United States: Washington Healthcare Update - December 14, 2015

Last Updated: December 21 2015
Article by Stephanie A. Kennan, Charlyn A. Iovino and Caroline Perrin

This Week: Congress unable to come to agreement on funding the government past Dec. 11 so a short-term funding bill was passed to give more time for negotiations... Tax extenders still being discussed as a vehicle for a suspension of the medical device tax... Repeal of the Cadillac tax still being discussed.

1. Congress


Bill on Meaningful Use Blanket Hardship Exemption Could Be Included in Upcoming Appropriations Bill

Rep. Tom Price's (R-GA) bill that gives the Centers for Medicare and Medicaid Services (CMS) the ability to grant a blanket hardship exemption for meaningful use in 2015 and give providers a 90-day reporting period in 2016 may be included in the upcoming omnibus appropriations bill. The bill would make it easier for CMS to process hardship exemptions, but its chances of making it into the appropriations package are unclear. The blanket hardship exemption for 2015 was included because of CMS's delay in publishing the Stage 2 meaningful use rule. CMS has reportedly been pushing for the bill under the radar, as it could be as good for CMS as it would be for providers.

Rep. Upton Pushes for Permanent Reauthorization of 9/11 First Responders Health Bill

House Energy and Commerce Committee Chairman Fred Upton (R-MI) is proposing to help pay for permanent reauthorization of the World Trade Center Health Program through various changes to Medicare and Medicaid. On Dec. 2, Upton outlined six permanent entitlement reforms totaling more than $4 billion to pay for permanent extension of the program:

  1. Instituting income-based premium hikes in Medicare Parts B and D, saving $1.9 billion;
  2. Closing a Medicaid loophole for community spouse annuities, saving $900 million;
  3. Establishing a federal cap on Medicaid's maximum allowable home equity allowance, saving $430 million;
  4. Closing a loophole that allows lottery winners to retain Medicaid, saving $400 million;
  5. Ensuring Medicaid coverage is not granted to those who are not legal immigrants, saving $865 million; and
  6. Protecting patients through the use of Medicaid Electronic Verification of in-home care, saving $300 million.

Upton says the reform to raise Medicare Part B and D premiums would require people with an annual income at or above $1 million or joint filers at or above $1.5 million to pay the total share of their premium — they would pay approximately $70 more every month.

To see a related press release, click here.

Waiting for the Omnibus Appropriations Bill

With the Dec. 11 deadline looming to pass funding for the government, Congress passed a short-term funding bill while they try to finalize an omnibus spending bill. Congress' new deadline is Dec. 16, but many sticking points remain, so if no agreement is reached, Congress can pass another short term bill while they continue to negotiate. There are many health policy riders that have been discussed and may be attached to the final bill. For example, a policy rider extending the requirement that risk corridors for the Affordable Care Act (ACA) health plans be "budget neutral", a rider that would grandfather hospitals currently developing outpatient departments from a new site neutral payment rule passed earlier this year, have been among those discussed, and policies related to Medicare Advantage star ratings are among the policies being watched. Another area many stakeholders are watching is the appropriations amount for the National Institutes of Health (NIH) as well as the Agency for Healthcare Research and Quality (AHRQ).


Senate Special Committee on Aging Holds Hearing on High Drug Prices

On Dec. 9, the Senate Special Committee on Aging held a hearing entitled "Sudden Price Spikes in Off-Patent Drugs: Perspectives from the Front Lines." The hearing examined the causes, impacts and potential solutions to dramatic price increases of off-patent drugs. The committee also looked at how current regulations and public policy may contribute to this problem. There will be subsequent hearings on this issue.

Sen. Susan Collins (R-ME), chairman of the committee, said she is looking at the idea of giving FDA authority to fast track applications for generic drugs when one product has a monopoly. She also liked ideas raised during the hearing related to transparency, including potentially creating a list of all off-patent drugs lacking competition.

At the hearing other ideas raised included the role that pharmaceutical compounding could play, although witnesses urged caution since compounded drugs don't go through the same scrutiny as FDA-approved pharmaceuticals; drug importation; and regulating drugs prices like a utility to address monopolies under certain circumstances.

