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Health Law & Policy Matters

Health Care Attorneys | Mintz Levin Law Firm

Behind the Curtain: Shkreli was NOT the Big Story on the Hill Today

Posted in biosimilars, Food and Drug Administration (FDA), Payors & PBMs, Pharma & Medical Devices, Pharmacies, Reimbursement

Congress’s complex relationship with prescription drugs was on display today in the House of Representatives.  In the House Committee on Oversight and Government Reform (OGR), Martin Shkreli pleaded the 5th at a hearing investigating drug pricing.  Meanwhile, the Energy and Commerce Committee (E&C) held a hearing regarding implementation of biosimilars.  While all the attention will be on the former, the latter was more important, especially for participants in the biosimilar space. Continue Reading

Latest OCR Enforcement Action: Underbed Storage is Not Appropriate for PHI

Posted in Enforcement, Home Health & Hospice, Hospitals & Health Systems, Physicians, Privacy & Security/HIPAA/HITECH, Uncategorized

Recent enforcement actions by the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) have highlighted that, not surprisingly, Covered Entities should not leave medical records in a physician’s driveway and should not dispose of protected health information (“PHI”) in a dumpster. From an action against a home health care provider announced yesterday, we can now add to that list the fact that PHI should not be stored under an employee’s bed or in a kitchen drawer.

Yesterday OCR announced a January 13, 2016 decision by an HHS Administrative Law Judge (“ALJ”) upholding the imposition of $239,800 in civil monetary penalties (“CMP”) against Lincare, Inc. (“Lincare”). Lincare is a home health care company that provides respiratory care, infusion therapy, and medical equipment from centers located throughout the United States. The enforcement action stems from a December 2008 complaint by the estranged husband of a Lincare employee. The husband reported to OCR that his wife, a center manager for a Lincare center in Arkansas, had moved out of the home they shared in August 2008. In November 2008, the husband found PHI of 278 Lincare patients in the home, specifically “under a bed and in a kitchen drawer.” Further investigation by OCR revealed that the employee continuously stored PHI in her car and in her home. The investigation also uncovered the fact that Lincare’s privacy policy did not include policies or instructions to employees for protecting PHI taken offsite or any type of logging systems for tracking PHI taken offsite. Continue Reading

Telemedicine Momentum Picking up Steam as New Legislation Introduced in U.S. Senate

Posted in Payors & PBMs, Physicians, Telemedicine

Today, a bipartisan group of Senators led by Senator Brian Schatz (D-HI) and Senator Roger Wicker (R-MS) have unveiled legislation that would expand the use of telemedicine and remote patient monitoring under Medicare. The CONNECT for Health Act (S.2484) is not seeking to overhaul telemedicine statutes overnight. Rather, it’s creating an opening for providers to incorporate telemedicine into their practices in a way that enables the federal government to further study and evaluate its application in health care delivery.

The CONNECT for Health Act would establish a program to help providers who would be subjected to new payment restrictions under the Medicare Access and CHIP Reauthorization Act (SGR-repeal) transition – through the use of telemedicine and remote patient monitoring services – into the new Merit-Based Incentive Payment System. Those providers who are eligible would be able to use telemedicine and remote patient monitoring services without the restrictions currently placed on telemedicine reimbursement in Medicare (42 U.S.C. 1834(m)). Continue Reading

ICYMI: Biosimilars and FDA Regulatory Webinar

Posted in biosimilars, Clinical Trials & Research/FDA, Food and Drug Administration (FDA), Pharma & Medical Devices

Our Biosimilar webinar series continued this month with Linda Bentley and Joanne Hawana’s Biosimilars FDA/Regulatory Overview presentation. Linda and Joanne discussed statutory provisions related to FDA’s authority to approve biosimilar products, as well as FDA guidance on demonstrating biosimilarity, biosimilar product development and user fees, “interchangeable” biosimilars, biosimilar product labeling and naming, and reference product and biosimilar exclusivity.

For those who missed the webinar, some of the key takeaways include the following: Continue Reading

FDA Releases Draft Guidance for Medical Device Cybersecurity

Posted in Food and Drug Administration (FDA), Pharma & Medical Devices

It seems that everything in our life is getting connected to the Internet. We now live in an age where household items like refrigerators have Internet-connected LCD screens and privacy experts talk about the so-called “Internet of Things.” Medical devices are increasingly becoming connected as well, and like any connected device, they are at risk of getting hacked.  In 2014, the U.S. Food and Drug Administration (“FDA”) released final guidance recommending that device manufacturers consider cybersecurity risks when designing and developing their devices. Last month, FDA released separate draft guidance with recommendations for how companies should address the cybersecurity of medical devices after they are released into the market. Continue Reading

The Challenge of Non-Interference

Posted in Payors & PBMs, Pharma & Medical Devices, Pharmacies

To understand the policy challenge created by repeal of the non-interference clause, consider this simple example.  Acme Drug Company brings a drug to the market as a single source innovator.  Essentially, they are without generic competition.  Acme prices their drug at $100.  Random Insurance Company wants to purchase the drug at $90 for beneficiaries in their Medicare Advantage Prescription Drug Plan.  Currently, many would argue that the flaw in the Medicare drug payment system is that Acme has the leverage to tell Random ‘no’ to their request for a lower drug price.

