entities, from traditional medical providers to newer start–up companies, now offer virtual visits with a physician around the clock and at an average cost of less than $50 per visit.
By contrast, it takes on average 20 days to secure a 20–minute appointment with a physician that, with travel and waiting, can consume two hours of an individual’s time. The authors identify three trends that are reshaping telehealth. The first is driven by the potential of telehealth to make care more accessible, convenient, and reduce cost. The second is the expanded application of telemedicine from its tradition use in acute conditions, such as telestroke programs that connect neurologists with physicians in distant emergency departments, to episodic conditions, such as a consultation between a pediatrician and a school nurse to diagnose an ear infection in a child, to the ongoing management of chronic conditions.


FDA approves first single injection PCSK9 inhibitor delivery system American College of Cardiology News, 07/18/2016
The U.S. Food and Drug Administration (FDA) has approved Amgen’s evolocumab (Repatha) Pushtronex system, which delivers a proprotein convertase subtilisin kexin 9 (PCSK9) inhibitor once per month. The hands–free system is the first of its kind and delivers 420 mg of evolocumab in a single dose. Evolocumab received FDA approval in August 2015 as a treatment to lower low–density lipoprotein cholesterol – in addition to diet and maximally–tolerated statin therapy – in patients with heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease


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