The committee will hold another hearing on drug prices to explore the FDA's role, including the cause of a generic drug application backlog.


Erin R. Fox, Pharm.D.
Director, Drug Information Service
University of Utah Healthcare

David W. Kimberlin, M.D.
Professor and Vice Chair for Clinical and Translational Research
Co-Director, Division of Pediatric Infectious Diseases
Department of Pediatrics
University of Alabama at Birmingham

Gerard Anderson, Ph.D.
Director, Center for Hospital Finance and Management
Professor, Johns Hopkins Bloomberg School of Public Health

Mark Merritt
President and Chief Executive Officer, Pharmaceutical Care Management Association

To see the press release, click here.

2. Administration

PhRMA Frustrated Over TPP Deal

Pharmaceutical Research and Manufacturers of America (PhRMA) has become more vocal about concerns about the Trans-Pacific Partnership (TPP) provision on data protection for biological drugs. However, the group stopped short of fully opposing the deal. Negotiators were not able to get 12 years of data protection for the new class of drugs due to opposition from TPP countries who refuse to change their current laws. The final deal will require a protection period of only eight years.

FTC Seeks Injunction to Block Merger of Penn State Hershey and PinnacleHealth

On Dec. 8, the Federal Trade Commission (FTC) took action to block the merger of Penn State Hershey Medical Center and PinnacleHealth System, citing that the merger would reduce competition, and lead to reduced quality and higher health care costs in the region. The FTC will file with the Pennsylvania Office of the Attorney General a complaint seeking a preliminary injunction to stop the merger. The merger would create a dominant provider of general acute care inpatient hospital services in the area of Pennsylvania consisting of Dauphin, Cumberland, Perry and Lebanon counties. The entity would essentially control 64 percent of the market for 500,000 residents.

Hershey offers 551 beds in Dauphin County and operates the Penn State Hershey Cancer Institute and the Penn State Hershey Children's Hospital. Its total revenue in FY 2014 was $1.39 billion. Pinnacle operates three acute care hospitals in Dauphin County and offers 610 beds. Its total revenue in FY 2015 was $1.07 billion. Both are nonprofit organizations.

The FTC's administrative trial is scheduled to begin on May 17, 2016.

Johnson & Johnson Asks CMS to Include Part D Drug Spending in Merit-Based Incentive Payment System (MIPS)

Johnson & Johnson wants the Centers for Medicare and Medicaid (CMS) to include Part D drug spending in the Merit-Based Incentive Payment System (MIPS), because it worries that if providers are accountable for Part B drug spending and not for Part D spending, they could potentially prescribe Part D drugs over Part B drugs in order to earn bigger bonuses. In the proposed 2015 Physician Fee Schedule Rule, CMS said it excluded Part D data from total per-person cost measures due to the complexity of the issue. "Due to complex interactions between the Part D bidding process, timing of Part D enrollment versus ACO alignment, regulatory and statutory constraints on defining Part D service areas, and the highly fragmented nature of the Part D market, CMS has concluded that it is not possible to explicitly combine Part D spending with Parts A and B spending in the Next Generation expenditure benchmark," according to CMS. CMS said 2017 is the earliest it could incorporate retail drug spending in next-generation ACOs.

GAO Approves Medicare Outpatient Payment Rule

On Dec. 8, the Government Accountability Office (GAO) found that the Centers for Medicare and Medicaid Services (CMS) followed the requirements in its final rule to update Medicaid outpatient and ambulatory surgical center payment systems. The final rule published on Nov. 13 updated the payment systems in accordance with statutory requirements, according to the GAO. CMS made changes to how Medicare payments are distributed, with adjustments to account for factors like growing Hospital Outpatient Prospective Payment System (OPPS) payout rates. This results in a 0.4 percent drop in estimated payments under OPPS. CMS expects that the hospital outpatient department fee increase in the rule will have the federal government paying $133 million more per year to outpatient hospitals.