So what exactly does the entry into the conversation of “government negotiation” entail?  If CMS or some other duly appointed federal authority steps in between Acme and Random, what power does it have?  This is the challenge of non-interference repeal.  Unless you assume that the intervention of federal authority brings with it some ability to force Acme to lower its price, repealing non-interference, in and of itself, is meaningless.  The federal authority can ask Acme nicely.  The federal authority can say “pretty please.”  But if Acme retains the right to say “$100,” the federal authority produces no savings to the taxpayer.

For repeal of the non-interference clause to be meaningful, the federal authority must be invested with tools to force Acme to lower its price.  The mechanisms the federal authority require involve potentially uncomfortable policy choices.  Repealing the non-interference clause is not enough.  Make no mistake about it: repealing non-interference in a way that achieves lower drug pricing requires providing the federal government with extensive powers and the mandate to use them.

CBO’s Budget Forecast and the Silver Tsunami

Posted in Accountable Care Organizations, Health Care Reform, Hospitals & Health Systems, Payors & PBMs, Pharma & Medical Devices, Physicians, Reimbursement

This week, the Congressional Budget Office (CBO) released a projection that shows Medicare enrollment will grow by more than 30 percent in the next decade alone, and the number of seniors will steadily grow from 55 million today to more than 80 million by 2036.  This is often referred to as the Silver Tsunami.  The challenge of responding to the growth of Medicare is going to drive policy in health care for the next decade.

Regardless of who is President or what party controls Congress, Medicare’s demographic surge will force policy makers to find ways to reduce health care spending to save other spending priorities from being crowded out.  CBO projects the national debt to increase by $9.4 trillion to $30 trillion by 2026.  Spending on federal health programs now exceeds spending on Social Security.  With interest on the national debt a growing and untouchable line in the budget, the next Administration and Congress will need to reduce health care costs if they want to fund priorities in defense, transportation, education and other discretionary spending. Continue Reading

Massachusetts Health Care Reform – Full Speed Ahead; Health Policy Commission 2015 Cost Trends Report

Posted in Accountable Care Organizations, Health Care Reform, Hospitals & Health Systems, Long-term Care/Skilled Nursing Facilities, Payors & PBMs, Pharma & Medical Devices, Pharmacies, Physicians, Reimbursement

The Massachusetts Health Policy Commission (HPC) has issued its 2015 Cost Trends Report, based on the HPC’s annual health care cost growth hearings. The report contained 13 key recommendations across a wide range of health care policy issues, all aimed at fostering initiatives to create an integrated strategy for tackling the benchmark-breaking rise in 2014 aggregate costs of 4.8%, which blew through the state’s benchmark of 3.6%.  Created by Chapter 224 of the Acts of 2012, as part of a comprehensive legislative approach, the HPC has a broad portfolio of responsibilities, including reviewing material changes in corporate and clinical affiliations, registering provider organizations, certifying (non-CMS) ACOs and patient-centered medical homes, and promoting alternative payment methods (APMs) and innovations in health care delivery. Continue Reading

Safety of Both Devices and Drugs Need to Be Better Tracked, FDA Hears from Oversight Bodies

Posted in Clinical Trials & Research/FDA, Enforcement, Food and Drug Administration (FDA), Health Care Reform, Hospitals & Health Systems, Pharma & Medical Devices

FDA lacks the appropriate data to effectively conduct postmarket surveillance and safety tracking activities, according to two reports released earlier this month. First, Senator Patty Murray’s Health, Education, Labor, and Pensions (HELP) Committee staff reported on systemic failures in FDA’s postmarket surveillance of medical devices, relating to the lack of information being received by the Agency on device changes and adverse events. Then on January 14, the Government Accountability Office (GAO) released a report finding that FDA lacks timely, accurate, and accessible data to effectively track postmarket safety issues for prescription drugs. Continue Reading

Senate Working Group Considers Telehealth Policy Changes to Medicare

Posted in Accountable Care Organizations, Telemedicine

In keeping with the boom of telehealth legislation introduced last year at both the state and federal level, the Senate Finance Committee is considering several policy changes that, if ultimately enacted, could make telehealth the preferred method of care delivery for millions of Medicare beneficiaries living with chronic conditions.

The policy document, released last month by the Senate Finance Committee’s Bipartisan Chronic Care Working Group, outlines five potential telehealth policy changes to expand the use of telehealth for Medicare beneficiaries: Continue Reading