The final rule also updates the reporting requirements for the Medicare payment systems and finalized updates on the "2-midnight" rule, which allows Medicare payments if the doctor expects the patient to spend at least two midnights in the hospital. The final rule also had policies to help transition payments for hospitals that lost their designation as small rural hospitals dependent on Medicare.

Healthcare.gov Enrollment Goes Up

There has been increased interest in health care enrollment recently, with 804,000 people choosing plans on healthcare.gov during the fifth week of open enrollment. This increase follows a slow fourth week. As of Dec. 5, over 2.8 million people had chosen plans during this open enrollment period, including 1 million new customers. These figures include only the 38 states using healthcare.gov.

Outpatient Therapy Supervision Rule Delayed

Congress has cleared legislation that delays the enforcement of the outpatient therapy supervision rule: one requiring direct physician supervision of outpatient therapy services for small rural hospitals and critical-access hospitals. Enforcement of the rule from the Centers for Medicare and Medicaid Services (CMS) was delayed by Congress in 2014 and once before that by CMS itself. Sens. John Thune (R-SD), Jerry Moran (R-KS) and Jon Tester (D-MT) said that the delay will hopefully give them time to pass a more comprehensive bill on this issue.

Disagreement Over Whether CMS Final Rule on Adequate Medicaid Provider Pay Rates Should Apply to Managed Care

Medicaid stakeholders disagree over whether the Centers for Medicare and Medicaid Services' (CMS) final rule on adequate Medicaid provider pay rates should apply to managed care. The rule addresses the equal access provision, which requires states to pay providers at rates that are sufficient to enlist enough providers so that services are available under the plan at least to the extent that they are available to the general population. The rule, however, applies only to fee-for-service Medicaid and some beneficiary advocates argue that it should also apply to managed care. Medicaid plans and Medicaid directors think that there should be two separate rules, one for fee-for-service and one for managed care. CMS's proposed managed care regulation will likely address the equal access provision for managed care.

CMS Releases FY 2016 Results for Hospital-Acquired Conditions (HAC) Reduction Program

On Dec. 10, the Centers for Medicare and Medicaid Services (CMS) released the fiscal year (FY) 2016 results for the CMS Hospital-Acquired Conditions (HAC) Reduction Program. This program was established to provide an incentive for hospitals to reduce HACs and was effective at the start of FY 2015. It requires that the payments be reduced to 99 percent of what would have been paid for discharges in hospitals that rank in the worst-performing quartile with respect to risk-adjusted HAC quality measures.

In FY 2016, 758 out of 3,308 hospitals are in the worst-performing quartile compared to 724 in FY 2015. CMS estimates the total savings in FY 2016 will be $364 million. Also in FY 2016, the 75th percentile of Total HAC Score cutoff was 6.75, compared to 7.00 in FY 2015 — the cutoff contributed to the increase in percentage of hospitals in the worst-performing quartile. Out of the 758 in the worst-performing quartile for FY 2016, around 53.7 percent were also in it in FY 2015.

For more information, click here.

CMS Expands Data on Physician Compare and Hospital Compare Websites

On Dec. 10, the Centers for Medicare & Medicaid Services (CMS) expanded data on the Physician Compare and Hospital Compare websites to try to improve the consumer online tools. CMS added new quality measures to Physician Compare for group practices, Accountable Care Organizations (ACOs) and individual health care professionals. Hospital Compare has been updated to include new information to its database of more than 100 quality measures and more than 4,000 hospitals.

The 2014 data released on Physician Compare include:

  • Additional performance scores on preventive care, diabetes care, cardiovascular care and patient safety by some group practices.
  • New performance scores on patients' experiences with some group practices.
  • First set of individual health care professional performance scores on preventive care, cardiovascular care and patient safety measures.
  • Updated performance scores for ACOs.

The 2014 data released on Hospital Compare include:

  • A new measure for the Inpatient Quality Reporting (IQR) program that shows whether a hospital uses safe surgery practices before administering anesthesia, before incision and closing, and prior to the patient's leaving the operating room for inpatient surgical procedures.
  • Additional data on certain health care-associated infections (HAIs).

For more information, click here.

CMS Publishes 2016 Updates to the Child and Adult Core Health Care Quality Measurement Sets

On Dec. 11, the Centers for Medicare and Medicaid Services (CMS) released a bulletin describing the 2016 updates to the set of adult's and children's health care quality measures for Medicaid and the Children's Health Insurance Program (CHIP). Center for Medicaid and CHIP Services (CMCS) Informational Bulletins are used to communicate with states and stakeholders interested in Medicaid and CHIP. They are designed to highlight recently released policy guidance and regulations and to share operational and technical information.

For more information, click here.

3. State Activities

South Dakota: Gov. Daugaard May Add Work Requirement for Medicaid Eligibility

South Dakota Gov. Dennis Daugaard may add a requirement that Medicaid expansion enrollees have jobs as part of a new proposal. Daugaard would be following many other Republican governors in pursuing a work requirement, including former Pennsylvania Gov. Tom Corbett and Utah Gov. Gary Herbert. However, the U.S. Department of Health and Human Services still maintains that employment cannot be a requirement for Medicaid enrollment. An estimated 49,000 more people could be covered by the Medicaid expansion in South Dakota.

Indiana: Gov. Pence Protests CMS Review of His Medicaid Expansion Program

Indiana Gov. Mike Pence wrote a letter to HHS Secretary Sylvia Burwell protesting the way his state's Medicaid expansion program is being reviewed. In the letter, Pence told Burwell to suspend a separate evaluation being conducted by the Urban Institute for federal officials, citing that it is biased against the program based on prior work. Indiana has already contracted with the Lewin Group to evaluate the program, called the Healthy Indiana Plan 2.0 (HIP).

Arkansas: Gov. Hutchinson Halting Project to Modernize Medicaid System

On Dec. 1, Arkansas Gov. Asa Hutchinson wrote to lawmakers explaining that the state is halting further efforts to make changes to its Medicaid eligibility and enrollment system. This action follows a report from consulting firm Gartner. The project started two years ago and originally had a budget of $108 million, but projected costs have since increased to $220 million. Hutchinson outlined a series of immediate actions he is taking to get the project back on track.

California: Kaiser Permanente Agrees to Buy Seattle-Based Group Health Cooperative

The nonprofit HMO and health system Kaiser Permanente is buying Seattle-based Group Health Cooperative, another nonprofit plan that insures almost 600,000 people. Kaiser said it would contribute $1.8 billion to a new foundation in Washington as part of the transaction. The deal is still subject to regulatory approval. Nearly 80 percent of Kaiser's 10.2 million members are in California.

Michigan: CMS Must Decide Whether to Approve the State's Controversial Waiver

The Centers for Medicare and Medicaid Services (CMS) must decide whether to approve the federal waiver Michigan needs to extend its Medicaid expansion or let the program end next year. The waiver incorporates some conservative concepts, including a requirement that enrollees above the poverty line must choose after four years of coverage to either enroll on healthcare.gov or stay in Medicaid and pay up to 7 percent of household income toward health care costs. This is higher than the 5 percent ceiling that CMS gives to other states. Medicaid expansion coverage in Michigan will end in April if the waiver isn't approved.

Massachusetts: Massachusetts Summarizes 1332 Waiver Request

Massachusetts is heading toward using a broad Obamacare waiver program to make fixes to its small group market. In the first phase, the state would request waiver authority to modify the definition of "merged market" to maintain unique features of a typical small group market for small group plans. Without a waiver, the state says it would need to ensure that its merged market meets federal requirements by Jan. 1, 2018. The state wants to submit an application for those changes sometime in the next year. The second request could include changes to the individual and employer mandates. Under the 1332 waivers, states can begin to opt out of many of the Affordable Care Act's (ACA) provisions to tailor their health care system to the specifics of the state system beginning in 2017.

To read the summary, click here.

Maine: Community Health Options CO-OP Stops Individual Enrollment

Maine CO-OP Community Health Options announced it will be cutting off individual enrollment on Dec. 15 due to financial problems. However, the health plan will continue to sign up small group customers for 2016 coverage. Community Health Options was initially one of the most successful CO-OPs, turning a profit after opening in 2013 and dominating enrollment in Maine during its first two years. It also expanded into New Hampshire last year. In the third quarter of this year, however, claims started exceeding premiums, creating a loss of $17.3 million. The CO-OP had over 70,000 enrollees at the end of September.

Over half of the 23 CO-OP plans initiated with $2.4 billion in loans under the Affordable Care Act (ACA) have collapsed due to financial problems. To date, roughly 600,000 customers have lost coverage as a result.

4. Regulations Open for Comment

Department of Health and Human Services (HHS) Proposes Updates to "the Common Rule"

HHS and 15 other agencies released a notice of proposed rulemaking Sept. 2 for the Common Rule, the existing regulatory framework to transparency and oversight for scientific research involving human subjects. The proposed changes are to address the substantial changes that have occurred within scientific research. Current regulations have been in place since 1991 and are followed by 18 federal agencies. Proposed updates to the rule include:

  • Strengthened informed consent provisions
  • Requirements for administrative or IRB review that would align better with the risks of the proposed research
  • New data security and information protection standards
  • Requirements for written consent for use of an individual's biological samples, for example, blood or urine, for research with the option to consent to their future use for unspecified studies
  • Requirement, in most cases, to use a single institutional review board for multisite research studies
  • Application of rule to clinical trials, regardless of funding source, if they are conducted in a US institution that receives funding from a Common Rule agency for research involving human participants.

In July 2011, HHS issued an Advance Notice of Proposed Rulemaking to seek the public's input on updating the Common Rule. The proposed rule issued reflects input and requests comments for HHS to consider as it drafts the final rule. HHS will take public comment on the proposed rule until Jan 6, 2016.

For a press release detailing changes to the rule visit hhs.gov.

Food and Drug Administration (FDA) Issues Final Rule to Phase Out Trans Fats

FDA issued a final rule June 16 that gives the food manufacturers three years to phase out partially hydrogenated oils (PHOs), which are still used in a wide variety of food products from microwave popcorn to cake frosting. The decision finalizes an agency determination that PHOs, the primary dietary source of artificial trans fat in processed foods, are not "generally recognized as safe" or GRAS for use in human food. Since 2006, manufacturers have been required to include trans fat content information on the Nutrition Facts label of foods. Between 2003 and 2012, the FDA estimates that consumer trans fat consumption decreased about 78 percent and that the labeling rule and industry reformulation of foods were key factors in informing healthier consumer choices and reducing trans fat in foods. Comments on the final rule are due by June 18, 2018.

More information on FDA's decision can be found in the agency's press release.

CMS Releases Proposed Rule with New Discharge Planning Requirements

The Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would require all hospitals develop a written discharge plan for all inpatient and many outpatients in an attempt to reduce readmissions. The proposed rule, "Medicare and Medicaid Programs; Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and Home Health Agencies," would require hospitals to develop a discharge plan based on the needs of each applicable patient within 24 hours of admission. The plan would include a medication reconciliation process. Hospitals would be required to establish a process for patients who are transferred to a different facility or who went home.

CMS noted that the requirements could help reduce readmissions by a third. Until now, hospitals have had the ability to decide which patients need a written discharge plan, and have increasingly used the plans to reduce readmission and avoid the Affordable Care Act's (ACA) financial penalties. Comments will be accepted until no later than 5 p.m. on Jan. 4, 2016.

A press release can be found here.

CMS Issues Final Rule to Ensure Medicaid Services for Beneficiaries and Issues Request for Information on the Rule

On Oct. 29, the Centers for Medicare and Medicaid Services (CMS) issued a final rule that ensures Medicaid beneficiaries have sufficient access to covered Medicaid services. CMS said that the rule, entitled "Methods for Assuring Access to Covered Medicaid Services," will allow states and CMS to make more informed decisions when considering whether proposed changes to Medicaid fee-for-service payment rates are sufficient to ensure the beneficiaries' access to those services. States will have to create access review plans that outline how states will ensure access to health care services and to examine how cuts to provider payments will affect the care received.

The rule strengthens CMS's oversight of Medicaid reimbursement and beneficiary access to providers. It will go into effect in January and CMS issued a Request for Information (RFI) to get feedback on how to make sure access requirements are being met. Comments will be accepted until no later than 5 p.m. on Jan. 4, 2016.

EEOC Issues Proposed Rule Amending the Genetic Information Nondiscrimination Act (GINA)

On Oct. 30, the U.S. Equal Employment Opportunity Commission (EEOC) issued a proposed rule clarifying when, under the Genetic Information Nondiscrimination Act (GINA), employers who offer wellness programs as part of group health plans can provide incentives to an employee's spouse to provide information about his or her current or past health status. (This is different from the April EEOC proposed rule related to the Americans with Disabilities Act.) The proposed rule clarifies that an employer can offer limited incentives in exchange for the employee's spouse providing information about his or her current or past health status. EEOC will accept comments on the new proposed rule through Dec. 29, 2015.

A press release on the proposed rule can be found here.

CMS Soliciting Comments on Episode Groups as Required by MACRA

The Centers for Medicare and Medicaid Services (CMS) is soliciting comments on episode groups and on specific clinical criteria and patient characteristics to classify patients into care episode and patient condition groups as required by Section 101(f) of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), enacted April 16, 2015. The purpose of this commentary is to provide background and context to solicit stakeholder input on the episode groups that CMS has developed pursuant to Section 3003 of the Affordable Care Act (ACA). CMS is also seeking stakeholder input on the future role of episode groups in resource use measurement.

Comments should be sent to episodegroups@cms.hhs.gov by 11:59 p.m. EST on Feb. 15, 2016.

FDA Seeks Comments on Whether It Should Define "Natural" and If So, How?

Because of a series of competing citizen petitions, GMO labeling issues and congressional concern, the US Food and Drug Administration (FDA) is seeking public input on whether it should define the term "natural" for use on food product labels, and, if so, how to do so.

On Nov. 12, FDA published a request for feedback. FDA policy to date has not restricted the use of the word "natural" on food labeling unless the product has added color, synthetic substances or flavoring.

FDA has received four citizen petitions over the past two years asking the agency to issue regulations on the use of the term, and in July the House of Representatives passed a proposal on GMOs that would require FDA to define the term "natural" for product labeling.

FDA seeks feedback on the following questions:

  • What types of foods should be able to use the term?
  • Should only raw agriculture products be able to use the term?
  • Should only single-ingredient foods, such as bottled water or bagged spinach, be able to use the term?
  • If multi-ingredient foods can use the term, what types of ingredients would disqualify a product from using it?
  • What data or other information shows how consumers associate, confuse or compare the terms "natural" with "organic"?
  • What data or other information shows how consumers associate, confuse or compare the term "natural" with the term "healthy"?

The comment period is open until Feb. 10, 2016.

HHS Releases Notice of Benefit and Payment Parameters Proposed Rule for Health Insurance Marketplaces for 2017

On Nov. 20, the U.S. Department of Health and Human Services (HHS) released the proposed rule providing the payment parameters that would apply to the 2017 benefit year and new standards relating to consumers' experience in the Marketplaces.

The policies included in the proposed rule include payment parameters, Market rules, eligibility, enrollment and benefits.

Highlights of the proposed rule are:

  • Another recalibration of risk adjustment factors for the 2017 year — the department is proposing to incorporate preventive services into their simulation of plan liability as part of the recalibration. They are seeking comments on other improvements that could be made to the risk adjustment methodology;
  • A separate, lower default risk adjustment charge for smaller issuers, defined as issuers with 500 or fewer billable member months in a state's individual and small group markets combined in a benefit year. HHS believes this proposal would have a minimal impact on risk transfers;
  • A raise in the default risk adjustment charge from the 75th percentile to the 90th percentile of absolute transfers nationwide as a percent of state average premium. This adjustment would be designed to prevent the charge from being a low-cost option for issuers;
  • A federally facilitated Marketplace (FFM) user fee rate of 3.5 percent for 2017 and a fee of 3 percent for those state-based Marketplaces using the federal platform;
  • A maximum annual limitation on cost sharing for 2017 of $7,150 for individual coverage and $14,300 cumulatively for family coverage;
  • Establishment of one or more separate risk pools for each college or university by issuers of student health insurance plans, provided the risk pools are based on a bonafide school-related classification and on a health status-related factor;
  • Requirement that all issuers submit the unified rate review template for all single risk pool products regardless of whether they propose rate increases, decreases or no change in rates for these products;
  • An enrollment period for the individual market to be Nov. 1, 2016, through Jan. 31, 2017;
  • Third employer choice models for the federally facilitated SHOP plans included and comments about a fourth option for the 2017 plan year sought. The third option would give employers the choice to offer all plans on all actuarial levels from one issuer, called a "vertical choice." The fourth option would allow employers to select a metal level and employees could choose from plans at that level and one level higher. CMS also seeks comments on whether FFM states should be able to add additional models to their SHOP programs; and
  • The role of navigators expanded to include more post-enrollment activities, such as filing appeals, applying for exemptions and assisting in the transition from coverage to care.

Comments are due at the close of business on Dec. 21, 2015.

For a related press release, click here.

FDA Reopens Comment Period for Tobacco Clarification Rule

The U.S. Food and Drug Administration (FDA) reopened the comment period for the proposed rule entitled "Clarification of When Products Made or Derived from Tobacco Are Regulated as Drugs or Devices." The rule describes the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). It is intended to provide direction to regulated industry following recent litigation.

FDA is taking this action in response to a request for an extension to allow interested parties additional time to submit comments. Comments must now be submitted by Dec. 30, 2015.

HHS Posts Guidance for State Innovation Waivers

On Dec. 11, the Department of Health and Human Services (HHS) posted guidance for states interested in seeking a State Innovation Waiver under section 1332 of the Affordable Care Act (ACA). State Innovation Waivers allow states to receive federal funding to implement alternative models of health care coverage that provide affordable coverage to their residents. The notice clarifies that the minimum length of public notice and comment periods for waiver applications is 30 days.

To see the guidance, click here.

5. Reports

Commonwealth Fund Survey Reports Challenges Caring for Country's Sickest Patients

According to a new Commonwealth Fund survey, nearly a quarter of primary care doctors in the U.S. say they are not prepared to care for the country's sickest patients. The survey found that 24 percent of U.S. primary care doctors say they are not prepared to care for patients with multiple chronic conditions and 84 percent say they are not prepared to help patients with severe mental illness. The study's lead author, Robin Osborn, said it is concerning that one in four primary care doctors in the U.S. say they aren't prepared to care for the sickest patients. He says that as a result, it is imperative that we continue to strengthen primary care. Just 31 percent of primary care doctors said they were notified when a patient was discharged and 50 percent said their practices had routine communication with home care providers.

The survey compared the U.S. to nine other countries and found that it ranks last (at 6 percent) in terms of offering patients home visits. The U.S. also falls behind in providing after-hours care — with about 94 percent of doctors providing it in the Netherlands and only 39 percent in the U.S. However, U.S. adoption of electronic health records has increased 15 percent in the past three years.

Commonwealth Fund surveyed doctors from Australia, Canada, Germany, the Netherlands, New Zealand, Norway, Sweden, Switzerland, the United Kingdom and the United States.

Health Experts Release Agenda for Reform Outline

On Dec. 9, an agenda for health care reform was released that includes replacing the Affordable Care Act (ACA), and proposes major reforms to Medicaid, Medicare, Health Savings Accounts and other areas of existing policy. The overall principles are as follows:

  • Citizens, not government agencies, should control health care
  • Government subsidies should be in the form of defined contributions
  • There should be more state and consumer power instead of federal control
  • Medical suppliers should have more power than insurers
  • There should be reduced long-term health care obligations for the federal government

The paper was released by Joseph Antos, James Capretta, Lanhee Chen, Scott Gottlieb, Yuval Levin, Thomas Miller, Ramesh Ponnuru, Avik Roy, Gail R. Wilensky and David Wilson.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions